To market new drugs in India, global trials must include Indians

New Delhi: The drug regulator in a recent technical committee meeting, headed by Jagdish Prasad, Director General of Health Services, has made it mandatory to include Indian patients in global clinical trials for the drug companies, if they want to market their new drug in India, according to a recent report in TOI. The move is being undertaken in order to ensure the safety and efficacy of drugs, which are developed outside the country and sold in India.

TOI quotes the Minutes of the meeting as stating, "Any firm intending to market a new drug which is being developed outside the country, should include Indian patients in the global clinical trial."

It was also decided by the committee if the clinical trial proposals are already approved by ICH countries then it will be considered on priority basis in India by the Drugs Controller General of India (DCGI) without referring to subject expert committee.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) 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.

DCGI G N Singh told TOI, "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."

The step is indeed expected to boost Indian hospitals and benefit clinical research organizations conducting clinical trials or testing of drugs on human beings on behalf of pharmaceutical companies, mainly multinational companies.

The clinical trial industry had suffered losses in India after certain unethical practices by a few organizations and hospitals came to light in 2011. This was followed by stringent regulatory norms and directions by the apex court itself for strict monitoring of trials reports TOI.