CDSCO notifies draft rules on inspection of clinical trial sites
August 09, 2012, 0800 IST – Source Pharmabiz News
In a move to further streamline the clinical trials in the country, the Central Drugs Standard Control Organisation (CDSCO) has finalized and issued draft rules regarding the inspection of premises of clinical trial sites by the regulatory officials with or without prior notice.
“The premises of sponsor/clinical research organization and clinical trials shall be open to inspection by the officer of the CDSCO, who may be accompanied by an officer of the concerned state drug control authority to verify compliance to the requirements of Schedule Y, good clinical practices and other applicable regulation,” according to the notification seeking to change the Drugs and Cosmetics Act (D&C Act).
“The sponsor/CRO, investigators shall allow CDSCO officer who may be accompanied by an officer of the concerned State Drug Control Authority to enter, with or without prior notice, any premises of sponsor/CRO and clinical trial site to inspect, search, seize any record, data, document, books, investigational drugs etc. related to clinical trials and provide adequate replies to any queries raised by the inspecting authority in relation to the conduct of the trial,” the document said.
The rules, already approved by the DTAB, will be the third amendment to the Drugs and Cosmetics Rules, 2012 and will be implemented after final notification, the notification said, while seeking inputs and suggestions from the stakeholders.
The rules, to be incorporated in Part X-A after Rule 122 DAB, in detail lays down mandatory procedures for getting permissions, approval of the ethics committee, registration with Clinical Trials Registry-India, reporting of injuries and death, and procedures for submitting replies if notices were issued by the CDSCO on the lapses.
If any company fails to comply with any of the conditions, the licensing authority, may after giving an opportunity, will take proceed to take actions, as required. The can be warning letter on the deficiency found during the inspection, recommendation for rejecting the study, suspension or cancellation of the trial permission and restriction of the investigator/CRO from conducting studies, the draft rules said.