In an attempt to ease norms for testing and introduction of new medicines in the country, the government has taken steps to fast-track approvals for clinical trials as well as launch of drugs already approved in other countries.
Pharmaceutical companies planning to launch new drugs already approved outside India after conducting pre-clinical or toxicological studies on animals will not be required to repeat such studies in India for importing or manufacturing them here unless some specific concerns are raised, the Drugs Controller General of India, under the health ministry, said in a latest circular issued this week. The drug regulator has also given more freedom and responsibility to the Ethics Committee– that monitors clinical trials for new medicines. As per the new norms, the Ethics Committee is expected to cut timelines for launch of new medicines, including biologics.
Ethics Committee has also been allowed to add trial sites and investigators without the need to obtain a no objection certificate from the DCGI. However, companies will have to inform any changes to the DCGI.
The move comes in the wake of concerns raised by the industry which complained of repeat tests and data submissions to different authorities. Of late, the regulator has also been cautious on approving new drug trials after the Supreme Court’s directive asking the government to ensure patient safety while approving clinical trials. The recommendations to ease the norms for additional tests were made by the Investigational New Drug Committee and Drug Technical Advisory Board.
Though, the latest order by the DCGI gives more power and independence to the ethics committee, but still the final authority of approval of the application will however be with the DCGI.
Apart from commercial testing and research, norms have also been eased for academic research. Making it easier to conduct clinical trials for academic and research purposes that are non-regulatory in nature, the DCGI has said its permission will not be needed provided that the trials are approved by the ethics committee. However, the regulator can raise objections if there are any concerns highlighted.