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Drug firms and hospitals conducting clinical trials on patients may now have to be on an alert. The country’s top drug regulator plans to do periodic inspection of clinical trial sites to ensure that they comply with norms and guidelines that were recently framed by the Centre. If discrepancies are found during inspection, the regulator will take strict action against the firm and may also suspend the clinical trial, a senior official in the DCGI’s office said.
In a letter, sent to all zonal offices, the Drugs Controller General of India (DCGI) has ordered to form expert teams headed by a senior drug inspector immediately. These teams will conduct surprise inspections of clinical trial sites on a regular basis, the official said.
“The expert committee along with drug inspectors shall visit the clinical trial sites at least once a year to verify the compliance with Schedule Y, GCP (good clinical practice) guidelines and applicable regulatory requirements,” the letter, reviewed by Business Standard, says.
The Central drug regulator has also asked its zonal offices to maintain records of investigators or companies conducting clinical trials including names and qualification of those involved in it along with details of the site.
The move comes in the wake of extensive criticism of the health ministry, particularly the DCGI working under it, for failing to monitor clinical trials conducted on human beings to test newer medicines. Till a few months ago, the health ministry had almost no guidelines or regulatory framework for those conducting clinical trials on patients in India.
After repeated slamming from the Supreme Court on the issue, the health ministry has hurriedly put in place a bunch of guidelines related to registration of clinical trials and ethics committee overlooking such trials. It has also framed norms linked to payment of compensation to victims of clinical trials.
However, the government is still awaiting amendment to the Drugs and Cosmetics Act to introduce penal provisions for those flouting the rules.
According to submissions made 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 submitted to the SC in March, the health ministry said there were 2,644 “serious adverse events” of deaths during clinical trials during 2005-2012. Of these, 80 have been attributed to clinical trials, while the other deaths could be due to terminal illnesses or other life-threatening diseases.
The government feels that regular inspection would help keep a tab on clinical trials going on in the country and will also ensure that all sites maintain proper data and follow good practices.
