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

In a move to ensure efficacy of medicines sold in India, the drug regulator has made it mandatory for companies to include Indian patients in global clinical trials if they want to market in India a new drug developed outside the country.

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.

“Any firm intending to market a new drug which is being developed outside the country, should include Indian patients in the global clinical trial…,” the minutes of the meeting, reviewed by TOI, said.

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 Harmonisation 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.

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.

The clinical trial industry had suffered losses in India after certain unethical practices by a few organisations 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.

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