Post on 21-Sep-2020
F.No.10-8/2020-OTC) (M-80)
Page 1 of 144
Government of Pakistan
Ministry of National Health Services, Regulations & Coordination
Drug Regulatory Authority Of Pakistan
Health & OTC Products Division (Non-Drugs)
*****
Islamabad, the 19th August, 2020
Subject: Submission of deficient information / documents
The applications of following applicants were placed before the Enlistment Evaluation
Committee (EEC) in its 80th meeting held on 26th June, 2020 and the same have been deferred being
deficient of the information / documents as specified in column (3) of the Table below which may be
furnished within 20 days of uploading of this letter on official website of DRAP but not later than 07th
September, 2020. Replies received after due date shall not be entertained:-
S.No Brand name Decision
(1) (2) (3)
M/s Herbion Pakistan Pvt, Ltd. (Eno 001)
Plot No. 30, Sector 28, Korangi Industrial Area, Karachi
1. Relenza Capsule
Deferred due to the following short comings:
Official testing methods of herbs not provided
Evidence of formulation required
Contains ephedra needs clarifications
Clarify if this plant of M/s Herbion has herbal sections or
nutraceutical section
M/s. Wilshire Laboratory (Pvt.) Ltd., (Eno 00155)
Plot No.5, Farooq Industrial Estate, 20-KM, Ferozepur Road, Lahore
2. INFERNO PLUS CAPSULE
Deferred due to the following short coming:
Official monograph of eurycoma longifolia root extract and
chrysin required
3. IMMUNE AE DROPS
Deferred due to the following short comings:
Vitamin A above RDA
Clarification required as the product is presented in vials, while
pack size is from 1ml to 1000ml
4. PREG-2 CAPSULE
Deferred due to the following short comings:
Clarify and give monographs of Citrus bioflavonoid complex,
Tummy Soothe blend,
Organic rainbow vibrant food blend and
Prebiotic and probiotic Digestive blend
Brand name to be changed
The firm does not possess probiotic section
5. PREG-3 CAPSULE
Deferred due to the following short comings:
Clarify and give monographs of Citrus bioflavonoid complex,
Tummy Soothe blend,
“SAY NO TO CORRUPTION”
F.No.10-8/2020-OTC) (M-80)
Page 2 of 144
S.No Brand name Decision
(1) (2) (3)
Organic rainbow vibrant food blend and
Prebiotic and probiotic Digestive blend
Brand name to be changed
The firm does not possess probiotic section
Clarify iodine from inactivated saccharomyces cerevisiae
6. PREG-1 CAPSULE
Deferred due to the following short comings:
Clarify and give monographs of Citrus bioflavonoid complex,
Tummy Soothe blend,
Organic rainbow vibrant food blend and
Prebiotic and probiotic Digestive blend
Brand name to be changed
The firm does not possess probiotic section
7. PRE PREG CAPSULE
Deferred due to the following short comings:
Folic acid above RDA
Clarify and give monographs of Organic Food &Vaggie blend
Organic Liver Support blend
Gentle digestive Support blend
Brand name to be changed
8. POST PREG
CAPSULE
Deferred due to the following short comings:
Clarify and give monographs of Citrus bioflavonoid complex,
Postnatal lactation Blend,
Organic rainbow vibrant food blend and Soothing Digestive
Support blend
Brand name to be changed
The firm does not possess probiotic section
Clarify iodine from inactivated saccharomyces cerevisiae
9. Wilyte R Sachet
Deferred due to the following short comings:
Official monograph of trisodium dehydrate and rice solid syrup
required
Deferred till the finalization of decision regarding common
molecules
M/s Hinucon, (Eno 0062)
Plot No. 12/1, Sector 15, Korangi Industrial Area, Karachi
10. HANAKIN PLUS SACHET Deferred due to the following short comings:
Official monograph of fish collagen required
11. HANAKIN SHOT
Deferred due to the following short comings:
Official monograph of fish collagen required
Clarify dosage form
M/s Dr. Masood Homoeopathic Pharmaceuticals (Eno 0016)
56-Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
12.
Dr. Masood’s
KALIUM PHOS Ф
(3DH)
Kalium phos
(EHPI) (EHPI Specifications)
Deferred due to the following short coming:
Mother tincture not mentioned in monograph
13. Dr. Masood’s
MAGNESIA PHOSPHORICAФ
Deferred due to the following short coming:
Mother tincture not mentioned in monograph
F.No.10-8/2020-OTC) (M-80)
Page 3 of 144
S.No Brand name Decision
(1) (2) (3)
(4CH=8X)
Magnesium phosphoricum
(EHPI)
(EHPI Specifications)
14.
Dr. Masood’s
NATRUM PHOSPHORICUM Ф
(3DH)
Natrum phosphoricum (EHPI)
(EHPI Specifications)
Deferred due to the following short coming:
Mother tincture not mentioned in monograph
15.
Dr. Masood’s
Borax Ф
(1CH=2X)
Borax (EHPI)
(EHPI Specifications)
Deferred due to the following short coming:
Mother tincture not mentioned in monograph
16.
Dr. Masood’s
Kali Muriaticum Ф
(3DH)
Kali muriaticum (EHPI)
(EHPI Specifications)
Deferred due to the following short coming:
Mother tincture not mentioned in monograph
17.
Dr. Masood’s
BARYTA CARBONICAФ
Baryta carbonica
(EHPI)
(EHPI Specifications)
Deferred due to the following short coming:
Mother tincture not mentioned in monograph
18.
Dr. Masood’s
CALCAREA FLOURФ
(4CH=8X)
Calcarea fluorica
(EHPI)
(EHPI Specifications)
Deferred due to the following short coming:
Mother tincture not mentioned in monograph
19.
Dr. Masood’s
CALCAREA PHOSФ
(4CH=8X)
Calcarea phosphorica
(EHPI)
(EHPI Specifications)
Deferred due to the following short coming:
Mother tincture not mentioned in monograph
20.
Dr. Masood’s
CALCAREA SULPHФ
(4CH=8X)
Calcarea sulphurica
(EHPI)
Deferred due to the following short coming:
Mother tincture not mentioned in monograph
F.No.10-8/2020-OTC) (M-80)
Page 4 of 144
S.No Brand name Decision
(1) (2) (3)
(EHPI Specifications)
21.
Dr. Masood’s
FERRUM PHOSФ
(4CH=2X)
Ferrum phosphoricum (EHPI)
(EHPI Specifications)
Deferred due to the following short coming:
Mother tincture not mentioned in monograph
22.
Dr. Masood’s
MERC SOLUBILIS Φ
(4CH=8X)
Merc solubilis
(EHPI)
(EHPI Specifications)
Deferred due to the following short coming:
Mother tincture not mentioned in monograph
23.
Dr. Masood’s
Eel Serum Potencies
Anguilla rostrata (EHPI)
(EHPI Specifications)
Deferred due to the following short coming:
Monograph prescribes 6x and higher potencies. The firm has
applied for 3, 3x as well. Justify
24.
Dr. Masood’s
Apocynum Cannabinum Potencies
Apocynum cannabinum (EHPI)
(EHPI Specifications)
Deferred due to the following short coming:
Contains indian hemp
25.
Dr. Masood’s
Cannabis Sativa Potencies
Cannabis sativa (EHPI)
(EHPI Specifications)
Deferred due to the following short coming:
Contains cannabis
26.
Dr. Masood’s
Paraffinum Potencies
Paraffinum (EHPI)
(EHPI Specifications)
Deferred due to the following shortcoming:
Monograph states “ used in crude form. Homeopathic proving
not available” whereas the firm has applied for dilutions. Justify.
M/s Nutra Biomed (Pvt.) Ltd., (Eno 0040)
Plot No. 17, Street E-3, National Industrial Zone, Rawat
27. Nutra Biomed’s
HEMNIL Cream
Deferred due to the following shortcomings:
Monograph of sulpher rich oil shale extract missing
Testing method and COA of peanut oil is submitted instead of
extract
Testing method and COA of clove oil is submitted instead of
extract
Testing method and COA of menthol is submitted instead of
extract
28. Nutra Biomed’s
INSTAFLEX Cream
Deferred due to the following shortcomings:
The list of ingredients indicate use of herbs, common names are
of oils while testing methods of active moieties are given. (ex
Eucalyptol, menthol etc) Clarify formulation.
Undertaking for stability studies missing
Evidence of formulation missing
Label missing
Deferred till the finalization of decision regarding common
molecules
F.No.10-8/2020-OTC) (M-80)
Page 5 of 144
S.No Brand name Decision
(1) (2) (3)
29. Emocare lotion Deferred since paraffin is added in schedule D (Repacking drugs) of
LRA rules 1976
30. Nutra Biomed’s
MIGNIL POWDER
Deferred due to the following shortcomings:
Testing methods of purple butter root extract and stevia leaf
extract are missing
31. Nutra Biomed’s
MEGAMIN Powder
Deferred due to the following shortcomings:
Testing methods of Chicory root ext,
Apple fruit juice powder Ext ,
Pear fruit juice powder extract,
Pineapple fruit juice powder Ext and
Carrot powder Ext are required
Testing method of finished dosage form require
Brand name to be changed
Justification of formulation required
32.
Nutra Biomed’s
Nutrabust Powder
Deferred due to the following shortcomings
Testing methods of Whey protein,
PGX,
Bilberry Extract and
Stevia extract required
M/s Claudia Health care
Plot. 32-33, industrial triangle, kahuta road, Islamabad.
33. CLAGEM SYRUP
Deferred for following reasons:
Monograph of collagen is required.
Choindroitin and glucosamine are added in common molecules
list.
Stability of selenium sulphide in oral liquid dosage form is
required.
34. CLATHIONE TABLET
Deferred for following reasons:
Monograph/ testing specfication of collagen is required.
Source of collagen is required.
Testing method of finished product is required.
35. CLYTE REHYDRATION LEMON
SACHET
Deferred for following reasons:
Monograph of rice maltodextrin is required.
Product resembles with ORS formulation, added in common
molecules list.
36. SUBLING SACHET Deferred for following reasons:
Stability of cyanocobalmin in sachet form is required.
37. SALBERRY sachet Deferred for following reasons:
Firm uses silvia officinalis in crude form, needs clarification.
38. SILA VITALITY SYRUP
Deferred for following reasons:
Justification regarding use of royal jelly in herbal product is
required.
Brand name needs to be changed.
39. DR TOSS SYRP Deferred for submission of Monograph of bharangyadikwath.
M/s AGP Limited (1112)
Plot No. F/46, S.I.T.E.-II, Phase – II Super Highway, Karachi.
40. Kosnate D Suspension Deferred for following reasons:
Owner/ CEO’s signature and stamp are required on form 3.
F.No.10-8/2020-OTC) (M-80)
Page 6 of 144
S.No Brand name Decision
(1) (2) (3)
Monograph/ testing specification of residual mineral salt is
required.
Brand name undertaking is required.
Owner/ CEO signature is required on content undertaking.
Ossein is added in common molecules list being dealt by PER
Division and HOTC Division.
Brand name needs to be changed.
41. Kosnate Suspension
Deferred for following reasons:
Owner/ CEO’s signature and stamp are required on form 3.
Monograph/ testing method of residual mineral salt
Brand name undertaking is required.
Ossein mineral complex is added in common molecules list
being dealt by PER Division and HOTC Division.
Brand name needs to be changed.
Owner/ CEO signature is required on content undertaking.
42. Colidrop Drops Deferred for following reasons:
Monograph/ testing method of matricaria extract is required.
43. Q-BEFOL Tablet Deferred till finalization of common molecules list being dealt by
division of H&OTC products and division of PER.
44. Kosnate 800 Tablet
Deferred for following reasons:
Owner/ CEO’s signature and stamp are required on form 3.
Monograph/ testing method of residual mineral salt is required.
Brand name undertaking is required.
Ossien mineral complex is added in common molecules list
being dealt by PER Division and HOTC Division.
Brand name needs to be changed.
Owner/ CEO signature is required on content undertaking.
45. Kosnate D Tablet
Deferred for following reasons:
Owner/ CEO’s signature and stamp are required on form 3.
Monograph/ testing method of residual mineral salt is required.
Brand name undertaking is required.
Ossien mineral complex is added in common molecules list
being dealt by PER Division and HOTC Division.
Brand name needs to be changed.
Owner/ CEO signature is required on content undertaking.
46. Tribumax Capsules
Deferred for following reasons:
Monograph/ testing method of tribulus extract is required.
Brand name needs to be changed.
47. Rehyde Sachet
Deferred for following reasons:
Owner/ CEO’s signature and stamp are required on form 3.
Monograph/ testing method of wheat dextrin is required.
Brand name undertaking is required.
Owner/ CEO signature is required on content undertaking.
ORS Formulation is added in common molecules list.
48. Kosnate-D Plus Sachet
Deferred for following reasons:
Owner/ CEO’s signature and stamp are required on form 3.
Monograph/ testing method of residual mineral salt is required.
Brand name undertaking is required.
F.No.10-8/2020-OTC) (M-80)
Page 7 of 144
S.No Brand name Decision
(1) (2) (3)
Ossien mineral complex is added in common molecules list
being dealt by PER Division and HOTC Division.
Brand name needs to be changed.
Stability of zinc oxide in sachet (powder/ granules) dosage form
is required.
Owner/ CEO signature is required on content undertaking.
M/s Phytocon International (Pvt) Ltd (Eno 0083)
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
49. Day-Vit Syrup Deferred due to the following deficiency:
Fee of 250/ Rs is submitted instead of 2000/
50. Tridium Capsule Deferred due to the following deficiency:
Evidence of fee submission and R&I is missing
51. Somina Tablet
Deferred due to the following deficiencies:
Evidence of fee submission and R&I is missing
Deferred till the finalization of policy regarding common
molecules
Testing method of L-ornithine L-Aspartate is not provided
Clarify/ justify use of metadoxine as nutritional supplement
52. Triwim Drops Deferred due to the following deficiency:
Evidence of fee submission and R&I is missing
53. Biovin Sachet
Deferred due to the following deficiencies:
Evidence of fee submission and R&I is missing
Testing method of cranberry extract and D-mannose to be
provided
M/s Bless Laboratories (Eno 0063)
Factory No.179, 1.5-KM, Kattar Band Road, Off Multan Road, Thokar Niaz Baig, Lahore
54. Brain Plus
Deferred due to the following deficiencies:
Form 3 not on prescribed format
Brand name to be changed
Form 3 not signed
Undertakings not signed
55. Branex
Deferred due to the following deficiencies:
Form 3 not on prescribed format
Form 3 not signed
Undertakings not signed
Testing method of onsoma extract is missing
56. Trumenol
Deferred due to the following deficiencies:
Form 3 not on prescribed format
Form 3 not signed
Undertakings not signed
Testing method of ivy leaf extract missing
57. D-Liv
Deferred due to the following deficiencies:
Form 3 not on prescribed format
Form 3 not signed
Undertakings not signed
Testing method of dandelion extract missing
M/s Phytocon International (Pvt) Ltd (Eno 0083)
F.No.10-8/2020-OTC) (M-80)
Page 8 of 144
S.No Brand name Decision
(1) (2) (3)
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
58. Leucon Capsule
Deferred due to the following deficiencies:
Form 3 not on prescribed format
Evidence of fee submission and R&I is missing
Testing method of agnus castus extract and maca root extract
not provided
59. Lutex Plus Capsule
Deferred due to the following deficiencies:
3 not on prescribed format
Evidence of fee submission and R&I is missing
Testing method of ginseng extract not provided
60. Glaxy-D Drops
Deferred due to the following deficiencies:
Form 3 not on prescribed format
Evidence of fee submission and R&I is missing
Testing method of L-methyl folate to be provided
61. Erisip Syrup
Deferred due to the following deficiencies:
Evidence of fee submission and receiving missing
Testing method of ginkgo extract and ginseng extract required
M/s. Alpha Nutraceutical Research Laboratories, (Eno 00229)
21/S, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
62. Hitein
Deferred due to the following deficiencies:
Form 3 not on prescribed format
Testing method of iron bisglycinate missing
63. Hicocid
Deferred due to the following deficiencies:
Form 3 not on prescribed format
Formulation contains extracts while monographs of herbs are
provided. The firm may be directed to clarify if the product is
herbal or nutraceutical and accordingly submit testing methods
of all ingredients.
Contains sodium bicarbonate
M/s SOIS Life Sciences (Pvt) Ltd (Eno 0090)
Plot No. A-84, S.I.T.E, Phase-I, Super Highway, Karachi
64. Nutrigold
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission and R&I to be provided
65. Curevit
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
66. Curelin
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission and R&I to be provided
Contains herb. The firm does not possess herbal section
67. Curevit Deferred due to the following deficiencies:
F.No.10-8/2020-OTC) (M-80)
Page 9 of 144
S.No Brand name Decision
(1) (2) (3)
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
68. Primolon-E
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission and R&I to be provided
Evidence of formulation required
69. Irolife
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission and R&I to be provided
Testing method of iron bisglycinate missing
70. Kadin-F
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission and R&I to be provided
Contains N-acetyl cysteine
Testing method of L methyl folate required
Evidence of formulation required
71. Omixo
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission and R&I to be provided
72. Oxamin
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
Label is missing
73. Vikron
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
Sign stamp on form 3 is missing
Testing method of iron bisglycinate is missing
Label is missing
74. Eptovir
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
Sign stamp on form 3 is missing
Testing methods of herbal extracts required
Evidence of formulation required
Label is missing
F.No.10-8/2020-OTC) (M-80)
Page 10 of 144
S.No Brand name Decision
(1) (2) (3)
75. Tri B Plus
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission and R&I to be provided
76. Queze
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission and R&I to be provided
77. Ocu Vision
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of formulation required
Testing method of lutein and zeaxanthin to be provided
Evidence of fee submission and R&I to be provided
78. Normens
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Herbal preparation while the firm does not possess herbal
section
Testing methods of ingredients missing
Evidence of fee submission and R&I to be provided
79. Calsure D
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
Label is missing
80. Ocu Vision
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
Sign stamp of form 3 is missing
Label is missing
Evidence of formulation required
Testing method of lutein and zeaxanthin to be provided
M/s. Alpha Nutraceutical Research Laboratories, (Eno 00229)
21/S, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
81. Alpha-Zee Deferred due to the following deficiency:
Testing method of fennel extract is missing
82. Apezite
Deferred due to the following deficiencies:
Testing method of alpinia galangal, piper nigrum, piper longum,
apium gravoelens, punica granatum, elettaria cardamomum,
mentha sylvestris are missing
Undertaking for safety required
83. Optic (120Ml) Deferred for further evaluation and clarification.
F.No.10-8/2020-OTC) (M-80)
Page 11 of 144
S.No Brand name Decision
(1) (2) (3)
84. Masvit
Deferred due to the following deficiencies:
Fee of herbal products i.e 250/Rs submitted
Contains herbs and vitamins in the same formulation, the firm
has only herbal tablet section
85. Apetac-D
Deferred due to the following deficiencies:
Testing method of piper longum and cinchorium intybus
missing
Undertaking for stability required
86. Dyso
Deferred due to the following deficiencies:
Testing method of terminalia bellerica and mentha piperita are
missing
Undertaking for safety required
M/s SOIS Life Sciences (Pvt) Ltd (Eno 0090)
Plot No. A-84, S.I.T.E, Phase-I, Super Highway, Karachi
87. Tusin
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Contains crude amla while the firm does not possess herbal
section
Testing methods of ingredients missing
Evidence of fee submission and R&I to be provided
88. Hmax-Sil
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Contains common molecule; sodium bicarbonate
Herbal preparation while the firm does not possess herbal
section
Testing methods of ingredients missing
Evidence of fee submission and R&I to be provided
89. Foliqam Mf
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Undertaking for stability studies missing
Evidence of fee submission and R&I to be provided
90. Opti-Cal 1000
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission and R&I to be provided
91. Curefys
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
F.No.10-8/2020-OTC) (M-80)
Page 12 of 144
S.No Brand name Decision
(1) (2) (3)
The product is herbal while the firm does not possess herbal
sections
M/s. Trends Pharmaceuticals (Nutraceuticals & Cam Division), (Eno 00305)
Plot 546/ 547, Sundar Industrial Estate, Lahore
92. Ulive Tablet Deferred due to the following deficiency:
Testing method of opti-zinc and tribulus extract required
93. Cintavit Syrup Deferred till the finalization of policy regarding common
molecules
94. Vietab Tablet
Deferred due to the following deficiencies:
Contains yohimbine bark extract. Required clarification.
Testing methods of all herbal extracts and opti-zinc required
Evidence of formulation required
95. Oscure Tablet Deferred for further evaluation and clarification.
96. Joveen
Deferred due to the following deficiencies:
Official monographs of marine collagen, horsetail powder,
grape seed extract and iron bisglycinate are missing
M/s. Alpha Nutraceutical Research Laboratories, (Eno 00229)
21/S, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
97. Milsure Food Supplement Deferred due to the following deficiency:
Provide evidence of food supplement section
Jawad Impex International, Lahore
98. Ioguard 300 Deferred for further evaluation and clarification.
M/s Novamed Healthcare (Pvt) Ltd (Health Care Division) (Eno 0018)
28-KM, Ferozepur Road, Lahore
99. Osteo Care
Deferred due to the following deficiencies:
Brand name to be changed
Form 3 incomplete and not signed stamped
Quantities of ingredients missing on form 3 and product profile
Label missing
Undertaking for stability, brand name and content is missing
100. Ut Sacal-D
Deferred due to the following deficiencies:
Form 3 incomplete and not signed stamped
Quantities of ingredients missing on form 3 and product profile
Label missing
Undertaking for stability, brand name and content is missing
101. Coten E
Deferred due to the following deficiencies:
Form 3 incomplete and not signed stamped
Quantities of ingredients missing on form 3 and product profile
Label missing
Undertaking for stability, brand name and content is missing
102. Irofer Sachet Deferred for further evaluation and clarification.
103. Irofer Syrup
Deferred due to the following deficiencies:
Brand name to be changed
Form 3 not signed stamped
Quantities of ingredients missing on form 3 and product profile
Label missing
Testing method of iron bisglycinate to be provided
M/s SOIS Life Sciences (Pvt) Ltd (Eno 0090)
F.No.10-8/2020-OTC) (M-80)
Page 13 of 144
S.No Brand name Decision
(1) (2) (3)
Plot No. A-84, S.I.T.E, Phase-I, Super Highway, Karachi
104. Emetistop
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Evidence of formulation is missing
Label is missing
Evidence of fee submission and R&I to be provided
M/s Mac & Rains Health Care (Pvt) Ltd (Eno 0059)
540-D, Sundar Industrial Estate, Raiwind Road, Lahore
105. Anorex
Deferred due to the following deficiencies:
Evidence of submission of fee and R&I is missing
Form 3 is not signed stamped
Evidence of formulation to be provided
Official monographs of herbal extracts missing
Common name not provided
Label is missing
Undertakings of brand name, stability and content is missing
106. Microlyte ORS Sachet
Deferred due to the following deficiencies:
Evidence of submission of fee and R&I is missing
Form 3 is not signed stamped
Clarify “probiotic powder”
Common name snot provided
Label is missing
Provide evidence of dedicated section for probiotic
Deferred till the finalization of policy regarding common
molecules
107. Mac Colic
Deferred due to the following deficiencies:
Evidence of submission of fee and R&I is missing
Form 3 is not signed stamped
Evidence of formulation to be provided
Official monographs of herbal extracts missing
Common name not provided
Label is missing
Undertakings of brand name, stability and content is missing
Mention quantity of ingredients per drop/ unit dose
108. Pakcid
Deferred due to the following deficiencies:
Evidence of submission of fee and R&I is missing
Form 3 is not signed stamped
Evidence of formulation to be provided
Official monographs of herbal extracts missing
Common name not provided
Label is missing
Undertakings of brand name, stability and content is missing
M/s SOIS Life Sciences (Pvt) Ltd (Eno 0090)
Plot No. A-84, S.I.T.E, Phase-I, Super Highway, Karachi
109. Carot
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
F.No.10-8/2020-OTC) (M-80)
Page 14 of 144
S.No Brand name Decision
(1) (2) (3)
Evidence of fee submission and R&I is missing
Sign stamp on form 3 is missing
Label is missing
110. Kindew
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
Label is missing
111. Foly Plus
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
Sign stamp of form 3 is missing
Label is missing
112. Silyliv-L
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
Label is missing
Testing methods of ingredients not provided
Deferred till the finalization of policy regarding common
molecules
113. Curemine
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission and R&I to be provided
Deferred till the finalization of policy regarding common
molecules
Evidence of formulation required
Testing methods of ingredients to be provided
114. Curexil
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission and R&I to be provided
The product is probiotic while the firm does not possess
probiotic section
Testing method of active ingredient missing
M/s Nutrimed Laboratories (Eno 0078)
Plot No. B-42, S.I.T.E. Super Highway, Karachi
115. Hepawar
Deferred due to the following deficiencies:
Fee submitted is of herbal products 250/ Rs
Official testing methods of herbal extracts required
Evidence of formulation required
116. Lecorex
Deferred due to the following deficiencies:
Fee submitted is of herbal products 250/ Rs
Official testing methods of herbal extracts required
F.No.10-8/2020-OTC) (M-80)
Page 15 of 144
S.No Brand name Decision
(1) (2) (3)
Evidence of formulation required
117. Hepawar
Deferred due to the following deficiencies:
Fee submitted is of herbal products 250/ Rs
Official testing methods of herbal extracts required
Evidence of formulation required
118. Besom
Deferred due to the following deficiencies:
Fee submitted is of herbal products 250/ Rs
Official testing methods of herbal extracts required
Evidence of formulation required
119. Femi Chos
Deferred due to the following deficiencies:
Evidence of fee and R & I is missing
Evidence of formulation required
120. Bycolic
Deferred due to the following deficiencies:
Fee submitted is of herbal products 250/ Rs
Official testing methods of herbal extracts required
Evidence of formulation required
121. Besom
Deferred due to the following deficiencies:
Fee submitted is of herbal products 250/ Rs
Official testing methods of herbal extracts required
Evidence of formulation required
122. Lecorex
Deferred due to the following deficiencies:
Fee submitted is of herbal products 250/ Rs
Official testing methods of herbal extracts required
Evidence of formulation required
M/s SOIS Life Sciences (Pvt) Ltd (Eno 0090)
Plot No. A-84, S.I.T.E, Phase-I, Super Highway, Karachi
123. Irowin Deferred for further evaluation and clarification.
124. Bresol
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Hyssopus herb is used whereas the firm does not possess herbal
section
Testing method of ingredients required
125. Foliqam Deferred for further evaluation and clarification.
126. Irowin
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Testing method of iron bisglycinate missing
Label is missing
Evidence of fee submission and R&I to be provided
127. Pherol
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
Sign stamp of form 3 is missing
Label is missing
128. Daily Multi Deferred due to the following deficiencies:
F.No.10-8/2020-OTC) (M-80)
Page 16 of 144
S.No Brand name Decision
(1) (2) (3)
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
Label is missing
129. Famvid
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
Label is missing
130. Maxtron
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Evidence of fee submission and R&I is missing
Sign stamp of form 3 is missing
Label is missing
131. Pure Folic Pearl
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
Clarify the term ‘soft pearl capsule’
M/s Nutrimed Laboratories (Eno 0078)
Plot No. B-42, S.I.T.E. Super Highway, Karachi
132. I V Tus Plus Cough
Deferred due to the following deficiencies:
Evidence of fee and R & I is missing
Testing method of herbal extract to be provided
133. Vitamag
Deferred due to the following deficiencies:
Sign stamp on form 3 missing
Testing methods of herbal extracts missing
Evidence of formulation required
Fee of herbal product i.e Rs 250/- submitted
134. Vitagesic
Deferred due to the following deficiencies:
Deferred till the finalization of policy regarding common
molecules
Official testing method of ingredients missing
M/s Polyfine Nutra-Sciences (Eno 0019)
Plot No. 39-40 D, Industrial Estate, Hayatabad, Peshawar
135. Loburna Deferred for further evaluation and clarification.
136. Apgrow Deferred for further evaluation and clarification.
137. Epitone Deferred for further evaluation and clarification.
138. Pectil Deferred for further evaluation and clarification.
139. Bless Baby
Carminative
Deferred due to the following deficiencies:
Common names missing
Testing methods of ingredients missing
Undertaking for stability studies missing
Undertaking for safety missing
140. Beano Deferred due to the following deficiencies:
Testing method of galactosidase missing
F.No.10-8/2020-OTC) (M-80)
Page 17 of 144
S.No Brand name Decision
(1) (2) (3)
Undertaking for stability missing
Deferred till the finalization of policy regarding common
molecules
141. Polyfine Liquid
Joshina
Deferred due to the following deficiencies:
Quantities of ingredients not provided
Only common names are written. The firm may be directed to
submit scientific names and the testing method of each
ingredient accordingly.
Undertaking for stability studies missing
Undertaking for safety required
142. Herbi-Coff
Deferred due to the following deficiencies:
common names are written. The firm may be directed to submit
scientific names and the testing method of each ingredient
accordingly.
Undertaking for stability studies missing
Undertaking for safety required
143. Polyfine Gripe Water
Deferred due to the following deficiencies:
Only common names are written. The firm may be directed to
submit scientific names and the testing method of each
ingredient accordingly.
Undertaking for stability studies missing
Undertaking for safety required
144. Allure Plus
Deferred due to the following deficiencies:
Contains herbal ingredients as well as arginine and zinc. Clarify
if the product is herbal or neutraceutical
Testing method of ginseng, L-arginine and asparagus are
missing
Undertaking for stability studies missing
Undertaking for safety required
Deferred till the finalization of policy regarding common
molecules
M/s. Derma Techno Pakistan (Eno 00272)
528-Sunder Industrial Estate, Lahore
M/s EON Pharmacy (Eno 0093)
Plot No. A/150, Sector 11-E, New Karachi
145. Ajwa Plus
Deferred due to the following deficiencies:
Undertaking for safety required
Herbs and vitamins used in the same formulation. Clarify if the
formulation is herbal or nutraceutical. (Fee submitted 2000/-)
146. Bio Malt Deferred for further evaluation and clarification.
147. Calcibex600 Deferred due to the following deficiency:
Quantity of vitamin D in IU required
148. Calcibion 600 Deferred for further evaluation and clarification.
149. Ginkobion Deferred due to the following deficiency:
Brand name to be changed
150. Ginko Plus Deferred due to the following deficiency:
Brand name to be changed
151. Livabion Deferred for further evaluation and clarification.
F.No.10-8/2020-OTC) (M-80)
Page 18 of 144
S.No Brand name Decision
(1) (2) (3)
152. Bio Fort Tonic Deferred due to the following deficiency:
Undertaking for safety required
153. Bio Rex Deferred due to the following deficiency:
Undertaking for safety required
154. Colizyme Deferred due to the following deficiency:
Undertaking for safety required
155. Cool Cid
Deferred due to the following deficiency:
Brand name to be changed
Undertaking for safety required
156. Hemo Plus Deferred due to the following deficiency:
Undertaking for safety required
157. Vitalac Tonic Deferred due to the following deficiency:
Undertaking for safety required
158. Flu Cough
Deferred due to the following deficiency:
Brand name to be changed
Undertaking for safety required
159. Gastogel Plus Deferred due to the following deficiency:
Undertaking for safety required
160. Gyno Rex Deferred due to the following deficiency:
Undertaking for safety required
161. Gynofer Deferred due to the following deficiency:
Undertaking for safety required
162. Heparic
Deferred due to the following deficiencies:
Undertaking for safety required
Testing method of tamarix dioica missing
163. Ipm Deferred for further evaluation and clarification.
164. Lycomerz Deferred due to the following deficiency:
Undertaking for safety required
165. Mensogen
Deferred due to the following deficiencies:
Brand name to be changed
Undertaking for safety required
166. Multi Fort Tonic Deferred due to the following deficiency:
Undertaking for safety required
167. Novacid
Deferred due to the following deficiencies:
Receiving and fee are for novacid gel while the product is syrup
Undertaking for safety required
168. Pepcid
Deferred due to the following deficiencies:
Brand name to be changed
Receiving and fee of pepcid gel while product is syrup
Undertaking for safety required
169. Pepsogel
Deferred due to the following deficiencies:
Brand name to be changed
Undertaking for safety required
170. Pepsogen
Deferred due to the following deficiencies:
Brand name to be changed
Undertaking for safety required
171. Pepsogen Deferred due to the following deficiency:
Undertaking for safety required
F.No.10-8/2020-OTC) (M-80)
Page 19 of 144
S.No Brand name Decision
(1) (2) (3)
172. Eon’S Sharbat E Faulaad Deferred due to the following deficiency:
Undertaking for safety required
M/s Phytocon International (Pvt) Ltd (Eno 0083)
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
173. Relicof Drops
Deferred due to the following deficiencies:
Evidence of fee submission and receiving missing
Testing method of herbal extract missing
174. Rosy Syrup
Deferred due to the following deficiencies:
Evidence of fee submission and receiving missing
Official testing method of melatonin missing
Deferred till the finalization of policy regarding common
molecules
M/s Polyfine Nutra-Sciences (Eno 0019)
Plot No. 39-40 D, Industrial Estate, Hayatabad, Peshawar
175. Apgrow
Deferred due to the following deficiencies:
Quantities of ingredients not given
Common names not mentioned
Testing methods of achillea milleforlium, tamarix gallica,
tribulus terrestris, cichorium intybus, terminalia chebula and
mentha sylvestris are not provided
Undertaking for stability studies missing
Undertaking for safety required
176. Epitone
Deferred due to the following deficiencies:
of ingredients not given
Common names not mentioned
Testing methods of achillea milleforlium, tamarix gallica,
tribulus terrestris, cichorium intybus and terminalia chebula are
not provided
Undertaking for stability studies missing
Undertaking for safety required
177. Loburna
Deferred due to the following deficiencies:
Quantities of extracts not provided
Testing methods of extracts missing
Undertaking for stability studies missing
Undertaking for safety required
M/s SOIS Life Sciences (Pvt) Ltd (Eno 0090)
Plot No. A-84, S.I.T.E, Phase-I, Super Highway, Karachi
178. C-Active
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
179. Cals D
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
180. Q-Sten Deferred due to the following deficiencies:
F.No.10-8/2020-OTC) (M-80)
Page 20 of 144
S.No Brand name Decision
(1) (2) (3)
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
Evidence of formulation required
M/s Stiflex Pharmaceuticals (Consumer Healthcare Division) (Eno 0012)
33-B, Small Industrial Estate, Bahtar Road, Wah Cant
181. Febriful Deferred due to the following deficiencies:
Official monograph of L-methyl folate required
182. Osais Deferred due to the following deficiencies:
Testing method of elemental zinc required
183. Progin Plus
Deferred due to the following deficiencies:
Contains herbs, while the firm does not have herbal section
Deferred till the finalization of policy regarding common
molecules
184. Ronadil F
Deferred due to the following deficiencies:
Contains herbs, while the firm does not have herbal section
Deferred till the finalization of policy regarding common
molecules
185. Biocit K Deferred till the finalization of policy regarding common molecules
186. Chestol Syp Deferred due to the following deficiencies:
Testing method of ivy leaf extract and thyme extract required
187. Ivolef Plus Deferred due to the following deficiencies:
Testing method of ivy leaf extract and thyme extract required
188. Colex Deferred due to the following deficiencies:
Testing method of cardamom extract and fennel extract required
189. Colex Deferred due to the following deficiencies:
Testing method of cardamom extract and fennel extract required
190. D-Ven Provide quantity of vitamin A in IU
191. Serodaze Ds Deferred till the finalization of policy regarding common molecules
192. Stiflex Gripe Water
Deferred due to the following deficiencies:
Testing method of dill oil and ginger extract required
Deferred till the finalization of policy regarding common
molecules
193. Curhoids
Deferred due to the following deficiencies:
Testing methods of hesperidin and diosmin required
Evidence of formulation as herbal product required
Undertaking for stability missing
194. Protec D Deferred due to the following deficiency:
Testing method of cranberry extract required
195. Mintvol Deferred due to the following deficiency:
Testing method of peppermint extract required
196. Tom Ad Deferred due to the following deficiency:
Brand name to be changed
197. D Take Deferred due to the following deficiency:
Clarify quantity of vitamin D in IU
198. Roz B Deferred due to the following deficiency:
Testing methods of iron polymaltose complex required
F.No.10-8/2020-OTC) (M-80)
Page 21 of 144
S.No Brand name Decision
(1) (2) (3)
199. Skyvit M
Deferred due to the following deficiency:
Methods of iron polymaltose complex required
Clarify quantity of vitamin D in IU
200. Amore Deferred due to the following deficiency:
Testing methods of herbal extracts to be provided
201. Lactimax
Deferred due to the following deficiency:
Contains moringa herb while the firm does not have herbal
section
202. Getcalvit
Deferred due to the following deficiencies:
Contains methylene chloride (Banned ingredient)
Testing method of ossein mineral complex missing
203. Liverin Deferred till the finalization of deficiencies regarding common molecules
204. Diabecinn
Deferred due to the following deficiency:
Contains raw cinnamon while the firm does not have herbal
section
205. Ageomore Deferred due to the following deficiency:
Contains herbs while the firm does not have herbal section
206. Skyvit M Deferred due to the following deficiency:
Testing methods of iron polymaltose complex required
207. Osteofit
Deferred due to the following deficiencies:
Testing method of alphacalcidol required
Quantity of vitamin D in RDA required
208. Neutrofast
Deferred due to the following deficiencies:
Testing method of blueberry extract and cranberry extract
required
209. Recco Deferred due to the following deficiency:
Undertaking for stability missing
M/s EON Pharmacy (Eno 0093)
Plot No. A/150, Sector 11-E, New Karachi
210. Anatacidgascon Gel
Deferred due to the following deficiencies:
Brand name to be changed
Undertaking for safety required
211. Broncos Cought
Deferred due to the following deficiencies:
Testing method of morus nigra required
Undertaking for safety required
212. Diapium Deferred due to the following deficiency:
Undertaking for safety required
213. Biolac Deferred due to the following deficiency:
Undertaking for safety required
214. Flu Cold
Deferred due to the following deficiencies:
Undertaking for safety required
Brand name to be changed
215. Hemo Plus Deferred for further evaluation and clarification.
216. Plexo V Deferred due to the following deficiency:
Undertaking for safety required
217. Plexo V Repeat from S no 210
218. Rnicef Deferred due to the following deficiencies:
Undertaking for safety required
F.No.10-8/2020-OTC) (M-80)
Page 22 of 144
S.No Brand name Decision
(1) (2) (3)
Testing method of piper longum required
219. Sengofer Deferred due to the following deficiency:
Undertaking for safety required
220. Uribion Deferred due to the following deficiency:
Undertaking for safety required
221. Urigon Deferred for further evaluation and clarification.
222. Veravit Deferred for further evaluation and clarification.
223. Verazyme Deferred due to the following deficiency:
Undertaking for safety required
224. Viobex
Deferred due to the following deficiencies:
Testing method of maca root missing
Undertaking for safety required
M/s Jawad Impex International, Lahore
21-Iftikhar Building, Chouburji, Lahore
Agent of M/s Zagro Singapore Pte Ltd Zagro Global Hub 5 Woodlands Terrace Singapore 738460
225. Anavite layer 0.25% premix
Deferred for following reasons:
Prescribed form 5 is required.
CoA of finished product bearing all testing specification in
terms of physical, chemical and microbial is required.
Accelerated and long term stability studies data (physical,
chemical and microbial) of at least 3 batches conducted on
requirements of zone IV-A is required and it should bear
product name.
Notarized and countersigned copies of manufacturing license
and GMP certificate is required.
Pakistan embassy/ consulate attestation of Free sale certificate
of product is required. However, Free sale certificate submitted
by the firm does not indicate any statement depicting either
product is freely available in country of origin or otherwise.
Agency agreement between importer and principal manufacturer
is required.
M/s SOIS Life Sciences (Pvt) Ltd (Eno 0090)
Plot No. A-84, S.I.T.E, Phase-I, Super Highway, Karachi
226. L.C. Mag
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
227. Calc U3
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
228. Vita-L
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
F.No.10-8/2020-OTC) (M-80)
Page 23 of 144
S.No Brand name Decision
(1) (2) (3)
Contains ginkgo biloba herb while the firm has no herbal
sections
229. 3D Deferred for further evaluation and clarification.
M/s Phytocon International (Pvt) Ltd (Eno 0083)
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
230. Hepa Guard Sachet
Deferred due to the following deficiencies:
Brand name to be changed
Evidence of use of L-ornithin L-aspartate as a nutraceutical
product
Testing method of L-ornithin L-aspartate missing
M/s. Alpha Nutraceutical Research Laboratories, (Eno 00229)
21/S, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
231. Pepeez
Deferred due to the following deficiencies:
Testing method of ginger and fennel are missing
Undertaking for safety required
M/s Bless Laboratories (Eno 0063)
Factory No.179, 1.5-KM, Kattar Band Road, Off Multan Road, Thokar Niaz Baig, Lahore
232. Dro Vit-D
Deferred due to the following deficiencies:
Form 3 and undertakings not signed
Evidence of fee submission and receiving missing
233. Hizyme
Deferred due to the following deficiencies:
Form 3 and undertakings not signed
Evidence of fee submission and receiving missing
Testing method of ajwain extract required
234. M-Min
Deferred due to the following deficiencies:
Evidence of submission of fee and receiving missing
Form 3 and undertakings not signed
Official testing methods of herbal extracts required
235. Jovotil
Deferred due to the following deficiencies:
Evidence of submission of fee and receiving missing
Form 3 and undertakings not signed
Official testing methods of herbal extracts required
236. Co-Ten
Deferred due to the following deficiencies:
Evidence of submission of fee and receiving missing
Form 3 and undertakings not signed
237. Retain Hns
Deferred due to the following deficiencies:
Evidence of submission of fee and receiving missing
Form 3 and undertakings not signed
Official testing methods of horsetail rush stem extract required
238. Olive Capsules
Deferred due to the following deficiencies:
Evidence of submission of fee and receiving missing
Form 3 and undertakings not signed
Testing method of tribulus extract required
239. H-Sil
Deferred due to the following deficiencies:
Form 3 and undertakings not signed
Evidence of fee submission and receiving missing
Official testing methods of herbal extracts required
Evidence of formulation required
F.No.10-8/2020-OTC) (M-80)
Page 24 of 144
S.No Brand name Decision
(1) (2) (3)
240. Apit
Deferred due to the following deficiencies:
Form 3 not signed
Undertakings not signed
The formulation contains extracts while testing of herbs is given
(articles) clarify if the formulation is herbal or nutraceutical
241. Vda
Deferred due to the following deficiencies:
Evidence of submission of fee and receiving missing
Form 3 and undertakings not signed
242. Oscal
Deferred due to the following deficiencies:
Evidence of submission of fee and receiving missing
Form 3 and undertakings not signed
243. Flow-D
Deferred due to the following deficiencies:
Evidence of submission of fee and receiving missing
Form 3 and undertakings not signed
244. Tribo Plus
Deferred due to the following deficiencies:
Evidence of submission of fee and receiving missing
Form 3 and undertakings not signed
Official testing methods of herbal extracts required
Evidence of formulation provided is different from applied
formulation
245. Theranex-Q
Deferred due to the following deficiencies:
Evidence of submission of fee and receiving missing
Form 3 and undertakings not signed
Evidence of formulation required
246. C-Plus-D
Deferred due to the following deficiencies:
Evidence of submission of fee and receiving missing
Form 3 and undertakings not signed
247. Plus-D
Deferred due to the following deficiencies:
Evidence of submission of fee and receiving missing
Form 3 and undertakings not signed
248. BL-Folate Plus Deferred due to the following deficiencies:
Testing method and clarification of lipofer required
249. Brain-B Plus
Deferred due to the following deficiencies:
Quantity of vitamin D in IU required
Brand name to be changed
250. Brain-B Deferred for further evaluation and clarification.
251. Branex
Deferred due to the following deficiencies:
Official testing methods of herbal extracts and bioperine
required
252. Celmin-D
Deferred due to the following deficiencies:
Official testing methods of bacopa and lavender extracts are
required
253. Db-Zinc Deferred for further evaluation and clarification.
254. D-Liv
Deferred due to the following deficiencies:
Official testing methods of herbal extracts required (Although
the firm has herbal sections too, the form 3 states extracts of
herbs, therefore testing of the same is required)
255. Ever Bless Deferred due to the following deficiencies:
F.No.10-8/2020-OTC) (M-80)
Page 25 of 144
S.No Brand name Decision
(1) (2) (3)
Official testing method of collagen required
Deferred till the finalization of policy on common molecules
256. Fyrobin Deferred for further evaluation and clarification.
257. Fyrobin
Deferred due to the following deficiencies:
Official testing method of zeaxanthin required
Evidence of formulation required
258. Hepabion Deferred due to the following deficiencies:
Official testing method of herbal extracts required
259. H-Vit M
Deferred due to the following deficiencies:
Evidence of formulation different from applied formulation
Deferred till the finalization of policy on common molecules
260. Liv-Chok Deferred till the finalization of policy on common molecules
261. Malt
Deferred due to the following deficiencies:
Official testing methods of all ingredients required
Undertaking for safety required
262. Microloc
Deferred due to the following deficiencies:
Official testing method of herbal extracts required
Evidence of formulation provided is different from applied
formulation
263. Microloc Deferred for further evaluation and clarification.
264. One-Z
Deferred due to the following deficiencies:
Official testing methods of herbal extracts required
Clarify formulation wrt energy, fats, proteins and carbohydrates
Justify all the minute quantities of vitamins being used (ex 0.127
IU vitamin A, 0.0469 mcg vit B6 etc)
265. R-Cof
Deferred due to the following deficiencies:
Contains papaver somniferum
Official testing methods of herbal extracts required
Evidence of formulation provided is different from applied
formulation
266. R-Vit
Deferred due to the following deficiencies:
Brand name to be changed
Evidence of formulation required
Deferred till the finalization of policy regarding common
molecules
267. Re-Vit
Deferred due to the following deficiencies:
Brand name to be changed
Testing method of iron bisglycinate required
268. Rizer Deferred due to the following deficiency:
Testing methods of herbal extracts required
269. Rizer Deferred due to the following deficiency:
Official testing methods of herbal extracts to be provided
270. Roging Plus Deferred till the finalization of policy regarding common molecules
271. Sp-Ton
Deferred due to the following deficiencies:
From 3 and undertakings not signed
Justify use of ‘talcum powder’ as inactive ingredient
Evidence of formulation required
272. Vital-30 Deferred due to the following deficiencies:
F.No.10-8/2020-OTC) (M-80)
Page 26 of 144
S.No Brand name Decision
(1) (2) (3)
Brand name to be changed
Testing method of cranberry extract missing
273. G-Live Deferred due to the following deficienciy:
Testing methods of herbal extracts required
M/s Izfaar Nutraceutical Industries,[Nutraceutical] (Eno 00629)
Sun Lane 7th Km, Sundar Raiwind Road, Lahore-Pakistan
274. Sarooco
Deferred due to the following deficiencies:
Sign stamp on form 3 missing
Undertakings for stability, content and brand name are missing
Fee submitted Rs 250/-
Testing methods of herbal extracts to be provided
275. Miracle
Deferred due to the following deficiencies:
Sign stamp on form 3 missing
Undertakings for stability, content and brand name are missing
Brand name to be changed
Testing methods of ingredients missing
Fee submitted Rs 250/-
276. Vimin Gold
Deferred due to the following deficiencies:
Sign stamp on form 3 missing
Undertakings for stability, content and brand name are missing
277. Hi-C-Vit
Deferred due to the following deficiencies:
Sign stamp on form 3 missing
Undertakings for stability, content and brand name are missing
278. Vetifaar
Deferred due to the following deficiencies:
Sign stamp on form 3 missing
Undertakings for stability, content and brand name are missing
Claims to be a topical antibiotic. Justify.
fee submitted Rs 250/-
Testing methods of herbal extracts required
279. Carminofaar
Deferred due to the following deficiencies:
Sign stamp on form 3 missing
Undertakings for stability, content and brand name are missing
Fee submitted Rs 250/-
280. Kilworm
Deferred due to the following deficiencies:
Sign stamp on form 3 missing
Undertakings for stability, content and brand name are missing
Fee submitted Rs 250/-
Brand name to be changed
Contains herbs. Clarify if the firm has herbal section.
281. Baby Water
Deferred due to the following deficiencies:
Sign stamp on form 3 missing
Undertakings for stability, content and brand name are missing
fee submitted Rs 250/-
Contains herbs. Clarify is the firm has herbal section
Deferred till the finalization of policy regarding common
molecules
282. Kilworm-P Deferred due to the following deficiencies:
Sign stamp on form 3 missing
F.No.10-8/2020-OTC) (M-80)
Page 27 of 144
S.No Brand name Decision
(1) (2) (3)
Undertakings for stability, content and brand name are missing
fee submitted Rs 250/-
Contains herbs. Clarify is the firm has herbal VETERINARY
section
M/s. Paragon Herbal Laboratories, (Eno 00186)
Plot No. Kht 285, Ktn 570, Allah Hoo Industrial Area, Near Sabzi Mandi, Gujumatta, Ferozepur Road, Lahore
283. Real-Cid Deferred for further evaluation and clarification.
M/s Phytocon International (Pvt) Ltd (Eno 0083)
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
284. Calidin Syrup Deferred due to the following deficiency:
Fee submitted of herbal product; 250/- Rs
285. Vitacon Suspension Deferred due to the following deficiency:
Fee submitted of herbal product; 250/- Rs
286. Ironase Tablet
Deferred due to the following deficiencies:
Fee submitted of herbal product; 250/- Rs
Official testing method of iron bisglycinate required
287. Dbon Syrup Deferred due to the following deficiency:
Fee submitted of herbal product; 250/- Rs
M/s Scotmann Pharmaceuticals (Health & OTC Division), (Nutraceutical) (Eno00639)
5-D, I-10/3 Industrial Area, Islamabad-Pakistan
288. Lipocardin
Deferred due to the following deficiencies:
Form 3 not signed stamped
Official monographs of ingredients are missing
Evidence of formulation required
289. Sunny D Marina
Deferred due to the following deficiencies:
Form 3 not signed stamped
Official monographs of ingredients are missing
290. Truflor
Deferred due to the following deficiencies:
Official monograph of probiotic is missing
Clarify if the firm has a probiotic section
Form 3 not signed stamped
Evidence of formulation required
291. Seacardin
Deferred due to the following deficiencies:
Form 3 not signed stamped
Official monographs of ingredients are missing
Evidence of formulation required
292. Dairyhelp
Deferred due to the following deficiencies:
Form 3 not signed stamped
Brand name to be changed
Deferred till the finalization of policy regarding common
molecules
293. Truflor
Deferred due to the following deficiencies:
Official monograph of probiotic is missing
Clarify if the firm has a probiotic section
Form 3 not signed stamped
Evidence of formulation required
294. Sunny D CV Deferred due to the following deficiencies:
Form 3 not signed stamped
F.No.10-8/2020-OTC) (M-80)
Page 28 of 144
S.No Brand name Decision
(1) (2) (3)
Official monographs of ingredients are missing
295. Align-Ut Deferred due to the following deficiency:
Form 3 not signed stamped
296. Sambuca
Deferred due to the following deficiencies:
Form 3 not signed stamped
Official monograph elderberry is missing
Evidence of formulation missing
297. Best Belly 50
Deferred due to the following deficiencies:
Brand name to be changed
Official monograph of probiotic blend is missing
Clarify if the firm has a probiotic section
Form 3 not signed stamped
Evidence of formulation required
298. Best Belly 10
Deferred due to the following deficiencies:
Brand name to be changed
Official monograph of probiotic blend is missing
Clarify if the firm has a probiotic section
Form 3 not signed stamped
Evidence of formulation required
299. Ps 100
Deferred due to the following deficiencies:
Form 3 not signed stamped
Testing methods of ingredients missing
Evidence of formulation required
300. Emkay-7 Deferred due to the following deficiency:
Form 3 not signed stamped
301. Sunny D 2K Deferred due to the following deficiency:
Form 3 not signed stamped
302. RLA 100
Deferred due to the following deficiencies:
Form 3 not signed stamped
Testing methods of ingredients missing
Evidence of formulation required
303. Best Belly 50
Deferred due to the following deficiencies:
Brand name to be changed
Official monograph of probiotic blend is missing
Clarify if the firm has a probiotic section
Form 3 not signed stamped
Evidence of formulation required
304. Best Belly 100 Capsule
Deferred due to the following deficiencies:
Brand name to be changed
Official monograph of probiotic blend is missing
Clarify if the firm has a probiotic section
Form 3 not signed stamped
Evidence of formulation required
305. Best Belly Jr Chewable
Deferred due to the following deficiencies:
Brand name to be changed
Official monograph of probiotic blend is missing
Clarify if the firm has a probiotic section
F.No.10-8/2020-OTC) (M-80)
Page 29 of 144
S.No Brand name Decision
(1) (2) (3)
Form 3 not signed stamped
Evidence of formulation required
M/s SOIS Life Sciences (Pvt) Ltd (Eno 0090)
Plot No. A-84, S.I.T.E, Phase-I, Super Highway, Karachi
306. Calcinix Deferred for further evaluation and clarification.
307. Greenofer
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
308. Calc Plus
Deferred due to the following deficiencies:
Brand name to be changed
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
309. Calc Plus
Deferred due to the following deficiencies:
Brand name to be changed
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
310. Vitafam
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
311. Vitafam
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
312. Multiban E
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
313. Oso-D
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
314. Multi Life
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Brand name to be changed
Evidence of submission of fee required
315. Super One
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
F.No.10-8/2020-OTC) (M-80)
Page 30 of 144
S.No Brand name Decision
(1) (2) (3)
Label is missing
Brand name to be changed
316. Pc -Cure Plus
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
Evidence of formulation required
Testing method of grape seed extract required
Brand name to be changed
Deferred till the finalization of policy regarding common
molecules
317. Dioqam
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Official testing methods of ingredients required
Label is missing
318. Cola-Gin
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
Contains glucosamine and chondroitin
Testing method of collagen missing
M/s. Alpha Nutraceutical Research Laboratories, (Eno 00229)
21/S, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
319. Sonex Plus
Deferred due to the following deficiencies:
Clarify quantity of potassium chloride (Units; IU)
Justify use of magnesium stearate as active ingredient
Testing method of iron bisglycinate and chromium picolinate
required
M/s Anza Pharma, (Eno 00540)
343-S, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
320. Anchel-F
Deferred due to the following deficiencies:
Applied on form 4 while no clinical data is provided
Official testing method of iron bisglycinate missing
321. Hepasun Deferred due to the following deficiency:
Evidence of formulation required
322. Hepasun Deferred due to the following deficiency:
Quantity of vitamin E in IU required
323. Vitasun Deferred due to the following deficiency:
Quantity of vitamin D in IU required
M/s. Calgan Phyto Pharma (Pvt) Ltd.,00146
Plot No. 2, Green Park Road, Near Band Road Grid Station, Lahore
324. Brain-Max
Deferred due to the following deficiencies:
Brand name to be changed
Product is nutraceutical while fee of herbal product i.e 250/- Rs
submitted
F.No.10-8/2020-OTC) (M-80)
Page 31 of 144
S.No Brand name Decision
(1) (2) (3)
325. Ocid Deferred for further evaluation and clarification.
326. Gastroset
Deferred due to the following deficiencies:
Brand name to be changed
Testing method of fenugreek extract and nepata cartaria extract
are required
327. Oscal-D Deferred due to the following deficiency:
Quantities of ingredients not mentioned
328. Vision
Deferred due to the following deficiencies:
Brand name to be changed
Evidence of formulation required
Testing method of L-theanine required
329. Rapid
Deferred due to the following deficiencies:
Contains vitamin and herbs. Clarify if the formulation is herbal
or nutraceutical
Testing methods of all herbs to be provided
Undertaking for safety required
330. Iv-Tuss
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name, stability and safety missing
331. Coral-One
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
332. Zymogel-M
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name, safety and stability missing
333. Arq-E-Sherien
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
334. Vitamark
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
Quantity of vitamin D in IU required
335. Arq-E-Kasani
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
336. Xano Plus
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
337. Arq-E-Gauzaban
Deferred due to the following deficiencies:
Form 3 not on prescribed format
Testing methods of ingredients are missing
F.No.10-8/2020-OTC) (M-80)
Page 32 of 144
S.No Brand name Decision
(1) (2) (3)
Undertaking for brand name, stability and safety missing
338. Eribion
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
339. Churqa
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name, safety and stability missing
340. Apitite Ultra
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
341. Action
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name, stability and safety missing
The product seems nutraceutical while fee of herbal is submitted
Deferred till the finalization of policy regarding common
molecules
342. Sa Tonic
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
Quantity of vitamin D in IU required
343. Gammet-S
Deferred due to the following deficiencies:
Form 3 missing
Evidence of formulation required
Testing methods of ingredients are missing
Undertaking for brand name, safety and stability missing
344. Arq-E-Mako
Deferred due to the following deficiencies:
Form 3 missing
Quantity of ingredient missing
Testing methods of ingredients are missing
Undertaking for brand name, stability and safety missing
345. Emvit-Z Protect
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
346. Malt Plus
Deferred due to the following deficiencies:
Form 3 missing
Evidence of formulation required
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
347. Vitamark
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
F.No.10-8/2020-OTC) (M-80)
Page 33 of 144
S.No Brand name Decision
(1) (2) (3)
Undertaking for brand name and stability missing
348. Vitamark
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
349. Irospan Repeated on number 368
350. Bonifit-D
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
351. Edibone Plus
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
Evidence of fee submission and receiving are missing
Quantities of ingredients not mentioned
352. Calgan Balam
Deferred due to the following deficiencies:
The receiving and fee are of calgan balm while the dossier is of
arq-e-saunf.
Form 3 missing
Testing methods for either product are missing
Undertaking for brand name, stability and safety missing
353. Zymogel-M
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
354. Arq-E-Podina
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name, stability and safety missing
355. Treblogen
Deferred due to the following deficiencies:
Form 3 missing
Evidence of formulation required
Testing methods of ingredients are missing
Undertaking for brand name, safety and stability missing
356. Calgan Gripewater
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name, stability and safety missing
357. Calif-D
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
358. Irospan
Deferred due to the following deficiencies:
Form 3 missing
Evidence of formulation required
Testing methods of ingredients are missing
F.No.10-8/2020-OTC) (M-80)
Page 34 of 144
S.No Brand name Decision
(1) (2) (3)
Undertaking for brand name content and stability missing
359. Calif-D Repeated on number 367
360. Cardiogen
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name, stability and safety missing
361. Arq-E-Saunf
Deferred due to the following deficiencies:
The receiving and fee are of arq-e-saunf while the dossier is of
calgan balam.
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name, stability and safety missing
362. Edibone
Deferred due to the following deficiencies:
Form 3 missing
Brand name to be changed
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
363. Malto Max
Deferred due to the following deficiencies:
Form 3 missing
Evidence of formulation required
Testing methods of ingredients are missing
Undertaking for brand name and stability missing
364. Kaozin
Deferred due to the following deficiencies:
Form 3 missing
Testing methods of ingredients are missing
Undertaking for brand name, safety and stability missing
M/s. Hiranis Pharmaceuticals (Pvt.) Ltd. (Eno 00174)
E-145-149, North Western Industrial Zone, Port Qasim, Karachi 75020
365. Myovite Deferred due to the following deficiency:
Undertaking for stability studies missing
366. Cranactin
Deferred due to the following deficiencies:
Applied on form 4 but no clinical data provided
Undertaking for stability studies missing
Testing method of potassium amino acid complex missing
Evidence of formulation missing
367. Neevo Dha Deferred due to the following deficiency:
Undertaking for stability studies missing
368. Zeplate Dha 7.5Mg
Deferred due to the following deficiencies:
Official testing method of L-methyl folate missing
Undertaking for stability studies missing
369. Zeplate Dha 15Mg
Deferred due to the following deficiencies:
Official testing method of L-methyl folate missing
Undertaking for stability studies missing
M/s Novamed Healthcare (Pvt) Ltd (Health Care Division) (Eno 0018)
28-KM, Ferozepur Road, Lahore
370. Vitral-M Capsule Deferred for further evaluation and clarification.
M/s Phytocon International (Pvt) Ltd (Eno 0083)
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
F.No.10-8/2020-OTC) (M-80)
Page 35 of 144
S.No Brand name Decision
(1) (2) (3)
371. Mefol Deferred due to the following deficiency:
Testing method of L-methyl folate missing
372. Lutex Syrup
Deferred due to the following deficiencies:
Testing method of iron bisglycinate missing
Vitamin A above RDA
373. Vitren Tablet
Deferred due to the following deficiencies:
Fee submitted of herbal product; 250/- Rs
Evidence of formulation required
Vitamin A above RDA
Testing method of iron bisglycinate, garlic extract and
chromium glycinate missing
374. Crano Powder Deferred till the finalization of policy regarding common molecules
375. Vitalex Syrup
Deferred due to the following deficiencies:
Sign stamp on form 3 missing
Quantities per 5 ml or 10ml required
Quantity of vitamin D in IU required
376. Ivycof Syrup
Deferred due to the following deficiencies:
Fee submitted of herbal product; 250/- Rs
Testing method of ivy leaf extract missing
Form 3 not signed stamped
377. Folisip Syrup Deferred due to the following deficiency:
Evidence of fee submission and receiving missing
378. Ulina Capsule
Deferred due to the following deficiencies:
Evidence of fee submission and receiving missing
Testing method of wild yam extract/ natural progesterone
missing
379. Sandil Syrup
Deferred due to the following deficiencies:
Evidence of fee submission and receiving missing
Testing method of methyl folate calcium
380. D-Colic Drops.
Deferred due to the following deficiencies:
Evidence of submission of fee and receiving missing
Deferred till the finalization of policy regarding common
molecules
381. Rosy Drops
Deferred due to the following deficiencies:
Evidence of fee submission and receiving missing
Official testing method of melatonin missing
Deferred till the finalization of policy regarding common
molecules
382. Florafix Tablet Deferred due to the following deficiency:
Evidence of fee submission and receiving missing
383. Alfacon Tablet Deferred due to the following deficiency:
Evidence of fee submission and receiving missing
384. Fitobact Tablet Deferred due to the following deficiency:
Evidence of fee submission and receiving missing
385. Fibogen ORS Deferred till the finalization of policy regarding common molecules
386. Cofix Deferred due to the following deficiency:
Testing method of herbal extract missing
387. Zecal Deferred due to the following deficiencies:
F.No.10-8/2020-OTC) (M-80)
Page 36 of 144
S.No Brand name Decision
(1) (2) (3)
Applied on form 4
Quantities of ingredients not mentioned
M/s Scotmann Pharmaceuticals (Health & OTC Division), (Nutraceutical) (Eno00639)
5-D, I-10/3 Industrial Area, Islamabad-Pakistan
388. Best Belly
Deferred due to the following deficiencies:
Brand name to be changed
Official monograph of probiotic blend is missing
Clarify if the firm has a probiotic section
Form 3 not signed stamped
Evidence of formulation required
389. Oral Biotic Chewable
Deferred due to the following deficiencies:
Official monograph of probiotic missing
Clarify if the firm has probiotic section
Form 3 not signed stamped
M/s SOIS Life Sciences (Pvt) Ltd (Eno 0090)
Plot No. A-84, S.I.T.E, Phase-I, Super Highway, Karachi
390. Cal D Deferred for further evaluation and clarification.
391. Winmax Deferred for further evaluation and clarification.
392. Curelin
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
Brand name to be changed
393. Nutra Junior
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
394. Pregnoease
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
Testing method of ginger extract required
Brand name to be changed
395. Ocu Vision + Plus
Deferred due to the following deficiencies:
Brand name to be changed
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
Contains herbs while the firm has no herbal sections
396. Enofam
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
F.No.10-8/2020-OTC) (M-80)
Page 37 of 144
S.No Brand name Decision
(1) (2) (3)
397. Cappy
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
Evidence of formulation required
398. C-Kas
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
399. Delife
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
Brand name to be changed
400. Nutra L Deferred for further evaluation and clarification.
401. Femixa
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
Evidence of formulation required
402. Epamol
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
403. Reeon
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
Evidence of formulation required
404. Ferfolate
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Official testing method of L-Methyl folate required
Label is missing
Evidence of fee submission required
405. Dal-C
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
406. Callus Deferred due to the following deficiencies:
F.No.10-8/2020-OTC) (M-80)
Page 38 of 144
S.No Brand name Decision
(1) (2) (3)
The firm as well as the field office Karachi may be directed to
clarify GMP status and production status of the firm
Label is missing
Evidence of fee submission required
407. Prunox
Deferred due to the following deficiencies:
The firm is directed to clarify GMP status and production status
of the firm
Label is missing
Evidence of fee submission required
Testing methods of herbal extracts required
M/s. Calgan Phyto Pharma (Pvt) Ltd.,00146
Plot No. 2, Green Park Road, Near Band Road Grid Station, Lahore
408. Urinal
Deferred due to the following deficiencies:
Brand name to be changed
Fee of herbal product i.e 250/- Rs submitted
Deferred till the finalization of policy regarding common
moelcules
409. E-Tizer
Deferred due to the following deficiencies:
Testing method of nepata cartaria required
Undertaking for safety required
410. Aborax Deferred due to the following deficiency:
Undertaking for safety required
411. Erapid Deferred due to the following deficiency:
Undertaking for safety required
412. Ov-Fert
Deferred due to the following deficiency:
Brand name to be changed
Fee of herbal product submitted while the product is
nutraceutical
413. Manadil
Deferred due to the following deficiencies:
Undertaking for safety required
Testing method of epimedium missing
414. Livon
Deferred due to the following deficiencies:
Testing method of glycyrrhiza extract and milk thistle extract
have been given while herb has been used
Testing methods of schisandra extract and Oregon grape extract
are missing
Undertaking for safety required
415. Vision
Deferred due to the following deficiencies:
Brand name to be changed
Undertaking for safety required
416. Menspro
Deferred due to the following deficiencies:
Testing of milk thistle extract is given while herb is used in
formulation
Undertaking for safety required
Greenworld Wholesales Co Pvt Ltd Rawalpindi
Mezzanine Floor, 29-B, Mid-City Mall, Main Murree Road, Rawalpindi
Agent of M/s World (Tianjin) Nutrition Health Food Co., Ltd., China
417. Glucoblock capsule Deferred for following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 39 of 144
S.No Brand name Decision
(1) (2) (3)
Breakup of fee is required.
Prescribed form 5 is required.
CoAs of raw materials and finished products are required on
principal manufacturer’s cover letter.
Manufacturing process is required.
Master formulation is required.
Accelerated and long term stability studies data conducted on
requirements of zone IV-A is required.
Packaging and labeling is required.
Manufacturing license is required.
Approval of product registration or marketing authorization in
country of origin is required.
GMP certificate of principal manufacturer by local regulatory
authority is required.
Free sale certificate in the country of origin is required.agency
agreement between importer and principal manufacturer is
required.
Last inspection report by local regulatory authority is required.
418. Spirulina Capsule
Deferred for following reasons:
Breakup of fee is required.
Prescribed form 5 is required.
CoAs of raw materials and finished products are required on
principal manufacturer’s cover letter.
Manufacturing process is required.
Master formulation is required.
Accelerated and long term stability studies data conducted on
requirements of zone IV-A is required.
Packaging and labeling is required.
Manufacturing license is required.
Approval of product registration or marketing authorization in
country of origin is required.
GMP certificate of principal manufacturer by local regulatory
authority is required.
Free sale certificate in the country of origin is required.
Agency agreement between importer and principal manufacturer
is required.
Last inspection report by local regulatory authority is required.
419. Hepatsure capsule
Deferred for following reasons:
Breakup of fee is required.
Prescribed form 5 is required.
CoAs of raw materials and finished products are required on
principal manufacturer’s cover letter.
Manufacturing process is required.
Master formulation is required.
Accelerated and long term stability studies data conducted on
requirements of zone IV-A is required.
Packaging and labeling is required.
Manufacturing license is required.
F.No.10-8/2020-OTC) (M-80)
Page 40 of 144
S.No Brand name Decision
(1) (2) (3)
Approval of product registration or marketing authorization in
country of origin is required.
GMP certificate of principal manufacturer by local regulatory
authority is required.
Free sale certificate in the country of origin is required.agency
agreement between importer and principal manufacturer is
required.
Last inspection report by local regulatory authority is required.
M/s. Hale Pharma, (Eno 00255)
B-Kh No. 285 Kh No. 570 Allah Hoo Industrial Estate, Allah Hoo Pul 22 Km Ferozpur Road, Lahore
420. Zee Cal Deferred due to the following deficiency:
Undertaking for brand name missing
421. Cal-Z
Deferred due to the following deficiency:
Undertaking for brand name missing
Brand name to be changed
422. Ten Days Deferred due to the following deficiency:
Undertaking for brand name missing
423. Ever 1
Deferred due to the following deficiencies:
Undertaking for brand name missing
Testing method of garlic powder missing
424. Azorox Tablet Deferred due to the following deficiency:
Undertaking for brand name missing
425. Malt-Max
Deferred due to the following deficiencies:
Undertaking for brand name missing
Testing method of iron bisglycinate missing
426. Poli-F
Deferred due to the following deficiencies:
Undertaking for brand name missing
Testing method of iron bisglycinate missing
427. Bone Zee
Deferred due to the following deficiencies:
Brand name to be changed
Undertaking for brand name missing
428. True Sip Deferred due to the following deficiency:
Undertaking for brand name missing
429. Myeloid Tablet
Deferred due to the following deficiencies:
Undertaking for brand name missing
Testing method of iron polymaltose missing
430. Jaxe Deferred due to the following deficiency:
Undertaking for brand name missing
431. Fast Vit
Deferred due to the following deficiencies:
Testing method of iron bisglycinate missing
Undertaking for brand name missing
M/s. Hiranis Pharmaceuticals (Pvt.) Ltd. (Eno 00174)
E-145-149, North Western Industrial Zone, Port Qasim, Karachi 75020
432. Asvin Deferred due to the following deficiency:
Official testing method of rutin is required
M/s. Medinoon Research Laboratories, (Eno 00156)
28-KM, Soay Assal Stop, Ferozepur Road, Lahore
433. Vim-D Deferred due to the following deficiencies:
F.No.10-8/2020-OTC) (M-80)
Page 41 of 144
S.No Brand name Decision
(1) (2) (3)
Undertakings of stability, brand name and content missing
Label missing
Brand name to be changed
434. Co Line
Deferred due to the following deficiencies:
Undertakings of stability, brand name and content missing
Label missing
435. Senses
Deferred due to the following deficiencies:
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
436. Telsium
Deferred due to the following deficiencies:
Undertakings of stability, brand name and content missing
Label missing
Deferred till the finalization of policy regarding common
molecules
437. Jelmin
Deferred due to the following deficiencies:
Undertakings of stability, brand name and content missing
Label missing
438. Ferbis
Deferred due to the following deficiencies:
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
439. Calmeg-Z
Deferred due to the following deficiencies:
Undertakings of stability, brand name and content missing
Label missing
440. Ris-D
Deferred due to the following deficiencies:
Undertakings of stability, brand name and content missing
Label missing
441. M-Cal
Deferred due to the following deficiencies:
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
442. Medivit-C
Deferred due to the following deficiencies:
Undertakings of stability, brand name and content missing
Label missing
443. Jemcal
Deferred due to the following deficiencies:
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
444. Xe Cor
Deferred due to the following deficiencies:
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
445. Xe Cor
Deferred due to the following deficiencies:
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
F.No.10-8/2020-OTC) (M-80)
Page 42 of 144
S.No Brand name Decision
(1) (2) (3)
446. Folcid
Deferred due to the following deficiencies:
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
447. Capsovit
Deferred due to the following deficiencies:
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
Deferred till the finalization of policy regarding common
molecules
448. Calmeg-Z
Deferred due to the following deficiencies:
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
449. Senses
Deferred due to the following deficiencies:
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
450. Maxvit-D Oral
Deferred due to the following deficiencies:
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
451. Medvit
Deferred due to the following deficiencies:
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
Deferred till the finalization of comments regarding common
molecules
452. Super Fit
Brand name to be changed
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
Contains common molecule; sodium bicarbonate
453. E-Ginko
Official testing methods of herbal extract required
Undertakings of stability, brand name and content missing
Label missing
454. Ferotab Undertakings of stability, brand name and content missing
Label missing
455. Vim-D
Deferred due to the following deficiencies:
Brand name to be changed
Undertakings of stability, brand name and content missing
Label missing
456. Femifrol
Deferred due to the following deficiencies:
Official testing methods of ingredients missing
Undertakings of stability, brand name and content missing
Label missing
M/s Millenium Laboratories (Eno 00274)
128/5, Shaikh Mohammad Raiz Road, Quaid-e-Azam, Industrial Estate Road, Kot Lakhpat, Lahore
F.No.10-8/2020-OTC) (M-80)
Page 43 of 144
S.No Brand name Decision
(1) (2) (3)
457. Multizanta Deferred for further evaluation and clarification.
458. Xpro Deferred for further evaluation and clarification.
459. Sb Fer Deferred for further evaluation and clarification.
460. Cinosil Deferred for further evaluation and clarification.
461. Mini Gold Junior Deferred for further evaluation and clarification.
462. Aminolive
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing methods of ingredients missing
Evidence of formulation required
Quantity of vitamin D in IU required
Vitamin A mentioned twice in formulation
463. Best D
Deferred due to the following deficiencies:
Evidence of receiving missing
Brand name to be changed
464. Bioglovit
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing method of grape seed extract and natural mixed
carotenoids required
465. Byzberi Deferred due to the following deficiency:
Evidence of receiving missing
466. Calceo D
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing method of iron bisglycinate required
467. Calceo D
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing methods of ingredients missing
468. Calceo
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing methods of ingredients missing
469. Colimox
Deferred due to the following deficiencies:
Evidence of receiving missing
Evidence of formulation required
Testing methods of ingredients missing
Deferred till the finalization of policy regarding common
molecules
470. Concieve Tablets
Deferred due to the following deficiencies:
Brand name to be changed
Evidence of receiving missing
Deferred till the finalization of policy regarding common
molecules
471. Crano Plus
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing method of elderberry extract required
472. Eco Gold Tablets
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing methods of ingredients missing
Contains herbs while firm does not possess herbal section
Evidence of formulation required
F.No.10-8/2020-OTC) (M-80)
Page 44 of 144
S.No Brand name Decision
(1) (2) (3)
473. Ecoba Tablets
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing methods of ingredients missing
Evidence of formulation required
474. Econa Tablets
Evidence of receiving missing
Testing methods of ingredients missing
Evidence of formulation required
The product contains herbs, whereas the firm does not possess
herbal section
475. Ozcal D Tablets
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing methods of ingredients missing
Evidence of formulation required
476. Ozcal D Syrup
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing method of iron protein succinate required
477. Ozorex Syrup Deferred for further evaluation and clarification.
478. Mac D Syrup
Deferred due to the following deficiencies:
Evidence of receiving missing
Justify quantity of omega 3
479. Minocal Syrup
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing methods of ingredients missing
Quantity of vitamin A and D in IU required
480. Multira Tablets
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing method of hydrolyzed marine collagen and grape seed
extract required
481. Occu Plus Tablets
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing methods of ingredients missing
482. Orra Forte Tablets
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing methods of ingredients missing
Quantities of ingredients per tablet required
Quantity of vitamin A in IU required
Evidence of formulation required
483. Sb Sure Powder
Deferred due to the following deficiencies:
Evidence of receiving missing
Testing methods of ingredients missing
Quantities per serving required
Justify formulation wrt energy, proteins, fats, carbohydrates
The firm has sachet section(not powder) whereas the packing
size mentions tin pack
484. Silbest Forte Tablets Deferred for further evaluation and clarification.
485. Tribex Tablets Deferred due to the following deficiencies:
Evidence of receiving missing
F.No.10-8/2020-OTC) (M-80)
Page 45 of 144
S.No Brand name Decision
(1) (2) (3)
Contains herbs with vitamins while the firm does not have
herbal sections
Polyfine Nutra-Sciences, Peshawar
Plot No. 39-40 D, Industrial Estate, Hayatabad, Peshawar
486. Flugo Liquid
Deferred for following reason(s):
Monographs of raw material testing and finished product testing
are missing.
Competitor / safety undertaking is missing.
487. Kofgo Liquid
Deferred for following reason(s):
Dose per 5ml/10ml is not provided.
Monographs of raw material testing and finished product testing
are missing.
Competitor / safety undertaking is missing.
488. Gikgofine Liquid
Deferred for following reason(s):
List of ingredients contain “Korean Ginseng” whereas testing
monograph provided is of “Powdered American Ginseng
Extract”.
Application is of a nutraceutical product whereas fee submitted
is 250/- rupees which is for herbal product
489. Brainwise Liquid
Deferred for following reason(s):
Ingredients provided in master formula are different from the
ones provided in Form-3 and master formula needs clarification.
Monographs of raw material testing and finished product testing
are not provided.
490. Kalzi Liquid
Deferred for following reason(s):
Ingredients not provided as per 5ml/10ml dose in the product
profile.
Monographs of finished product testing are not provided.
491. Gasvin Liquid
Deferred for following reason(s):
Monographs of Carum copticum, Valerana jatamansi,
Cinnamomum bark and Menths piperita are missing
Monographs of finished product testing are missing.
Competitor / safety undertaking is missing.
Dose per 5ml/10ml is not provided.
492. Fine Colic Liquid
Deferred for following reason(s):
Monographs of finished product testing are missing.
Competitor / safety undertaking is missing.
493. Q-Fex Liquid
Deferred for following reason(s):
Monographs of Licorice, Jujuba fruit, Hyssopus and Eucalyptus
oil are missing.
Monographs of finished product testing are missing.
Competitor / safety undertaking is missing.
494. Q-Kof Liquid
Deferred for following reason(s):
Monograph of Hyssopus officinale is missing.
Monograph of finished product testing are missing.
Competitor / safety undertaking is not provided.
495. Coflet Liquid Deferred for following reason(s):
Dose per 5ml/10ml is missing.
F.No.10-8/2020-OTC) (M-80)
Page 46 of 144
S.No Brand name Decision
(1) (2) (3)
Monographs on Ephedra vulgaris. Ziziphus vulgaris, Hyssopus
officinalis, Adiantum capillus, Mentha piperita, and Eucalyptus
globules are missing.
Monographs of finished product testing are missing.
Competitor / safety undertaking is missing.
496. Sunkof Liquid
Deferred for following reason(s):
Finished product testing monographs missing.
Competitor / safety undertaking is missing.
497. Resvoday Liquid
Deferred for following reason(s):
Application is of a nutraceutical product whereas fee submitted
is 250/- rupees which is for herbal product.
Monographs for finished product testing are not provided.
498. Kapec-Z Liquid
Deferred for following reason(s):
Monographs for raw material and finished product testinga re
missing.
Competitor / safety undertaking is missing.
499. Kao-Tin Liquid
Deferred for following reason(s):
Monographs of raw material testing and finished product testing
are missing.
Competitor / safety undertaking is missing.
Dose per 5ml/10ml is not provided.
500. Multiplus-L Liquid
Deferred for following reason(s):
Raw material testing monographs of Lysine and Inositol are not
provided.
Monographs of finished product testing are not provided.
501. Epicolic Liquid
Deferred for following reason(s):
Dose per 5ml/10ml is not provided
Monograph of Dill oil and anise oil are not provided.
Monographs of finished product testing are not provided.
Competitor / safety undertaking is not provided.
502. Episeek Liquid
Deferred for following reason(s):
Monographs of raw material testing and finished product testing
are missing.
Competitor / safety undertaking is missing.
503. Osteva Tablet
Deferred for following reason(s):
Product profile contains “Vitamin K1” whereas testing
monograph is provided for “Vitamin K3”.
504. Hivita Tablet
Deferred for following reason(s):
Monographs of Nicotinamide, Calcium Pantothenate, Vitamin
B1, Vitamin B6, Vitamin B12, and Folic acid are not provided.
505. Vitasun Liquid
Deferred for following reason(s):
Monographs of raw material testing and finished product testing
are missing.
Competitor / safety undertaking is missing.
506. Calroot Tablet Deferred for following reason(s):
Stability of zinc oxide in tablet dosage form is required.
507. Bex Gold Tablet Deferred for following reason(s):
F.No.10-8/2020-OTC) (M-80)
Page 47 of 144
S.No Brand name Decision
(1) (2) (3)
Product contains ingredients of herbal origin whereas firm does
not possess the herbal section.
508. Vilcal-D Tablet
Deferred for following reason(s):
Dose per tablet is missing.
Product profile contains “Vitamin K2” whereas testing
monograph is provided for “Vitamin K3”.
509. Kalfine Tablet
Deferred for following reason(s):
Product profile contains “Vitamin K2” whereas testing
monograph is provided for “Vitamin K3”
510. Hi-F Tablet
Deferred for following reason(s):
Quantities of active ingredients per tablet are not provided in
Form-3.
Raw material testing monograph of L-methyl folate is not
provided.
511. Viliron-F Tablet
Deferred for following reason(s):
Monograph of Iron (III) Hydroxide Polymaltose complex is
missing.
512. Enersitol Sachet Deferred till finalization of common molecules list.
513. Magfil Tablet Deferred for following reason(s):
Monograph of L-methyl folate is not provided
514. Introfer-F Tablet
Deferred for following reason(s):
Monograph of Iron (III) Hydroxy Polymaltose complex is not
provided
515. Fossa-D Tablet Deferred for following reason(s):
Dose per tablet is not provided.
516. Polyvit Tablet
Deferred for following reason(s):
Monographs of Iron, Magnesium, Copper and Manganese are
missing.
517. Bit-Folic 400 Tablet Deferred for submission of strength of elemental iron.
518. Ossgen chewable tablet
Deferred for following reason(s):
Product applied is a chewable tablet whereas on COA,
disintegration test results are given which are not performed for
chewable tablets.
519. Biosan liquid
Deferred for following reason(s):
Monograph of Dill oil, Chicorium intybus, Achillea millefolium,
Cassia occidentalis, and Tamarix gallica are missing.
Monographs of finished product testing are missing.
520. S-Lax syrup
Deferred for following reason(s):
Monograph of Prune Juice extract is not provided.
Formulation is herbal in nature whereas testing monograph for
Senna leaf prowdered extract is provided.
Competitor / safety undertaking is missing.
Finished product testing is missing.
521. Hepasun Syrup
Deferred for following reason(s):
Monographs for raw material testing and application on Form-3
contains ingredients in the form of standardized extracts
whereas fee submitted is for herbal product i.e. 250 rupees.
Monographs of finished product testing are missing.
F.No.10-8/2020-OTC) (M-80)
Page 48 of 144
S.No Brand name Decision
(1) (2) (3)
Competitor / safety undertaking is missing.
522. Evermax D Sachet
Deferred for following reason(s):
Monographs of raw material and finished product testing are
missing.
523. Calvion Tablet
Deferred for following reason(s):
Quantity of ingredients not provided as “quantity per tablet” in
the product profile.
524. Vilvita tablet
Deferred for following reason(s):
Monographs of Vitamin D, Vitamin E, Vitamin B1,
Nicotinamide, Vitamin B6, Vitamin B12, Calcium pantothenate,
Iron, Magnesium, Copper, Manganese, Calcium and folic acid
are missing.
525. Carlo-3 tablet Deferred for following reason(s):
Dose per tablet is missing.
526. Evermax-D Sachet
Deferred for following reason(s):
Monographs of raw material and finished product testing are
missing.
527. Enersitol sachet Deferred till finalization of common molecules list.
528. Ossgen chewable tablet Deferred for following reason(s):
Dose per tablet is missing.
529. Kapec –Z suspension
Deferred for following reason(s):
Monographs for raw material and finished product testing are
missing.
Competitor / safety undertaking is missing.
530. Kao-tin suspension
Deferred for following reason(s):
Monographs of raw material testing and finished product testing
are missing.
Competitor / safety undertaking is missing
Dose per 5ml/10ml is not provided.
531. Gasvin Syrup
Deferred for following reason(s):
Monographs of Carum copticum, Valerana jatamansi,
Cinnamomum bark and Menths piperita are missing
Monographs of finished product testing are missing.
Competitor / safety undertaking is missing.
Dose per 5ml/10ml is not provided.
M/s Novamed Healthcare,
28-KM, Ferozepur Road, Lahore
532. Vita Chewas Vita Deferred for further evaluation and clarification.
533. Vita A To Z tablets
Deferred for following reason(s):
Availability of softgel is required.
Monographs of all ingredients are required.
Strength of ingredients is required.
Form 3 is un-signed and un-stamped.
534. Vita E Capsule
Deferred for following reason(s):
Availability of soft gel is required.
Monograph of crodamol oil is required.
M/s Alpha Nutraceutical Research Laboratories
21/S, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
F.No.10-8/2020-OTC) (M-80)
Page 49 of 144
S.No Brand name Decision
(1) (2) (3)
535. Procid Syrup
Deferred for following reason(s):
Breakup of fee is required.
Monographs of all ingredients are required.
Solubility of calcium carbonate in syrup dosage form is
required.
Testing method of finished product is required.
536. Galdi-Fb Tablet Deferred for further evaluation and clarification.
M/s Novamed Healthcare,
28-KM, Ferozepur Road, Lahore
537. Fybol Sachet
Deferred for following reason(s):
Form 3 is un-signed and un-stamped.
Stability of vitamin D in sachet is required
538. Umvit Tablet
Deferred for following reason(s):
Form 3 is un-signed and un-stamped.
Monographs of ingredients are required.
Brand name needs to be changed.
M/s Izfaar Nutraceutical Industries
Sun Lane 7th Km, Sundar Raiwind Road, Lahore-Pakistan
539. Coffnol Liquid
Deferred for following reason(s):
Report regarding GMP compliance status is required.
Fee evidence is required.
Form 3 is without signature and stamp.
Ammonium chloride is added in common molecules list.
M/s Medi formers Neutraceutical
9-D Punjab Small Industrial Estate, 46-Km, District Kasur (Nutraceutical)
540. Omax Milk
Deferred for following reason(s):
Food supplement section alongwith its requirements are
required.
Dextrose is added in common molecules list.
Testing method of finished product is required.
Monograph/ testing specification of milk powder is required.
M/s Novamed Healthcare,
28-KM, Ferozepur Road, Lahore
541. Omega Bright Capsule
Deferred for following reason(s):
Monograph of salmon fish oil is required.
Brand name needs to be changed.
Form 3 is un-signed and un-stamped.
542. Cod Vit Capsules
Deferred for following reason(s):
Availability of soft gel section is required.
Form 3 is unsigned and un-stamped.
Undertaking regarding contents of dossier and brand name are
required.
Monograph of cod liver oil is required.
543. Coten – E Capsule
Deferred for following reason(s):
Monograph of ingredient is required.
Form 3 is un-signed and un-stamped.
544. Coten Capsule Capsule Deferred for further evaluation and clarification.
545. D3-Up Capsule Deferred for following reason(s):
F.No.10-8/2020-OTC) (M-80)
Page 50 of 144
S.No Brand name Decision
(1) (2) (3)
Availability of soft gel section is required.
Form 3 is unsigned and un-stamped.
Undertaking regarding contents of dossier and brand name are
required.
M/s Vega Pharmaceuticals (Pvt) Ltd,
Plot No. 4, Pharma City, 30-Km Multan Road, Lahore
546. Fovit Syrup
Deferred for following reason(s):
Monographs of all ingredients are required.
Stability of cyanocobalamin in syrup dosage form is required.
Brand name undertaking is required.
547. Fovit Plus Capsule
Deferred for following reason(s):
Monographs of all ingredients are required.
Stability of cyanocobalamin in syrup dosage form is required.
Brand name undertaking is required.
548. Fovit Capsule Deferred for further evaluation and clarification.
549. Glucho-Vit Tablet
Deferred for following reason(s):
Monographs of all ingredients are required.
Chondroitin and glucosamine are added in common molecules
list.
Brand name undertaking is required.
550. Osca-DTablet Deferred for further evaluation and clarification.
551. Osca-D Deferred for further evaluation and clarification.
552. Calcate Tablet Deferred for further evaluation and clarification.
553. Safe-D
Drop Deferred for further evaluation and clarification.
554. Safe-Ad
Drop Deferred for further evaluation and clarification.
555. Sach-C
Sachet Deferred for further evaluation and clarification.
556. Bio-10 Plus
Tablet Deferred for further evaluation and clarification.
557. Bio-10
Tablet Deferred for further evaluation and clarification.
558. Biogomad
Tablet Deferred for further evaluation and clarification.
559. Folvamin
Tablet Deferred for further evaluation and clarification.
560. Daid-P
Syrup Deferred for further evaluation and clarification.
561. Promise
Tablet Deferred for further evaluation and clarification.
562. Xtra Teen
Tablet Deferred for further evaluation and clarification.
563. Paids Pro
Deferred for further evaluation and clarification.
564. Cutcuo
Capsule Deferred for further evaluation and clarification.
565. Biocire Deferred for further evaluation and clarification.
F.No.10-8/2020-OTC) (M-80)
Page 51 of 144
S.No Brand name Decision
(1) (2) (3)
Capsule
566. Calviro
Sachet Deferred for further evaluation and clarification.
567. Sillin
Sachet Deferred for further evaluation and clarification.
568. Hns
Tablet Deferred for further evaluation and clarification.
569. Geriatic
Capsule Deferred for further evaluation and clarification.
570. Aenel
Tablet Deferred for further evaluation and clarification.
571. Post Meno
Capsule Deferred for further evaluation and clarification.
572. Necentum
Capsule Deferred for further evaluation and clarification.
573. Uricran
Sachet Deferred for further evaluation and clarification.
574. Uricran-D
Sachet Deferred for further evaluation and clarification.
575. Uri-Dm
Sachet Deferred for further evaluation and clarification.
576. Xanthin-M
Tablet Deferred for further evaluation and clarification.
577. Xanthin-M
Syrup Deferred for further evaluation and clarification.
578. Xanthi Plus
Tablet Deferred for further evaluation and clarification.
579. Xanthi Plus
Syrup Deferred for further evaluation and clarification.
580. Xanthi
Tablet Deferred for further evaluation and clarification.
581. Xanthi
Syrup Deferred for further evaluation and clarification.
M/s Wilshire Laboratories Pvt Ltd,
Plot No.5, Farooq Industrial Estate, 20-KM, Ferozepur Road, Lahore
582. Agnese Natural
Syrup
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
Differential fee is required.
583. Alcanlex D3
Suspension
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
584. Daze 10Mg (Enlisted As Sierra)
Tablet Deferred till finalization of common molecules list.
585. Exen-D Plus
Tablet
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
F.No.10-8/2020-OTC) (M-80)
Page 52 of 144
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is missing.
586. Iva
Syrup
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
Differential fee is required.
587. Naozit
Syrup
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
588. Nufol
Tablet
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
589. Vakid Oral
Drops
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing
590. Xiqrant
Capsule
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
Differential fee is required.
591. Zinish
Tablet
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
Differential fee is required.
M/s. Trends Pharmaceuticals (Nutraceuticals & Cam Division),
Plot 546/ 547, Sundar Industrial Estate, Lahore
592. Cintavit Syrup Deferred for further evaluation and clarification.
593. C-Motion Syrup
Deferred for following reason(s):
Solubility and stability profile of wheat dextrin fiber in syrup is
required.
Brand name needs to be changed.
594. Ferosa Syrup
Deferred for following reason(s):
Monograph of calcium pantothenate is required.
Stability of cyanocobalamin in syrup is required.
595. Ferosa Tablet Deferred for following reason(s):
Monograph of L-methyl folate is required.
596. Hepatren Tablet
Deferred for following reason(s):
Monographs of horny goat weed extract, tribulus terrestris
extract, miura pauma extract, macca root extract, yohimbe bark
extract and pine bark extract are required.
Testing method of finished product is required.
597. Inosifem Sachet Deferred till finalization of common molecules list.
598. Insotren Tablet Deferred for following reason(s):
F.No.10-8/2020-OTC) (M-80)
Page 53 of 144
S.No Brand name Decision
(1) (2) (3)
Monographs of tribulus extract, garlic extract and L-optic zinc
are required.
Justification/ clarification of formulation is required.
Testing method of finished product is required.
599. Mensotren Tablet
Deferred for following reason(s):
Monographs of sage extract, dong quai extract, chasteberry, red
raspberry powder, wild yam extract and trans resveroterol are
required.
Brand name needs to be changed.
Testing method of finished product is required.
600. Nokabz Syrup
Deferred for following reason(s):
Monographs of zingiber extract, tracyspermum ammi extract,
foeniculum extract and wheat dextrin fiber are required.
Brand name needs to be changed.
601. Osdura Syrup Deferred for following reason(s):
Stability of calcium citrate in syrup dosage form is required.
602. Plumtran Syrup
Deferred for following reason(s):
Monographs of folate, zinc citrate, chromium picolinate,
Vitamin B8, hesperidine, cranberry extract and amino acid
complex are required.
Per serving dose of syrup (5ml, 10ml) is required.
Stability of cyanocobalamin in syrup is required.
testing method of finished product is required.
Availability of filling machine upto 900ml is required.
603. Tralcar Tablet
Deferred for following reason(s):
Monographs of hawthrone berry extract, damiania leaf extract,
catuba bark extract, miura pauma, cuscuta seed extract and
horny goat weed leaf extract are required.
Testing method of finished product is required.
604. Trencough Syrup
Deferred for following reason(s):
Monograph of ivy leaf extract is required.
Brand name needs to be changed.
605. Trencough-S Syrup
Deferred for following reason(s):
Monographs of ivy leaf extract and morus nigra are required.
Brand name needs to be changed.
606. Trendgink Syrup
Deferred for following reason(s):
Monograph of salvia officinalis extract is required.
Testing method of finished product is required.
607. Trendgink Tablet
Deferred for following reason(s):
Monographs of huperzia serrate extract, liom’s mane extract,
acetyl L-carnitine and alpha GPC are required.
Caffeine is added in common molecules list.
Testing method of finished product is required.
608. Vistren Syrup
Deferred for following reason(s):
Stability of cyanocobalamin in syrup dosage form is required.
Availability of inductively coupled plasma-optical emission
spectrophotometry technique for determination of zinc content
is required.
F.No.10-8/2020-OTC) (M-80)
Page 54 of 144
S.No Brand name Decision
(1) (2) (3)
Testing method of finished product is required.
609. Orthotren Tablet
Syrup Deferred for further evaluation and clarification.
610. Omalac Sachet
Deferred for following reason(s):
Monographs of acetyl L-carnitine is required.
Stability of zinc oxide in oral powder/ granules is required.
Role of use of fructose in formulation is required.
611. Vistren Tablet Deferred for following reason(s):
Monographs of L-optic zinc is required.
612. Mooder Tablet
Deferred for following reason(s):
Fee evidence is required.
Caffeine is added in common molecules list.
Monographs of tyrosine, passion flower aerial part extract,
GABA, L-theanine, rhodiola root extract, chamomile flowere
extract are required.
Justification about formulation is required.
Testing method of finished product is required.
Brand name needs to be changed.
613. Trend Husk Sachet Deferred for following reason(s):
Monograph of green tea extract is required.
614. Osdura Sachet
Deferred for following reason(s):
Stability of cyanocobalamin, zinc oxide and copper sulphate in
sachet is required.
N-acetyl cysteine is added in common molecules list.
Testing method of finished product is required.
615. Qtren-50 Tablet
Deferred for following reason(s):
Monograph of bromelain is required.
Testing method of finished product is required.
Glucosamine and chondriotin are added in common molecules
list.
616. Qtren-100 Tablet Deferred for following reason(s):
Stability of DHA in tablet is required.
617. Nokabz Tablet
Deferred for following reason(s):
Monographs of oat fiber and fennel are required.
Justification regarding use of guar gum and acacia gum is
required as these ingredients are not supposed to be active
ingredients.
Brand name needs to be changed.
618. Femotren Tablet
Deferred for following reason(s):
N-acetyl cysteine is added in common molecules list.
Testing method of finished product is required.
M/s Orbit Natural, Rawalpindi
22-KM, Adyala Road, Rawalpindi
619. Repavil
Ointment Deferred for further evaluation and clarification.
620. Repagesic
Spray Deferred for further evaluation and clarification.
621. Repagesic Deferred for further evaluation and clarification.
F.No.10-8/2020-OTC) (M-80)
Page 55 of 144
S.No Brand name Decision
(1) (2) (3)
Ointment
622. Orifit Capsules
Deferred for following reason(s):
Monographs of glocomannan, tamarind seed extract and oak
galls are required.
Justification of formulation and its use is required.
623. Orimin
Tablet Deferred for further evaluation and clarification.
624. Calbone-D Tablet Deferred for following reason(s):
Signed shelf life data submission undertaking is required.
625. Nu-D3 Tablet Deferred for following reason(s):
Strength of vitamin D3 exceeds RDA and upper tolerable limit.
626. Osteopan Tablet
Deferred for following reason(s):
Monograph of vitamin K2 is required.
Brand name needs to be changed.
627. Calcip
Tablet Deferred for further evaluation and clarification.
628. Zer Tablet Deferred for following reason(s):
Monograph of di-calcium phosphate is required.
629. Orbit’S Citocholine Tablet
Deferred for following reason(s):
Monograph of citicholine is required.
Citicholine is added in common molecules list.
630. Multiplex
Tablet Deferred for further evaluation and clarification.
631. Mesub Tablet Deferred for following reason(s):
Monograph of methylcobalamin is required.
632. Nu Hope Tablet
Deferred for following reason(s):
Monographs of vitex agnus castus extract, cinnamon bark
extract, licorice root extract are required.
Stability of omega-3 in tablet dosage form is required.
Brand name needs to be changed.
633. Ori-Cough
Syrup Deferred for further evaluation and clarification.
634. Multiplex Syrup
Deferred for following reason(s):
Stability of zinc oxide in syrup is required.
Undertaking regarding contents of dossier and brand name are
un-signed.
Monograph of liquorice is required.
635. Iroglobin Plus Syrup
Deferred for following reason(s):
Monographs of iron bisglycinate and folic acid are required.
Brand name needs to be changed.
636. Oricid Syrup
Deferred for following reason(s):
Monographs of menthe piperata and emblica officinalis extract
are required.
637. Irogin Tablet
Deferred for following reason(s):
Monograph of iron bisglycinate is required.
Brand name needs to be changed.
638. Nurix Syrup Deferred for following reason(s):
F.No.10-8/2020-OTC) (M-80)
Page 56 of 144
S.No Brand name Decision
(1) (2) (3)
Monographs of ivy leaf extract, licorice, adhatoda vasica extract
and thyme are required.
Testing method of finished product is required.
639. Cufmed Syrup Deferred for following reason(s):
Monographs of all ingredients are required.
640. Hp-API Syrup
Deferred for following reason(s):
Monographs of all ingredients are required.
Brand name needs to be changed.
641. Dumax
Sachet Deferred for further evaluation and clarification.
642. Calcip Syrup Deferred for following reason(s):
Brand name needs to be changed.
643. Brain On Syrup
Deferred for following reason(s):
Monographs of panax ginseng, centella asiatica, piperine,
lavandula officinalis, medicago sativa, zinc, copper and sulphar
are required.
Brand name needs to be changed.
644. Procardin Capsules
Deferred for following reason(s):
Monograph of salvia miltirrhiza extract is required.
Brand name needs to be changed.
645. Nitrix
Capsules Deferred for further evaluation and clarification.
646. Menx Capsules
Deferred for following reason(s):
Monographs of all ingredients are required.
Brand name needs to be changed.
647. Regen Capsules
Deferred for following reason(s):
Monographs of all ingredients except for milk thistle extract are
required.
Testing method of finished product is required.
M/s Scotmann Pharmaceutical,
5-D, I-10/3 Industrial Area, Islamabad-Pakistan (Nutraceutical)
648. Sunny-D Pink Softgel
Deferred for following reason(s):
Stability of folic acid in softgel dosage form is required.
Brand name needs to be changed.
Form 3 is required.
Type/ kind of vitamin B12 is required
M/s Nutrimed Laboratories
Plot No. B-42, S.I.T.E. Super Highway, Karachi
649. Gartum Tablet Deferred for following reason(s):
Monograph of artichoke extract is required.
650. Colinorm Tablet
Deferred for following reason(s):
Availability of atomic absorption spectrophotometer is required
as firm claimed to perform test/ analysis of magnesium by such
technique.
Monographs of hawthorn extract and cleus forskohli extract and
Humulus lupulus extract are required.
651. Glymax Tablet Deferred for following reason(s):
F.No.10-8/2020-OTC) (M-80)
Page 57 of 144
S.No Brand name Decision
(1) (2) (3)
Stability of soybean extract (soy isoflavone) in tablet dosage
form is required.
652. Sinufit Tablet
Deferred for following reason(s):
Monographs of Echinacea root extract are required.
Justification of use of echinacea herb powder in health product
is required.
Brand name undertaking is un-signed.
653. Mori Vit Syrup
Deferred for following reason(s):
Monograph of moringa olifera extract is required.
Undertaking regarding brand name and contents of dossier are
required to be signed by owner/ CEO.
654. Garsona Tablet Deferred for following reason(s):
Brand name needs to be changed.
655. Spirula Tablet
Deferred for following reason(s):
Monograph of spirulina extract is required.
Form 3 is without owner/ CEO’s signature.
656. Healcar Tablet
Deferred for following reason(s):
Monographs of Ester C, soybean extract, L-methyl folate and
green tea extract are required.
Testing method of finished product is required.
Availability of atomic absorption spectrophotometer is required
as firm claimed to perform test/ analysis of magnesium by such
technique.
Stability of soy bean extract in tablet dosage form is required.
657. Ov Drone Sachet
Deferred for following reason(s):
Melatonin and N acetyl cysteine are added in common
molecules list.
Stability of vitamin D3 in powder/ granules dosage form is
required.
658. Elumax Effervescent Tablet
Deferred for following reason(s):
Fee evidence is required.
Monograph of cranberry extract is required.
Manufacturing method of formulation w.r.t Effervescent
(modification) is required.
659. Nutriva Effervescent Tablet Deferred for following reason(s):
Stability of cranberry liquid extract in tablet is required.
M/s Miksons Healthcare SMC (Pvt) Ltd,
Plot No.30&31, St. No. Central Road, RCCI, Rawat, Rawalpindi
660. Glamour Drink
Deferred for following reason(s):
Fee evidence is required.
Hyaluronic acid is added in common molecules list.
Signed and stamped form 3 is required.
Monographs of collagen, black current seed oil, biotin, zinc and
selenium are required.
Stability of selenium sulphide in oral dosage form is required.
Brand name needs to be changed.
661. Real Max Tablet Deferred for following reason(s):
Fee evidence is required.
F.No.10-8/2020-OTC) (M-80)
Page 58 of 144
S.No Brand name Decision
(1) (2) (3)
Signed and stamped form 3 is required.
Brand name needs to be changed.
662. Z-Sense Syrup
Deferred for following reason(s):
Zinc sulphate is added in common molecules list.
Fee evidence is required.
Signed and stamped form 3 is required.
M/s Viegen Pharma,
Plot No. 74-G, Sundar Industrial Estate, Sundar Raiwind Road, Lahore
663. Acurex-Br
Syrup Deferred for further evaluation and clarification.
M/s Sanofi aventis , Plot no.23, Sector no. 22, Korangi
664. Depura Plus Tablet Deferred for further evaluation and clarification.
M/s Neutra Cure,
SB-02 & 15, Sector 6-G, Korangi Township, Karachi
665. Neemed capsule
Deferred for following reason(s):
monograph of collagen is required.
Fee challan is endorsed by concerned division of DRAP.
form 3 is required to be signed by CEO/ owner.
M/s Mac & Rains Life Sciences Pvt Ltd, Lahore
537-A, Sunder Industrial Estate Lahore
666. Effer Tablet
Deferred for following reason(s):
signed and stamped form 3 is required.
Fee evidence is required.
Manufacturing process of effervescent dosage form is required.
Monographs of all ingredients are required.
Undertakings regarding brand name and contents of dossier are
required.
M/ Nutrimed Laboratories,
Plot No. B-42, S.I.T.E. Super Highway, Karachi
667. Revocep-D Sachet
Deferred for following reason(s):
Stability of vitamin D3 in powder/ granules is required.
Monographs of salts of zinc, magnesium and boron are required.
668. Nutri Vit Sachet
Deferred for following reason(s):
Dextrose is added in common molecules list.
Role of sodium chloride in formulation is required.
Justification of word “Ester C” is required.
Stability of vitamin D in powder/ granules is required.
Testing method of finished product is required.
669. Panto Vit Plus
Syrup Deferred for further evaluation and clarification.
M/s Scotmann Pharmaceutical, Islamabad
5-D, I-10/3 Industrial Area, Islamabad-Pakistan (Nutraceutical)
670. Folica Softgel 600mcg
Deferred for following reason(s):
Form 3 is required.
Monograph of quatrefolic (methyl tetrahydrofolate as
glucosamine salt) is required.
671. Folica Softgel Deferred for following reason(s):
Form 3 is required.
F.No.10-8/2020-OTC) (M-80)
Page 59 of 144
S.No Brand name Decision
(1) (2) (3)
Monograph of quatrefolic (methyl tetrahydrofolate as
glucosamine salt) is required.
M/s Izfaar Nutraceutical Industries, Lahore
Sun Lane 7th Km, Sundar Raiwind Road, Lahore-Pakistan
672. Diaranil Liquid
Deferred for following reason(s):
Kaolin is added in common molecules list.
Firm uses crude form of punica granatum, needs clarification.
Contents and brand name undertakings are required.
Monograph of pectin is required.
673. Cranfar Ut Sachet
Deferred for following reason(s):
Differential fee is required.
Prescribed form 3 is required.
Product profile shows that dosage form is capsule while
evidence of in-complete fee depicts that dosage form is sachet,
needs clarification.
Stability of cranberry liquid extract in sachet (powder/granules)
is required.
Contents and brand name undertakings are required.
674. Folaad Liquid
Deferred for following reason(s):
Signed and stamped form 3 is required.
Brand name needs to be changed.
Monograph of iron poylmaltose is required.
Signed and stamped undertakings regarding contents of dossiers
and brand name are required.
GMP compliance report needs to be submitted.
675. Hivit Liquid
Deferred for following reason(s):
Signed and stamped form 3 is required.
Monographs of calcium gluconate and magnesium oxide are
required.
Brand name needs to be changed.
Signed and stamped undertakings regarding contents of dossier
and brand name are required.
676. Fortamin Liquid
Deferred for following reason(s):
Signed and stamped form 3 is required.
Monographs of all ingredients are required.
Brand name needs to be changed.
Signed and stamped undertakings regarding contents of dossier
and brand name are required.
677. Cranfar Ut Capsule
Deferred for following reason(s):
Signed and stamped form 3 is required.
Monograph of cranberry extract is required.
Brand name needs to be changed.
Signed and stamped undertakings regarding contents of dossier
and brand name are required.
678. Tribufar Capsule
Deferred for following reason(s):
Brand name needs to be changed.
Signed and stamped form 3 is required.
F.No.10-8/2020-OTC) (M-80)
Page 60 of 144
S.No Brand name Decision
(1) (2) (3)
Monographs of tribulus terrestris, panax ginseng, agnus castus,
damiana are required.
Stability of zinc oxide in capsule dosage form is required.
Mac & Rains Life Sciences Pvt Ltd, Lahore
679. Makky J-Fit Tablet
Deferred for following reason(s):
Chondrointin and glucosamine are added in common molecules
list.
Signed and stamped form is required.
Stability of zinc oxide in tablet dosage form is required.
brand name needs to be changed.
Monographs of all ingredients are required.
Undertakings regarding brand name and contents of dossier are
required.
Nutrabiotics Nutritional Life Sciences, Peshawar
680. Concebir Capsule
Deferred for following reason(s):
N-acetyl cysteine is added in common molecules list.
Monograph of respective salt of zinc is required.
Testing method of finished product is required.
Brand name needs to be changed.
681. Meliski Tablet
Deferred for following reason(s):
Sodium alginate and sodium bicarbonate are added in common
molecules list.
Fee evidence is required.
Prescribed form 3 is required.
682. Genmax Capsule
Deferred for following reason(s):
Brand name needs to be changed.
Monograph of tribulus terrestris is required.
Testing method of finished product is required.
Prescribed form 3 is required.
Fee evidence is required.
683. Impedo Capsule
Deferred for following reason(s):
Monographs of all ingredients are required except for vitamin E
and zinc sulphate.
Testing method of finished product is required.
Brand name needs to be changed.
Fee evidence is required.
Prescribed form 3 is required.
684. Hustab Tablet
Deferred for following reason(s):
Fee evidence is required.
Prescribed form 3 is required.
Stability of psyllium husk in tablet dosage form is required.
685. Nutralax Tablet
Deferred for following reason(s):
Monographs of all ingredients are required.
Prescribed form 3 is required.
Fee evidence is required.
686. Nutragink Tablet
Deferred for following reason(s):
Prescribed form 3 is required.
Fee evidence is required.
F.No.10-8/2020-OTC) (M-80)
Page 61 of 144
S.No Brand name Decision
(1) (2) (3)
Brand name needs to be changed.
687. Nutralyte ORS sachet
Deferred for following reason(s):
Formulation is ORS, added in common molecules list.
Fee evidence is required.
Prescribed form 3 is required.
688. Motaran Capsule
Deferred for following reason(s):
Stability of cyanocobalamin in capsule is required.
Fee evidence is required.
Prescribed form 3 is required.
689. Algrace Tablet
Deferred for following reason(s):
Fee evidence is reduced.
Brand name needs to be changed.
Prescribed form 3 is required.
690. Tablet Cd-3 Tablet
Deferred for following reason(s):
Fee evidence is required.
Prescribed form 3 is required.
691. Qtenzyme Tablet
Deferred for following reason(s):
Fee evidence is reduced.
Undertakings regarding contents of dossier and brand name are
required.
Prescribed form 3 is required.
692. Nutralax Tablet
Deferred for following reason(s):
Fee evidence is required.
Prescribed form 3 is required.
Testing method of finished product is required.
Monographs of all ingredients are required.
Repetition of brand name is there.
693. Nutragink Syrup
Deferred for following reason(s):
Fee evidence is reduced.
Undertakings regarding contents of dossier and brand name are
required.
Prescribed form 3 is required.
694. Pydra-X Tablet
Deferred for following reason(s):
Potassium citrate is added in common molecules list.
Fee evidence is required.
Prescribed form 3 is required.
Monograph of ingredient is required.
Justification of use of methylene blue in dosage form is
required.
695. Figura Capsule
Deferred for following reason(s):
Monographs of garcinia combogia extract, green tea extract,
acaiberry extract and grape seed extract are required.
Prescribed form 3 is required.
Testing method of finished product is required.
Fee evidence is required.
696. Nutragest 240 Syrup Deferred for following reason(s):
F.No.10-8/2020-OTC) (M-80)
Page 62 of 144
S.No Brand name Decision
(1) (2) (3)
Monographs of bromelain, fennel extract, ginger extract,
chamomile extract, artichoke extract, noni extract and
peppermint extract are required.
Fee evidence is required.
Prescribed form 3 is required.
Testing method of finished product is required.
Papain and bromelain are added in common molecules list.
697. Xolestenil Capsule
Deferred for following reason(s):
Monographs of all ingredients are required except for calcium
carbonate and magnesium oxide.
Beta sitosterol is added in common molecules list.
Brand name needs to be changed.
Fee evidence is required.
Prescribed form 3 is required.
698. Nutradol Capsule
Deferred for following reason(s):
Prescribed form 3 is required.
Monographs of all ingredients are required.
Testing method of finished product is required.
Fee evidence is required.
699. Cranbio Sachet
Deferred for following reason(s):
Monograph of cranberry fruit extract is required.
Fee evidence is required.
Prescribed form 3 is required.
700. Tebonin Syrup
Deferred for following reason(s):
Monograph of gingko biloba is required.
Fee evidence is required.
701. Subcran Sachet
Deferred for following reason(s):
prescribed form 3 is required.
Monographs of cranberry extract is required.
Fee evidence is required.
702. Ezocid-H Syrup
Deferred for following reason(s):
Brand name mentioned on Form 3 is “ Ezocid-H sodium free
while brand name on FIFO list is “ Ezocid-H syrup, needs
clarification.
Sodium bicarbonate is added in common molecules list.
Fee evidence is required.
703. Nutrakuf Syrup
Deferred for following reason(s):
Monograph of ivy leaf extract is required.
Fee evidence is required.
Prescribed form 3 is required.
Brand name needs to be changed.
704. Spacid-G 120 Syrup
Deferred for following reason(s):
Fee evidence is reduced.
Prescribed form 3 is required.
Monographs of all ingredients in extract form are required.
Testing method of finished product is required.
Justification of rationale use of product is required.
Brand name needs to be changed.
F.No.10-8/2020-OTC) (M-80)
Page 63 of 144
S.No Brand name Decision
(1) (2) (3)
705. Nutramax 120
Syrup Deferred for further evaluation and clarification.
706. Ferrium Syrup
Deferred for following reason(s):
Stability of cyanocobalamin in syrup dosage form is required.
Fee evidence is required.
707. Moloir Capsule
Deferred for following reason(s):
Fee evidence is required.
Monographs of tribulus terrestris, chlorophytum extract and
pine bark extract are required.
Testing method of finished product is required.
708. Semenator Capsule
Deferred for following reason(s):
Stability of B12 in capsule dosage form is required.
Monographs of withania somnifera extract, mucuna pruriens
extract, CoQ10, angelica sinensis and quercetin are required.
Fee evidence is required.
Brand name needs to be changed.
Testing method of finished product is required.
709. Skrill Syrup Deferred for following reason(s):
Fee evidence is required.
710. Tebonin 240Ml
Syrup Deferred for further evaluation and clarification.
711. Xinc-10 Syrup
Deferred for following reason(s):
Zinc sulphate is added in common molecules list.
Fee evidence is required.
712. XLE Capsule
Deferred for following reason(s):
Monographs of ginseng extract, chlorophytum borivillianum
extract, damiana and piperine are required.
Stability of cyanocobalamin in capsule dosage form is required.
Brand name needs to be changed.
713. Zelac Syrup
Deferred for following reason(s):
Monograph of prune juice concentrate is required.
Fee evidence is required.
714. Colifix Syrup
Deferred for following reason(s):
Monographs of zinger officinale extract, fennel, carium
copticum and chamomile are required.
Fee evidence is required.
715. Enduros Capsule
Deferred for following reason(s):
Monographs of tribulus terristris extract, chlorophytum extract,
pink bark extract and yohimbe bark extract are required.
Stability of cyanocobaamin in capsule dosage form is required.
Brand name needs to be changed.
716. Luzeb Tablet
Deferred for following reason(s):
fee evidence is required.
N-acetyl cysteine is added in common molecules list.
Monographs of bilberry fruit extract and citrus bioflavonioids
are required.
717. Profemin Syrup Deferred for following reason(s):
Stability of cyanocobalamin in syrup dosage form is required.
F.No.10-8/2020-OTC) (M-80)
Page 64 of 144
S.No Brand name Decision
(1) (2) (3)
Monograph of vitamin K2 is required.
Testing method of finished product is required.
718. Coen-10 Tablet Deferred for following reason(s):
Fee evidence is required.
719. Algrace Syrup
Deferred for following reason(s):
Brand name needs to be changed.
Fee evidence is required.
720. Boncal-Z Syrup Deferred for following reason(s):
Fee evidence is required.
721. Calzia-3 Syrup Deferred for following reason(s):
Fee evidence is required.
722. Cidonil Syrup
Deferred for following reason(s):
Sodium bicarbonate is added in common molecules list.
Fee evidence is required.
723. Diod Tablet
Deferred for following reason(s):
Fee evidence is required.
Brand name needs to be changed.
724. Dorix Syrup Deferred for following reason(s):
Fee evidence is required.
725. Doraim Capsule
Deferred for following reason(s):
Fee evidence is required.
Monographs of tribulus extract, ginseng, withania somnifera
piper nigrum and chlorophytum are required.
726. Dutra Tablet
Deferred for following reason(s):
Fee evidence is required.
Form 3 to be revised w.r.t “5ml” as serving dose in tablet
dosage form.
727. Feriset F Syrup Deferred for following reason(s):
Fee evidence is required.
728. Feriset F Tablet Deferred for following reason(s):
Fee evidence is required.
729. Heptorack Syrup
Deferred for following reason(s):
Fee evidence is required.
Silymarin is added in common molecules list.
Brand name needs to be changed.
730. Heptorack Tablet
Deferred for following reason(s):
Monographs of silymarin and co-enzyme Q10 are required.
Brand name needs to be changed.
Fee evidence is required.
731. Impedo Plus Capsules
Deferred for following reason(s):
Monographs of chlorophytum extract and pine bark extract are
required.
Fee evidence is required.
732. Jointcalm Tablet
Deferred for following reason(s):
Fee evidence is required.
Glucosamine and chondroitin are added in common molecules
list.
Brand name needs to be changed.
F.No.10-8/2020-OTC) (M-80)
Page 65 of 144
S.No Brand name Decision
(1) (2) (3)
733. Kaybone Syrup
Deferred for following reason(s):
Fee evidence is required.
Brand name needs to be changed.
734. Kaybone Tablet
Deferred for following reason(s):
Fee evidence is required.
Brand name needs to be changed.
735. Mintacid Syrup
Deferred for following reason(s):
Sodium bicarbonate is added in common molecules list.
Fee evidence is required.
736. Mioter Tablet
Deferred for following reason(s):
Stability of omega 3 fish protein in tablet dosage form is
required.
Fee evidence is required.
737. Multimine Tablet
Deferred for following reason(s):
Stability of omega 3 fish protein in tablet dosage form is
required.
Fee evidence is required.
738. Neocalvit Syrup Deferred for following reason(s):
Fee evidence is required.
739. Neocalvit Tablet Deferred for following reason(s):
Fee evidence is required.
740. Nacul-C
Sachet Deferred for further evaluation and clarification.
741. Nucal-C Tablet
Deferred for following reason(s):
Sodium bicarbonate is added in common molecules list.
Fee evidence is required.
742. Pregnamin Tablet
Deferred for following reason(s):
Stability of cyanocobalamin and magnesium oxide in tablet
dosage form is required.
Brand name needs to be changed.
Fee evidence is required.
743. O2-Plex Tablet
Deferred for following reason(s):
Stability of zinc oxide in tablet dosage form is required.
Brand name needs to be changed.
Fee evidence is required.
744. Perfecare Tablet
Deferred for following reason(s):
Monograph of chromium is required.
Fee evidence is required.
Testing method of finished product is required.
745. Perfective Capsule
Deferred for following reason(s):
Monograph of vitamin B12 is required.
Fee evidence is required.
Testing method of finished product is required.
746. Potencia Capsule
Deferred for following reason(s):
Monographs of chlorophytum extract and tribulus terrestris
extract are required.
Brand name needs to be changed.
Fee evidence is required.
F.No.10-8/2020-OTC) (M-80)
Page 66 of 144
S.No Brand name Decision
(1) (2) (3)
747. Romical Syrup Deferred for following reason(s):
Fee evidence is required.
748. V-Minta Tablet
Deferred for following reason(s):
Monographs of all ingredients in extract form are required.
Fee evidence is required.
749. Volic Tablet Deferred for following reason(s):
Fee evidence is required.
750. Zoid Plus Tablet
Deferred for following reason(s):
Monograph of bacopa monniera is required.
Fee evidence is required.
751. Zoid Syrup
Deferred for following reason(s):
Monograph of gingko biloba extract is required.
Fee evidence is required.
752. Brona Syrup
Deferred for following reason(s):
Monograph of ivy leaf extract is required.
Fee evidence is required.
753. Apti-Up Syrup
Deferred for following reason(s):
Stability of cyanocobalamin in syrup dosage form is required.
Brand name needs to be changed.
Fee evidence is required.
754. Apeton Syrup
Deferred for following reason(s):
Fee evidence is required.
Stability of cyanocobalamin in syrup dosage form is required.
755. Cal-3 Tablet
Deferred for following reason(s):
Monograph of boron is required.
Brand name needs to be changed.
Fee evidence is required.
756. D-Cuf Syrup
Deferred for following reason(s):
Monograph if ivy leaf extract is required.
Fee evidence is required.
757. Nutracid Syrup
Deferred for following reason(s):
Sodium bicarbonate is added in common molecules list.
Fee evidence is required.
758. Vitacare-F Syrup
Deferred for following reason(s):
Stability of cyanocobalamin in syrup dosage form is required.
Fee evidence is required.
759. Nutramax Syrup Deferred for following reason(s):
Fee evidence is required.
760. Everslim Capsule
Deferred for following reason(s):
Monographs of garcinia extract, acaiberry extract and hoodia
gordonii extract are required.
Brand name needs to be changed.
Testing method of finished product is required.
Fee evidence is required.
Prescribed form 3 is required.
761. Zigot
Capsule Deferred for further evaluation and clarification.
762. Demento Syrup Deferred for following reason(s):
F.No.10-8/2020-OTC) (M-80)
Page 67 of 144
S.No Brand name Decision
(1) (2) (3)
Brand name needs to be changed.
Fee evidence is required.
Eon Pharmacy, Karachi
Plot No. A/150, Sector 11-E, New Karachi
763. Florazyme Syrup Deferred till finalization of fate of common molecules being dealt by
H&OTC Division and PER Division.
764. Arcolic Syrup Differed due to following reasons:
Breakage of fee is required.
765. Folibion Drops
Differed due to following reasons:
Breakage of fee is required.
Rationale for 10mcg dose per drop of folic acid in drops dosage
form.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
766. Saferva Tablet
Differed due to following reasons:
Breakage of fee is required.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
767. Milk Safe Supplement Powder
Differed due to following reasons:
Breakage of fee is required.
Change of brand name is required.
Stability of cyanocobalamin, zinc oxide and selenium sulfide in
oral powder dosage form is required.
Monographs of L-methylfolate, Vitamin K1 USP
(Phylloquinone) and iron bisglycinate are required.
Strength of elemental manganese is required.
Clarification is required for ingredient “Calcium carbonate”,
firm mentioned its common name as “Molybdenum” on form-3.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
768. Laxosafe Syrup
Differed due to following reasons:
Breakage of fee is required.
Safety undertaking is required.
Brand name needs to be changed.
Official monograph mentioning the testing specification of
Prunus Domestica Extract (prune juice) is required
Since the product seems to be nutraceutical the firm is directed
to submit an undertaking stating that the product “Laxosafe”
will only be manufactured either in nutraceutical facility or
herbal facility in order to comply GMP.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
769. Gink Safe Syrup
Differed due to following reasons:
Breakage of fee is required.
Brand name needs to be changed.
Monographs of Ginko Biloba Extract and Withania somnifera
extract are required.
F.No.10-8/2020-OTC) (M-80)
Page 68 of 144
S.No Brand name Decision
(1) (2) (3)
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
770. Anacid Syrup
Differed due to following reasons:
Breakage of fee is required.
Safety undertaking is required.
Brand name needs to be changed.
771. Urigon Syrup
Differed due to following reasons:
Brand name needs to be changed.
Safety undertaking is required.
Breakage of fee is required.
Monograph of Artimisia (Mugwort) is required.
772. Gynosue Syrup
Differed due to following reasons:
Fifo list name is gynosue however name on from-3 is Gyno
Cure Syrup. Clarification is required.
Breakage of fee is required.
Safety undertaking is required.
773. Felxus Tablet
Differed due to following reasons:
Breakage of fee is required.
Brand name needs to be changed.
Zinc oxide stability is required in oral tablet dosage form.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
774. Urimac Syrup
Differed due to following reasons:
Breakage of fee is required.
Safety undertaking is required.
Brand name needs to be changed.
Monographs of Betula penula (BP), Curcuma longa (BP) and
Salvia rosmarinus (BP) are required.
775. Gasnol Sf Syrup
Differed due to following reasons:
Breakage of fee is required.
Safety undertaking is required.
Brand name needs to be changed.
Monographs of Betula penula (BP), Curcuma longa (BP) and
Salvia rosmarinus (BP) are required.
776. Arsal Baby Balm
Differed due to following reasons:
Breakage of fee is required.
Safety undertaking is required.
Brand name needs to be changed.
Conversion of strengths is required.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
777. Arsal Balm
Differed due to following reasons:
Breakage of fee is required.
Safety undertaking is required.
Brand name needs to be changed.
Conversion of strengths is required.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
F.No.10-8/2020-OTC) (M-80)
Page 69 of 144
S.No Brand name Decision
(1) (2) (3)
778. Arsal Junior Cough Syrup
Differed due to following reasons:
Breakage of fee is required.
Safety undertaking is required.
Brand name needs to be changed.
Monograph of Morus nigra (Mulberry) is required.
779. Diarro Syrup
Differed due to following reasons:
Breakage of fee is required.
Brand name needs to be changed.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
780. Gasnol Plain Syrup
Differed due to following reasons:
Breakage of fee is required.
Safety undertaking is required.
Brand name needs to be changed.
781. Eon’s Toot Siyah Syrup
Differed due to following reasons:
Breakage of fee is required.
Safety undertaking is required.
Monograph of Morus nigra (Mulberry) is required.
782. Feroplex Syrup
Differed due to following reasons:
Breakage of fee is required.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
Cyanocobalamin stability in syrup dosage form is required.
Strength of elemental zinc is required.
783. Vita Diet Tablet
Differed due to following reasons:
Breakage of fee is required.
Brand name needs to be changed.
Zinc oxide stability is required in oral tablet dosage form.
Monographs of Pantothenic acid and Iron bisglycinate are
required.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
784. Vita Diet Drops
Differed due to following reasons:
Breakage of fee is required.
Revise the form -3 w.r.t. monograph/specification of active.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
785. Eg Card Syrup
Differed due to following reasons:
Breakage of fee is required
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
Monographs of Pantothenic acid and Iron bisglycinate are
required.
786. Sinofer Tablet
Differed due to following reasons:
Breakage of fee is required.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
Monograph of iron bisglycinate is required.
F.No.10-8/2020-OTC) (M-80)
Page 70 of 144
S.No Brand name Decision
(1) (2) (3)
787. Eg Card
Syrup In duplication of product mentioned against serial number 1361
788. Sinofer
Tablet In duplication of product mentioned against serial number 1362
789. Eden Lac Powder
Differed due to following reasons:
Label of product doesn’t correlate with the product applied in
sachet dosage fomr need clarification.
Magnesium Oxide, Zinc oxide and selenium sulfide stability is
required in oral dosage form.
Monographs of L-methylfolate and iron bisglycinate are
required.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
790. Multi Need Syrup
Differed due to following reasons:
Breakage of fee is required.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
Monograph of fish oil powder (providing omega 3 fatty acids,
EPA and DHA) is required, as the provided one is for omega - 3
acid ethyl esters.
791. Multi Need Tablet
Differed due to following reasons:
Breakage of fee is required.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
Zinc oxide and selenium sulfide stability is required in oral
tablet dosage form.
Monographs of Vitamin A and iron bisglycinate are required.
Vitamin K exceeds RDA and upper tolerable limits.
Dose of elemental zinc (being border line on upper tolerable
limit) needs to be adjusted w.r.t. to labeled claimed daily dose
(submitted by the firm) i.e. 1-2 tablets per day.
Justification regarding use of sodium in the formulation is
required.
Strength of elemental boron used in the formulation as sodium
borate is required.
792. Karmin Syrup
Differed due to following reasons:
Breakage of fee.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
Monograph of Chicorium intybus, Trigonella foenum-graecum,
Zingiber officinale and Manganese gluconate
793. Eden Cid Syrup
Differed due to following reasons:
Breakage of fee.
Monograph of all the ingredients except calcium carbonate in
extract form are required.
Calcium carbonate monograph also required.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
F.No.10-8/2020-OTC) (M-80)
Page 71 of 144
S.No Brand name Decision
(1) (2) (3)
794. Sinofer Syrup
Differed due to following reasons:
Breakage of fee is required.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
Monograph of iron bisglycinate is required.
Cyanocobalamin stability in syrup dosage form is required.
795. Arofen Herbal Syrup
Differed due to following reasons:
Breakage of fee is required.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
Common name of Ammonium chloride i.e. Noshadar to be used
in formulation and revised form-3 is required accordingly.
796. Minovit Syrup
Differed due to following reasons:
Breakage of fee is required.
Product specific testing (chemical) parameters of finished
product including chemical assay are required.
Stability of Selenium sulfide in oral syrup dosage form.
Miksons Healthcare SMC (Pvt) Ltd, Islamabad
797. Tressmet Syrup
Deferred for following reason(s):
fee evidence is required.
Monographs of cardamom oil, piper longum extract, emblica
officinale extract and vitamin A are required.
Testing method of finished product is required.
798. Hapicalm Syrup
Deferred for following reason(s):
fee evidence is required.
Brand name needs to be changed.
Silymarin is added in common molecules list.
Monograph of taraxacum officinale extract is required.
799. Hapicalm Tablet
Deferred for following reason(s):
Fee evidence is required.
Brand name needs to be changed.
Silymarin is added in common molecules list.
Monograph of taracum officinale extract is required.
M/s. The Searle Company Limited,
First Floor, N.I.C.L Building, Abbasi Shaheed Road, P.O. Box 5696, Karachi-75530
800. Gutcare sachet Deferred for further evaluation and clarification.
Phytocon International Private Limited, Lahore
801. Octafol Capsule
Deferred for following reason(s):
Monographs of pyridoxine and DHA (omega 3) are required.
Signature of owner/ CEO on form 3 is required.
Differential fee is required.
802. Arthrix Tablet Tablet
Deferred for following reason(s):
Glucosamine and chondroitin are added in common molecules
list.
Signature of owner/ CEO on form 3 is required.
803. X+Ovi Tablet Tablet
Deferred for following reason(s):
Differential fee is required.
Monograph of L-methyl folate is required.
F.No.10-8/2020-OTC) (M-80)
Page 72 of 144
S.No Brand name Decision
(1) (2) (3)
Brand name needs to be changed.
Izfaar Nutraceutical Industries, Lahore
804. Listro Liquid
Deferred for following reason(s):
Methyl salicylate is added in common molecules list.
The product is intended for cosmetics purpose.brand name
needs to be changed.
Undertakings regarding brand name and contents of dossier are
required.
Eon Pharmacy, Karachi
805. Pepikal Syrup
Deferred for following reason(s):
Sodium bicarbonate and sodium alginate are added in common
molecules list.
M/s Alpha Nutraceutical Research Laboratories
21/S, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahor
806. Neustim Syrup
Deferred for following reason(s):
Differential fee is required.
Source of amino acid is required and clarification is required
which type of amino acids are used and testing method also
required accordingly.
Monograph of magnesium is required.
Signature of owner/ CEO on form 3 is required.
M/s Wilshire Laboratories Pvt Ltd, Lahore
Plot No.5, Farooq Industrial Estate, 20-KM, Ferozepur Road, Lahore
807. Thiavit
Tablet
Deferred for following reason(s):
Original Form-3 is missing.
Fee slip is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
808. Biot
Tablet
Deferred for following reason(s):
Original Form-3 is missing.
Fee slip is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
809. Ribovit
Tablet
Deferred for following reason(s):
Original Form-3 is missing.
Fee slip is not provided.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
810. Argin 3Gm
Sachet
Deferred for following reason(s):
Original Form-3 is missing.
Fee slip is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
811. Argin 1Gm
Sachet
Deferred for following reason(s):
Original Form-3 is missing.
Fee slip is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
F.No.10-8/2020-OTC) (M-80)
Page 73 of 144
S.No Brand name Decision
(1) (2) (3)
812. Careon 3Gm
Sachet
Deferred for following reason(s):
Original Form-3 is missing.
Fee slip is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
813. Careon 1Gm
Sachet
Deferred for following reason(s):
Original Form-3 is missing.
Fee slip is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
814. Thiavit
Syrup
Deferred for following reason(s):
Original Form-3 is missing.
Fee slip is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
815. Ribovit
Syrup
Deferred for following reason(s):
Original Form-3 is missing.
Fee slip is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
816. Soben Syrup
Syrup
Deferred for following reason(s):
Original Form-3 is missing.
Fee slip is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
AR Nutraceutical Pharma, Karachi
817. Zinkor Plus Syrup Deferred for following reason(s):
Monograph of banana root extract is required.
818. Malexeed Sachet
Deferred for following reason(s):
Monographs of selenomethionine, L-citruline and L-ornithine
are required.
Testing method of finished product is required.
819. Aptilex-B Syrup
Deferred for following reason(s):
Monographs of all ingredients are required.
Form 3 is un-signed and un-stamped.
Per serving dose (5ml or 10ml) is required.
820. Neurotone
Syrup Deferred for further evaluation and clarification.
821. Gain-D
Tablet Deferred for further evaluation and clarification.
822. Save-Baby
Drops Deferred for further evaluation and clarification.
823. Femi-Care Tablet
Deferred for following reason(s):
Monographs of smilax china extract and areca catechu are
required.
Fee evidence is required.
Brand name needs to be changed.
Testing method of finished product is required.
F.No.10-8/2020-OTC) (M-80)
Page 74 of 144
S.No Brand name Decision
(1) (2) (3)
824. Life-Carrient Sachet
Deferred for following reason(s):
The firm does not possess probiotic section.
Stability of zinc oxide in sachet is required.
825. Essen-D Drop
Deferred for following reason(s):
Monograph of vitamin D3 is required.
Pack size is required.
Brand name needs to be changed.
826. Deracuf Syrup
Deferred for following reason(s):
Monographs of all ingredients are required.
Fee evidence is required.
827. Cranze Sachet
Deferred for following reason(s):
Monograph of cranberry extract is required.]
Stability of zinc oxide in sachet dosage form is required.
828. Adon Drop
Deferred for following reason(s):
Availability of drop filling machine is required.
Form-3 is un-stamped and un-signed.
Pack size is required.
Fee evidence is required.
829. Vitalife Tablet
Deferred for following reason(s):
Monograph of vitamin K2 is required.
Brand name needs to be changed.
M/s Wilshire Laboratories Pvt Ltd, Lahore
Plot No.5, Farooq Industrial Estate, 20-KM, Ferozepur Road, Lahore
830. Calci Vit
Tablet
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
Wrong fee is submitted i.e. 250 rupees is submitted for
nutraceutical product.
831. Calci Vit Plus
Tablet
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
Wrong fee is submitted i.e. 250 rupees is submitted for
nutraceutical product.
832. Bio Vit
Tablet
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
Wrong fee is submitted i.e. 250 rupees is submitted for
nutraceutical product.
833. D-Flor
Capsule
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
Wrong fee is submitted i.e. 250 rupees is submitted for
nutraceutical product.
834. Ferti-W Deferred for following reason(s):
F.No.10-8/2020-OTC) (M-80)
Page 75 of 144
S.No Brand name Decision
(1) (2) (3)
Capsule Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
Wrong fee is submitted i.e. 250 rupees is submitted for
nutraceutical product.
835. B-12 1000Mcg
Capsule
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
Wrong fee is submitted i.e. 250 rupees is submitted for
nutraceutical product.
836. Penemia
Capsule
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
Wrong fee is submitted i.e. 250 rupees is submitted for
nutraceutical product.
837. Qubenza
Capsule
Deferred for following reason(s):
Original Form-3 is missing.
Documents required as per Form-3 are not provided.
Brand name undertaking is missing.
Wrong fee is submitted i.e. 250 rupees is submitted for
nutraceutical product.
M/s Izfaar Nutraceutical Industries,
Sun Lane 7th Km, Sundar Raiwind Road, Lahore-Pakistan
838. Icough Rex Liquid
Deferred for following reason(s):
Monograph of piper longum extract is required.
Brand name needs to be changed.
Testing method of finished product is required.
Signed and stamped undertakings regarding contents of dossier
and brand name are required.
839. Pepragem Liquid
Deferred for following reason(s):
Sodium bicarbonate is added in common molecules list.
Monograph of cardamom oil is required.
Signed and stamped form 3 is required.
Signed and stamped undertakings regarding contents of dossier
and brand name are required.
840. M. Vit Liquid
Deferred for following reason(s):
Signed and stamped form 3 is required.
Monographs of all ingredients are required.
Brand name needs to be changed.
Signed and stamped undertakings regarding contents of dossier
and brand name are required.
841. Belgeri Powder
Deferred for following reason(s):
Brand name needs to be changed.
Signed and stamped form 3 is required.
Monograph of aegle marmelos extract is required.
F.No.10-8/2020-OTC) (M-80)
Page 76 of 144
S.No Brand name Decision
(1) (2) (3)
Signed and stamped undertakings regarding contents of dossier
and brand name are required.
M/s Hiranis Pharmaceuticals (Pvt) Limited,
E-145-149, North Western Industrial Zone, Port Qasim, Karachi 75020
842. Neevo Drops
Deferred for following reason(s):
stability of cyanocobalamin in oral drop is required.
Stability of zinc oxide in oral dosage form is required.
Monographs of vitamin B3, pantothenic acid, iron, lysine and
malt extract are required.
843. Min-D 2000 I.U Sachet
Deferred for following reason(s):
Firm applied on form 4 without clinical evidence, needs
justification.
Stability of vitamin D in powder/ granules is required.
844. Min-D 4000 I.U Sachet
Deferred for following reason(s):
Firm applied on form 4 without clinical evidence, needs
justification.
Stability of vitamin D in powder/ granules is required.
845. Urisan Sachet
Deferred for following reason(s):
Firm applied on form 4 without clinical evidence, needs
justification.
846. Uticleanse Sachet
Deferred for following reason(s):
Firm applied on form 4 without clinical evidence, needs
justification.
Brand name needs to be changed.
847. Zeplate DHA 7.5Mg Tablet
Deferred for following reason(s):
Monograph of DHA is required.
Brand name needs to be changed.
848. Hilyte Sachet Deferred for following reason(s):
ORS is added in common molecules list.
M/s Calgan Phyto Pharma Pvt Ltd,
Plot No. 2, Green Park Road, Near Band Road Grid Station, Lahore
849. Kofless Tablet
Deferred for following reason(s):
Fee evidence is required.
Justification of 2 tablets per serving is required.
Monograph of ivy leaf extract is required.
850. Armax Tablet
Deferred for following reason(s):
Fee evidence is required.
Monograph of ginger extract is required.
M/s AR Nutraceutical Pharma, Karachi
Plot No. F-4/C, S.I.T.E., Phase-II, Super Highway, Karachi
851. Xseed Tablet
Deferred for following reason(s):
Fee evidence is required.
Form 3 is unsigned and unstamped.
Monograph of pycogenol is required.
Brand name needs to be changed.
Signed and stamped undertakings regarding contents of dossier
and brand name are required.
852. Mecfem Tablet Deferred for following reason(s):
F.No.10-8/2020-OTC) (M-80)
Page 77 of 144
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Monographs of all ingredients are required except for vitamin
D, chromium piconilate, magnesium oxide, L-carnitine and
arginine.
Testing method of finished product is required.
853. Vegrite-X Tablet
Deferred for following reason(s):
Signed and stamped Form 3 is required.
Monographs of tribulus extract, Korean ginseng and zinc
chelated are required.
Testing method of finished product is required.
Brand name needs to be changed.
Fee evidence is required.
854. AP Conception Sachet
Deferred for following reason(s):
Fee evidence is required.
N-acetyl custeine is added in common molecules list.
Monographs of Acetyl L-carnitine, arginine, iron salt and
selenium salt are required.
Stability of zinc oxide and vitamin B12 in sachet dosage form is
required.
Brand name needs to be changed.
855. Memrite Tablet Deferred for following reason(s):
Monograph of medicago sativo is required.
856. Rositol Sachet
Deferred for following reason(s):
Fee evidence is required.
Monograph of chiro-inositol is required.
Signed and stamped undertakings regarding contents of dossier
and brand name are required.
857. Calci-4 Tablet
Deferred for following reason(s):
Signed and stamped form 3 is required.
Signed and stamped undertakings regarding contents of dossier
and brand name are required.
858. Heracal-D Tablet
Deferred for following reason(s):
Signed and stamped form 3 is required.
Monograph of collagen is required.
Stability of zinc oxide in tablet dosage form is required.
859. Faliq Aid Tablet
Deferred for following reason(s):
Fee evidence is required.
Form 3 is unsigned and unstamped.
Product file bears name “ faliq acid” while brand name given on
form 3 is “ Heracal-D tablets, needs clarification.
Signed and stamped undertaking regarding contents of dossier
And brand name are required.
860. Germixeed Tablet
Deferred for following reason(s):
Fee evidence is required.
Monographs of all ingredients are required except for L-
carnitine, arginine, Vitamin C, folic acid and vitamin B12.
Stability of zinc oxide in tablet dosage form is required.
Brand name needs to be changed.
F.No.10-8/2020-OTC) (M-80)
Page 78 of 144
S.No Brand name Decision
(1) (2) (3)
Signed and stamped undertakings are required.
Signed and stamped form 3 is required.
861. Lasta Tablet
Deferred for following reason(s):
Fee evidence is required.
Signed and stamped Form 3 is required.
Monographs of all ingredients are required.
Testing method of finished product is required.
862. Nu-Sitol Sachet
Deferred for following reason(s):
Fee evidence is required.
Stability of vitamin D3 and cyanocobalamin in sachet dosage
form is required.
Signed and stamped undertakings regarding contents of dossier
and brand name are required.
863. Collapep Sachet
Deferred for following reason(s):
Form 3 is unstamped and unsigned.
Monograph of collagen and its stability in sachet dosage form
are required.
Signed and stamped undertakings regarding contents of dossier
and brand name are required.
Brand name needs to be changed.
864. Artholex Tablet
Deferred for following reason(s):
Fee evidence is required.
Signed and stamped form 3 is required.
Glucosamine, chondroitin and hyaluronic acid are added in
common molecules list.
Monograph of methylsulfonylmethane is required.
M/s Phytocon International Private Limited
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
865. Ora-A Drops Drops
Deferred for following reason(s):
Fee evidence is required.
Signature of owner/ CEO of firm is required on form 3.
M/s Otsuka Pakistan Ltd., Karachi
866. Proten gold supplement Deferred for further evaluation and clarification.
Nutris Laboratories, Lahore
867. Aciloc Deferred for Justification of minute quantities.
M/s Scotmann Pharmaceutical,
5-D, I-10/3 Industrial Area, Islamabad-Pakistan (Nutraceutical
868. Sunny Dee 10000IU Softgel
Deferred for following reason(s):
Form 3 is required.
Brand name needs to be changed.
Fee evidence is required.
M/s Alpha Nutraceutical Research Laboratories
21/S, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
869. Action Spray
Deferred for following reason(s):
Monograph of menthol is required.
Clarification regarding spray is required
M/s Amarant Healthcare,
Plot No. 168, Sector 23, Korangi Industrial Area, Karachi
F.No.10-8/2020-OTC) (M-80)
Page 79 of 144
S.No Brand name Decision
(1) (2) (3)
870. Gerox-C
Tablet Deferred for further evaluation and clarification.
M/sHiranis Pharmaceuticals (Pvt) Limited,
E-145-149, North Western Industrial Zone, Port Qasim, Karachi 75020
871. Lomis 5Mg Tablet Deferred for following reason(s):
Serratiopeptidase is added in common molecules list.
872. Lomis 10Mg Tablet Deferred for following reason(s):
Serratiopeptidase is added in common molecules list.
873. Lomis 15Mg Tablet Deferred for following reason(s):
Serratiopeptidase is added in common molecules list.
874. Lomis 20Mg Tablet Deferred for following reason(s):
Serratiopeptidase is added in common molecules list.
875. Lomis 30Mg Tablet. Deferred for following reason(s):
Serratiopeptidase is added in common molecules list.
M/s Phytocon International Private Limited,
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
876. Ubicare Tablet
Deferred for following reason(s):
Differential fee is required.
Monograph of iron bisglycinate is required.
M/s Cibex (Private) Limited,
F-405, SITE Area, Karachi
877. Cibcos-Ch (Honey)
Syrup Deferred for further evaluation and clarification.
878. Cibcos-Ivy
Syrup Deferred for further evaluation and clarification.
879. Cibcos-Ivy Plus
Syrup Deferred for further evaluation and clarification.
M/s Incepta Pharma,
17-A, Punjab Small Industrial Estate, Taxila
880. Megamin Tablets Deferred for following reason(s):
Monograph of boron is required.
M/s Scotmann Pharmaceutical,
5-D, I-10/3 Industrial Area, Islamabad-Pakistan (Nutraceutical)
881. Folica Plus Softgel Deferred for further evaluation and clarification.
882. Scotmann'S Alpoc 600 Softgel
Deferred for following reason(s):
Fee evidence is required.
Form 3 is required.
883. Scotmann'S Agex Tablet
Deferred for following reason(s):
Fee evidence is required.
Form 3 is required.
Monograph of resveratrol is required.
Justification regarding use of both vitamin A and beta carotene
in same formulation is required.
884. Scotmann'S Folica Plus Softgel
Deferred for following reason(s):
Fee evidence is required.
Stability of methlycobalamin in soft gel dosage form is required.
M/s Hi-Nutrition (Eno 0077)
Hashim Park, 9.5-KM, Sheikhupura Road, Lahore
F.No.10-8/2020-OTC) (M-80)
Page 80 of 144
S.No Brand name Decision
(1) (2) (3)
885. Lactofer-S Syrup
Deferred due to following reasons:
Official monograph of ferrochel required
Undertaking of content and stability missing
M/s Genbiotech Nutraceuticals (Eno 00263)
Plot No. 24, Street No. NS-2, NIZ RCCI, Rawat, Rawalpindi
886. Hierro Syrup
Deferred due to following reasons:
Official monograph of iron bisglycinate missing
Undertaking for stability missing
887. Gencholine Capsule Deferred due to following reasons:
Undertaking for stability missing
888. Bio-D Chewable Tablet Deferred for further evaluation and clarification.
889. Bio Sachet
Deferred due to following reasons:
Clarify if the firm has a probiotic sachet section
Undertaking for stability missing
890. Myo F Sachet Deferred due to following reasons:
Undertaking for stability missing
M/s MPC Health & Food, Karachi
SF-13, 5th Floor, Shahnaz Arcade, Main Shaheed-e-Millat Road, Karachi
Is an agent of M/s Weihai Baihe Biology Technological Co. Ltd. No. 522, Chengda Toad, Swan Lake Economic
Technology Development Zone, Rongcheng, Shandong, China, 264321
891. Ginkgo biloba 120 softgel
Deferred for following reasons:
CoA of active ingredient in raw form is required.
Brand name given on Form 5 and on CoA of finished product
does not match, needs clarification.
Accelerated and long term stability studies (physical, chemical,
microbial testing) data of at least 3 batches conducted in zone
IVA is required.
Manufacturing license of the principal manufacturer in the
country, issued by regulatory body is required.
Approval of product registration or marketing authorization in
the country of origin, issued by regulatory authority is required.
Copy of free sale certificate issued by FDA of china, submitted
by firm does not depict name of product and its availability in
country of origin. Free sale certificate of said product issued by
regulatory authority of country of origin is required.
Last inspection report issued by regulatory body is required.
Differential fee is required.
Agency agreement between importer and principal manufacturer
is required.
892. Pine bark plus tablets
Deferred for following reasons:
Brand name mentioned on Form 5 is “ pine bark plus tablet”
while brand name given on CoA of finished product is “ picno
plus tablet”, needs clarification.
Accelerated and long term stability studies (physical, chemical,
microbial testing) data of at least 3 batches conducted in zone
IVA is required.
Manufacturing license of the principal manufacturer in the
country, issued by regulatory body is required.
F.No.10-8/2020-OTC) (M-80)
Page 81 of 144
S.No Brand name Decision
(1) (2) (3)
Approval of product registration or marketing authorization in
the country of origin, issued by regulatory authority is required.
Last inspection report issued by regulatory body is required.
Differential fee is required.
Agency agreement between importer and principal manufacturer
is required.
CoA of active ingredients (pine bark extract, beta carotene) in
raw form is required.
Justification of role of calcium carbonate in formulation is
required either it is used as active ingredient or inactive
ingredient.
Free sale certificate issued by regulatory body, notarized and
countersigned by embassy/ consulate of Pakistan in country of
origin is required.
893. Mint oil 300 softgel
Deferred for following reasons:
Accelerated and long term stability studies (physical, chemical,
microbial testing) data of at least 3 batches conducted in zone
IVA is required.
Manufacturing license of the principal manufacturer in the
country, issued by regulatory body is required.
Approval of product registration or marketing authorization in
the country of origin, issued by regulatory authority is required.
Last inspection report issued by regulatory body is required.
Differential fee is required.
Agency agreement between importer and principal manufacturer
is required.
CoA of active ingredients (pine bark extract, beta carotene) in
raw form is required.
Free sale certificate issued by regulatory body, notarized and
countersigned by embassy/ consulate of Pakistan in country of
origin is required.
894. Cranberry+ hibiscus softgel
Deferred for following reasons:
Accelerated and long term stability studies (physical, chemical,
microbial testing) data of at least 3 batches conducted in zone
IVA is required.
Manufacturing license of the principal manufacturer in the
country, issued by regulatory body is required.
Approval of product registration or marketing authorization in
the country of origin, issued by regulatory authority is required.
Copy of free sale certificate issued by FDA of china, submitted
by firm does not depict name of product and its availability in
country of origin. Free sale certificate of said product issued by
regulatory authority of country of origin is required.
Last inspection report issued by regulatory body is required.
Differential fee is required.
Agency agreement between importer and principal manufacturer
is required.
895. Pine bark extract 150 tablet Deferred for following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 82 of 144
S.No Brand name Decision
(1) (2) (3)
Brand name mentioned on Form 5 is : pine bark plus tablet:
while brand name given on CoA of finished product and
accelerated stability studies is “ pine tablet”, needs clarification.
Accelerated and long term stability studies (physical, chemical,
microbial testing) data of at least 3 batches conducted in zone
IVA is required.
Manufacturing license of the principal manufacturer in the
country, issued by regulatory body is required.
Approval of product registration or marketing authorization in
the country of origin, issued by regulatory authority is required.
Last inspection report issued by regulatory body is required.
Differential fee is required.
Agency agreement between importer and principal manufacturer
is required.
CoA of active ingredient in raw form is required.
Testing specification/ monograph(s) of active ingredient(s) is
required.
Justification of role of calcium carbonate in formulation is
required either it is used as active ingredient or inactive
ingredient.
Free sale certificate issued by regulatory body, notarized and
countersigned by embassy/ consulate of Pakistan in country of
origin is required.
896. Epo 500 Softgel Deferred for further evaluation and clarification.
897. EPO 500 softgel
Deferred for following reasons:
Accelerated and long term stability studies (physical, chemical,
microbial testing) data of at least 3 batches conducted in zone
IVA is required.
Manufacturing license of the principal manufacturer in the
country, issued by regulatory body is required.
Approval of product registration or marketing authorization in
the country of origin, issued by regulatory authority is required.
Last inspection report issued by regulatory body is required.
Differential fee is required.
Agency agreement between importer and principal manufacturer
is required.
Composition mentioned on Form 5 and given label claimed are
different from each other, needs clarification.
898. Liquid filled absorbable calcium softgel
Deferred for following reasons:
Brand name mentioned on Form 5 is “ liquid filled absorbable
calcium softgel” while CoA of finished product bears “ liquid
calcium softgel, needs clarification.
Accelerated and long term stability studies (physical, chemical,
microbial testing) data of at least 3 batches conducted in zone
IVA is required.
Manufacturing license of the principal manufacturer in the
country, issued by regulatory body is required.
Approval of product registration or marketing authorization in
the country of origin, issued by regulatory authority is required.
F.No.10-8/2020-OTC) (M-80)
Page 83 of 144
S.No Brand name Decision
(1) (2) (3)
Last inspection report issued by regulatory body is required.
Agency agreement between importer and principal manufacturer
is required
899. Milk thistle tablet
Deferred for following reasons:
Brand name (milk thistle tablet) mentioned on Form 5 and
brand name (silymarin) on CoA of finished product do not
match, needs clarification.
CoAs of balck radish, beet root, beet root, dandelion root, egg
albumin and methionine are required.
CoA of finished product should depict physical, chemical,
microbial and any other test (if required).
Accelerated and long term stability studies (physical, chemical,
microbial testing) data of at least 3 batches conducted in zone
IVA is required.
Manufacturing license of the principal manufacturer in the
country, issued by regulatory body is required.
Approval of product registration or marketing authorization in
the country of origin, issued by regulatory authority is required.
Copy of free sale certificate issued by FDA of china, submitted
by firm does not depict name of product and its availability in
country of origin. Free sale certificate of said product issued by
regulatory authority of country of origin is required.
Last inspection report issued by regulatory body is required.
Differential fee is required.
Agency agreement between importer and principal manufacturer
is required.
M/s. Kaap Pharmaceutical (Pvt) Ltd (Eno 00306)
18 Km Ferozepur Road, Lahore
900. Thera-Vit Jr. Tablet
Deferred due to following reasons:
Undertaking for stability, content and brand name missing
Contains zinc oxide (Unstable orally)
901. Senalax Plus Tablet
Deferred due to following reasons:
Fee submitted is 250/- Rs
Contain common molecule; sennosides
Sign stamp on form 3 missing
Undertaking for stability, content and brand name missing
Elaborate the ingredient “Phospholipid
902. Hi-Z Plus Suspension
Deferred due to following reasons:
Herbal supplement while the firm does not have herbal sections
Official monographs and undertakings not present in file
903. Thera-Vit Gold Tablet
Deferred due to following reasons:
Contains phytonadione which is used in bleeding disorders
Contains zinc oxide (Unstable orally)
Official monograph of grape seed extract required
Undertaking for stability, content and brand name missing
904. No Loss Capsule
Deferred due to following reasons:
Applied on form 4 while no clinical data provided
Fee submitted is 250/- Rs
F.No.10-8/2020-OTC) (M-80)
Page 84 of 144
S.No Brand name Decision
(1) (2) (3)
Official testing method of ginkgo extract required
Undertaking for stability, content and brand name missing
905. Be-Mom Tablet
New name: oval vit
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
Phytocon International Private Limited, Lahore
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
906. Ova-D Sachet
Deferred due to following reasons:
Differential fee is required,
Brand name needs to be changed.
Rationale of dose of Myo-inositol i.e. 2000mg is required.
Form-3 needs to revised w.r.t. specification of L-methylfolate as
well as common names of all ingredients are required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name stating
the name is not enlisted under DRAP Act, 2012, on notarized
stamp paper is required.
M/s Phytocon International (Pvt) Ltd (Eno 0083)
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
907. Co-Cell Capsule Capsule Deferred due to following reasons:
Fee submitted 250/- Rs
908. D-Move Tablet Deferred due to following reasons:
Fee submitted 250/- Rs
909. Ubicare Syrup
Deferred due to following reasons:
Fee submitted 250/- Rs
Official monograph of iron bisglycinate required
910. Biofolic Capsule
Deferred due to following reasons:
Brand name to be changed
Fee submitted 250/- Rs
Contains tribilius herb in nutraceutical product
Contains zinc oxide (unstable orally)
911. Bestage Capsule Deferred due to following reasons:
Fee submitted 250/- Rs
Alpha Nutraceutical, Lahore
21/S, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
912. Salberri Sachet
Deferred due to following reasons:
Differential fee is required.
Form-3 need revision w.r.t. specification of active ingredients.
Formulation needs revision w.r.t. cranberry juice extracts.
Monograph of cranberry extract.
Product specific monograph is required including assay of
product.
Phytocon International Private Limited, Lahore
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
Evaluator: Arslan Tariq (AD-I)
913. Cystinum Tablet Deferred due to following reasons:
Form-3 need to be revised w.r.t. specification of ingredient.
F.No.10-8/2020-OTC) (M-80)
Page 85 of 144
S.No Brand name Decision
(1) (2) (3)
Rationale of dose of active ingredient is required in same dosage
form.
Justify the use of Cranberry Liquid Extract in tablet dosage
form.
Product specific monograph and testing methods of finished
dosage form is required.
Undertaking Signed by the owner regarding submission of
Stability data is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
M/s. Filix Pharmaceuticals (Pvt) Ltd. (Dedicated Section) (Eno 00120)
Plot No. 4-B, Main Road, RCCI, Rawat, Rawalpindi
914. Kolin Capsule
Deferred due to following reasons:
Form 3 not signed stamped
Official monographs of choline bitartarate required
Undertaking for stability, content and brand name required
915. Exebrain Capsule
Deferred due to following reasons:
Form 3 not signed stamped
Undertaking for stability, content and brand name required
916. Bio-Seng Capsule Deferred for further evaluation and clarification.
917. Glossy Capsule
Deferred due to following reasons:
Form 3 not signed stamped
Official monographs of ingredients required
Undertaking for stability and content not signed
Undertaking for brand name missing
Evidence of formulation required
918. Triseng Capsule
Deferred due to following reasons:
Formulation contains ginseng and ginkgo herbs while testing of
ginkgo extract and ginseng herb is given. Clarify.
Form 3 not signed stamped
Undertaking for stability, content and brand name required
M/s Nutrimed Laboratories (Eno 0078)
Plot No. B-42, S.I.T.E. Super Highway, Karachi
919. Osovit D Syrup
Deferred due to following reasons:
Form 3 not signed
Official testing method of ossein mineral complex
M/s Tarrot Health Care (Eno 0085)
595, Sundar Industrial Estate, Raiwind Road, Lahore
920. Gestrophin Suspension
Deferred for further evaluation and clarification. 921. Unical Syrup
922. Gestrophin Syrup
923. Acnotil-D Cream
Trends Pharmaceuticals Lahore
Plot 546/ 547, Sundar Industrial Estate, Lahore
924. Ferment-S Tablet
Deferred due to following reasons:
Brand name needs to be changed.
Rationale of dose of each ingredient is required.
F.No.10-8/2020-OTC) (M-80)
Page 86 of 144
S.No Brand name Decision
(1) (2) (3)
Form-3 needs to be revised w.r.t. specifications of each
ingredient.
Stability of selenium sulfine in tablet dosage form is required.
Product specific monograph for testing of finished product
including quantitative assay of each ingredient is required.
Undertaking Signed by the owner regarding submission of
Stability data is required.
925. K-Zyme 100 Tablet
Deferred due to following reasons:
Safety of methylene chloride as coating ageing is required.
Form-3 needs to be revised w.r.t. specification of Co-enzyme
Q10 is required.
Undertaking Signed by the owner regarding submission of
Stability data is require
926. Ferment-S Tablet Duplicate entry
927. K-Zyme 100 Tablet Duplicate entry
M/s. Blossom Laboratories (Pvt.) Ltd.,
30-KM, Badian Road, ½ K.M Off Roda Bohgal Road, Lahore Cantt
928. Sharbat-E-Joshanda Syrup
Deferred due to following reasons:
Revision of form-3 is required w.r.t. brand name according to
section granted for homeopathic production.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Drosera Rotundifolia 1CH, Bryonia
alba 3CH and Belldonna 3CH are required according to the
monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Monographs of all ingredients except Drosera Rotundifolia
1CH, Bryonia alba 3CH and Belldonna 3CH are required.
929. Blasmozyme Syrup
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Revision of form-3 is required w.r.t. brand name according to
section granted for homeopathic production.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Nat Phos 12C(EH), Silica 6C(EH),
Carboveg 6C9EH) is required according to the monograph
either it is given in mother tincture/solution/trituration or in
respective potency.
Monograph of Avena Sativa (Oat), Asafoetida (Hing),
Anacardium (Bhallatak) and Robina (Black locust), are
required.
930. BL 35 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
F.No.10-8/2020-OTC) (M-80)
Page 87 of 144
S.No Brand name Decision
(1) (2) (3)
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monograph of Kali Carb is required.
931. BL-36 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of Baryta mur D4, Kalium iod D6 and Arnica
Montana D2 are required.
932. BL-39 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of all ingredients except for pulsatilla are required.
933. BL-34 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Conversion of strength of Kali Phos 6x is required according to
the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of all ingredients except for Kali Phos and Sepia
are required.
934. BL-37 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of all ingredients except Podophylum are required.
935. BL-38 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
F.No.10-8/2020-OTC) (M-80)
Page 88 of 144
S.No Brand name Decision
(1) (2) (3)
Monographs of all ingredients except Belladona, Bryonia and
Cantharis are required.
936. Liverton Syrup
Deferred due to following reasons:
Breakage of fee is required.
Brand name needs to be changed.
Undertaking regarding Safety of product is required.
937. Blossom’s Pipra Mint Syrup
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Monograph of Croton Tig 30 and Ipecac 30 are required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
938. BL-33 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of Borax, Merc Sol and Zinc Sulph are required.
939. BL-30 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Zinc met and Kali phos are required
according to the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Monographs of Belladona, Physostigma, Zincum sulphate and
Euphrasia are required.
940. BL-29 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Meg Phos D2 (Magnesium
Phosphate) is required according to the monograph either it is
given in mother tincture/solution/trituration or in respective
potency.
Monographs of all ingredients except Belladona and Meg Phos
D2 (Magnesium Phosphate) are required.
941. BL-28 Drops Deferred due to following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 89 of 144
S.No Brand name Decision
(1) (2) (3)
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Santonine (Worm seed) is required
according to the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Monographs of China off and Cinnabaris are required.
942. BL-27 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of all ingredients except for Aconite Net and
Bellanoda D4 are required.
943. BL-26 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of Bryta mur D4, Kalium Iod D6 and Arnica
Montana D2 are required.
M/s. Xecutive Pharma (Eno 00312) 171-S, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
944. Silnergy Tablet
Deferred till finalization of fate of common molecule list being
dealt by Division of H&OTC and Division of PE&R.
Contains common molecules: melatonin, glucosamine
Official testing method of melatonin required
945. Cvm Tablet
(new name fertilaid) Tablet
Deferred due to following reasons:
Contains zinc oxide (orally unstable)
Official monograph of L methyl folate required
946. Cidus Tablet
(new name winfol) Tablet
Deferred due to following reasons:
Official monograph of L methyl folate required
947. Cobin Tablet
(new name perinef) Tablet
Deferred due to following reasons:
Quantity per tablet required
Official monograph of L methyl folate required
948. Q-Tel Plus (new name ardin)
Syrup
Deferred due to following reasons:
Evidence of formulation provided is different form applied
formulation
949. Mt5 (new name folitek)
Tablet
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
950. Cyodine (New name mensolex) Deferred due to following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 90 of 144
S.No Brand name Decision
(1) (2) (3)
Tablet Testing method of herbal extracts required
Brand name to be changed
951. Apogent (new name spasmo)
Syrup
Deferred due to following reasons:
Contains sodium bicarbonate
Testing methods of emblica extract and ginger extract required
952. Kufeze (new name respivil)
Syrup
Deferred due to following reasons:
Herbal formulation while firm does not have herbal sections
953. Aescuvin (new name pregnatin)
Tablet
Deferred due to following reasons:
Evidence of formulation provided is different form applied
formulation
Testing method of flax seed extract and alfafa extract required
954. Stoneby (new name orthocal)
Tablet
Deferred due to following reasons:
Official testing method of algae calcium required
955. Acidiconil (New name Lowcid)
Syrup
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
956. Codil-P (new name A+farfly)
Syrup
Deferred due to following reasons:
Undertaking for stability not signed
957. Trigogen (new name menoper)
Tablet
Deferred due to following reasons:
Contains zinc oxide (orally unstable)
Form 3 mentions tribulus and ginkgo herb. Testing of ginkgo
extract is given.
Official testing method of tribulus extract required
958. Cozas (new name mediov)
Tablet
Deferred due to following reasons:
Contains zinc oxide (orally unstable)
Official monograph of tribulus extract required
Undertaking for stability missing
959. Zygotin (new name Ambrosia F)
Tablet
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
960. Neodine (new name neorobal tablet)
Tablet
Deferred due to following reasons:
Official monograph of L methyl folate required
961. Neubaron Plus (new name neuroberg)
Tablet
Deferred due to following reasons:
Brand name to be changed
Official testing method of bacopa monnieri extract and guarana
seed extract required
M/s. Blossom Laboratories (Pvt.) Ltd.,
30-KM, Badian Road, ½ K.M Off Roda Bohgal Road, Lahore Cantt.
962. Shafa Sadar Syrup
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Firm applied on Form-4 with submission of any clinical
evidence.
Revision of Form-4 is required w.r.t. monograph of active
ingredients.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
F.No.10-8/2020-OTC) (M-80)
Page 91 of 144
S.No Brand name Decision
(1) (2) (3)
Monographs of all ingredients except Ephedra vulgaris and
Glycyrrhiza glabra are required.
963. Gastomex Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Brand name needs to be changed.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monograph of Robina pseudacacia is required.
Conversion of strengths of ingredients is required according to
the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
964. B30 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of all ingredients Cactus grandiflorus, Arnica
Montana, Spartium, Glonoium, Plumbium acetic and Aur. Mur.
Nat. are required.
Conversion of strengths of ingredients is required according to
the monograph either it is given in mother
tincture/solution/trituration or in respective potency, where
applicable.
965. Gasto Off Syrup
Deferred due to following reasons:
Brand name needs to be changed.
Breakage of fee is required.
Monographs of Baharay (terminelia belerica) required.
Safety undertaking is required.
966. Blossom’s Colic Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Firm applied on Form-4 with submission of any clinical
evidence.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Nat Phos (Natrum Phosphoricum),
Santonine (Worm seed) are required according to the
monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Monographs of Colocynth (Bitter apple) and Dioscorea (purple
yam) are required.
967. Blosmo Gel Syrup Deferred due to following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 92 of 144
S.No Brand name Decision
(1) (2) (3)
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Form-3 needs to be revised w.r.t. monographs of active
ingredients.
Breakage of fee is required.
Brand name needs to be changed.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of all ingredients except Carboveg and Nux
Vomica are required.
Strengths of all ingredients are required according to the
monograph either it is given in mother
tincture/solution/trituration or in respective potency
968. Coughnol Syrup
Deferred due to following reasons:
Brand name needs to be changed
Breakage of fee is required
Safety undertaking is required
Monographs of Zizphys sativa/Ziziphus jujube, Menthapiperita,
Hyssopus officinalis, papver somniferum and ammonium
chloride
969. Dyro Stop Dry Syrup
Deferred due to following reasons:
Revision of form-3 is required w.r.t. brand name according to
section granted for homeopathic production.
Brand name needs to be changed.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of all ingredients except Podophyllum and china
off are required.
970. Worm Iex Syrup
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Brand name needs to be changed.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Nat Phos (Natrum Phosphoricum),
Santonine (Worm seed) are required according to the
monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Monographs of Cina, Cinnabaris, Cucurbita pepo and Teucrium
are required.
971. B20 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
F.No.10-8/2020-OTC) (M-80)
Page 93 of 144
S.No Brand name Decision
(1) (2) (3)
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of Carduus mar, Thymus serpyllum, Chionanthus
and Nat sulph are required.
972. Fevotox Syrup
Deferred due to following reasons:
Breakage of fee is required.
Monograph of Viola Odorata, Borago officinalis amd Fumaria
officinalis are required.
Undertaking regarding Safety of product is required.
973. B10 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monograph of Calc renalis, Berberis vul, Epigea rep,
Sarsaparilla, Rubia tinc and Hydrangea are required.
974. Bl-42 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monograph of Kali Bich (Kali Bichromicum) and Bellis per
(Daisy) are required.
975. Bl-44 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monograph of Cenathus (Buckbrush) and Cholestrinum
(Chloesterine) are required.
976. Bl-41 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of all ingredients except Dulcamara and Syphlinum
are required.
F.No.10-8/2020-OTC) (M-80)
Page 94 of 144
S.No Brand name Decision
(1) (2) (3)
Conversion of strengths of ingredients is required according to
the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
977. Bl-45 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strengths of Calc flour is required according to
the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
978. Bl-4 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monograph of Aurum met, Spartium, Lycopus and Gloninum
are required.
979. Bl-46 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monograph of Pulsatilla, Clematis vit and Populous trem are
required.
980. Bl-47 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strengths of ingredients is required according to
the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Monographs of atropine sulphate is required.
981. Bl-1 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
F.No.10-8/2020-OTC) (M-80)
Page 95 of 144
S.No Brand name Decision
(1) (2) (3)
Conversion of strength of Lachesis, Calc iod and Mercurius are
required according to the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Monograph of Hepar sulph and Kali bisc are required.
982. Bl-9 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Graphites, Calc Carb and Nat sulf are
required according to the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Monograph of Phytolacca (Pokeweed) is required.
983. Bl-5 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Sulpher, Ars brom, Kali brom and
Hepar Sulfuris are required according to the monograph either it
is given in mother tincture/solution/trituration or in respective
potency.
984. Bl-52 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Silicae (Silica) is required according
to the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Monographs of all ingredients except Echinacae, Sulphur and
Silicae are required.
985. Bl-51 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of Avena sativa, Orchitinum and Agnus cactus are
required.
986. Bl-50 Drops Deferred due to following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 96 of 144
S.No Brand name Decision
(1) (2) (3)
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monograph of Rhus tox, Urtica uren, Caulophyllum and Apis
mel are required.
987. Bl-49 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of Apid mel and Pulsatilla (pasque flower) are
required.
Conversion of strengths of Nat mur (sodium chloride) is
required according to the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
988. Bl-48 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monographs of all ingredients except Nux vomica, lycopodium
and sulphur are required.
Conversion of strengths of ingredients is required according to
the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
989. Bl-13 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monograph of Serenoa repens and Champaphilla are required.
990. Bl-14 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monograph of Magnesia Chlor (Magnesiumm Chloride) is
required.
F.No.10-8/2020-OTC) (M-80)
Page 97 of 144
S.No Brand name Decision
(1) (2) (3)
Conversion of strength of Chlosterinum is required according to
the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
991. Bl-2 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
992. Bl-3 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monograph of Anamrita Cocculus (Moonseed) and Cratageus
monogyna (Hawthorn) are required.
993. Bl-7Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Arsenicum Bromatum (Bromide of
Arsenic) is required according to the monograph either it is
given in mother tincture/solution/trituration or in respective
potency.
Monograph of Nat Sulph (Natrum sulphuricum) is required.
994. Bl-11 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Monograph of Coffea Crub (Coffe Scrub) is required.
995. Bl-10 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Calcarea Phosphorica (Calcium
Phosphate), Kali Phos ( Potassium Phosphate), Thyroidium
(Thyroid Extract), Mag Phos (Magnesium Phosphate), Natrum
F.No.10-8/2020-OTC) (M-80)
Page 98 of 144
S.No Brand name Decision
(1) (2) (3)
Phos (Sodium Phosphate) and Ferrum Phos (Iron Phosphate) are
required according to the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Monograph of Barium Carb (Barium Carbonate) is required.
Undertaking to be submitted stating source of Thyroidium D8
(Thyroid Extract) is free from TSE/BSE.
996. Bl-17 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Sepia D7 (Cuttle Fish), Ferrum Phos
(Iron Phosphate), Mag Phos (Magnesium Phosphate) is
required according to the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Monographs of Pulsatilla vulgaris D4 and Viburnum Opulus are
required.
997. Bl-43 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Calc Flor is required according to the
monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Monographs of Redium bromat and Aconite nep are required.
998. Bl-16 Drops
Deferred due to following reasons:
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Breakage of fee is required.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
Conversion of strength of Calc Flour is required according to
the monograph either it is given in mother
tincture/solution/trituration or in respective potency.
Monographs of Pulsatilal (Pasque Flower) and Clematis
vitabulis are required.
Acti Health food,
Suite no. 1 Shireen Arcade plot A-41, K.U.C.H.S Block 7-8, Karachi
999. Ultra Cranberry Tablet Already enlisted
M/s Genbiotech Nutraceuticals (Eno 00263)
Plot No. 24, Street No. NS-2, NIZ RCCI, Rawat, Rawalpindi
1000. Cogen E Tablet Deferred due to following reasons:
Undertaking for stability missing
F.No.10-8/2020-OTC) (M-80)
Page 99 of 144
S.No Brand name Decision
(1) (2) (3)
Evidence of formulation required
M/s Nutrimed Laboratories (Eno 0078)
Plot No. B-42, S.I.T.E. Super Highway, Karachi
1001. Fertidl-F Capsule
Deferred due to following reasons:
Contains zinc oxide(unstable orally)
Official testing method of tribulus extract, epimedium extract
required
1002. Rozana Capsule
Deferred due to following reasons:
Contains zinc oxide(unstable orally)
Official testing method of tribulus extract required
1003. Iodomom-Z Tablet Deferred due to following reasons:
Contains zinc oxide(unstable orally)
M/s Apple Laboratories (Eno 0076)
National Industrial Zone, RCCI Road, 1.5-KM, Rawat, Rawalpindi
1004. Basil Plus Tablet
Deferred due to following reasons:
Quantity of zinc is above RDA (mention elemental quantity)
Clarification and official testing method of citrus biflavonoids
1005. Ginzee Syrup
Deferred due to following reasons:
Official testing method of ginkgo extract, bacopa extract,
tribulus extract and testofen required
1006. Antacil Syrup
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1007. Opti-M Tablet
Deferred due to following reasons:
Contains zinc oxide (orally unstable)
Testing methods of herbal extracts required
1008. Ezee Kuff Syrup
Deferred due to following reasons:
Testing method of morus alba extract and viola odorata extract
required
M/s. Medwell Pharmaceuticals, (Dedicated Section), (Eno 00124)
1-Km, Terbella Road, Lawrencepur District, Attock
1009. Q Max Tablets / Procor Tablet
Deferred due to following reasons:
The file has no required documents except form 3 and evidence
of fee submission.
1010. Qualifit Tablets
Deferred due to following reasons:
The file has no required documents except form 3 and evidence
of fee submission.
M/s Nutrimed Laboratories (Eno 0078)
Plot No. B-42, S.I.T.E. Super Highway, Karachi
1011. Robitus Tablet
Deferred due to following reasons:
Evidence of formulation required
Official monograph of ribwort extract required
1012. Robitus Syrup
Deferred due to following reasons:
Evidence of formulation required
Official monograph of ribwort extract required
1013. Ayron Syrup Deferred for further evaluation and clarification.
1014. Iodomom-Z Tablet Deferred due to following reasons:
Master formula not provided
F.No.10-8/2020-OTC) (M-80)
Page 100 of 144
S.No Brand name Decision
(1) (2) (3)
1015. Balwel Sachet
Deferred due to following reasons:
Form 3 not signed stamped
Testing method of iron bisglycinate required
Zinc quantity above RDA
1016. Balwel Tablet
Deferred due to following reasons:
Testing method of iron bisglycinate required
Zinc quantity above RDA
M/s. Nutris Laboratories (Eno 00262) 46(B)-M Block, Quaid-e-Azam Industrial Estate, Lahore
1017. Soelab Pass Powder Deferred for further evaluation and clarification.
Eon Pharmacy, Karachi
Plot No. A/150, Sector 11-E, New Karachi
1018. Calceon Drops
Deferred due to following reasons:
Confirmation regarding availability of drop manufacturing
facility is required as part of liquid (nutraceutical) section.
Rationale of dose of vitamin A and Vitamin D3 is required,
Conversation of strengths of each active ingredient is required
from “IU” to “weight units”
Safety of methyl paraben and propyl paraben is required in
children.
Quantitative assay of each ingredient in finished product is
required,
M/s Heal The World, Karachi
Located at City Shopping Mall, Suite No.l07, Marston Rd, Karachi
an agent of M/s Alaska Sprin Pharmaceuticals 609-1 Cantiague Rock Road Westbury, NY 11590, United States
1019. Vitabay multi softgel Considered and decided by EEC in its 72nd meeting.
1020. Vivioptal Women Softgel Capsule Considered and decided by EEC in its 72nd meeting.
M/s. Medwell Pharmaceuticals, (Dedicated Section), (Eno 00124)
1-Km, Terbella Road, Lawrencepur District, Attock
1021. Bifernate Syrup
Syrup
Deferred due to following reasons:
Official testing method of iron biosglycinate required
1022. Colic Drops
Deferred due to following reasons:
The file has no required documents except form 3 and evidence
of fee submission
1023. Cough Syrup
Deferred due to following reasons:
The product is herbal while the firm does not have herbal
sections
The file has no required documents except form 3 and evidence
of fee submission.
Brand name to be changed
1024. Gastonil Syrup Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1025. Glucomin Tablet Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1026. Liverex Tablet
Deferred due to following reasons:
Brand name to be changed
The file has no required documents except form 3 and evidence
of fee submission
F.No.10-8/2020-OTC) (M-80)
Page 101 of 144
S.No Brand name Decision
(1) (2) (3)
1027. Niswaani Syrup
Deferred due to following reasons:
The product is herbal while the firm does not have herbal
sections
The file has no required documents except form 3 and evidence
of fee submission.
1028. Relexa Tablet
Deferred due to following reasons:
The product is herbal while the firm does not have herbal
sections
Undertakings and testing methods missing
1029. Shaafi Syrup
Deferred due to following reasons:
The product is herbal while the firm does not have herbal
sections
The file has no required documents except form 3 and evidence
of fee submission.
1030. Sharbat E Folad Syrup
Deferred due to following reasons:
The file has no required documents except form 3 and evidence
of fee submission.
1031. Toot Syah Sharbat Syrup
Deferred due to following reasons:
The product is herbal while the firm does not have herbal
sections
The file has no required documents except form 3 and evidence
of fee submission.
1032. Welgink Syrup
Deferred due to following reasons:
Undertaking for brand name and content missing
1033. Pro Go Cream
Deferred due to following reasons:
The product is herbal while the firm does not have herbal
sections
The file has no required documents except form 3 and evidence
of fee submission.
Cure Inn Phytoceuticals Pvt Ltd, Lahore
Plot No. 10,11-C ,Punjab Small Industrial Estate,44-Km from Lahore,Ferozepur Road, Kasur
1034. Vitanour Tablet
Deferred due to following reasons:
Stability of Zinc oxide in oral tablet dosage form is required,
Safety of methylene chloride as tablet coating agent is required.
Safety and rational of using rectified spirit in coating of tablet is
required,
Submission of source of Be 95% proanthocynidins is required
along with monograph or otherwise revise Form-3 accordingly.
Quantitative assay of each ingredient in finished product is
required.
Undertaking Signed by the owner regarding submission of
Stability data is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Eon Pharmacy, Karachi
Plot No. A/150, Sector 11-E, New Karachi
1035. Lizbone Tablet Deferred due to following reasons:
Stability of zinc oxide in oral solid dosage form is required.
F.No.10-8/2020-OTC) (M-80)
Page 102 of 144
S.No Brand name Decision
(1) (2) (3)
Conversion of strength of Vitamin D3 from “IU” to “weight
units” is required in Master formula.
Quantitative assay of each ingredient in finished product is
required.
M/s. Medwell Pharmaceuticals, (Dedicated Section), (Eno 00124)
1-Km, Terbella Road, Lawrencepur District, Attock
1036. Abm plus Supplement Powder
Deferred due to following reasons:
Form 3 not signed stamped
Evidence of formulation required
Testing methods of gugulsterones, synephrine and bioperine
required
Undertaking for stability, brand name and content missing
1037. Anagen Supplement Powder
Deferred due to following reasons:
Contains synephrine; justify use as supplement
Contains herbs (ephedra viridis, schisandra berry, hordia
gordoni ext) while firm does not have herbal section
Form 3 not signed stamped
1038. Be App Syrup
(new name cholino) Syrup
Deferred due to following reasons:
Evidence of formulation required
Clarify if ginkgo herb or extract is used
Undertaking for stability and content missing
1039. Berry Gold Sachet Powder
Deferred due to following reasons:
The file has no required documents except form 3, master
formula and evidence of fee submission.
1040. Corum D Syrup
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1041.
Eatmore Plus Syrup
(new name tricod)
Deferred due to following reasons:
Brand name to be changed
Undertaking for stability, brand name and content missing
Evidence of formulation required
1042. Enzimax Syrup
Deferred due to following reasons:
The product is herbal while the firm does not have herbal
sections
1043. G I Releif Syrup
Deferred due to following reasons:
Testing method of herbal extracts to be provided
1044. Heamolyte Syrup
Deferred due to following reasons:
Evidence of formulation required
Undertaking for content, stability and brand name missing
1045. Heamolyte Tablet
Deferred due to following reasons:
Contains banned ingredient; methylene chloride
Evidence of formulation required
1046. Kof Fight Syrup
Deferred due to following reasons:
Formulation contains herbs
Testing methods of ingredients missing
Undertaking for stability, content and brand name missing
1047. Libidonil Capsules
Deferred due to following reasons:
The product is herbal while the firm does not have herbal
sections
F.No.10-8/2020-OTC) (M-80)
Page 103 of 144
S.No Brand name Decision
(1) (2) (3)
Form 3 not signed stamped
Evidence of submission and fee deposit missing
1048. Pain Go Cream
Deferred due to following reasons:
Brand name to be changed
Undertaking for stability missing
2 different form 3 with different formulations are present in file.
Clarify.
1049. P-Cure
Cream
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1050. Q Zee 10 Tablets
Deferred due to following reasons:
Form 3 not signed stamped
Contains methylene chloride; banned ingredient
Undertaking for brand name and content missing
1051. Rise O Vit Tablet
Deferred due to following reasons:
Quantity of vitamin D is above RDA
Revise form3 as the quantities and ingredients are jumbled
The file has no required documents except form 3 and evidence
of fee submission.
1052. Saint Berry Tablets
Deferred due to following reasons:
Testing method of cranberry extract required
1053. Snooz Tablets
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1054. Succeed Tablet
Deferred due to following reasons:
Is a sweetner. Does not fall in the purview of SRO 142 (I)
The file has no required documents except form 3 and evidence
of fee submission.
1055. Succeed Tablet
Deferred for further evaluation and clarification.
1056. Sylivel Tablets
Deferred due to following reasons:
The file has no required documents except form 3 and evidence
of fee submission.
1057. Sillyvel Syrup
Deferred due to following reasons:
The file has no required documents except form 3 and evidence
of fee submission.
1058. Take A Day Syrup
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1059. Take A Day Tablets
Deferred due to following reasons:
Contains herbs and drug; vinpocetine
1060. Tokocid Syrup
Deferred for further evaluation and clarification.
1061. Tonseez Tablets
Deferred due to following reasons:
The product is herbal while the firm does not have herbal
sections
The file has no required documents except form 3 and evidence
of fee submission.
1062.
Tusso V Syrup
(new name braintronix)
Deferred due to following reasons:
Brand name to be changed
F.No.10-8/2020-OTC) (M-80)
Page 104 of 144
S.No Brand name Decision
(1) (2) (3)
The product is herbal while the firm does not have herbal
sections
Testing methods of ingredients missing
Undertaking for brand name missing
1063.
Viskeez
(New name napwel)
Drops
Deferred due to following reasons:
The product is herbal while the firm does not have herbal
sections
1064.
Vita-Moul Tablets
(new name D-chiro wel)
Deferred due to following reasons:
Testing methods of ingredients missing
Undertaking for content, brand name and stability missing
1065. Vitomax Tab
(new name Maxwell) Tablet
Deferred due to following reasons:
Brand name to be changed
Undertaking for stability, brand name and content missing
Eon Pharmacy, Karachi
1066. Bio Malt Syrup Deferred for further evaluation and clarification.
Nutrimed Laboratories, Karachi
Plot No. B-42, S.I.T.E. Super Highway, Karachi
1067. Ferti Vit Capsule
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specification of active
ingredient including elemental equivalents in their respective
salts..
Dose of Zinc i.e. 20mg per capsule is exceeding RDA/ upper
tolerable limits according to recommended dose of 2 capsule
per day as per label claim, need clarification.
Master Formula stating batch size mentioning quantities of in-
active ingredients is required.
Product specific testing method of finished product is required
including assay of product.
Stability of cyanocobalamin as capsule dosage form is required.
Justify use of pure iodine and salenium in capsule dosage form.
1068. Sacroflor Sachet
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specification of active
ingredient i.e. Sachharomyces boulardii (lyophilize powder).
Brand name needs to be changed.
Monograph of Sachharomyces boulardii (lyophilize powder) is
required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1069. Gas Ref Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specification of each ingredient.
Brand name needs to be changed.
As per monograph attached firm is using peppermint oil instead
of mentha piperata extract as mentioned on form-3. Clarification
or revision of form-3 is required.
F.No.10-8/2020-OTC) (M-80)
Page 105 of 144
S.No Brand name Decision
(1) (2) (3)
Monograph of Cuminium Cyminum Extract, Foeniculum
vulgare extract, Mesua Ferrea Extract are required.
Product specific monograph and method of testing of finished
product is required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1070. Ib Fer Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Monograph of all ingredients except Zingiber officinalis extract,
Emblica officianlis extract, Peppermint extract and
Cinnamomum cassia are required.
Undertaking Signed by the owner regarding submission of
Stability data is required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1071. Tums Lozenges
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specification of each ingredient.
Monographs of all ingredients except Adhota Vasica Extract
and Glycerrhiza Glabra Extract are required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper are required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1072. Divazin Syrup
Deferred due to following reasons:
Zinc Gluconate is registered as single ingredient drug product
by the Registration Baord.
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
F.No.10-8/2020-OTC) (M-80)
Page 106 of 144
S.No Brand name Decision
(1) (2) (3)
1073. Fikar Cough Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specification of each ingredient.
Brand name needs to be changed.
Monograph of Ivy leaf extract is required.
Product specific monograph and method of testing of finished
product is required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1074. Heptomin Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Brand name needs to be changed.
Monograph of L-Ornithine is required.
Stability of zinc oxide in syrup dosage form is required.
Product specific monograph and method of testing of finished
product is required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1075. Hydrofit Effervescent Tablet
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Brand name needs to be changed.
Monograph of Vitamin B2 is required.
Stability of vitamin B2 in effervescent tablet is required.
Role of citric acid as active ingredient is required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper are required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1076. Pregner Tablet Deferred till finalization of fate of common molecules being dealt by
H&OTC Division and PER Division.
1077. Simrin Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Brand name needs to be changed.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Monograph of Vitamin B2 is required.
F.No.10-8/2020-OTC) (M-80)
Page 107 of 144
S.No Brand name Decision
(1) (2) (3)
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1078. Clasteon Tablet
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications, scientific names
of chaste berry extract, salt alongwith elemental equivalent in
their respective salts are required.
Stability of Zinc oxide in oral tablet dosage form is required,
Monograph of Chaste Berry Extract is required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1079. Fincor Tablet
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Rationale and evidence of dose for supplementation of D-Chiro
inositol and myo inositol.
Monograph of D-Chiro inositol is required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1080. Oxytrol Tablet
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Brand name needs to be changed.
Monograph of all ingredients except Zingiber officinalis extract
are required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1081. Merabol Tablet Deferred till finalization of fate of common molecules being dealt by
H&OTC Division and PER Division.
1082. Bilonic Tablet
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Product Profile as per check list is required.
F.No.10-8/2020-OTC) (M-80)
Page 108 of 144
S.No Brand name Decision
(1) (2) (3)
Master Formula stating batch size mentioning quantities of
active and inactive ingredients.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1083. Hydrofit Sachet
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Brand name needs to be changed.
Role of citric acid as active ingredient is required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper are required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1084. Berymax Forte Sachet
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Brand name needs to be changed.
Monograph of all ingredient are required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper are required.
Patient informatio n leaflet under packaging and labeling
information is required as per checklist of form-3.
1085. Gasfer Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Brand name needs to be changed.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Monograph of all ingredients except Zingiber officinalis extract
are required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1086. M-Plex M Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications, salts alongwith
elemental equivalents of each ingredient are required.
Monograph of folic acid is required.
F.No.10-8/2020-OTC) (M-80)
Page 109 of 144
S.No Brand name Decision
(1) (2) (3)
Stability of zinc oxide in syrup dosage form is required.
Product specific monograph and method of testing of finished
product is required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1087. Iv Tus Lozenges
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications, of each
ingredient are required.
Brand name needs to be changed.
Monographs of all ingredients except licorice extract are
required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1088. Cufkir Cough Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications, salts alongwith
elemental equivalents of each ingredient are required.
Brand name needs to be changed.
Monographs of Alpinia galangal extract, Hyoscyamus niger
extract, Cordia latifolia extract and Ocimum bacilicum extract
are required.
Product specific monograph and method of testing of finished
product is required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1089. Zinot Syrup Deferred till finalization of fate of common molecules being dealt by
H&OTC Division and PER Division.
1090. Cufkir Lozenges
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specification and salts of each
ingredient.
Monograph of Ivy leaf extract is required.
Formulation in product profile and master formula is different
need clarification.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1091. Bonazer Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specification and salts of each
ingredient.
F.No.10-8/2020-OTC) (M-80)
Page 110 of 144
S.No Brand name Decision
(1) (2) (3)
Brand name needs to be changed.
Monographs of respective salt of zinc is required.
Product specific monograph and method of testing of finished
product is required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Packaging and labeling information is required as per checklist
of form-3.
1092. Multi 365 Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications, salt alongwith
respective elemental equivalents are required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Monographs of all ingredients are required.
Stability of zinc oxide in oral syrup dosage form is required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1093. Tuscor Drops
Deferred due to following reasons:
Availability of Liquid Drop facility (Nutraceutical) is required
or justify.
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Monograph of Ivy Leaf Extract (Hydera helix) is required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper are required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1094. Simrin Tablet
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Brand name needs to be changed.
Monograph of Vitamin B2 is required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
F.No.10-8/2020-OTC) (M-80)
Page 111 of 144
S.No Brand name Decision
(1) (2) (3)
1095. Ceretec Capsule
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of Natural Egg
Shell membrane.
Monograph of Natural Egg Shell membrane is required.
Rationale and evidence of dose is required.
Signed undertaking regarding submission of stability data is
required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
1096. D-Tan Od Tablet
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specification of each ingredient
is required.
Brand name needs to be changed.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper are required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1097. Metanx Tablet
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specification of each ingredient
is required.
Strength of folic acid in L-methyl folate is required.
L-methylfolate and mecobalamin dose is exceeding RDA/ upper
tolerable limits according to recommended dose of 2 tablets per
day as per label claim, need clarification.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper are required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1098. Cofca Plus Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specification of each ingredient.
Brand name needs to be changed.
Monographs of Ivy leaf extract and thyme extract are required.
Product specific monograph and method of testing of finished
product is required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper are required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1099. Cereban Tablets Deferred due to following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 112 of 144
S.No Brand name Decision
(1) (2) (3)
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Product specific monograph and method of testing of finished
product is required.
Monograph of all ingredients are required.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper are required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1100. Bilonic Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name on
notarized stamp paper is required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
1101. Licozer Capsule
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Monograph of all ingredients except Emblica officinalis extract
are required.
Product specific monograph and method of testing of finished
product is required.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper are required.
Patient information leaflet under packaging and labeling
information is required as per checklist of form-3.
Hale Pharma, Lahore
B-Kh No. 285 Kh No. 570 Allah Hoo Industrial Estate, Allah Hoo Pul 22 Km Ferozpur Road, Lahore
1102. Endo-Plus Tablet
Deferred due to following reasons:
Brand name needs to be changed.
Form-3 is unsigned by the owner/MD/CEO of the firm.
Form-3 need to be revised w.r.t. elemental equivalents in their
respective salts.
The safety profile of methylene chloride as coating agent is
required.
Stability of zinc oxide in tablet oral dosage form is required.
Signed and stamped undertaking regarding submission of
stability data is required by the owner/MD/CEO of firm.
Signed and stamped undertaking regarding brand name is
required on notarized stamp paper.
Paragon Herbal Laboratories, Lahore
Plot No. Kht 285, Ktn 570, Allah Hoo Industrial Area, Near Sabzi Mandi, Gujumatta, Ferozepur Road, Lahore
1103. Pee-Cid Syrup Deferred due to following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 113 of 144
S.No Brand name Decision
(1) (2) (3)
Brand name needs to be changed.
Form-3 is unsigned and unstamped.
Monograph of Zingiber officinale is required.
Packaging and labeling information in required as per checklist
of form-3.
Method of testing of finished product is required.
Signed and stamped undertaking by the owner is required
regarding submission of stability data.
Signed and stamped undertaking regarding brand name and
contents are required on notarized stamp paper
Alaq Laboratories, Lahore
5-Main Road, Amir Town, Lahore"
1104. Khaba Syrup
Deferred due to following reasons:
Breakage of fee is required.
Brand name needs to be changed.
Monograph of Piper longum Extract, Tribulus terrestis extract,
Zingiber officinale extract and cardamom oil are required.
Confirmation regarding availability of Gas Chromatography
facility is required as mentioned on monograph of Bitter Fennel
Fruit Oil (BP).
Packaging and labeling information is required as per checklist
of form-3.
1105. Khaba Tablet
Deferred due to following reasons:
Breakage of fee is required.
Brand name needs to be changed.
Monograph of Piper longum Extract, Tribulus terrestis extract,
Zingiber officinale extract and cardamom oil are required.
Confirmation regarding availability of Gas Chromatography
facility is required as mentioned on monograph of Bitter Fennel
Fruit Oil (BP).
Disintegration time and dissolution testing are missing from
finished formulation testing.
Phytocon International Private Limited, Lahore
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
1106. Ad-More Drops
Deferred due to following reasons:
Differential fee is required.
Brand name needs to be changed.
Products on Form-3 need to be applied by the owner/MD/CEO
of the firm.
Confirmation of availability of drop manufacturing facility as
part of liquid section is required.
Signed and stamped undertaking regarding submission of
stability data is required by the owner/MD/CEO of firm.
Signed and stamped undertaking regarding brand name is
required stating this brand name is not registered under DRAP
Act, 2012.
1107. E-M0Re Tablet Deferred for further evaluation and clarification.
1108. Sacro-B Sachet Deferred due to following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 114 of 144
S.No Brand name Decision
(1) (2) (3)
Products on Form-3 need to be applied by the owner/MD/CEO
of the firm.
Form-3 need to be revised w.r.t. elemental equivalent of calcium
in calcium carbonate.
Monograph of algea calcium is required.
Strength of zinc (BP) i.e. 50mg mentioned on Form-3 is
exceeding RDA/ upper tolerable limits.
Signed and stamped undertaking regarding submission of
stability data is required by the owner/MD/CEO of firm.
Signed and stamped undertaking regarding brand name is
required stating this brand name is not registered under DRAP
Act, 2012.
1109. Calgee Syrup
Deferred due to following reasons:
Differential fee is required.
Brand name needs to be changed.
Products on Form-3 need to be applied by the owner/MD/CEO
of the firm.
Monograph of algea calcium is required.
Stability of cyanocobalamin in syrup dosage form is required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Signed and stamped undertaking regarding submission of
stability data is required by the owner/MD/CEO of firm.
Signed and stamped undertaking regarding brand name is
required stating this brand name is not registered under DRAP
Act, 2012.
1110. Qutrix Capsule
Deferred due to following reasons:
Differential fee is required.
Form-3 is unsigned by the owner/MD/CEO of the firm.
Undertaking stating that gelatin capsules are free from
TSE/BSE.
Monograph of tribulus terrestris extract (BP) is required.
Signed and stamped undertaking regarding submission of
stability data is required by the owner/MD/CEO of firm.
Signed and stamped undertaking regarding brand name is
required on notarized stamp paper.
Trends Pharmaceuticals Lahore
Plot 546/ 547, Sundar Industrial Estate, Lahore
1111. Ed-4 Tablet
Deferred due to following reasons:
Brand name needs to be changed.
Stability of zinc oxide in tablet dosage form is required.
Salt of selenium is required.
Rationale of dose of each ingredient is required.
Form-3 needs to be revised w.r.t. authentic specifications of
each ingredient along with its monographs are required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Xecutive Pharma, Lahore
F.No.10-8/2020-OTC) (M-80)
Page 115 of 144
S.No Brand name Decision
(1) (2) (3)
171-S, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
1112. Osteoline-D Syrup Deferred for further evaluation and clarification.
1113. Pencid Syrup
Deferred due to following reasons:
Form-3 needs to be revised w.r.t. specifications of each
ingredient.
Rationale of dose of each ingredient is required.
Monograph of all ingredient except Fennel Oil, Sodium
Bicarbonate and Mentha pipperita oil are required.
Label of product contradict the formulating applied on
prescribed form-3 w.r.t herbal extract/oil ingredients.
1114. Fusa-D Tablet
Deferred due to following reasons:
Firm applied for FOSA-D Tablet on prescribed form-3 and
breakage of fee challan (No.:0578041 dated:08-02-2017,
however in FIFO list @ sr. no. 1798 ‘Fusa-D Tablet’ is
mentioned.
Rational of dose of each ingredient is required.
Dose of L-lysine is different on form-3 i.e. 100mg than master
formula i.e. 50mg, need clarification.
Monograph of calcium carbonate (EP) is required.
Testing of quantitative method of each ingredient in finished
product is required.
1115. Mycyt Tablet
Deferred due to following reasons:
Formulation and evidence of competitor availability in the local
or international market. Rationale of dose of each ingredient is
required.
Form-3 needs to be revised w.r.t. specification of L-methylfolate
from EP to JECFA.
Product specific testing methods of finished product including
quantitative assay is required.
1116. W Kix Tablet
Deferred due to following reasons:
Stability of zinc oxide in tablet dosage form is required.
Form-3 needs to be revised w.r.t. mentioning “Tribulus
Extract” instead of “Tribulus”.
Rationale of dose of each ingredient is required.
Monograph of Tribulus extract, Tongat Ali extract, Mcca Root
Extract, Cayenne Pepper Extract and Sodium Borate are
required.
Testing method of quantitative assay of each ingredient in
finished product is required.
1117. X Zofil Tablet
Deferred due to following reasons:
Product specific monograph of finished product is required.
Calculations of vitamin B6 and B12 in master formula are
wrong.
Monographs of all ingredients are missing.
Rationale of dose of each ingredient is required.
Product specific method for testing of finished product
including quantitative assay is required.
1118. Lac-D Deferred due to following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 116 of 144
S.No Brand name Decision
(1) (2) (3)
(new name PH PRO)
Tablet Contains zinc oxide; orally unstable
1119.
Q-Mayo
(new name: Quat-F)
Tablet
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1120.
Ocitol C
(new name ; R colin)
Tablet
Deferred due to following reasons:
Evidence of submission and fee deposit missing
1121.
Vitacure
(new name: livton Tab)
Tablet
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1122.
Grolak
(new name Sepep)
Tablet
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1123.
Ovacure
(new name: fertive-F)
Tablet
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1124.
Cystol
(new name; adfast)
Tablet
Deferred due to following reasons:
Evidence of submission and fee deposit missing
1125.
Q-Tel Plus
(new name Greet)
Tablet
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1126. Eko Pllus Cough Syrup
Deferred for further evaluation and clarification. 1127. Ergo Syrup
1128. Eko Cough Syrup
1129.
X-Zed
(new name multipro-M)
Tablet
Deferred due to following reasons:
Contains zinc oxide (unstable orally)
Testing method of fennel and ginger extract missing
1130.
Sextra
(new name multinex)
Tablet
Deferred due to following reasons:
Contains zinc oxide; orally unstable
Testing method of ginkgo extract, ginseng extract and garlic
powder extract required
Evidence of formulation required
1131.
Ov Bost
(new name algenox syrup)
Tablet
Deferred due to following reasons:
Testing method of ginger extract and chamomile extract
required
Evidence of submission and fee deposit missing
The Best Laboratories Lahore
Plot No.348, Sunder Industrial Estate, Lahore
1132. Feerest Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications all ingredients
are required.
Stability of cyanocobalamin in oral syrup dosage form is
required.
Safety profile of Methyl paraben and Propyl Paraben in children
is required.
Quantitative method for identification of each ingredient in
finished dosage form is required.\
F.No.10-8/2020-OTC) (M-80)
Page 117 of 144
S.No Brand name Decision
(1) (2) (3)
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1133. Danical Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. elemental equivalent of calcium
in calcium carbonate. The given strength i.e. 375mg/5ml is
exceeding the RDA/upper tolerable limits as per recommended
dose on label i.e. 15ml twice daily.
Safety profile of Methyl paraben and Propyl Paraben in children
is required.
Product specific method of finished product is required
including assay.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1134. Danical Tablet
Deferred due to following reasons:
Form-3 needs to be revised w.r.t. to specification of calcium
carbonate and elemental calcium in this salt. The dose of
calcium i.e. 600mg is exceeding the RDA/upper tolerable limits
as per maximum recommended dose i.e. 3 tablets per day.
Safety of methylene chloride as coating agent in tablet dosage
form is required.
Method of assay of each ingredient in finished product is
required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required
1135. Feerest Tablet
Deferred due to following reasons:
Form-3 needs to be revised w.r.t. specification of ingredients are
reqired.
The dose of folic acid i.e. 400mcg and iron i.e. 26mg is
exceeding the RDA/upper tolerable limits as per maximum
recommended dose i.e. 3 tablets per day.
Safety of methylene chloride as coating agent in tablet dosage
form is required.
Product specific monograph of finished product including assay
is required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1136. Rohmest Tablet
Deferred due to following reasons:
Rationale of dose of each ingredient w.r.t. clinical significance
is required.
Stability of tri-calcium phosphate and zinc oxide in oral solid
dosage form is required.
F.No.10-8/2020-OTC) (M-80)
Page 118 of 144
S.No Brand name Decision
(1) (2) (3)
Dose of iodine i.e. 700mcg is exceeding the RDA/upper
tolerable limits.
Justification is required for using single salt i.e. tri-calcium
phosphate as a source of Calcium (90mg) and Phosphorus
(31mg) w.r.t to equivalency of each element.
Safety profile of methylene chloride as coating agent is
required.
Salt of potassium used in the formulation is required.
Product specific method of finished product including assay is
required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1137. Rohmest Syrup
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications, salt alongwith
respective elemental equivalents are required.
Safety of Copper as Cupric sulphate (CuSO4) in given strength
and dose of 4mg twice daily is required.
Stability of zinc oxide and cyanocobalamin in oral syrup
dosage form is required.
Monograph of vitamin C is required.
Safety profile of Methyl paraben and Propyl Paraben in children
is required.
Quantitative method for identification of each ingredient in
finished dosage form is required.\
Patient information leaflet is required as per approved checklist
of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on 7company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
Alpha Nutraceutical, Lahore
1138. Bay-Kuf Syrup Deferred for further evaluation and clarification.
1139. Citrocran Sachet
M/s. Convell Laboratories (Dedicated Section),
Saidu Sharif, Swat
1140. Kidvell Baby Drops
Deferred due to following reasons:
Evidence regarding fee submission of Kidvell Baby Drops as
firm attached evidence of fee submission for “Kidvell Drop”,
needs clarification.
Brand name needs to be changed.
Confirmation regarding availability of drop manufacturing
facility as part of oral liquid (syrup) section is required,
Strength of ingredient per unit delivery volume is required.
Form-3 needs to be revised w.r.t. elemental equivalents of iron
and zinc in their respective salts.
Monograph of malt extract USP (maltodextrin) is required.
F.No.10-8/2020-OTC) (M-80)
Page 119 of 144
S.No Brand name Decision
(1) (2) (3)
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Stability of cyanocobalamin in oral liquid dosage form is
required.
Stepwise Manufacturing process in-detail, testing
methods/specification of raw and finished product,
recommended conditions for use and packaging & labeling
information of product is required as per check list of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1141. Convell-D Drop
Deferred due to following reasons:
Confirmation regarding availability of drop manufacturing
facility as part of oral liquid (syrup) section is required,
Stepwise Manufacturing process in-detail, testing
methods/specification of raw and finished product,
recommended conditions for use and packaging & labeling
information of product is required as per check list of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1142. Hileaf Junior Syrup
Deferred due to following reasons:
Brand name needs to be changed.
Monograph of ivy leaf extract is required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Manufacturing process, testing methods/specification of raw and
finished product, recommended conditions for use and
packaging & labeling information of product is required as per
check list of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1143. Ginkovell Capsules
Deferred due to following reasons:
Firm possess only Capsule (Nutraceutical) Section. Therefore,
Form-3 need to be revised w.r.t Bacopa monnieri extract rather
than Bacopa monnieri.
Monograph of Bacopa monnieri extract is required.
Manufacturing process, testing methods/specification of raw and
finished product, recommended conditions for use and
packaging & labeling information of product is required as per
check list of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
F.No.10-8/2020-OTC) (M-80)
Page 120 of 144
S.No Brand name Decision
(1) (2) (3)
1144. Ginkovell Syrup
Deferred due to following reasons:
Firm possess only Oral Liquid (Syrup) Section. Therefore,
Form-3 need to be revised w.r.t Bacopa monnieri extract rather
than Bacopa monnieri.
Monograph of all ingredients are required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Manufacturing process, testing methods/specification of raw and
finished product, recommended conditions for use and
packaging & labeling information of product is required as per
check list of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1145. Velmarine Syrup Deferred till finalization of fate of common molecules being dealt by
H&OTC Division and PER Division.
1146. Hileaf Plus Syrup
Deferred due to following reasons:
Brand name needs to be changed.
Strength of ingredient per unit delivery volume is required.
Monograph of ivy leaf extract is required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Manufacturing process, testing methods/specification of raw and
finished product, recommended conditions for use and
packaging & labeling information of product is required as per
check list of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1147. Ovavell Plus Capsules
Deferred due to following reasons:
Brand name needs to be changed.
Form-3 needs to be revised w.r.t. mentioning Tribullus
terristress extract rather then Tribullus terristress.
Monograph of Tribullus terristress extract is required.
Manufacturing process, testing methods/specification of raw and
finished product, recommended conditions for use and
packaging & labeling information of product is required as per
check list of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1148. Nilcough Junior Syrup
Deferred due to following reasons:
Brand name needs to be changed.
Strength of ingredient per unit delivery volume is required.
Monograph of ivy leaf extract is required.
F.No.10-8/2020-OTC) (M-80)
Page 121 of 144
S.No Brand name Decision
(1) (2) (3)
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Manufacturing process, testing methods/specification of raw and
finished product, recommended conditions for use and
packaging & labeling information of product is required as per
check list of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1149. Convit-D Tablets
Deferred due to following reasons:
Form-3 needs to be revised w.r.t elemental equivalent of
calcium in calcium carbonate.
Manufacturing process, testing methods/specification of raw and
finished product, recommended conditions for use and
packaging & labeling information of product is required as per
check list of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1150. Optivell –Z Capsules
Deferred due to following reasons:
Brand name needs to be changed.
Form-3 needs to be revised w.r.t. mentioning Ginko biloba
extract rather than Ginko biloba. The dose of folic acid i.e.
1.5mg and Zinc sulphate i.e. 40mg needs to be revised. The
elemental equivalents of each ingredient in their respective salt.
Monograph of Tribullu s terristress extract is required.
Stability of selenium sulfide or selenium sulphate in capsule
dosage form is required.
Manufacturing process, testing methods/specification of raw and
finished product, recommended conditions for use and
packaging & labeling information of product is required as per
check list of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required
1151. Multi –Vell Capsules
Deferred due to following reasons:
Evidence of fee submission is required.
Brand names needs to be changed.
Form-3 needs to be revised w.r.t. specifications of selenium.
Elemental equivalent in their respective salt is required.
Stability of selenium sulfide or selenium sulphate in capsule
dosage form is required.
Monograph of Vitamin B12 is required. Specify
methycobalamin or cyanocobalamin as source of vitamin B12 in
the formulation.
F.No.10-8/2020-OTC) (M-80)
Page 122 of 144
S.No Brand name Decision
(1) (2) (3)
Stability of methycobalamin/cyanocobalamin in capsule dosage
form is required.
Manufacturing process, testing methods/specification of raw and
finished product, recommended conditions for use and
packaging & labeling information of product is required as per
check list of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1152. Cardiovell Plus Capsules
Deferred due to following reasons:
Brand names needs to be changed.
Elemental equivalent in their respective salt is required.
Stability of selenium sulfide or selenium sulphate in capsule
dosage form is required.
Monographs of Garlic extract and alpha lipoic acid are required.
Stability of cyanocobalamin in capsule dosage form is required.
Manufacturing process, testing methods/specification of raw and
finished product, recommended conditions for use and
packaging & labeling information of product is required as per
check list of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1153. Ncad3 Tablets
Deferred to seek justification from the firm for applying same
formulation with different brand name i.e.
Convit-D Tablet (FIFO No. 1836).
1154. Denvel Ds Tablets Deferred till finalization of fate of common molecules being dealt by
H&OTC Division and PER Division.
1155. Berry Sip Sachets
Deferred due to following reasons:
Evidence of fee submission is required.
Monograph of Cranberry extract is required.
Manufacturing process, testing methods/specification of raw and
finished product, recommended conditions for use and
packaging & labeling information of product is required as per
check list of form-3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
Kaap Pharmaceuticals Pvt Ltd, Lahore
18 Km Ferozepur Road, Lahore
1156. Enzokap 10Mg Tablet Deferred till finalization of fate of common molecules being dealt by
H&OTC Division and PER Division.
M/s. Blossom Laboratories (Pvt.) Ltd.,
30-KM, Badian Road, ½ K.M Off Roda Bohgal Road, Lahore Cantt
1157. Blossom Colic Syrup Deferred due to following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 123 of 144
S.No Brand name Decision
(1) (2) (3)
Firm applied for blossom colic tablet on prescribed form-3 and
fee challan (No.:0848039 dated:070-02-2019, however in FIFO
list @ sr. no. 1845 ‘blossom colic syrup’ is mentioned.
Availability of Syrup/Drop (Liquid) Section (Homeo) is
required or justify.
Fomr-3 needs to be revised w.r.t. to specifications and complete
scientific names of each ingredient.
Since the product is a homeopathic combination therefore
requirements laid down in para 2 of notification vide F.No.04-
02/2017-DD(H&OTC) dated 21-04-2020 needs to be fulfilled.
As per manufacturing processes submitted on form-3 the
applied tablet is a “coated” one however no coating material is
mentioned in list of excipients/inactive ingredients. Need
clarification.
Monograph of all ingredinets except ipecac, aethusa and alfalfa
are required.
Signed and stamped undertaking regarding submission of
stability data is required by the owner/MD/CEO of firm.
Testing method for qualitative assay of each ingredient in
finished product is required,
M/s Greektec (Pvt) Ltd (Eno 0091)
Plot No. D-30/A (First Floor), S.I.T.E,-II, Phase-I, Super Highway, Karachi
1158. Multiflex Tablet Deferred due to following reasons:
Form 3 missing
1159. Macfer Tablet
Deferred due to following reasons:
Form 3 missing
Contains banned ingredient; methylene chloride
Undertaking for stability missing
1160. Q-Mag Tablet
Deferred due to following reasons:
Form3 missing
Undertaking for stability and brand name missing
Official monograph of spirulina extract, horsetail extract
required
Evidence of formulation required
1161. Femeline 2 Tablet
Deferred due to following reasons:
Form 3 missing
Official testing methods of ingredients missing
1162. Liprolex Tablet
Deferred due to following reasons:
Form 3 missing
Evidence of formulation required
Testing methods of plant sterols/ stanols required
Provide salt of sodium
Undertaking for stability and brand name missing
1163. Ceebrox Tablet Deferred due to following reasons:
Form 3 missing
M/s Genbiotech Nutraceuticals (Eno 00263)
Plot No. 24, Street No. NS-2, NIZ RCCI, Rawat, Rawalpindi
1164. Gencordin Capsule Deferred due to following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 124 of 144
S.No Brand name Decision
(1) (2) (3)
Official monograph of danshenform compound, salvia extract
and borneol required
Evidence of formulation required
Fee submitted per product is 250/-
Phytotia Laboratory, Peshawar
1165. Flex-Jo Tablet
Deferred for further evaluation and clarification. 1166. Ekovit Tablet
1167. Malt-C Sachet
Phytocon International Private Limited, Lahore
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
1168. Algaewam Tablets
Deferred due to following reasons:
Brand name needs to be changed.
Products on Form-3 need to be applied by the owner/MD/CEO
of the firm.
Form-3 need to be revised w.r.t. elemental equivalents in their
respective salts.
Monograph of algea calcium is required.
Strength of zinc (BP) i.e. 50mg mentioned on Form-3 is
exceeding RDA/ upper tolerable limits.
Signed and stamped undertaking regarding submission of
stability data is required by the owner/MD/CEO of firm.
Signed and stamped undertaking regarding brand name is
required stating this brand name is not registered under DRAP
Act, 2012.
1169. Ferrowam Tablet
Deferred due to following reasons:
Brand name needs to be changed.
Products on Form-3 need to be applied by the owner/MD/CEO
of the firm.
Monograph of iron bisglycinate is required.
Signed and stamped undertaking regarding submission of
stability data is required by the owner/MD/CEO of firm.
Signed and stamped undertaking regarding brand name is
required stating this brand name is not registered under DRAP
Act, 2012.
1170. Men-Force Tablet
Deferred due to following reasons:
Prescribed form-3 is required signed an stamped by the
owner/MD/CEO of the firm.
Form-3 need to be revised w.r.t. elemental equivalents in their
respective salts.
Brand name needs to be changed.
Stability of zinc oxide is required in oral tablet dosage form.
Strength of zinc oxide i.e. 50mg is exceeding RDA/ upper
tolerable limits.
Specific test w.r.t tablet dosage form are required including
weight variation.
Confirmation of availability of drop manufacturing facility as
part of liquid section is required.
F.No.10-8/2020-OTC) (M-80)
Page 125 of 144
S.No Brand name Decision
(1) (2) (3)
Signed and stamped undertaking regarding submission of
stability data is required by the owner/MD/CEO of firm.
Signed and stamped undertaking regarding brand name is
required stating this brand name is not registered under DRAP
Act, 2012.
1171. Gestrowim Syrup
Deferred due to following reasons:
Differential fee is required.
Brand name needs to be changed.
Products on Form-3 need to be applied by the owner/MD/CEO
of the firm.
Firm uses Zingiber officinale (USP) and Mentha pierita (USP)
crude form while it possess only oral liquid section.
Monograph of algea calcium is required.
Stability of cyanocobalamin in syrup dosage form is required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Signed and stamped undertaking regarding submission of
stability data is required by the owner/MD/CEO of firm.
Signed and stamped undertaking regarding brand name is
required stating this brand name is not registered under DRAP
Act, 2012.
M/s. Medwell Pharmaceuticals, (Dedicated Section), (E No 00124)
1-Km, Terbella Road, Lawrencepur District, Attock
1172. Glucofit Tablets
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1173. Hemonil Tablets
Deferred due to following reasons:
Methylene chloride (banned ingredient) used
Undertaking for stability, brand name and content missing
1174. Hicin Ds Tablets
Deferred due to following reasons:
Contains methylene chloride (banned ingredient)
Undertaking for stability, brand name and content missing
1175. Juvile Tablets
Deferred for further evaluation and clarification.
1176. Lactofid Capsules
Deferred due to following reasons:
Contains probiotics while the firm does not have a probiotic
section
Evidence of submission and fee deposit missing
1177. Lactofid Sachets Powder
Deferred due to following reasons:
Contains probiotics while the firm does not have a probiotic
section
Evidence of submission and fee deposit missing
1178. Sea Cool Syrup
Deferred due to following reasons:
Contains sodium bicarbonate
Form 3 not signed stamped
Testing method of herbal extracts required
Evidence of formulation required
1179. Surty Hair Supplement Powder Deferred due to following reasons:
Contains minoxidil; registered as drug
F.No.10-8/2020-OTC) (M-80)
Page 126 of 144
S.No Brand name Decision
(1) (2) (3)
Undertaking for content and brand name missing
Nayas Impex, Lahore
Suit No.18-A, 2nd floor Gohar Center, Wahdat Road, Lahore-Pakistan
an agent of M/s Eurobio 9, Lotissement Le Bois 22340 Treffrin, France [Principal Manufacturer: M/s Artimon, 5 rue
Brindejonc des Moulinais, 22190 Plerin, France] (Veterinary)
1180. Euro Vita Mix
Deferred due to following reasons:
CoAs of all active ingredients and CoA of finished product are
required from principal manufacturer.
Accelerated and long term stability studies data of at least 3
batches conducted on requirements of zone IV-A is required
from principal manufacturer.
Manufacturing license of the principal manufacturer in the
country, issued by regulatory body is required.
Approval of product registration or marketing authorization in
the country of origin, issued by regulatory authority is required.
GMP issued by regulatory authority is required.
Last inspection report issued by regulatory body is required.
Agency agreement between importer and principal manufacturer
is required.
Document is required from principal manufacturer stating
relationship between former and M/s Eurobio 9, Lotissement Le
Bois 22340 Treffrin, France as an agent.
1181. Euro E Sel 20%
Deferred due to following reasons:
CoAs of all active ingredients and CoA of finished product are
required from principal manufacturer.
Composition of active ingredients mentioned on master
formulation and CoA of finished product is different, needs
clarification.
Accelerated and long term stability studies data of at least 3
batches conducted on requirements of zone IV-A is required.
Prescribed form 5 is required.
Manufacturing license of the principal manufacturer in the
country, issued by regulatory body is required.
Approval of product registration or marketing authorization in
the country of origin, issued by regulatory authority is required.
GMP issued by regulatory authority is required.
Last inspection report issued by regulatory body is required.
Agency agreement between importer and principal manufacturer
is required.
Document is required from principal manufacturer stating
relationship between former and M/s Eurobio 9, Lotissement Le
Bois 22340 Treffrin, France as an agent.
1182. Euro Vit C
Deferred due to following reasons:
CoAs of all active ingredients and CoA of finished product are
required from principal manufacturer.
Accelerated and long term stability studies data of at least 3
batches conducted on requirements of zone IV-A is required.
Manufacturing license of the principal manufacturer in the
country, issued by regulatory body is required.
F.No.10-8/2020-OTC) (M-80)
Page 127 of 144
S.No Brand name Decision
(1) (2) (3)
Approval of product registration or marketing authorization in
the country of origin, issued by regulatory authority is required.
GMP issued by regulatory authority is required.
Last inspection report issued by regulatory body is required.
Agency agreement between importer and principal manufacturer
is required.
Document is required from principal manufacturer stating
relationship between former and M/s Eurobio 9, Lotissement Le
Bois 22340 Treffrin, France as an agent.
1183. Hepa Euro
Deferred due to following reasons:
CoAs of all active ingredients and CoA of finished product are
required from principal manufacturer.
Accelerated and long term stability studies data of at least 3
batches conducted on requirements of zone IV-A is required.
Manufacturing license of the principal manufacturer in the
country, issued by regulatory body is required.
Approval of product registration or marketing authorization in
the country of origin, issued by regulatory authority is required.
GMP issued by regulatory authority is required.
Last inspection report issued by regulatory body is required.
Agency agreement between importer and principal manufacturer
is required.
Document is required from principal manufacturer stating
relationship between former and M/s Eurobio 9, Lotissement Le
Bois 22340 Treffrin, France as an agent.
Xecutive Pharma, Lahore
171-S, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
1184. Calcifan D Tablet
Deferred due to following reasons:
Form-3 need to be revised w.r.t. specifications, salts alongwith
elemental equivalents of each ingredient are required.
The dose of calcium i.e. 750mg is at upper border of RDA/upper
tolerable limits as per label claim dose i.e. two tablets a day.
Monograph of Bromelain Extract is required.
Product specific monograph of finished product is required.
1185. White Extra Tablet
Deferred due to following reasons;
Brand name needs to be changed.
Form-3 needs to be revised w.r.t. specification of active
ingredient.
Rationale of dose of glutathione i.e. 500mg is required.
Monograph of glutathione is required.
Product specific testing method of finished product including
quantitative assay.
1186. Guteez Syrup
Deferred due to following reasons:
Monograph of all ingredients are required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Product specific monograph of finished product is required.
1187. Ascilex Deferred for further evaluation and clarification.
F.No.10-8/2020-OTC) (M-80)
Page 128 of 144
S.No Brand name Decision
(1) (2) (3)
Syrup
1188.
Xecos
(new name pencid)
Syrup
Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
Phytocon International Private Limited, Lahore
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
1189. Astaberry Sachet
Deferred for further evaluation and clarification.
1190. Astalax Syrup
Deferred due to following reasons:
Products on Form-3 need to be applied by the owner/MD/CEO
of the firm.
Stability of cyanocobalamin in syrup dosage form is required.
The dose of elemental iron i.e. 27mg is exceeding the
RDA/upper tolerable limits as per label claim dose i.e. three
times daily.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Signed and stamped undertaking regarding submission of
stability data is required by the owner/MD/CEO of firm.
Signed and stamped undertaking regarding brand name is
required stating this brand name is not registered under DRAP
Act, 2012.
The Best Laboratories Lahore
1191. Kranberry Sachet
Deferred due to following reasons:
Differential fee is required.
Brand name needs to be changed.
Form-3 need to be revised w.r.t. specifications of each
ingredient.
Monograph of Cran berry extract is required.
Quantitative identification of each ingredient in finished dosage
form is required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1192. Colky Drops
Deferred due to following reasons:
Confirmation regarding availability of drops manufacturing
facility as part of syrup (herbal) section is required.
Justification regarding strengths of each ingredient is required
w.r.t. decoction process as mentioned in manufacturing process
submitted on form-3.
Safety undertaking regarding product on notarized stamp paper
is required.
Safety profile of Methyl paraben and Propyl Paraben in children
is required.
Monographs of Mentha arvensis, Foeniculum vulgare and
Cuminum cyminum are required.
Method of assay of each ingredient in finished product is
required.
F.No.10-8/2020-OTC) (M-80)
Page 129 of 144
S.No Brand name Decision
(1) (2) (3)
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1193. Aracure Syrup
Deferred due to following reasons:
Form-3 need to be revised mentioning United State
Pharmacopoeia as specification of Silybum marianum.
Justification regarding strengths of each ingredient is required
w.r.t. decoction process as mentioned in manufacturing process
submitted on form-3.
Safety profile of Methyl paraben and Propyl Paraben in children
is required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1194. Health-33 Tablet
Deferred due to following reasons:
Brand name needs to be changed.
Form-3 needs to be revised w.r.t. salt of potassium along with
its monograph is required.
Stability of zinc oxide in oral tablet dosage form is required.
Safety of methylene chloride as coating agent in tablet dosage
form is required.
Justification of chloride in formulation is required.
Justification is required for using single salt i.e. tri-calcium
phosphate as a source of Calcium (162mg) and Phosphorus
(125mg) w.r.t to equivalency of each element.
Monographs of potassium dichromate and niacin are required.
Product specific monograph of finished product including assay
is required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1195. Bestocid Syrup
Deferred due to following reasons:
Justification regarding strengths of each ingredient is required
w.r.t. decoction process as mentioned in manufacturing process
submitted on form-3.
Safety profile of Propyl Paraben in children is required.
Firm mentioned mentha piperita/viridis (API,Vol-V) in product
profile on form-3. Need clarification.
Monograph of Cuminum cyminum (API, Vol I) is required.
Qualitative/identification test of ingredients in finished product
is required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
F.No.10-8/2020-OTC) (M-80)
Page 130 of 144
S.No Brand name Decision
(1) (2) (3)
1196. Aracin-Ds
Tablet Deferred for further evaluation and clarification.
1197. Leaf Up Syrup
Deferred due to following reasons:
Form-3 need to be revised mentioning European Pharmacopeia
as specification of Hedra Helix.
Justification regarding strengths of each ingredient is required
w.r.t. decoction process as mentioned in manufacturing process
submitted on form-3.
Safety profile of Methyl paraben and Propyl Paraben in children
is required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1198. Apitizer Syrup
Deferred due to following reasons:
Justification regarding strengths of each ingredient is required
w.r.t. decoction process as mentioned in manufacturing process
submitted on form-3..
Safety profile of Methyl paraben in children is required.
Monographs of Achellia mellefolium, Anethum soye oil and
cassia occidentalis are required.
Qualitative/identification testing method for ingredients in
finished product is required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1199. Gink Up Syrup
Deferred due to following reasons:
Form-3 needs to be revised w.r.t. mentioning of “Ginkgo Biloba
Extract (USP)” instead of “Ginkgo Biloba (USP)”
Safety profile of Methyl paraben and propyl paraben in children
is required.
Quantitative/identification testing method for ingredients in
finished product is required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1200. Sencof Syrup
Deferred due to following reasons:
Form-3 need to be revised mentioning European Pharmacopeia
as specification of Hedra Helix and Glycyrrhiza glabra.
Justification regarding strengths of each ingredient is required
w.r.t. decoction process as mentioned in manufacturing process
submitted on form-3.
Safety profile of Methyl paraben and Propyl Paraben in children
is required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
F.No.10-8/2020-OTC) (M-80)
Page 131 of 144
S.No Brand name Decision
(1) (2) (3)
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1201. D-Card Capsule
Deferred due to following reasons:
Clarification is required regarding whether firm want to use
Salvia militorrhiza or its extract.
o If using extract then differential fee is required.
o If using herb then confirmation regarding availability
of capsule section (herbal) is required.
Form-3 needs to be revised w.r.t. specification of active
ingredient.
Master Formula stating batch size mentioning quantities of
inactive ingredients is required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
Phytocon International Private Limited, Lahore
339-A, Sundar Industrial Estate, Raiwind Road, Lahore
1202. Qtrefol-B6 Tablet Deferred till finalization of fate of common molecules being dealt by
H&OTC Division and PER Division.
Sind Medical Stores, Karachi
13-B, Block-6, PECHS, Shahrah-e-Faisal, Karachi-Pakistan
Is an agent of Agent of M/s Martinez Nieto S.A., Pol. Ind. Los Camachos Sur, Avda. Del Carboneo, 96 30369 Los
Camachos, Cartagena, Spain
1203. Cistomar Capsule
Deferred for following reasons:
Fee evidence is required.
Form 5 is required.
Testing specification/ monographs are required.
Master formulation or batch manufacturing record is required.
Manufacturing process is required.
GMP certificate issued by regulatory authority is required.
Accelerated and long term Stability studies conducted on
requirements in zone IV-A are required.
CoAs of active ingredients and finished product are required.
Label claim and clinical safety of product are required.
Manufacturing license issued by regulatory authority in English
language, is required.
Justification is required to establish relationship between
Martinez Nieto S.A and Marnys.
Agency agreement bearing signature of principal manufacturer
in the country of origin and importer in Pakistan, is required.
Last inspection report issued by regulatory body is required.
1204. Trazamin ClordetoxVials
Deferred for following reasons:
Testing method/ monographs of chlorella, broccoli and zin
gluconate and iron (salt) are required.
Form 5 to be revised w.r.t salts of active ingredients and
botanical name of herbs.
CoA of finished product is required on principal manufacturer’s
cover letter.
F.No.10-8/2020-OTC) (M-80)
Page 132 of 144
S.No Brand name Decision
(1) (2) (3)
Formulation is applied in vial dosage form without mentioning
either route of administration is oral or parenteral, needs
clarification in this regard and CoA of finished product should
bear conformity of sterility testing.
Accelerated and long term Stability studies data comprising of
chemical testing (identification) of herbs being used in
formulation in addition to other information that have been
provided, is required.
Manufacturing license issued by regulatory authority in English
language, is required.
Justification is required to establish relationship between
Martinez Nieto S.A and Marnys.
Agency agreement bearing signature of principal manufacturer
in the country of origin and importer in Pakistan, is required.
Last inspection report issued by regulatory body is required.
1205. Memory Plus Capsule
Deferred for following reasons:
Strength of active ingredients per single capsule is required.
Form 5 to be revised w.r.t salts of active ingredients.
CoA of choline citrate, phosphotidylserine, sodium and
selenium are required.
CoA of finished product depicting chemical assay or test of
active ingredients is required.
Accelerated and long term stability studies data (chemical
testing of active ingredients) in addition to other information
that have been provided, are required.
Evidence of clinical safety and efficacy and packaging and
labeling mockup of said product is required.
Monograph/ testing specification of phosphotidylserine is
required.
Manufacturing license issued by regulatory authority in English
language, is required.
Justification is required to establish relationship between
Martinez Nieto S.A and Marnys.
Agency agreement bearing signature of principal manufacturer
in the country of origin and importer in Pakistan, is required.
Last inspection report issued by regulatory body is required.
Nutrabiotics Nutritional Life Sciences, Peshawar
"Plot No. 32-33, Small Industrial Estate, Kohat Road, Peshawar"
1206. A-Q Drops
Deferred due to following reasons:
Evidence of fee submission is required.
Confirmation regarding availability of drops manufacturing
facility as part of syrup section.
Form-3 needs to be revised w.r.t. specifications of Vitamin A.
Viscosity/specific gravity test is missing in finished product
testing specification.
1207. Cv-Q10 Tablet
Deferred due to following reasons:
Evidence of fee submission is required.
Form-3 needs to be revised w.r.t. specifications of ingredients.
F.No.10-8/2020-OTC) (M-80)
Page 133 of 144
S.No Brand name Decision
(1) (2) (3)
Global Vets Corporation
1208. Global Vi-C 95
Deferred for further evaluation and clarification.
1209. Casoline
1210. Ewha E-10 Sel Sol
1211. Ewha Adek Sol
1212. Ewha Adek Sol
M/s Siddiqui Pharma (Pvt) Ltd.,
located at the address 2055 W-9 Opp. Fatima Jinnah Hospital Abdali Road, Multan
1213. Lifeguard-T
Deferred for further evaluation and clarification.
1214. Hepatonic-L
1215. Vigomax-G
1216. Vital Chorus Forte
M/s Zaidi Chemist, Peshawar
15 Soekarno Square, Khyber Bazar, Peshawar
Agent of M/s Rowa Pharmaceuticals Ltd, Newtown, Bantry, Cork, Ireland
Evaluator: Zain Ul Abidin, AD-V)
1217. Rowatinex Drop Deferred for further evaluation and clarification.
1218. Rowachol soft capsules
Deferred for following reasons:
Fee evidence is required.
Form 5 is required.
Testing specification/ monographs are required.
Master formulation or batch manufacturing record is required.
Manufacturing process is required.
Accelerated and long term Stability studies conducted on
requirements in zone IV-A are required.
Label claim and clinical safety of product are required.
Manufacturing license issued by regulatory authority in English
language, is required.
Agency agreement bearing signature of principal manufacturer
in the country of origin and importer in Pakistan, is required.
Last inspection report issued by regulatory body is required.
Zestech Sciences, Karachi
1219. Floriva Tablet Deferred for further evaluation and clarification.
Alaq Laboratories, Lahore
5-Main Road, Amir Town, Lahore"
1220. Bronkof Syrup
Deferred due to following reasons:
Brand name needs to be changed.
Breakage of fee is required.
Form-3 needs to be revised w.r.t. mentioning glycyrrhiza glabra
extract instead of glycyrrhiza glabra
F.No.10-8/2020-OTC) (M-80)
Page 134 of 144
S.No Brand name Decision
(1) (2) (3)
Monograph of morus nigra extract is required.
Product specific testing method of finished product including
quantitative assay is required
1221. Brooklyn International, Rawalpindi
1222. Orenda Sachet Deferred for further evaluation and clarification.
Ghazi Brothers, Karachi
1223. Addcon Xlm Deferred for further evaluation and clarification.
1224. Kofa Grain Ph.5
Hinucon, Karachi
1225. Fe-Max Sachet Deferred for further evaluation and clarification.
Novae Nutraceuticals, Hattar
1226. Mela Bright Tube
Deferred for further evaluation and clarification. 1227. Prolex Cream
1228. Urelia Ointment
1229. Cosalik Cream
Trends Pharmaceuticals Lahore
1230. Vitaderm-M Tablet Deferred for further evaluation and clarification.
M/s Zaidi Chemist, Peshawar
15 Soekarno Square, Khyber Bazar, Peshawar
Agent of M/s Rowa Pharmaceuticals Ltd, Newtown, Bantry, Cork, Ireland
1231. Rowachol oral drops Deferred for further evaluation and clarification.
1232. Rowatinex Capsules
Deferred for following reasons:
Fee evidence is required.
Form 5 is required.
Testing specification/ monographs are required.
Master formulation or batch manufacturing record is required.
Manufacturing process is required.
Accelerated and long term Stability studies conducted on
requirements in zone IV-A are required.
Label claim and clinical safety of product are required.
Manufacturing license issued by regulatory authority in English
language, is required.
Agency agreement bearing signature of principal manufacturer
in the country of origin and importer in Pakistan, is required.
Last inspection report issued by regulatory body is required.
Alaq Laboratories, Lahore
5-Main Road, Amir Town, Lahore"
1233. Rego-V Syrup
Deferred due to following grounds.
Calculation of Ginseng extract is wrong in master formula w.r.t
to given strength on form-3 i.e. 130mg/5ml.
Quantitative Assay of each ingredient in finished product is
required as part of testing methods.
Ghazi Brothers, Karachi
1234. Addcon Xf Superfine Deferred for further evaluation and clarification.
Innova Life Sciences, Lahore
1235. Gasmet Syrup
Deferred for further evaluation and clarification. 1236. Gasmet Drops
1237. Peefer Junior Sachet
F.No.10-8/2020-OTC) (M-80)
Page 135 of 144
S.No Brand name Decision
(1) (2) (3)
Bio Life Enterprises Nutraceuticals, Rawalpindi
1238. Cali + Tablet Deferred for further evaluation and clarification.
AR Nutraceutical Pharma, Karachi.
Plot No. F-4/C, S.I.T.E., Phase-II, Super Highway, Karachi
1239. Memrite-X Tablet
Deferred due to following reasons:
Fee challan and evidence of fee submission including breakage
of fee are not attached with application.
Form-3 is unsigned and un-stamped.
Form-3 need to be revised w.r.t. specification and salts/extracts
of each ingredient.
Brand name needs to be changed.
Herbal drugs the scientific name and species name of plant
along with following:-
o State part used, nature of ingredient i.e. powder
drugs,extracts (aqueous, alcoholic or any other solvent
used for extraction)
o In case of standardized extracts state the percentage of
active ingredient(s) case may be.
In case of extracts state Drug Extract Ratio if the extract is not
standardized.
Monograph of Medico sativa (alfalfa) is required.
Product specific monograph of finished product is required.
1240. Memrite-X Syrup
Deferred due to following reasons:
Fee challan and evidence of fee submission including breakage
of fee are not attached with application.
Form-3 is unsigned and un-stamped.
Form-3 need to be revised w.r.t. specification and salts/extracts
of each ingredient.
Brand name needs to be changed.
Monograph of Medico sativa (alfalfa) is required.
Herbal drugs the scientific name and species name of plant
along with following:-
o State part used, nature of ingredient i.e. powder
drugs,extracts (aqueous, alcoholic or any other solvent
used for extraction)
o In case of standardized extracts state the percentage of
active ingredient(s) case may be.
In case of extracts state Drug Extract Ratio if the extract is not
standardized.
Strength of Methyl Paraben and Propyl Paraben and its safety
profile in children is required.
De-ionized water advantages over RO water use in formulation,
needs clarification.
Product specific monograph of finished product is required.
Form-3 need revision regarding ”recommended use” as the firm
has applied for syrup but given data of tablet.
Packaging and labeling is required:
i. Primary and secondary labels
1241. Vegrite-X Tablet Deferred for further evaluation and clarification.
F.No.10-8/2020-OTC) (M-80)
Page 136 of 144
S.No Brand name Decision
(1) (2) (3)
1242. Agnum Syrup
1243. Brainite Syrup
1244. Bycof Syrup
1245. Movrise Tablet
1246. Moveplex Syrup
1247. Recol Syrup
1248. Zigut Sachet
1249. Ostomove Syrup
1250. Femol Tablet
1251. Bycof Drop
1252. Moverise Drop
1253. Milkyvit Sachet
1254. Vilter-I Tablet
Deferred due to following reasons:
Fee challan and evidence of fee submission are not attached
with application.
Breakage of fee is required.
Form-3 need to be revised w.r.t. specification and salts of each
ingredient.
Product specific monograph of finished product is required.
1255. Vitrite Tablet
Deferred due to following reasons:
Fee challan and evidence of fee submission are not attached
with application.
Breakage of fee is required.
Brand name needs to be changed.
Form-3 need to be revised w.r.t. specification of each ingredient.
Form-3 also need to be revised w.r.t. submission of salts of
mineral (Copper) and its monographs.
Zinc oxide stability is required in oral tablet dosage form.
Manufacturing process mentions Starch, iron bisglycinate, L-
methylfolate, vitamin B12, Vitamin C, however the same are
not given in list of active or in-active ingredients in master
formula. Needs clarification.
Manufacturing process mentioned tablet coating however no in-
active coating material is given in master formula, need
clarification.
Monograph of Zinc Oxide is required.
Label of firm states a warning: “if you are pregnant, nursing
women or if taking any medications, consult your doctor
before use. All ingredients are of Food Grade from Natural
Source & all statements has been evaluated by the Food &
Drug Administration”. Need clarification.
Product specific monograph of finished product is required.
1256. Agnum Tablet
Deferred due to following reasons:
Fee challan and evidence of fee submission including breakage
of fee are not attached with application.
Stability studies of omega-3 in tablet dosage form is required.
F.No.10-8/2020-OTC) (M-80)
Page 137 of 144
S.No Brand name Decision
(1) (2) (3)
Form-3 need to be revised w.r.t. specification and salts/extracts
of each ingredient.
Patient information leaflet needs revision.
Product specific monograph of finished product is required.
1257. Brainite Tablet
Deferred due to following reasons:
Fee challan and evidence of fee submission including breakage
of fee are not attached with application.
Brand name needs to be changed.
Form-3 need to be revised w.r.t. specification and salts/extracts
of each ingredient.
Monograph of piperine is required. Product specific monograph
of finished product is required.
Product specific monograph of finished product is required.
1258. Vilter Syrup
Deferred for further evaluation and clarification. 1259. Vilter-I Syrup
1260. Vigrite Tablet
1261. Memrite Tablet
Deferred due to following reasons:
Fee challan and evidence of fee submission including breakage
of fee are not attached with application.
Form-3 is unsigned and un-stamped.
Form-3 need to be revised w.r.t. specification and salts/extracts
of each ingredient.
Brand name needs to be changed.
Form-3 need to be revised w.r.t. specification and salts/extracts
of each ingredient.
Monographs of ginseng and piperine are required.
Letter of commitment for shelf life studies is unsigned and
unstamped.
Undertaking regarding brand name is unsigned and unstamped.
Product specific monograph of finished product is required.
1262. Memrite Syrup
Deferred due to following reasons:
Fee challan and evidence of fee submission including breakage
of fee are not attached with application.
Form-3 is unsigned and un-stamped.
Form-3 need to be revised w.r.t. specification and salts/extracts
of each ingredient.
Brand name needs to be changed.
Monographs of ginseng and piperine are required.
Safety profile of Methyl Paraben and Propyl Paraben in children
is required.
Patient information leaflet needs revision.
Species name of herbal ingredients.
Product specific monograph of finished product is required.
Packaging and labeling is required:
i. Primary and secondary labels
1263. Vitrite Syrup
Deferred due to following reasons:
Fee challan and evidence of fee submission including breakage
of fee are not attached with application.
F.No.10-8/2020-OTC) (M-80)
Page 138 of 144
S.No Brand name Decision
(1) (2) (3)
Brand name needs to be changed.
Zinc oxide stability is required in oral tablet dosage form.
Strength of elemental ingredients in their respective salts is
required.
Safety profile of Methyl Paraben and Propyl Paraben in
children is required.
Form-3 need to be revised w.r.t. specification and salts/extracts
of each ingredient.
Form-3 need revision regarding ”recommended use” as the firm
has applied for syrup but given data of tablet.
Product specific monograph of finished product is required.
1264. Sidium Syrup Deferred for further evaluation and clarification.
1265. Viterite-D Tablet
Deferred due to following reasons:
Fee challan and evidence of fee submission are not attached
with application.
Breakage of fee is required.
Brand name needs to be changed.
In FIFO list the name is “Viterite-D Tablet” however on form-3
“Vitrite Tablet” is mentioned. However, firm also applied
another formulation with same name “Vitrite Tablet” given at
FIFO Sr. No. 1947.
As per form-3, Vitamin D3 dose is 15000IU which exceed the
RDA/Upper Tolerable Limits.
Product specific monograph of finished product is required.
1266. Viterite-D Syrup
Deferred due to following reasons:
Fee challan as evidence of fee submission is not attached with
application.
Firm applied for Vitrite-D Syrup however Brand name needs to
be changed.
attached all documents of Vitrite-D drops Needs clarification
and revision of complete Form-3.
Keeping in view the difference of emulsion and syrup dosage
forms stability of Vitamin-D in syrup dosage form is required.
Product specific monograph of finished product is required.
1267. Viterite-D Drop
Deferred due to following reasons:
Fee challan as evidence of fee submission is not attached with
application.
Brand name needs to be changed.
Composition mentioned in product profile is different as given
in master formula and certificate of analysis (finished product).
Needs clarification and revision of complete Form-3.
Specifications and rationale strength of vitamin D3 per unit drop
is required.
Strength of Methyl Paraben and Propyl Paraben and its safety
profile in children is required.
Product specific monograph of finished product is required.
1268. Lungest Syrup Deferred due to following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 139 of 144
S.No Brand name Decision
(1) (2) (3)
Fee challan as evidence of fee submission is not attached with
application.
Brand name needs to be changed.
Form-3 having name of product with signed and stamped by the
owner/CEO is required.
Strength and specification of all active ingredients
Monograph of all ingredients are required.
The formulation contains ephedra which is a controlled
substance/precursor.
Product specific monograph of finished product is required.
1269. Prolite Syrup Deferred for further evaluation and clarification.
Awacs Laboratories, Rawalpindi
1270. Awacs-D Syrup Deferred for further evaluation and clarification.
Innova Life Sciences, Lahore
1271. A2D Sachet Deferred for further evaluation and clarification.
Phytocon International Private Limited, Lahore
1272. Diva Tablet Deferred for further evaluation and clarification.
Bion Life Sciences, Lahore
1273. D-Plus Drop Deferred for further evaluation and clarification.
1274. Promeg Syrup
Aulton Neutraceuticals, Hattar
Plot No. 84/1, Block A/1, Phase V, Industrial Estate, Hattar
(Evaluator Arslan Tariq, AD-I)
1275. Brovit Syrup
Deferred due to following reasons:
Products on Form-3 need to be applied by the owner/MD/CEO
of the firm.
Form-3 needs to be revised w.r.t. strength of folic acid i.e.
500mg to 500mcg as given in master formula.
Stability of cyanocobalamin in syrup dosage form is required.
Safety of methyl paraben and propyl paraben is required in
children.
Strengths of ingredients are given as per 15ml of syrup however
dose is recommended as per teaspoon “5ml”, need clarification.
Product specific monograph is required including quantitative
assay of all vitamins and mineral elements.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking by the owner regarding brand
name and contents on notarized stamp paper is required.
Bion Life Sciences, Lahore
1276. Omvit Tablet Deferred for further evaluation and clarification.
1277. D-Plus Tablet
Gerishon International, Karachi
Plot No. 146, St-13/1, Sector 6-B, Abdulllah Industrial Estate, North Karachi, Industrial Area, Karachi
1278. Leuconor Syrup
Deferred due to following reasons:
Form-3 needs to be revised w.r.t. to specification of active
ingredients.
F.No.10-8/2020-OTC) (M-80)
Page 140 of 144
S.No Brand name Decision
(1) (2) (3)
Justify that the manufacturing process will deliver desired
strength of each ingredient as mentioned on form-3.
Safety profile of Propyl Paraben in children is required.
Qualitative/identification test of ingredients in finished product
is required.
Product specific testing methods are required including assay of
finished product.
1279. Cilavit-D Tablet Deferred for further evaluation and clarification.
1280. Incepta Pharma, Taxila
1281. Eat More Syrup Deferred for further evaluation and clarification.
M/s. Nutris Laboratories (Eno 00262) 46(B)-M Block, Quaid-e-Azam Industrial Estate, Lahore
1282. Nephcit-K Tablet Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1283. Multi-G Tablet
Deferred due to following reasons:
Form-3 needs to be revised w.r..t elemental equivalents in their
respective salts.
Rationale of dose of each ingredient is required.
Safety of methylene chloride as coating agent is required.
Monograph of calcium pentothenate (USP), Ferrous fumarate
(USP) and Potassium Sulphate (BP) are required.
1284. Ovacure Sachet Deferred till finalization of fate of common molecule list being
dealt by Division of H&OTC and Division of PE&R.
1285. Melatris Tablet Deferred till finalization of fate of common molecule list being
dealt by Division of H&OTC and Division of PE&R.
PCP Healthcare, Okara
98-KM, Multan road, Akhtarabad, Okara
1286. Vitron Capsule
Deferred due to following reasons:
Form-3 is unstamped.
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Justify the dose of each ingredient.
Stability of cyanocobalamin in capsule dosage form is required.
Calculations in master formula are not in accordance with form-
3.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
Zahi Nutraceutical Laboratories, Peshawar
C-16, Hayatabad Industrial Estate, Peshawar
1287. Zahi Max Capsule
Deferred due to following reasons:
Brand name needs to be changed.
Rationale of dose of each ingredient is required.
Monographs of all ingredients in their extract form are required.
Form-3 needs to be revised w.r.t. mentioning Yohimbe bar
extract instead of Yohimbine bark extract.
F.No.10-8/2020-OTC) (M-80)
Page 141 of 144
S.No Brand name Decision
(1) (2) (3)
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
As per checklist of form-3 testing specifications of Raw
Material and Finished Products are required, as follows:
Identity, Purity and strength
Acceptable limits, ranges and criteria
Testing procedures and methodology.
Certificate of Analysis (COA)
PCP Healthcare, Okara
98-KM, Multan road, Akhtarabad, Okara
1288. Ortholex-G Gel Deferred till finalization of fate of common molecules being dealt by
H&OTC Division and PER Division.
1289. Capsinol Spray Deferred till finalization of fate of common molecules being dealt by
H&OTC Division and PER Division.
1290. Capsinol Gel Deferred till finalization of fate of common molecules being dealt by
H&OTC Division and PER Division.
1291. Irofol Capsule
Deferred due to following reasons:
Form-3 is unstamped.
Brand name needs to be changed.
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Monograph of Mecobalamin is required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
Product specific monograph and method of testing of finished
product is required.
1292. Calzee-M Capsule
Deferred due to following reasons:
Form-3 is unstamped.
Form-3 need to be revised w.r.t. specifications, salts alongwith
elemental equivalents of each ingredient are required.
Strength of Calcium Carbonate i.e. 800 mg an Zinc sulphate i.e.
22mg mentioned on Form-3 is exceeding RDA/ upper tolerable
limits.
Monograph of magnesium sulphate is required.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
Following packaging and labeling information is required as per
checklist:
Primary and secondary labels
Patient information leaflet
Product specific monograph and method of testing of finished
product is required.
M/s Genbiotech Nutraceuticals (Eno 00263)
Plot No. 24, Street No. NS-2, NIZ RCCI, Rawat, Rawalpindi
1293. Omofer Capsule Deferred due to following reasons:
F.No.10-8/2020-OTC) (M-80)
Page 142 of 144
S.No Brand name Decision
(1) (2) (3)
The formulation is herbal, clarify if the firm has herbal section
1294. Ottimochel Capsule
Deferred due to following reasons:
Brand name on form 3 ism Hierro whereas all the documents are
of ottimochel
1295. Sanobac Capsule Deferred due to following reasons:
The formulation is herbal, clarify if the firm has herbal section
1296. Macula Guard Tablet Deferred due to following reasons:
Official testing method of EPA and DHA required
1297. Ik-Vit Tablet Deferred due to following reasons:
Undertaking for stability missing
1298. Reosso Sachet Deferred due to following reasons:
Monograph of calcium from algae required
Nutrabiotics Nutritional Life Sciences, Peshawar
"Plot No. 32-33, Small Industrial Estate, Kohat Road, Peshawar"
1299. Diacin Tablet Deferred till finalization of fate of common molecules being dealt by
H&OTC Division and PER Division.
M/s Paramount HealthCare, (Eno 00395)
36-Industrial Triangle, Kahuta Road, Islamabad
1300. Deferred for further evaluation and clarification.
1301. Osson Suspension
Deferred due to following reasons:
Brand name to be changed
Testing method of ossein mineral compelx required
PCP Healthcare, Okara
1302. Calvid-3 Capsules
Deferred due to following reasons:
Form-3 is unstamped.
Brand name needs to be changed.
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Justify the dose of each ingredient.
Calculations in master formula are not in accordance with form-
3.
Label needs to be revised w.r.t. composition of ingredients in
the light to form-3
Justify the assay limits of Vitamin D3 i.e. 90-165% in finished
product.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1303. Calvit-S Capsules
Deferred due to following reasons:
Form-3 is unstamped.
Brand name needs to be changed.
Form-3 need to be revised w.r.t. specifications of each
ingredient are required.
Justify the dose of each ingredient.
Calculations in master formula are not in accordance with form-
3.
F.No.10-8/2020-OTC) (M-80)
Page 143 of 144
S.No Brand name Decision
(1) (2) (3)
Justify the assay limits of Vitamin D3 i.e. 90-165% in finished
product.
Undertaking Signed by the owner regarding submission of
Stability data is required on company letter head.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
1304. Ortholex-S Spray Deferred till finalization of fate of common molecules being dealt by
H&OTC Division and PER Division.
Well Grow Nutraceuticals Faisalabad
1305. Chestec D (well grow) Syrup Deferred due to following reasons:
Evidence of submission and fee deposit missing
1306. Mr. Cufy (well grow) Syrup
Deferred due to following reasons:
Brand name to be changed
Evidence of submission and fee deposit missing
Undertaking for brand name missing
1307. Chestnol (well grow) Syrup Deferred due to following reasons:
Evidence of submission and fee deposit missing
Cure Inn Phytoceuticals Pvt Ltd, Lahore
1308. L-Crana
Deferred for further evaluation and clarification. 1309. Joint Inn
1310. Fere'Soin
1311. Paramount Healthcare, Islamabad
1312. Juene (Pramount) Sachet
Deferred due to following reasons:
Testing methods of fish collagen and black pepper extract
missing
1313. Osson Tablet
Deferred due to following reasons:
Brand name to be changed
Testing method of ossein mineral compelx required
Cure Inn Phytoceuticals Pvt Ltd, Lahore
1314. Viss Deferred for further evaluation and clarification.
M/s. Nutris Laboratories (Eno 00262) 46(B)-M Block, Quaid-e-Azam Industrial Estate, Lahore
1315. Reston Tablet Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1316. Reston Drops Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1317. Reston Syrup Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1318. Protolax Syrup Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1319. Actizer Syrup Deferred due to following reasons:
Evidence of formulation required
1320. Q-well Syrup
Deferred due to following reasons:
Contains herbs, whereas the firm does not have herbal section
Undertaking for content, label and stability missing
1321. Vesoril Tablet
Deferred due to following reasons:
Contain Yohimbine (form 3 mentions yohimbine bark extract
while testing method of yohimbine HCl is given)
F.No.10-8/2020-OTC) (M-80)
Page 144 of 144
S.No Brand name Decision
(1) (2) (3)
Testing method of epimedium grandiflorum extract, muira
puama extract, L-opti-zinc and sodium selenate are missing
Clarify “arginine extract”
Xecutive Pharma, Lahore
1322. Glytofer Tablet Deferred for further evaluation and clarification.
Adcok Pharmaceutical (Pvt) Ltd, Lahore
1323. Incal-C Tablet Deferred for further evaluation and clarification.
Bion Life Sciences, 19/40, St-13, Al-Faisal Town, Lahore
Lakhoki, off 4km Bandia Road, (1-E Alamdar Road, Near Ranger Head Quarter Al-Faisal Town) Lahore
1324. Adon oral drops
Deferred due to following reasons:
Confirmation of drop (nutraceutical) manufacturing facility is
required,
Quantitative method of each ingredient in finished product is
required.
Signed and stamped undertaking regarding brand name and
contents on notarized stamp paper is required.
Nutrifactor Laboratories (Pvt) Ltd, Faisalabad
1325. Glucofactor Plus Deferred for further evaluation and clarification.
Paramount Healthcare, Islamabad
1326. ACD (Paramount) Drops
Deferred due to following reasons:
Quantities per 5 ml or per drop required
Brand name to be changed
1327. Emolen Deferred for further evaluation and clarification.
1328. Viton Tablet Deferred till finalization of fate of common molecule list being dealt by
Division of H&OTC and Division of PE&R.
1329. Mintox Deferred for further evaluation and clarification.
Route 2 Health (Pvt) Ltd Lahore
1330. Confido Tablet Deferred for further evaluation and clarification.
Hi-Tech Pharma, Lahore
1331. Strolitin Deferred for further evaluation and clarification.
(Muhammad Abdul Ghaffar)
Secretary, EEC