CHENNAI: A new Bill proposed by the government seeks to regulate e-pharmacies and medical devices and provides for jail sentence for failing to pay compensation for injury or death during clinical trials for drugs and medical devices.
The draft New Drugs, Medical Devices and Cosmetics Bill, 2022, which seeks to replace the existing Drugs and Cosmetics Act of 1940, also brings under its purview the regulations for the conduct of clinical trials for new drugs and medical devices.
Currently, the conduct of clinical trials and the provisions for compensation for injury or death during such trials, medical management of the trial participants and regulation of ethics committee etc. come under the New Drugs and Clinical Trials Rules, 2019. Medical devices are currently treated as drugs and there is no separate definition of them.
The draft bill has been put up on the Union Health Ministry’s website for feedback and objections, if any, from the public and stakeholders have been sought within 45 days from the date the notice was issued, i.e., July 8.