India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), is preparing to introduce fixed timelines for drug approvals and increase the use of artificial intelligence to strengthen efficiency and transparency. According to Drugs Controller General Rajeev Raghuvanshi, the focus will be on easing regulatory processes while tightening enforcement where necessary.

Key reforms already implemented include cutting the processing time for drug test licences to 45 days, allowing certain clinical trials to proceed with only prior intimation instead of formal licensing, and reducing export certification times to fewer than seven days.

These initiatives are part of a broader strategy to improve regulatory performance and support the expansion of India’s pharmaceutical industry on the global stage. In the last fiscal year, the United States—India’s largest pharmaceutical export destination, accounting for more than one-third of overall exports—saw a 20 per cent rise in Indian generic drug sales, reaching approximately USD 10.5 billion.