The recent meeting by the DCGI with the industry associations has hammered out a consensus on the controversial definition of counterfeit drugs and worked out India's viewpoints to be placed before the WHO executive board later this month.

The meeting, attended by all major pharmaceutical associations, has discussed the concerns in the new definition being forwarded by the IMPACT and went through the suggestions made by the industry, sources said. The final definition would be worked out in line with the decisions taken in the meeting.

"A medical product (medicine, vaccine, diagnostics and medical implants/devices) is counterfeit when it is deliberately and fraudulently mislabelled with respect to its identity and/or source. Counterfeit can apply to components with wrong ingredients/components without active ingredients, with incorrect amounts of active ingredients, or with fake package," according to the finalized version of definition agreed upon by the industry.

One of the major concerns about the IMPACT definition was that the term `medicinal product' was not defined. Another area was about false representation in relation to identity, history or source. As per the IMPACT version, it could include intellectual property right issues and Indian generics could run into the risk of being branded as counterfeit.

The meeting suggested that violations or disputes concerning patent should be deleted. IPR must not be confused with counterfeiting of medical products. Medical products (whether generic or branded) that are not authorized for marketing in a given country but authorized elsewhere should not be considered counterfeit, sources said. The industry and authorities also agreed that substandard batches or quality defects or non-compliance with good manufacturing practices/good distribution practices in legimate and medical products should not be confused with counterfeiting.

According to the definition finalized in the meeting attended by SPIC, IPA, IDMA, OPPI, CIPI and FOPE, "This includes any misleading statements with respect to name, composition, strength and other elements. This includes any misleading statement with respect to manufacturer, country of manufacturing, country of origin, marketing authorization holder or steps of distributions. This refers to all components of a medical product."

Welcoming the consensus at the meeting, SPIC joint secretary Saurabh Gupta said the government has finally become aware of the tactics of multinationals through IMPACT and WHO to block the competitiveness of SME pharma units in providing quality medicines at affordable prices to the developing countries.