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Indian drug regulator working on policy to respond to safety alerts by foreign regulators

27 May 2013 Evaluate

In order to respond to the drug safety issues raised by the US Food and Drug Administration (US FDA), India's drug regulator is working on a clear policy to respond to safety alerts by foreign regulators on medicines manufactured by Indian companies. The US FDA has blocked imports of some drugs manufactured by the Indian companies such as Wockhardt and Ranbaxy on the back of drug safety issues and also fined them.

Earlier this month, Ranbaxy had pleaded guilty and agreed to pay a $500-million fine to the US government to settle criminal and civil charges against it, while, Wockhardt's management projected that the firm may take an annual hit of $100 million as a result of the US FDA action.

The present Drugs and Cosmetics Act does not empower the drug regulator to take action based on a red-flag raised by a foreign counterpart. By modifying the present law, Indian government may take a cue from the action of foreign drug regulators; however it would assess the good manufacturing practices of Indian firms according to the Indian law (Drugs and Cosmetics Act).   

The Drug Controller General of India (DCGI) GN Singh said our decisions would strictly be based on law which has been clearly laid down by Indian drug regulator. The regulatory regimes of different countries vary and there is no one set of globally harmonized good manufacturing practices. My mandate is to ensure quality, safety and efficacy of drugs marketed in the country, while alerts by other regulators can help raise scrutiny levels here, he added.

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