Claiming that the proposed new definition of counterfeit drugs as per the IMPACT initiative came in conflict with the Drugs and Cosmetic Act provisions, the SME Pharma Industries Confederation (SPIC) has urged the authorities to work out and press for a definition that would be fair to all stakeholders from all countries.

In a detailed representation pointing out the crippling drawbacks in the proposed definition, the SPIC has said the final definition should not be skewed against small manufacturers from developing countries. "We hope that you will take a firm stand and also be able to garner international support for a reasonable position on the amendments," the association said in its letter to DCGI who had requested the industry bodies to forward their comments so that India could finalise its stand ahead of the WHO board meeting slated by the end of this month.

"The term medical product needs to defined and the definition should restrict to only end product and not APIs, excipients etc. The word false representation and the explanatory note on false representation needs to be deleted. Then it should be replaced with 'a counterfeit medical product' is one which is deliberately and fraudulently mislabelled with respect to identity and /or source," the SPIC said.

It also urged to delete the sentences 'this applies to the product, its container or other packaging or labelling information. Counterfeiting can apply to both, branded and generic product' from the proposed definition. The definitions of terms 'identity and source' should be made explicit and specific. The term identity should be restricted to the international non proprietary name of the drug. The term source should be restricted to name of manufacturer and country of manufacturing, the SPIC said.

The term 'correct ingredient' should be deleted. The term 'fake packaging' should be deleted or should be defined exhaustively. And the term patents in the second paragraph of the definition should be replaced with intellectual property, the association said.

"The proposed definition comes in conflict with Section 17 B of Drugs and Cosmetics Act. The definition of spurious drug under Section 17 B covers only false information with regard to manufacture and the name of the drug. However, the new definition expands the false representation of identity and source to product, container, label and package. The containers are by and large procured from outside source and not manufactured by the pharmaceutical manufacturer. Its inclusion in the definition of 'counterfeit drugs' shall be disastrous," the letter said.