Drugs and Clinical Trials Rules, 2019
The Union Ministry for Health and Family Welfare has notified the Drugs and Clinical Trials Rules, 2019 with an aim to promote clinical research in the country.
Features of the New Rules
- 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 new rules mandates that in case of injury to the clinical trial subject, medical management will be provided as long as required as per the opinion of the investigator or till such time it is established that the injury is not related to the clinical trial.
- Compensation in cases of death and permanent disability or other injuries to a trial subject will be decided by the Drug Controller General.
- 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.
- The DCGI has waived off the clinical trial for the drugs approved and marketed in the European Union, the UK, Australia, Canada, Japan and the US.
The new rules aim to promote clinical research in India by providing for a predictable, transparent and effective regulation for clinical trials and by ensuring faster accessibility of new drugs to the Indian population.