The Drugs Controller General of India (DCGI), after issuing guidelines on registration of ethics committees and inspection of trial sites, has now issued directions to the committees to keep a vigil on drug trials.
“The Schedule Y of the Drugs and Cosmetics Rules 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 trial subjects. The ethics committee should exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the study. The committee should also make appropriate intervals an ongoing review of trials for which they review protocols,” the order by the DCGI to all zonal CDSCO officers and ethics committees said.
“The Ethics Committee involved in clinical trials in the country is hereby requested to keep vigil on clinical trials being conducted under jurisdiction. Further, if necessary you may make surprise visit to ensure that clinical trial is being conducted as per the requirements of Schedule Y, GCP guidelines and other applicable regulations to ensure that the rights, safety and wellbeing of the subjects involved are protected,” the order said.
The DCGI also asked them to take remedial measures and also inform his office in time to take appropriate action in any case of discrepancies.
“The detailed requirements and guidelines for undertaking clinical trials are provided under Schedule Y. It further specifies that the clinical trial is conducted and data generated, documented and reported in compliance with the protocol and GCP guidelines specified for the purpose as well as with all applicable statutory provisions. It is therefore, necessary that the clinical trials are conducted in compliance to the provisions of the Drugs and Cosmetic Rules and the care is taken to protect the rights, safety and wellbeing of the subjects participating in the trial and data generated is scientifically and ethically sound,” the DCGI order said.