Usha Sharma – Mumbai
In the latest attempt to protect clinical trial subjects in India, the Drug Controller General India (DCGI) has written to Ethics Committees (ECs), who are in charge of approving clinical trial protocols of drugs undergoing trials in India.
Dr G N Singh, Drugs Controller General of India said, “Globally, there is an attitude that Indians are guinea pigs but being an Indian I strongly feel that nobody is a guinea pig. For us health is more important than anything else. For clinical trial subjects, we feel safety issues are important and subjects have full right to know which medicines are being used on them. To ensure this, it has been made mandatory that only doctors of repute are allowed to conduct clinical trials. We have also made the consent forms public, which will help subjects to get a clear idea before hand.”
In his letter to the ECs dated August 16, Dr G N Singh, DCGI reminds them of their responsibilities under Schedule Y of the Drugs & Cosmetic Rules to review and accord their approval to a trial protocol to safeguard the rights, safety and well being of all trial subjects. Schedule Y mandates that the ECs should exercise particular care to protect the rights, safety and well being of all vulnerable subjects participating in the study, and can, at appropriate intervals, conduct an ongoing review of the trails for which they review the protocol(s).
In the light of these specifications, the DCGI’s letter goes on to request ECs involved in clinical trials in the country to “keep vigil on clinical trials being conducted under their jurisdiction.”
The DCGI further recommends, surprise visit if necessary to ensure that clinical trials are conducted as per the requirements of Schedule-Y of Drugs and Cosmetics Rules GCP guidelines and other applicable regulations to ensure that the rights, safety and well being of the subjects involved in clinical trials in the country are protected.
If any deviation is observed at any point of time, the DCGI requests the ECs to take remedial measures and also inform the Office of DCGI to take appropriate action in the matter.
Singh commented, “We have already circulated this notice to all the zonal and sub zonal offices of the CDSCO. And, we firmly believe that this movement will be in the interest of the public health.”
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