Health and Family Welfare Ministry have notified the Drugs and Clinical Trials Rules, 2019 with an aim to promote clinical research in the country.
- The new rules will change the regulatory landscape for the approval of new drugs and conduct of clinical trials in the country.
- These rules will apply to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study and Ethics Committee.
- It has reduced the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
- The rules stated that in case of no communication from Drugs Controller General of India, the application will be deemed to have been approved.