Drug regulator to periodically inspect all clinical trial sites

Move to ensure compliance with recent guidelines; discrepancies to attract severe action

The country's apex drug regulator plans periodic inspection of clinical trial sites to ensure these comply with the recently issued guidelines. If discrepancies are found, strict action is to be taken against the company and the trials might also be suspended, said a senior official in the the Drug Controller General of India (DCGI) office.

All its zonal offices have been directed to form expert teams headed by a senior drug inspector. "The expert committee, along with drug inspectors, shall visit the clinical trial sites at least once a year to verify compliance with

Schedule Y, GCP (good clinical practice) guidelines and applicable regulatory requirements," says the letter, reviewed by Business Standard.

The zonal offices are to maintain records of investigators and of companies conducting clinical trials, including names and qualification of those involved, with details of the site.

The move comes in the wake of extensive criticism of the health ministry, particularly the DCGI, for failing to monitor clinical trials on human beings to test new medicines. Till a few months earlier, the health ministry had almost no guidelines or regulatory framework for those doing this.

After repeated slamming from the Supreme Court (SC) on the issue, the ministry put in place a  bunch of guidelines related to registration of clinical trials and an ethics committee to monitor these. It also framed norms on compensation to victims of clinical trials.

However, the government is still awaiting an amendment to the Drugs and Cosmetics Act to introduce penal provisions for those flouting the rules.

According to data given by the government to the apex court, around 80 people died due to clinical trials in India in the past seven years. In an affidavit to the SC in March, the health ministry said there were 2,644  such "serious adverse events" during clinical trials during 2005-2012. Of these, 80 have been attributed to clinical trials, while the others could be due to terminal illnesses or other life-threatening diseases.

The government feels regular inspection would help keep a watch on such trials and ensure proper practices are followed.