After SC rap, govt set to notify rules to regulate drug trials

After over 2,242 deaths during clinical drug trials in last five years, government plans to regulate the USD 500 million sector by bringing changes in drug laws to make lapses by pharma MNCs a punishable offence and enhance compensation among other steps.

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 -- making it mandatory for them to address issue of medical management of subjects involved in trials in case of serious adverse events such as death.

The new rules will also prescribe a formula providing for higher compensation in case of serious adverse event like death during the trials and fix a minimum compensation amount. So far, drug companies have been getting away with arbitrary payments sometimes as less as Rs 50,000 in case of a life lost during a trial.

Health Ministry officials finalised the draft rules following a series of meetings yesterday after the apex court came down heavily on the Ministry for sending a junior officer to file an affidavit in such a serious health matter. Asking for the personal presence of Health Secretary in the matter, the Supreme Court gave the Ministry four weeks to respond to a PIL in the matter.