Cipla Vs GSKV3.0

8/7/2019 Cipla Vs GSKV3.0

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Group 1

Aakriti Mahajan (001)

Avishek Tarun (011)

Raghavendar Raja (021)

Nathan R K (032)

Raman Chaudhary (042)

Suhan Sarkar (052)



� 2000 -> 24 million Africans infected with the

virus

� Every Day 6,000 Africans die from AIDS Additional 11,000 get infected.

� No Known Cure Or Vaccine

�

Antiretroviral Treatment Expensive and unavailable for most LDC

countries



� Triomune (Cocktail) Lamivudine (GlaxoSmithKline,

Heptovir)

Stavudine (Bristol-Myers Squibb,Zerit)

Nevirapine (Boehringer-Ingelheim,Viramune)

� Generic Vs Patented Cipla

Humanitarian Relief should outweigh IPConsiderations

Patented Drug Manufacturers High Prices are vital to offset high R&D Costs



� What Is TRIPS

Negotiated at the end of the Uruguay Round of

theGATT (1994).� Doha Declaration

Flexibility of TRIPS in Circumventing Patent

Rights

� The Indian Patent Act 1970



� Parallel Importing� Compulsory Licensing

�

Regulatory Exception Aimed at assisting the generic pharmaceutical

industry to obtain regulatory approval for theeventual sale of patented medicine

�

Exclusive Marketing Rights (EMR) To sell or distribute the article or substance

covered in a patent or patent application in thecountry



What is surprising is that no African country has aggressivelypursued the mechanisms in the WTO agreement

Salih Booker, Executive Director, US Based advocacy group AfricaAction



� 1997: Medicines & Related Substances ControlAmendment Act

Compulsory Licensing

Parallel Imports� 39 drug TNCs including GSK challenged the

constitutionality of the Act�

EU & the US backed the drug companies� Feb 2001: Cipla offers triple-therapy cocktail using

3-tier pricing� All 3 patented companies were offered royalties



"Companies that make generic copies are like pirates on the high

seas. We don't believe in piracy. We tried to stamp it out in theseventeenth and eighteenth centuries.

Sir Richard Sykes, Chairman, Glaxo-SmithKline

If were pirates, litigate against us. Where is the question of piracy

when we abide by the laws of the land?

Yusuf Hamied. After drug Companies filed a lawsuit



� Mar 2001: CIPLA asked for a Compulsory License� Govt, AIDS Activists & Human Rights Groups

accused them of wringing profits out of a pandemic� Sustained Campaign by Medecins Sans

Frontieres(MSF)& Treatment Action Campaign� US and EU withdrew their support�

April 2001: TNCs dropped lawsuit opening up thedoor to Cipla



� TNCs announced huge reductions in

drug prices

� GSK granted voluntary license to Aspen

� Mar 2002:WHO included Cipla aspreferred supplier of AIDS Drugs



� 2000: Ghana attempted to purchase Combivirfrom Cipla

� Cipla offered Duovir at $1.74 against GSKs $16

(per patient per day)� GSK threatened Cipla with legal action� Cipla had to pull out of the contract � Later, ARIPA said that Glaxo's patents were Invalid

in Ghana� GSK conceded that it had made an error� An overzealous company official made the

mistake



� AIDS: Pandemic in African Nations

� Within The Purview of TRIPS

� Misguiding Huge R&D Expenses

�

R&D Expenses by University-IndustryCollaborations

� Exorbitant Marketing Expenses



I am not a westerner marketing drugs for western markets. I represent thethird world and the capabilities of a country with a population of a billion.

We havent broken any laws. The average cost of the AIDS cocktail in thewest is $ 10000 to $ 15000 per patient per year not because the drugsare prohibitively expensive to produce they are not. It is the drug

pricing structure imposed by multinational manufacturers which makesthe drugs prohibitively expensive.

Yusuf Hamied (Pointing High Margins of MNCs even by Western Standardsand for Generics also)



� Hidden Intentions of MNCs

� Cipla: Not an Innovation Stealer

� Unethical Practices by PharmaceuticalCompanies

� Transfer Pricing Practices of MNCs

� High Margins Even byWestern Standards

Even For Generics

� Misguided MNCs Concede



On average, drugs manufactured in India are between 1000 and 4000

percent cheaper than the same products produced in USA. In India,

monthly supply of an Anti Hypertensive cost about $4.20 and the same inBoston cost about $44.48. So, in USA, even the cheap generic was

marked up by as much as 10 to 40 times.

AIDS Activist David Scondras during his visit to India in 1999



"I am delighted. This proves that we adhere to good manufacturing practices on apar with other companies. It says Cipla is kosher, so now the multinationals can'tthrow at us what they have said: `They're Indian, they're Third World, the quality

might be iffy.' "

DrYusuf Hamied (When WHO recognized Cipla Generic Drugs as Effective)

"I won't say we don't mind that. We always defend our patents. But in this case, theW.H.O. made the decision and we've got to abide by it. We believe the way to do

this is to negotiate arrangements with governments and employers in thedeveloping world, and in poorer countries we've said we will supply at cost."

Adam Chandler, Spokesman, GSK (a change in tone of the pharma MNCs)



� Exports Raw Materials, Intermediates, PrescriptionDrugs, OTC Products

�

Drug Master File: Submitted to FDA Provide bulk drugs to companies in the USA

� Abbreviated New Drug Application (ANDA):Application for a U.S. generic drug

�

Cipla filed forDMF rather than ANDA

It avoids the need for a Marketing Infrastructure

� Strategic alliances with US Drug Manufacturers



� Andrx Corp� Biogenerics Inc�

Watson� Morton Grove Pharmaceuticals Inc (MGP)� Pentech Pharmaceuticals� 2004: Cipla had 140 ongoing projects�

Strategic Alliance with 6 US Generics Majors� Ciplas Alliance Partners had filed 31 ANDAs� Additional 35 ANDAs in the next 12-15

months



Between our trade and our health, we have chosen to look after ourhealth."

President Luiz Inacio Lula da Silva (recognizing the repercussions thatBrazil might face after Brazil issued a compulsory license to produce a

lowers cost generic version of Merckss Efavirenz in 2007)

Cipla Vs GSKV3.0

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