A new rule for global trails by Indian drug regulator
To ensure the efficacy of medicines marketed in India. Drug regulator has made an new rule to include in the clinical trails if they want to market in India which has been developed in other countries.
The decision was taken in a recent technical committee meeting, headed by director general of health services Jagdish Prasad. The committee, which was formed following directions from the Supreme Court, has a mandate to supervise clinical trials on new chemical entities.
The committee also decided that if proposal of such global clinical trials are already approved in ICH countries such as the US, Europe and Japan, then it will be reviewed on priority by the Indian drug regulator.
The ICH or International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. Clinical trial proposals approved by an ICH country will also be considered for approval by the Drugs Controller General of India (DCGI) without referring to subject expert committee, unless there is some specific reasons which should be recorded in writing. “The decision has been taken in public interest keeping in mind the safety of Indian patients. It is important that drugs which are sold in the country are being tested on Indian subjects prior to their launch,” DCGI G N Singh said.Great move. I would call it an innovative idea to ban the products that do unethical practice. US pharma will be badly hit.The move is expected to benefit clinical research organisations and hospitals operating in India. These organisations along with various hospitals conduct clinical trials or testing of drugs on human beings on behalf of pharmaceutical companies, mainly multinational drug makers.