New set of rules for clinical trials in India

A major fillip has been provided by the Indian government for new drugs approved for use in the EU, UK, Australia, Japan and the USA. Newly-minted clinical trial rules in India state drugs that have been approved in these countries no longer require trials in India, reports The Pharma Letter’s India correspondent.

In a bid to fast-track approvals for new drugs and promote clinical research in the country, the government has allowed companies a waiver on conducting trials for new drugs in India, in case the drug is already approved and marketed in countries specified by India’s apex drug regulator, the Central Drugs Standard Control Organization (CDSCO).

The waiver would also extend to drugs that receive marketing approvals even while a trial is underway in India.