India proposes faster drug approval process, cuts license timeline to 45 days

India's Ministry of Health has proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at expediting drug development and approval in India.

Under the draft changes, the statutory processing time for test licence applications would be halved - from the current 90 days to 45 days - in a bid to reduce delays in bringing new medicines to market.

Companies will now be permitted to initiate certain clinical trials and manufacture the necessary investigational drugs without obtaining prior licenses. Instead, a simple notification to the regulatory authority will suffice, significantly cutting down on delays, according to the draft notification.