Clinical trials may come under regulator's lens

The Drug Controller General of India (DCGI) has decided to conduct random inspection and audit of clinical trials all over the country. The checks will begin next month.

The entire link in clinical trials will come on the regulator's radar including, sponsors of the trials, contract research organisations and ethics committees.

The sponsors are usually pharmaceutical companies while ethics committees oversee the trials and are supposed to act as the moral police.

For this, the DCGI is looking to put in place 25-30 trained professionals from medical institutions and the industry. "We have identified some people who may have had exposure to, say, US Federal Drug Administrator's clinical trials inspection. The World Health Organisation is lending financial support and we would begin inspecting from January next year," said Ashwini Kumar, DCGI.

The inspectors would look at discrepancies in records, in "informed consent" forms and any other suspicious data. "Audits would be randomly chosen after evaluation of the submitted paperwork. We are also planning to make it voluntary where audit may be conducted at the initiation of the sponsor too. But all trials cannot be audited and that is accepted internationally," explained Kumar.

Currently, quality benchmarks have been specified in Good Clinical Practices while Schedule Y in the Drugs and Cosmetics Act lays down the norms for clinical trials in India.

Explaining the lacunae, Kumar said, "We need a system of inspection and we are preparing for that." So far, India's regulatory system has been tuned to investigation of pharma products, but in clinical trials there are no products, only processes and data.

"All our inspectors have focussed so far on Good Manufacturing Practices. Now the focus will have to shift to Good Clinical Practices. Regulations are evolving as much as the business,segment that it is seeking to regulate. We are bound to have new experiences, but we can learn from organisations like USFDA, " said Kumar.