A day after the Supreme Court rapped the Health Ministry for allowing Indians to be used as 'guinea pigs' in the conduct of drug trials, top sources told PTI that the rules meant to monitor clinical trials under the Drugs and Cosmetics Act would be notified within this month.
After notifying these rules which will lay down guidelines for pharma companies engaging in drug trials in India, government will further amend the Drugs and Cosmetics Act to make lapses by pharma MNCs a punishable offence under law, they said.
Waking up to regulate the clinical trial sector, the ministry under the new rules will for the first time put specific responsibility on investigators and sponsors of drug trials --
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