The Indian Pharmaceutical Alliance (IPA), an organization representing large Indian drug companies, has put forward several conditions for extending support to the World Health Organisation (WHO)'s efforts to give a new definition to counterfeit drugs. The IPA informed its decision on the issue to the WHO director general Margaret Chan at a meeting in Geneva recently.

"We have apprised the WHO about the Indian generic drug industry's concerns on the issue for extending support to anti-counterfeiting programme of the IMPACT, a WHO-funded organization," said IPA director general DG Shah, who represented the IPA in Geneva meeting.

The IPA has asked the WHO to omit the word 'history' from the IMPACT definition of counterfeit. It has also demanded that the text MUST clearly state that infringement of patent is not a counterfeit issue and that counterfeits have nothing to do with patents. The text should further state that counterfeits are a public health hazard. However, products alleged to have infringed patents are not a health hazard and must be dealt with separately as provided in the patent laws of the country.

The IPA also asked the WHO to incorporate separate definition of 'counterfeit' from that of 'sub-standard'. In this connection, the IPA suggestions include, Counterfeits: 'Medicines which are deliberately and fraudulently mislabeled with respect to identity or source' and Sub-standards: 'Medicines with wrong ingredients, without active ingredients or with insufficient active ingredients'.

The IPA has also submitted a detailed note on counterfeit medicines to Chan.

Earlier, the Indian drug industry and the NGOs working in the health sector had opposed the WHO move on counterfeit drugs. They feared that if the changes go through, foreign drug firms could stall exports of low-cost versions of patent expired medicines to key markets. Today, Indian firms have several brands that sound similar to those of multinational brands. For example, global drug major Pfizer has an erectile dysfunction brand, Viagra, while Indian companies make generic versions of Viagra with similar sounding names. Currently, this would at the most be treated as a trademark violation (under Indian Patent and Trade Mark Act). However, according to the definition proposed by IMPACT, the Indian product could be rejected as counterfeit.

Indian companies, increasingly dependant on exports of cheap off-patented medicines to developed markets to drive business growth, will find this a major roadblock. "The IMPACT definition refers to 'history', which is mischievous. This could lead to generics being treated as counterfeits," the Indian drug industry argued.