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India fears generic drugs may be hit by fake medicine definition

India fears generic drugs may be hit by fake medicine definition
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First Published: Fri, May 23 2008. 12 40 AM IST

The New York-based Center for Medicines in the Public Interest predicts global fake drug sales will reach $75 billion by 2010
The New York-based Center for Medicines in the Public Interest predicts global fake drug sales will reach $75 billion by 2010
Updated: Fri, May 23 2008. 12 40 AM IST
New Delhi: A day before member nations of the World Health Organization, or WHO, meet in Geneva to discuss measures needed to deal with the increasing incidence of counterfeit drugs, the Indian government and public health activists have strongly opposed adopting a broad definition of such medicines and the steps to tackle their growing availability in global markets.
The New York-based Center for Medicines in the Public Interest predicts global fake drug sales will reach $75 billion by 2010
The groups believe such a definition would potentially create another entry barrier for legitimate non-patented drug versions, or generics, allowing some countries to clamp down on such medicines in the name of nailing counterfeits.
Activists are also sceptical about the independence of the agency implementing these measures, and have urged the members of the World Health Assembly, the apex gathering at the WHO, to reject the resolution, which is trying to forge a global strategy on an issue that has largely been dealt by countries on their own so far.
The New York-based Center for Medicines in the Public Interest predicts that global counterfeit drug sales will reach $75 billion (Rs3.23 trillion) by 2010, nearly double from 2005. Sales of drugs globally, growing at 5-6%, are expected to be between $735 billion and $745 billion this year, according to global pharmaceuticals tracker IMS Health.
The agency tasked with finding ways to tackle fake drugs, International Medical Products Anti-Counterfeiting Taskforce, or IMPACT, set up in 2006, has representation from drug maker lobbies, Interpol, World Trade Organization, World Intellectual Property Organization, European Commission, Asean nations and the US Pharmacopeia, which sets standards in drug manufacture, among others.
In its efforts, IMPACT has defined a “counterfeit medical product” It notes that currently the definition is absent or inadequate—in a broad manner. It has defined “a medical product... (as)... counterfeit when there is a false representation in relation to its identity, history or source. This applies to the product, its container or other packaging or labelling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients/components, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging.”
Public health experts argue that IMPACT’s definition was too broad, and went beyond drugs—it includes medical devices, diagnostics, accessories and active pharmaceutical ingredients—and could brand even genuine generics as counterfeit that are similar either in look or colour.
“The resolution being introduced in the World Health Assembly has the potential to create another entry barrier for generic drugs and delay their entry,” said Gopa Kumar, research officer in Centre for Trade and Development, adding that this would add another layer of protectionism. “We are urging the members to reject the proposals in this resolution totally. Counterfeiting is an issue of trademark violation and has no bearing on public health,” he added.
The activists may find the Indian government on their side on the issue. A ministry official close to the development said India doesn’t support IMPACT or felt the need for a new, broader definition.
The country might support an older WHO definition that stressed on “medicines which are deliberately and fraudulently mislabelled with respect to identity and source” without specifying the components of misrepresentation at Friday’s meeting.
Details of stances of other countries will emerge once the discussions open on Friday. The fight is also on to keep out the word “substandard” drugs from the text as it can be interpreted subjectively and used against generic companies.
“We don’t want WHO to mandate IMPACT as the global police on this issue,” said Amit Sengupta, secretary of Public Health Movement, as some members on the body—coming from International Federation of Pharmaceutical Manufacturers and Associations, the lobby arm of global drug makers—would clearly have a conflict of interest. IMPACT, he added, was set up not by the consent of all WHO members, but only at a 2006 conference of some members, assisted by experts, of the global body.
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First Published: Fri, May 23 2008. 12 40 AM IST
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