India: New Clinical Research Regulations

The Central Drug Standard Control Organization (CDSCO) of India is responsible for the regulation of clinical trials. On July 17th, 2012 the CDSCO drafted several amendments to the Drugs and Cosmetics Rules of 1945. The changes are intended to improve supervision over clinical research, which is a rapidly growing field in India and has received much backlash recently. As a result, one of the new provisions is a mandatory 14 day time window to report any suspected adverse reactions during a clinical trial to the head of the CDSCO, the Drug Controller General of India (DCGI). It is also now an obligation to provide full compensation for trial related injuries or deaths. This compensation must be outlined in patient consent forms as well as reported to the licensing authorities.

Clinical trials must be registered with the Clinical Trial Registry – India (CTRI) prior to enrollment of any patients. Additionally, a status report of on-going, completed, or terminated trials must be submitted annually. When a trial is terminated, a detailed explanation must accompany the report.

The ethics committee of each CRO has new rules as well. The role of the ethics committee is to ensure that the Good Clinical Practice Guidelines for Clinical Trials in India are being met. Registration of CRO ethics committees in India is mandatory and must take place before initiating a clinical study. Re-registration of the committee must occur every five years. If the licensing authority decides not to grant registration to a committee, the ethics committee has 90 days to appeal to the Central Government.

CROs must provide an adequate response to the CDSCO officials for any query related to the conduct of clinical trials. The CROs must also allow inspectors to enter the premises and review any record, data, document, etc. related to the clinical trial. These inspection visits may take place without any prior notice to the CRO.