In a bid to promote clinical research in India, the Union Ministry of Health & Family Welfare has come up with ‘New Drugs and Clinical Trials Rules, 2019’.
Focusing more on patient safety, new rules will reduce time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country, the Ministry notification stated.
S Eswara Reddy, Drugs Controller General of India (DCGI) said “the aim is to promote clinical research in India, have predictable, transparent and effective regulations for such trials and also make faster accessibility of new drugs to Indian population.”
There will be a ethics committee that will monitor the trials. The committee will also decide about the compensation in cases of adverse events.
“In case of injury to 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.
“Also, compensation in cases of death and permanent disability or other injury to a trial subject will be decided by the Drug Controller General,” Reddy said.
These rules will apply to clinical trial, bio-availability or bio-equivalence study, new drugs and regulation of ethics committee relating to clinical trial and biomedical health research.
These rules provide for disposal of clinical trial applications by way of approval or rejection or seeking further information within 90 days for drugs developed outside India.