India bats for generics, seeks clarity on counterfeits

In the global battle against counterfeit medicines, India has sought clarity on the proposed expanded definition of counterfeits, staving off attempts to equate counterfeits with generic medicines.

Counterfeiting is a trademark-related issue that affects branded, patented and generic medicines, the Indian delegation said at the recent World Health Assembly (WHA) in Geneva.

At present, the World Health Organisation defines counterfeits as medicines that are deliberately and fraudulently mis-labelled, regarding identity or source. Also, counterfeits could contain varying levels to no level of the active ingredient of the original medicine. The expanded definition refers to the “history” of the drug, bringing in several implications, a Union Health Ministry source familiar with the development told Business Line.

India has its own norms and punishments on counterfeit medicines and is not opposed to being part of global initiatives to tackle them, the source said. But, a clear global definition on counterfeits was necessary, as countries often rely on WHO’s norms and definitions when framing their laws, and an ill-thought-through definition could cast a shadow on generic medicines, the source said.

Indian drug companies are largely producers of generic drugs or medicines that are chemically similar and are as efficacious as an innovative medicine. And India’s stance at the WHA brought cheer to the local industry, as they feared that the expanded counterfeit definition could be used as a non-tariff barrier against medicine exports from India.

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