The Union Health Ministry has notified the Drugs and Clinical Trials Rules, 2019, with the government stating that the move is aimed at promoting clinical research in the country. The rules will apply to all new drugs, investigational new drugs for human use, clinical trials, bio-equivalence studies and ethics committees. Time reduction The highlights of the notification include reduction in time for approving applications, which has now come down to 30 days for drugs manufactured in India and 90 days for those developed outside the country. “Also, in case of no communication from Drugs Controller General of India, the application will be deemed to have been approved,” the notification said. As per the new rule, the requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries (EU, U.K., Australia, Japan and U.S.) specified by the Drugs Controller General with the approval of the government. “The new rules will ensure patient safety and an ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events,” the Ministry said.