India’s Union Health Ministry has suggested amending the New Drugs and Clinical Trial Rules, originally issued in 2019, to simplify approvals and encourage pharmaceutical innovation. The modification in the draft would permit drug companies to conduct some of the bioavailability and bioequivalence (BA/BE) tests — utilized to demonstrate that new formulations function in the same way as approved medicines — without authorization by the Central Drugs Standard Control Organisation (CDSCO). Instead, clinical trials in India could begin only with a notification, as long as they involve oral formulations that already hold approvals in the US, EU, UK, Japan, Australia, or Canada.
Notably, this relaxation will not extend to drugs considered high-risk, such as hormone therapies, narcotics, cytotoxic drugs, etc. Although permission from the CDSCO is not needed, these clinical trials need to be authorized by a CDSCO-registered Ethics Committee and confined to a maximum of 48 subjects. In addition, under this proposed notification system, manufacturers will be allowed to produce drugs for these studies without first obtaining approval for these drugs in India.
The action follows last year’s policy to allow some globally approved drugs to enter India without local trials. This move further aligns India’s regulatory regime with international practice and benefits both foreign and local drug innovators.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.