Aiming to promote clinical research in the country, Union Health Ministry has notified the Drugs and Clinical Trials Rules, 2019.
The new rules will apply to all new drugs, investigational new drugs for human use, clinical trials, bio-equivalence studies and ethics committees.
The highlights of the notification includes 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. 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, UK, Australia, Japan and US) 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. Meanwhile, the Indian Society for Clinical Research (ISCR) said that the new Clinical Trial Rules are well balanced and will further the conduct of ethical and quality clinical trials in the country which, in turn, will benefit patients.