The Union Ministry for Health and Family Welfare has notified the Drugs and Clinical Trials Rules with an aim to promote clinical research in the country.
The new rules will ensure patient safety and the ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.
Drug Controller General of India (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.
Clinical trial is a research study that determines whether a new drug is both safe and effective for humans.