WHO drops plan to declare generic drugs 'spurious'


29 Jan 2009, 0222 hrs IST,

NEW DELHI: Domestic generic industry can now breathe easy. A resolution if implemented posed a big threat to availability and production of legitimate Indian generics — has been dropped by the World Health Organization (WHO).

The resolution was dropped after stiff opposition from developing countries mainly Brazil, Bangladesh, India and south east Asian countries. There were apprehensions that legitimate generic drugs may be declared counterfeit or confused with spurious, if a proposal pushed by developed nations, in particular European Commission and EU and US pharma bodies, was accepted at the WHOs executive board meet in Geneva.

Developing countries Brazil, Bangladesh, Indonesia and Sri Lanka came together and asked WHO to look at drugs that are falsely labelled, sub-standard or spurious, and concentrate on public health concerns, sources said, addiing, “We don’t want good quality generic drugs to become inaccessible, and be used as non tariff barriers under the garb of counterfeit”, health ministry sources said.

Developing countries voted against the resolution and the WHO secretariat report as it would lead to measures where exports of genuine and legitimate generic drugs will be blocked or seized on suspicion of them being counterfeit by customs authorities.

Under this resolution, generic medicines could fall under definition of counterfeiting being proposed, mixing the issue of quality with intellectual property rights — leaving room for doubt and confusion.

One of the definitions was being pushed by a MNC pharma body, IMPACT (International Medical Products Anti-Counterfeit Taskforce) from within the WHO, which says “a medical product is counterfeit when there is a false representation in relation to its identity or source. This applies to the product, its container, packaging or other labelling information. Counterfeiting can apply to both branded and generic products.’’

Developing countries were concerned that IMPACTs focus on policy and legislation on counterfeit drugs will be counter productive and will create barriers to trade in and access to legitimate medicines.