Current Affairs - Miscellaneous - Discussion

The Union Ministry for Health and Family Welfare have added new ruled to the Drugs and Clinical Trials Rules, 2019 with an aim to promote clinical research in the country. The new rules reduce the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country. The new rules state that in case of no communication from Drug Controller General of India (DCGI), the application will be deemed to have been approved. The new rules will ensure patient safety, as they would be enlisted for trials with informed consent and the ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events. The rules also waive off the requirement of a local clinical trial if the drug is approved and marketed in countries specified by the DCGI with the approval of government from time to time and certain other conditions.