IPR for SMEs in Pharma: Challenges & Opportunities Conference on IPR in Pharmaceuticals Balancing...
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Transcript of IPR for SMEs in Pharma: Challenges & Opportunities Conference on IPR in Pharmaceuticals Balancing...
IPR for SMEs in Pharma:Challenges & Opportunities
Conference on IPR in PharmaceuticalsBalancing Innovation & Access7th October, 2015, Ahmedabad, Gujarat
by Dr. Gopakumar G. NairGopakumar Nair AssociatesUrl: www.gnaipr.comEmail: [email protected]
Status of Indian Pharma IndustryPeriod Domestic Imports Exports Research Export - Import
ratio.Domestic Mfr. to Imports ratio
Domestic to exports ratio turnover
Pre- 1970 Low High Negligible Very Low 5/95 10/90 (API) 95/5
1970-1980 + ve + ve(API)
+ ve API Process(Reverse
Engineering)
15/85 40/60 (API) 85/15
1980-1990 ++ ve + ve + ve API + Dosages processes
25/75 60/40 75/25
(APIs & Intermediates)
APIs turnover
1990-2005 +++ve +ve (APIs &
Intermediates)
++ve API + Dosages processes
NDDS
60/40APIs turnover
90/10(Dosage form)
60/40 (API/ Intermediates)
60/40
2005 onwards
+++ve ++ve (APIs / Intermediates)
++ve (Patented
formulations)
+++ve API processesNDDS
combinationsEarly NCE leads.
Me too drugs Herbals/ Nutra.
70/30(API dosage forms / API
formulations)
80/20(API patented formulation)
30/70
NCE/NME API Product Patent Process Patent ‘Me too’ derivatives – Imatinib,
Erlotinib Formulation Dosage Forms – Tablet, Capsule, etc Release Profile – Controlled, Slow etc. NDDS – ex. Transdermal Patches,
Transmucosal Drug Delivery. New Use – Aspirin (analgesic & blood
thinner)3
Famotidine
Tiotidine
Strategies for Indian Pharma• Super Generics & Value added Generics.• Sec.505 (b)(2)/ Para IV challenge/ Orphan
drugs.• Ranbaxy – Canadian Co. - Cipher – Absorica.
• Cipla –Swedish firm - Meda – Dymista.
• Lupin– Japan’s - Fujisawa – Suprax.
Source: BusinessWorld, Jan, 2014.
RESEARCH in Pharma• MSMEs
- continue with low innovation- generics.• Larger Units
- NDDS, Combinations, Processes.• Top 20 Companies- NCE Research(Drug Discovery)- Biosimilars- Vaccines( Dr. Reddys, Cadila, Glenmark, Sunpharma, Aurobindo,
Lupin, Biocon, Cipla, Wockhardt, Torrent, Jubilant Life, etc.)
Niche Models of Research in India• Discovery Research
ADVINUS (Contract Research)SUVEN (CRAM)
• Generic ResearchCiplaNatco
• Stents/ SuturesMeril
Post 2005: Generic Pharmacy of the World
+ ves:• Strong in Anti HIV/Anti Cancer Drugs.• Emerges as Leader in CRAM.• Thrust to Developed Markets.• Greenfield domestic developments.
- ves:• Intensive infringement litigations.• Damaging Regulatory Reviews/ Status.• Divergent Industry Associations/ NGO’s.• Approach on key issues such as CL, FDI, MSME role –
non uniform, irrational.
Key industry trends impacting Indian Pharmaceutical market
Source: Strategies for Indian Pharma in a volatile world, Manish Panchal, Charu Kapoor, Mansi Mahajan- TSMG.
IN THE PINK OF HEALTH? Drug-inspection systems in India and the US
INDIA• 1,200-1,500: The current strength of drug inspectors in India• 150: Number of Central drug inspectors• 20,000: Number of drug inspectors required to monitor India’s Pharma industry• 650: Staff at Central Drugs Standard Control Organization• 10,300: Number of pharmaceutical manufacturing units in India (of these 300 are big and
the rest small & medium)• Rs. 79,000 crore: The size of the domestic Pharma market by sales
UNITED STATES• 13,000 (approx) The staff of the US Food and Drug Administration• $400-500 bn: Size of the US pharma market by sales• $80 bn: Size of the US generic drug market
Source: DCGI office, industry estimates
Conclusions:• Indian Pharma must take note of faster growth in China,
Korea, Indonesia, Brazil etc.• Must resolve serious Regulatory issues and counter PICs
challenge.• Must respond strongly to TPP, SPLT, SSFFC & others.• Must ally for a balanced Patent law with BRIICS and others.• Must respond strongly to USTR actions (ITC/ super 301)• Efforts to declare India priority watch Country and to drag
India to WTO.• India must beware/ Be aware of TBT, NTB &“Q” propaganda
and take corrective measures.• India must strengthen the API sector for guaranteed &
continued support to dosage forms.• Strengthen policy support, resources & counter motivated (?)
NGOs.