India’s Health Ministry has rejected the new definition of counterfeit drugs proposed by an agency backed by the World Health Organization. In so doing, “[t]he government is concerned about certain words being used in the new definition of counterfeits proposed by IMPACT. We are afraid developed countries may use such a definition to stifle the growth of our generic industry,” drug controller general of India (DCGI) Surinder Singh said.
It is learnt that the new definition considers apparent ‘trademark violations’ as ‘counterfeit’ cases. The government feels this may harm exports of generic medicines from India. “Calling trademark violations counterfeit may also mean that if a drug is not registered in a country then it becomes a counterfeit, which is completely wrong. The drug may not be registered because it may not suit that country’s environment. This does not make it a counterfeit,” Dr Singh said.