The Ministry of Health and Family Welfare released a draft of the  New Drugs, Medical Devices, and Cosmetic Bill 2022 to keep up with the changing needs of the population and the developments in healthcare technologies. The draft bill seeks to replace the existing Drugs and Cosmetic Act of 1940. 

The draft bill has proposed new definitions for clinical trials, over-the-counter drugs, manufacturers, cosmetics, medical devices, new drugs, bioavailability studies, etc. The new draft also introduced a separate definition for medical devices that include all types of diagnostic equipment and its software, implants, devices of assistance with disabilities, a life support system, any reagent or kit, etc.  

In Chapter II of the draft, the Ministry made a provision for the creation of a medical device technical advisory board that will include medical professionals from the Health Ministry, Department of Atomic Energy, Department of Science & Technology, etc. Chapter III of the draft stated that the Union Government can regulate or restrict the import and export of drugs, in the public interest if the drug is essential to meet the requirement of an emergency due to an epidemic or natural disaster.

The draft bill has highlighted the regulations for conducting clinical trials for new drugs and medical devices in Chapter IV. For the first time, the draft bill has added regulations stating that clinical trials of drugs and medical devices will require compulsory permission from the central licensing authority. It also mentioned that medical management and compensation have to be provided to participants who were injured in the clinical trial. Several new provisions have been added to the draft bill relating to Ayurveda, Siddha, Unani, and Homeopathy drugs. Chapter V of the draft has proposed an establishment of a scientific research board to support the regulatory authorities on the advances used for developing innovative drugs, safety, efficacy, making devices, and other related matters of Ayurveda, Siddha, Unani, and Homeopathy drugs. 

Chapter VI of the draft regulates medical devices, investigational medical devices, and clinical trials of investigational medical devices. Similar to the clinical trial of drugs, medical compensation has to be provided to participants who were injured in the clinical trial. The draft also recognizes the issue of e-pharmacies in its first schedule and states that “No person shall himself or by any other person on his behalf, sell, stock, exhibit or offer for sale or distribute any drug by online mode except in accordance with a permission issued by the regulatory authority”. The second schedule of the draft mentions the fee payable for the license, permission, registration certificate, and approval.