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. It said the requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries to be specified by the Drugs Controller General with the approval of the government.
The new rules will ensure patient safety, as they would be enlisted for trials with informed consent. The ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.