New drugs sold in India must include Indians in clinical trials: Govt

SC had constituted a committee under Jagdish Prasad to suggest inputs relating to clinical trials

The CDSCO (Central Drugs Standard Control Organisation) has decided to make it mandatory for pharma companies to include Indian patients in global clinical trials for drugs developed abroad, according to report in The Times of India.

The drug regulator has also decided to process medicines already approved by countries party to the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), such as Japan, US, on priority to reduce the time required for go-ahead to new drugs.

The ICH is a project that brings together the regulatory authorities of Europe, Japan and the US to look into scientific and technical aspects of drug registration.

The Supreme Court had constituted a 15-member committee under the Director-General of Health Services Jagdish Prasad to suggest inputs relating to clinical trials.

The clinical trial services industry in India was hit hard by reports of unethical practices a few years back. This decision could give a fillip to the industry in the near future.