India – Indian regulators tweak drug trial rules

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…