In the first half of July 2014, India’s Central Drugs Standard Control Organization (CDSCO) released more than 10 notices and orders related to clinical trials.
Clinical trial investigators, sponsors, Ethics Committees, and the regulator will be held responsible for ensuring that trials are properly designed. Investigators are restricted to working on a maximum of 3 clinical trials at the same time. The CDSCO also addressed the level of care that should be provided for participants and the issue of compensation if a trial participant dies or is injured.
Biosimilars and generics that have been marketed in countries such as the U.S. for more than 4 years and are safe and efficacious can receive marketing approvals in India through a shorter clinical trial process.
In addition, the CDSCO is reforming the committees that are involved in the pharmaceutical approval process. Subject Expert Committees will replace New Drug Advisory Committees. The number of committees will be expanded significantly. Subject Expert Committees’ recommendations will be valuated by a new Technical Review Committee, under the Directorate General of Health Services.
The CDSCO has further clarified the list of 14 medical device categories that are subject to the same Drugs and Cosmetics Act requirements as pharmaceuticals. Devices not on the list do not require registration or permission for import or sale in India for now. The CDSCO also announced that medical device clinical trials must follow the same procedures as trials of new drugs/vaccines, including trial approval and accreditation of investigators, Ethics Committee and trial sites.