The Centre on Monday told the Supreme Court that committees have been formed to supervise the regulation of clinical trials of drugs in the country and a new bill containing penal provisions for violation on conduct of trials for untested medicines has already been introduced in Parliament.
In an affidavit filed in the apex court, the Ministry of Health and Family Welfare submitted it is committed to safeguarding the safety and well-being of people subjected to trial.
It said an apex committee, headed by the Health and Family Welfare Secretary, has been formed to supervise the regulation of clinical trials based on the recommendation of the Technical Committee constituted under the chairmanship of the Director General Health Services.
“It is submitted that the government is committed in its resolve for safeguarding the rights, safety and well-being of the subjects participating in the clinical trials and has been taking sincere and concerted steps in that direction,” the affidavit said.
“It is submitted that the Drugs and Cosmetics (Amendment) Bill, 2013 has been introduced in Parliament. The Bill has a separate chapter containing penal provisions for violation and non-compliance of the provisions relating to conduct of the clinical trials,” it said.
The Centre also told the apex court that central Drugs Standard Control Organisation (CDSCO) is being expanded and its strength will be increased from 327 posts with 169 drug inspectors to 1,102 during the 12th Five Year Plan.
It said that out of 89 cases of clinical trial death between 2005-12, compensation has been paid in 82 cases so far and the CDSCO is looking into rest of the cases.
(Copy corrected for a typo).