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Government to Act as a Watchdog over Clinical Trials

The Supreme Court of India (“SC”) while hearing the PIL filed by an NGO Swasthya Adhikar Manch expressed its concern over illegal clinical trials of drugs being allegedly conducted on humans by the multinational companies in India.

The SC further mentioned that the Government being under an obligation to protect the health of the citizens of the country, all the clinical trials should be conducted under the supervision of the Union Health Secretary. The SC has also directed the Government to take stringent action against any multinational companies engaged in conducting illegal clinical trials in India.

The observations of the SC and the order passed by its is expected to be of major concern to the clinical trial industry and also to affect the drug development process in India and abroad.

By: Alishan Naqvee, Partner (anaqvee@lexcounsel.in) and Dhruv Manchanda, Associate (dmanchanda@lexcounsel.in)