India blocking WHO counterfeit definition

An attempt to develop a universally-agreed definition of counterfeit medicines by the World Health Organization (WHO) is being held up by opposition from the Indian government, which fears it could extend to legitimate generics.

The change from the current terminology has been pushed by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), a WHO-backed partnership established in 2006 to tackle the emerging problem of drug counterfeiting and substitution.

IMPACT - a collaboration between the WHO, International Federation of Pharmaceutical Manufacturers and Associations and other groups including national governments - has been striving to develop a definition that differentiates between counterfeit, mislabelled or substandard medicines.
 
Dr. Eric Noehrenberg, director of international trade and market policy at the IFPMA, told SecuringPharma.com recently that difficulties arise when trying to define counterfeit medicines in emerging markets, where theft and relabelling of expired drugs take genuine products out of the legitimate supply chain.

The Indian Pharmaceutical Association - which represent the generic drugs industry, has been lobbying the national government and claims an attempt to include an expanded trademark provision is placing some genuine generic products at risk of being branded fakes.

"This is absolutely not the case," insists Noehrenberg, "but it provides clear evidence of the need for a common frame of reference if the fight against counterfeits is to be taken forward."

The Indian generics companies fear that any suggestion of counterfeit could lead to seizure of goods in transit. Specifically, Indian firms fear that legitimate drugs destined for non-EU markets could be confiscated if they pass EU borders on the grounds they were not registered in Europe. 

The existing WHO definition of a fake drug is "a medicine, which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging."

The definition resolution has now been referred to the WHO Executive Board, which will meet to review it in January 2009.

The size of the fake and substandard market in India is estimated at 1.5bn rupees ($35.6m) and is growing at a massive 25 per cent per year, according to the Drugs Controller General of India (DCGI).