WHO shelves redefinintion amidst protest from Indian drug makers
27 Jan 2009
In what is seen as a major victory for Indian drug manufacturer's, the World Health Organisation (WHO) has decided to drop its planned move to redefine "counterfeit" medicine following strong opposition from generics manufacturers in India, Brazil and other developing countries.
The proposed action could have seriously hurt the interests of India's drug manufacturers.
The Indian drug industry is known for its cheap but high quality generic drugs. The proposed WHO move could have seriously impacted sales and export of legitimate generic medicines according to a government official.
The strong opposition which culminated in the WHO deciding to drop its move has ensured continued access to lucrative foreign markets to Indian generic drug makers such as Ranbaxy, Cipla, Lupin and Dr Reddy's.
The move was shelved over concerns voiced by India and several other developing countries about the possibility of the low cost medicines being labeled as counterfeits under the guise of patent and trademark infringement.
Under the proposed new definition regime that was to be ushered in by the International Medical Products Counterfeiting Taskforce (IMPACT), a WHO agency, counterfeit drugs were to be defined as medical products with ''false representation about its identity, history or source.'' This led to apprehensions amongst the domestic industry about the possibility of their products being labeled counterfeit in the event of deviations in packaging and related aspects like labeling despite the product being authentic.
Generics are drugs that can be produced cheaply since there are no patent restrictions on them following expiry of original patent. In India though, few drugs are patent-protected and almost all drugs are 'generic' as defined in international parlance. Indian companies sell ''generic'' or off-patent drugs at prices that are much lower as compared to the original prices. Indian generic drug industry generates revenues around Rs30,000 crore in exports annually.
Organisation of Pharmaceutical Producers of India (OPPI), representing global drugmakers, had earlier this month written to the Drug Controller General of India (DCGI) to endorse the new definition. "OPPI re-affirms the proposed WHO-IMPACT definition is a step in the right direction and we remain aligned to the changes that are being proposed by WHO-IMPACT," OPPI director general Tapan Ray said.
In what is seen as a major victory for Indian drug manufacturer's the World Health Organisation (WHO) has decided to drop its planned move to redefine counterfeit medicine following strong opposition from India, Brazil and other developing countries.
The proposed action could have seriously hurt the interests of India's drug manufacturers.
The Indian drug industry is known for its cheap but high quality generic drugs. The proposed WHO move could have seriously impacted sales and export of legitimate generic medicines according to a government official.
The strong opposition which culminated in the WHO deciding to drop its move has ensured continued access to lucrative foreign markets to Indian generic drug makers such as Ranbaxy, Cipla, Lupin and Dr Reddy's.
The move was shelved over concerns voiced by India and several other developing countries about the possibility of the low cost medicines being labeled as counterfeits under the guise of patent and trademark infringement.
Under the proposed new definition regime that was to be ushered in by the International Medical Products Counterfeiting Taskforce (IMPACT), a WHO agency, counterfeit drugs were to be defined as medical products with ''false representation about its identity, history or source.'' This led to apprehensions amongst the domestic industry about the possibility of the products of generic manufacturers being labelled as counterfeit in the event of deviations in packaging and related aspects like labelling, despite the product being authentic.
