Health Ministry to amend rules for new drug, clinical trials to promote ease of doing business

The Indian government is taking major steps to make the pharmaceutical and clinical research sectors easier to do business in. On September 3, the Union Health Ministry announced plans to simplify rules for drug testing and clinical trials, aiming to boost India’s reputation as a global hub for pharmaceutical research.

The upcoming changes focus on amending the New Drugs and Clinical Trials (NDCT) Rules, 2019. The goal? Make it simpler and quicker for companies to get test licenses and submit applications for bioavailability and bioequivalence (BA/BE) studies — key steps in drug development.

The Ministry shared that these proposals are part of India’s broader effort to improve ease of doing business and align with international standards. This move is expected to attract more clinical research projects to India, strengthening the country’s position in global pharmaceutical innovation.

One of the key reforms is replacing the current test license system with a notification or intimation process. This means companies will no longer need to wait for a license before starting certain tests — they can just notify the authorities, speeding things up. The time needed to process test license applications will be cut in half, from 90 days to just 45 days.

The amendments also propose removing the license requirement for some BA/BE studies, allowing firms to start tests upon simple notification. These changes will save time, cut down on paperwork, and make India a more attractive destination for clinical research companies.

Overall, these reforms will help reduce application backlog, speed up drug testing and approval, and make better use of the resources available to health regulators. This is great news for the pharmaceutical industry, researchers, and patients alike, as it promises faster development of new medicines and improved healthcare innovation in India.