Pharma Challenges amp Opportunities Conference on IPR in Pharmaceuticals Balancing Innovation amp Access 7 th October 2015 Ahmedabad Gujarat by Dr Gopakumar G Nair Gopakumar Nair Associates ID: 335435
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Slide1
IPR for SMEs in Pharma:Challenges & Opportunities
Conference
on IPR
in Pharmaceuticals
Balancing Innovation & Access
7
th
October,
2015, Ahmedabad, Gujarat
by
Dr. Gopakumar G. Nair
Gopakumar Nair Associates
Url: www.gnaipr.com
Email:
gopanair@gnaipr.netSlide2
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
60/40
APIs turnover
90/10
(Dosage form)
60/40 (API/ Intermediates)
60/40
2005 onwards
+++ve
++ve (APIs /
Intermediates)
++ve
(Patented formulations)
+++ve
API
processes
NDDS combinations
Early NCE leads.
Me too drugs
Herbals/ Nutra.
70/30
(API dosage forms / API formulations)
80/20
(API patented formulation)
30/70Slide3
NCE/NME
API
Product Patent
Process Patent
‘Me too’ derivatives –
Imatinib, ErlotinibFormulation Dosage Forms – Tablet, Capsule, etcRelease Profile – Controlled, Slow etc.NDDS – ex. Transdermal Patches, Transmucosal Drug Delivery. New Use – Aspirin (analgesic & blood thinner)
3
Famo
tidine
Tio
tidineSlide4
Strategies for Indian PharmaSuper 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.Slide5
RESEARCH in PharmaMSMEs - continue with low innovation- generics.Larger Units- NDDS, Combinations, Processes.Top 20 CompaniesNCE Research(Drug Discovery)Biosimilars
Vaccines
( Dr. Reddys, Cadila, Glenmark, Sunpharma, Aurobindo, Lupin, Biocon, Cipla, Wockhardt, Torrent, Jubilant Life, etc.)Slide6
Niche Models of Research in IndiaDiscovery Research ADVINUS (Contract Research)SUVEN (CRAM)Generic ResearchCiplaNatcoStents/ Sutures
MerilSlide7
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.Slide8
Key industry trends impacting Indian Pharmaceutical market
Source: Strategies for Indian Pharma in a volatile world, Manish
Panchal
,
Charu
Kapoor, Mansi Mahajan- TSMG.Slide9
IN THE PINK OF HEALTH? Drug-inspection systems in India and the USINDIA1,200-1,500: The current strength of drug inspectors in India150: 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 STATES13,000 (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 marketSource: DCGI office, industry estimatesSlide10
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.