Global Drug Trials in India Must Now Include Indians

The Indian Central Drugs Standard Control Organization (CDSCO) has made it mandatory for global drug clinical trials to include Indian patients for internationally developed drugs. Additionally, global clinical trials that are already approved in ICH (international Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) countries such as the US and Japan will receive priority review status by the CDSCO. These regulations are meant to increase the safety of Indian patients as a part of efforts to reform the Indian clinical trial industry after unethical practices were exposed in 2011.

The CDSCO has also proposed to remove the local clinical trial requirement for drugs that have not been found to have major adverse events on patients. In order to waive the local clinical trial requirement, drugs must be approved and marketed for at least two years in the EU, US, UK, Australia, Canada, or Japan. This proposed regulation will make it easier for pharmaceutical manufacturers to introduce drugs that have already been used in well-regulated countries.