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New rules sweeten the deal for clinical trials by Indian pharma cos

Maitri Porecha New Delhi | Updated on February 15, 2019

Proposals to be deemed approved if status is not intimated within 30 days

The latest set of clinical trial rules, likely to be notified in March, will fast-track proposal clearances for Indian companies rather than their multinational counterparts.

Officials said that while the turnaround time for clearing clinical trial proposals was not defined earlier, it is going to change once new rules take effect.

30-day timeline

“Indian companies will be provided incentive to start clinical trials and their proposals will be deemed approved in case they do not hear from the Drug Controller General of India (DCGI) on the status of their application within 30 days,” said Eswara Reddy, DCGI.

DCGI has taken a leaf out of United States Food and Drug Administration’s (US-FDA) workings while tweaking this rule.

While domestic approvals will be fast-tracked, for multinational pharma companies, the waiting period will be defined mostly at six months in the notified rules, which were framed in the hope that indigenous pharmaceutical companies will boost drug research efforts. Earlier, pharmaceutical companies, be it domestic or MNCs, had no clue as to when their paperwork would be accepted by the DCGI.

Chirag Trivedi, President, Indian Society of Clinical Research, said the new rules would boost indigenous pharma research in India and help bring more global trials both from domestic and MNCs.

Reddy said, “The DCGI-led expert committees had to provide verbal feedback to companies for tweaking their clinical trial proposals earlier. Now, a clause for pre-submission and post-submission meetings with pharma companies will be inserted.” “It will bring in more transparency, processes will be well-defined and consultation will be allowed in a defined time frame,” Trivedi said.

Compensation clause

In the new rules, DCGI has decided to change the compensation clause in case of death or disability presumably caused by clinical trials. Earlier, the draft rules had said 60 per cent of the amount would be non-refundable, even if an expert committee at a later stage found the death or disability was not related to the clinical trial. Now the non-refundability clause has been done away with.

The current rules which were notified in 2015, provide compensation to those enrolled in clinical trials according to a set formula, when participants are reimbursed anywhere from ₹4 lakh75 lakh, and that clause will be continued in the new rules as well. Since 2015, close to ₹ 5 crore has been paid in compensation to those enrolled in clinical trials, the Ministry of Health informed Parliament recently.

Falling numbers

While few years ago, India conducted 1.5 per cent of global clinical trials and studies this has now fallen to 1.2 per cent. As of February 13, international repository of clinical trial data reported 2,97,101 clinical trials of which 3,618 (1.2 per cent) are occurring in India.

Trivedi said that the new rules would help bridge the unmet medical need for research in India.

“India has 17 per cent of global population, 20 per cent of global disease burden and yet only 1.2 per cent of global clinical trials are done in India now,” he said.

Published on February 15, 2019

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