The Drug Controller General of India (DCGI) has asked the ethics committees to ensure that clinical trials are conducted in the country strictly in accordance with the provisions of Schedule Y of the Drugs and Cosmetics Rules and the Good Clinical Practice (GCP) guidelines.

“It is reiterated that ethics committee that reviews and accords its approval to a clinical trial protocol is mandatorily required to operate according to the GCP guidelines published by the CDSCO as well as applicable regulations to safeguard rights, safety and well-being of all trial subjects,” DCGI Dr G N Singh said in a circular.

The trials on new drugs are regulated under the provisions of the D&C Act 1945 as amended from time to time. The detailed requirements and guidelines for undertaking clinical trials are specified under Schedule Y and it further provides that the clinical trials are required to be conducted and data generated, documented and reported in compliance with the approved protocols and GCP, as well as application regulations, the notice said.

“The Schedule Y specifies that it is the responsibility of ethics committee that reviews and accords its approval to a trail protocol to safeguard the rights, safety and well being of all trials subjects. The Clause 3.1.7 of the GCP guidelines under para `Confirmation of Review by the Ethics Committee’ requires that the sponsor shall obtain from the investigators or the institutions an undertaking that the ethics committee is organized and operates according to the GCP guidelines and the application regulations,’’ the notice said.

In order to ensure that the trials are conducted strictly in accordance with the provisions and guidelines, the sites of sponsors or clinical research organizations as well as ethics committees shall remain open for inspection by the inspectors or officials of the CDSCO, the DCGI has instructed.

“Any activities in clinical trials in contravention to any provision of the Schedule Y, the GCP guidelines or other application regulations will be viewed as non-compliance to the statutory requirements and action will be taken as per the Drugs and Cosmetics Act and rules made there under,” the order said.