The Union Ministry of Health and Welfare on Monday notified the New Drugs and Clinical Trials Rules, 2019, to reduce the time for approving applications for drugs manufactured in India to 30 days, and for those manufactured abroad to 90 days, PTI reported.
According to the new rules, patients will be enlisted for trials with informed consent and the ethics committee of the ministry will monitor the trials. In case of an adverse event, the committee will decide on the amount of compensation, Drugs Controller General of India S Eswara Reddy said.
“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,” Reddy said, according to PTI. “Also, compensation in cases of death and permanent disability or other injury to a trial subject will be decided by the Drug Controller General.”
Meanwhile, a report in Mint said approval for the use of new drugs, from select markets, will be waived in India if the global trials included Indian patients. “For example, if a US-based company conducted clinical trials that also included Indian patients and the drug is marketed in the US, there will be no need for conducting local clinical trials to prove its efficacy in India,” an unidentified official told the newspaper.
The approval or rejection of clinical trial applications for domestic drugs will be done within 90 days. In case of application for clinical trial of a new drug as part of discovery, research and manufacture in India, the application has to be disposed of within 30 days.
“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,” Reddy said.
The application would be deemed to have been approved in case there is no communication from DGCI.