India to help WHO define counterfeit drugs

A World Health Organization (WHO) committee has initiated steps to take India on board while proposing a change in the definition of counterfeiting at the next World Health Assembly.

In the recently concluded inter-country consultations on combating counterfeit medicines here, members of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) have laid stress on the need for a consensus in finalising the matter.

The new definition says any “false representation in relation to identity, history or source” would be considered a case of counterfeiting.

The significance of the move stems from fears that the new definition could lead to India’s authorised exports of genuine drugs being termed counterfeit, if, by no fault of the exporters, the medicine is smuggled into a different foreign destination. Under the new definition, if medicines originally intended for one country end up in another country where they are not registered, they would be declared counterfeit.

The IMPACT proposal to enlarge the scope of “counterfeit definition” by including such “trade mark violations” was not considered by the WHA during its last meeting in May due to Indian objection.

India has opposed the new definition saying it goes beyond the issue of “quality, safety and efficacy”, and could be used as a tool to project India as a centre of substandard and counterfeit drug production.

India also called for further discussions among the WHO member countries to harmonise the definition of “counterfeit” to avoid genuine medicines being tagged as counterfeit — a term normally associated with illegally produced or supplied medicines that may or may not conform to quality specifications.

India had also stated that a generic or branded medicine not registered in a particular country, but available in that country (by whatever means) is not counterfeit but simply an unregistered product.

The domestic drug industry had also expressed apprehensions over the WHO negotiations meant to bring non-health issues that have no direct implications on the safety of a drug within the ambit of the definition of “counterfeit medicine”.

The industry had also pointed out that the IMPACT definition, if read with the EC Regulation, Article 2.1(c) of the European Union, could mean a serious threat to India’s exports of pharmaceutical products. The EC Regulation allows seizure of “counterfeit” products even during transit.

IMPACT has representatives from 22 organisations, including INTERPOL, the Organisation for Economic Co-operation and Development (OECD), the World Intellectual Property Organisation (WIPO) and the WTO.

At the World Health Assembly in May, a draft resolution on counterfeit medical products was proposed by Gambia, Ghana, Nigeria, Tunisia and the United Arab Emirates. The draft resolution, however, was not adopted because consensus could not be arrived at due to differing viewpoints. It has been referred to the Executive Board for further discussion.