Supreme Court pans government for denying data on clinical trials

NEW DELHI: The Supreme Court on Tuesday severely criticised the Union government for failing to submit a proper status report on clinical trials of new chemical entities in the country and directed that these henceforth be held under the direct supervision of health secretary.

A two-judge bench, led by Justice R M Lodha, directed that such trials be conducted as per Schedule Y of the Drugs and Cosmetics Rules, which make it mandatory for those seeking to conduct trials to seek approval of the licensing authority and maintain data on the trials.

"He can then be held responsible," Justice Lodha said justifying his order. Hitherto, clinical trials were conducted under a senior official of the Drugs Controller General (India).

The DGCI has a host of committees to deal with clinical trials. But acting on a PIL by Swasthya Adhikar Manch, which has alleged several deaths due to such clinical trials, the top court had asked the health ministry to submit a status report on them.