IMPORT AND REGISTRATION OF DRUGS AND

COSMETICS

(Drugs and cosmetics act,1945)

FACILITATED BY –DR.BALAMURALIDHARA V PREPARED BY – KAUSHIK DEVARAJU

ASST.PROFESSOR 1ST M. PHARM

DEPT. OF PHARMACEUTICS PHARM. REGULATORY AFFAIRS

REGULATORY AFFAIRS GROUPS JSSCP, MYSORE

JSSCP, MYSORE

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INTRODUCTION IMPORT-Bring (goods or services) into a country from abroad for sale.

REGISTRATION-The action or process of registering or of being registered.

EX-“The registration of births, marriages, and deaths”.

DRUG-A medicine or other substance which has a physiological effect when

ingested or otherwise introduced into the body.

COSMETICS-A preparation applied to the body, especially the face, to

improve its appearance. The range covers everything from the latest

cosmetics to skin and hair care.

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WHY ?

Drugs & Cosmetics Act 1940 and Rules 1945

To Regulate the import, manufacture and sale or distribution of drugs and

cosmetics through Licenses and permits etc.

Manufacture, distribution and sale of drugs and cosmetics by qualified persons

only.

To prevent substandard of drugs, presumably for maintaining high standards of

medical treatment.

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History

British misrule-providing poor healthcare system to Indian citizens.

Observation made by –Drugs enquiry committee, Indian medical

association

Reports in-Indian medical Gazzette during 1920-1930.

1940-Drugs and cosmetics

1945-Rules under the act.

Extended to whole of India

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Appoint an India Authorized Agent to interact with the Central Drugs Standard Control Organization (CDSCO) on your behalf. Your Agent must have a valid wholesale license

(Forms 20B and 21B).

Grant Power of Attorney to your India Authorized Agent to manage your registration in India.

Apply for Import License using Forms 8 and 8-A available from CDSCO. You must identify your chosen distributors on these forms as well.

Obtain Import License (Form 10) from CDSCO. License valid for up to 3 years, or until the Registration Certificate expires.

Register

Import

Market

You are

now

authorized

to market

PHASES PHASE 1

REGISTRATION CERTIFICATE

PHASE 2

IMPORT LICENSE

MARKETING

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PHASE 1

Form and process of application for

Registration Certificate

Application for registration

certificate to LA in

FORM 40

It should satisfy

the Schedules

D-1 and D-II

Name & address of authorized

agent in India, power of

attorney

Fee of 1500

US $ for

manufacturing

premises &

1000 US $ for

each drug

The applicant should pay sum of 5000 US $ as expenditure that is required for

inspection, visit by licensing authority

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LA – Licensing Authority

PHASE 1

Free Sale

Certificate

DETAILS TO BE CAPTURED IN FORM 40:

1. Authorized Signatory.

2. The address of manufacturing premises shall be captured.

3. The drug(s) name shall be captured.

4. Fee structure for Import Registration.

5. Covering Letter.

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Authorized Signatory

The person authorized preferably

Director

approved by the Board of Directors in case of company or

by the proprietor in case of proprietorship firm.

The application should accompany affidavit in respect of

authorized person or the Power of Attorney in the name of the

authorized person.

The Form shall detail the Foreign Manufacturer‘s contact person in the

manufacturing site complete address, (i.e. address of the

manufacturing premises), with corporate office address, along with

the Telephone number, Fax number and E-mail address.

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The address of manufacturing premises:

Undertaking on the document contents by the responsible person at the

manufacturing site (contact person in the manufacturing site).

In respect of import of more than one drug or class of drugs

manufactured by the same manufacturer, provided that drug or the

classes of drugs, are manufactured at one factory or more than one

factory functioning conjointly as a single manufacturing unit.

If the tablets are manufactured at one location and packed at another

location, Name and Address of both the locations indicating the activity

of each location.

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The drug(s) name shall be captured as

below

The brand name shall be captured.

Different pack, pack size and/or different strengths of the same brand shall

be captured.

Importer‘s undertaking letter declaring for the information specified in

Schedule D (I)(for registration of the manufacturing Premises) and Schedule D

(II)(for registration of the drugs), provided by the original manufacturer.

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Fee structure for Import Registration under

Form 40:

Applicant shall make a payment of 1500 USD (or its equivalent to Indian Currency), as

registration fee for the Manufacturing premises.

Applicant shall make an payment of 1000 USD (or its equivalent to Indian Currency),

as registration fee for a single drug and additional fee of 1000 USD for each additional

drug in case the manufacturing site remains the same.

Fees shall be paid through a Callan in the Bank of Baroda, Kasturba Gandhi Marg, New

Delhi- 110 001 or any other Bank, as notified, from time to time by the authority.

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Details to be captured in the Covering

Letter

Information of the drugs to be imported

Manufacturer information like address and contact details.

Brief information about the application and List of Documents

a) Original Challan and the details of the Challan.

b) Form 40

c) Schedule D(I) documents as provided by the drug(s) manufacturer (Module 1 of CTD

format)

d. Schedule D(II)-documents as provided by the drug(s) manufacturer(Module 2 to 5 of CTD

format) .

e. Power of Attorney issued by the manufacturer .

f. Copy of Whole Sale License of applicant & Copy of Authorization letter of Applicant .

g. An Undertaking shall be submitted by the proprietor of the firm in case of proprietorship

firm and in case of Private limited Company, by the board of Directors. 14

SCHEDULE D(I)Information & undertaking required to be submitted by manufacturer of

his authorized agent with the application form for a registration

certificate. The format shall be properly filled in for the each

application in Form 40. The detailed information, secret in nature, may

be furnished on a computer floppy.

SCHEDULE D(II)Information required to be submitted by the manufacturer or his authorized

agent with the application form for the registration of the

bulk/formulation/special product for its import into India. The format shall

be properly filled in and the detailed information, secret in nature, may be

furnished on the computer floppy. 15

Free Sale Certificate-A document required in certain countries or for

certain commodities (such as pharmaceuticals), certifying that the

specified imported goods are normally and freely sold in the exporting

country's open markets and are approved for export.

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PHASE 2

Form and procedure of application for

import licence An application for an import licence shall be made to the licensing authority

In Form 8 for drugs excluding those specified in Schedule X, and in

In Form 8-A for drugs specified in Schedule X.

By the manufacturer himself having a valid wholesale licence for sale or distribution

of drugs under these rules, or

by the manufacturer's agent in India either having a valid licence under the rules to

manufacture for sale of a drug or having a valid wholesale licence for sale or

distribution of drugs under these rules.

Rs.1000 for a single drug and an additional fee at the rate of 300rps for each

additional drug.

Any application for import licence in Form 8 or Form 8-A, shall be accompanied

by a copy of Registration Certificate issued in Form 41 under rule 27-A.

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PHASE 2

FORM 10

(See rules 23 and 27)

License to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetic Rules,

1945

License Number.............. Date...…………..

........................................................................................ (Name and full address of the importer)

is hereby Licensed to import into India during the period for which the License is in force, the

drugs specified below, manufactured by M/s..................................................

(name and full

address) and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this License.

2. This License shall be in force from ........................... to ............. unless it is

sooner suspended or cancelled under the said rules.

3. Names of drugs to be imported.

Place : ……….

Date : ………. Licensing Authority

Seal/Stamp

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Forms Form 9-Form of undertaking to accompany an application for an import

license.

FORM 12-Application for license to import drugs for purpose of examination,

test or analysis.

FORM 11- license to import drugs for the purpose of examination, test or

analysis.

FORM 11A – License to import drugs by a government hospital or autonomous

medical institution for the treatment of patient.

FORM 12A –Application for the issue of a permit to import small quantities of

drugs for personal use.

FORM 12B- Permit for the import of small quantities of drugs for personal use.

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,sir