Counterfeit worries for Indian pharma

By M H Ahssan

Domestic generic companies worst fears seem to be coming true, even as certain countries and entities like World Health Organisation are still debating on what consti tutes counterfeit drugs. Cus toms authorities in Netherlands have seized big consignments of legitimate generic medicines by Dr Reddy’s and Ind-Swift which were in transit recently labelling them as counterfeit.

While Dr Reddy’s consign ment of active pharmaceutical ingredient (raw material) of losartan was headed to Brazil the second company Ind-Swift was exporting generic pan taprazole to Venezuala. Sources said the consignments were seized as both drugs infringed valid patents in EU. Both drugs were patented neither in India nor in the countries they were exported to, they said.

According to regulations passed in Europe in July 2003 custom action is authorised against goods on grounds of in tellectual property infringe ment, if they are moving through its territory.

The regulation says “con cerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights”.

As a result of these regula tions, EU custom authorities are increasingly seizing Indian drugs for patent infringements in European ports. In particular there have been several seizures at Amsterdam port, referring to these drugs as counterfeit sources said.

Experts believe EU is delib erately trying to create legal bar riers to prevent movement of drugs to developing countries to protect its own industry. They say the problem lies in what is termed as counterfeit. The WHO defines counterfeit as a product whose identity or source is de clared wrongly. In this case, ex perts point out these cannot be termed counterfeit as their product description of the generic drugs was correct, and their identity or source was not hidden.

The pharma industry has taken up the issue with com merce ministry, and wants it to be flagged under Indo-EU free trade agreement. Indian Phar maceutical Alliance (IPA) sec retary general DG Shah told HNN: ‘‘The problem lies in what is counterfeit. The EU definition goes further than WHO’s defi nition (of counterfeit), by say ing that if a drug—being ex ported or passing through — holds a valid patent in EU then it will be termed as counterfeit It is proved beyond doubt that counterfeit is no longer just a public health issue but has be come a trade issue.”

In fact, European Commis sion’s report ‘Community Cus toms Activities on Counterfeit and Piracy, Results at the Eu ropean Border 2007’ also high lights the role of European cus toms in IPR enforcement, and indirectly corroborates these drug seizures.

The report lists India as one of leading sources of counter feit drugs, mainly on the basis of seizures made by EU custom authorities on grounds of in tellectual property infringment