India Weighs Opening Markets to FDA, EU-Approved Drugs

Indian regulators may begin letting some FDA and EU approved drugs onto the Indian market without local Phase III clinical trials.

The Drugs Technical Advisory Board, an advisory group to the Central Drugs Standard Control Organization, has recommended that drugs approved in well-regulated countries with approved postmarketing surveillance plans should be eligible to forego the current Indian requirements for further clinical studies, provided there is a strong local need for them.

The move is needed in part because drug companies had all but stopped conducting trials in India following stricter regulations brought on by a 2012 lawsuit by patient activists seeking compensation for deaths that occurred during clinical trials. That resulted in a slowdown in medications reaching the Indian market.

Drugmakers will need more details about the proposal before knowing whether it is a sound idea, according to PhRMA spokesman Mark Grayson. The Indian government has considered accepting FDA and EU approval in lieu of local trials in the past, but only for drugs that have been on the market for four years.

If the current proposal includes the four-year waiting provision, it would create an unacceptable lag in drugs getting on the market in India, he says. The proposal now heads to CDSCO for review later this year.

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