Govt. notifies new rules for drugs, clinical trials

Health and Family Welfare Ministry have notified the Drugs and Clinical Trials Rules, 2019 with an aim to promote clinical research in the country.

Key Facts:

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.

Source:The Hindu