In a bid to stay abreast with changing technology and remove obsolete laws and regulations, the Government of India has released the draft New Drugs, Medical Devices and Cosmetics Bill 2022, replacing the existing Drugs and Cosmetics Act of 1947. The new draft Bill seeks to, among others, regulate e-pharmacies and medical devices, providing for penalties including imprisonment for failure to provide compensation for injury or death arising from clinical trials for both drugs and medical devices.
As per the new draft Bill, the Central government will constitute a consultative committee called the Drugs, Medical Devices and Cosmetics Consultative Committee, which will advise the Central and State Governments, the Drugs Technical Advisory Board and the Medical Devices Technical Advisory Board on matters related to the secure implementation of the project across the country.
Further, the draft Bill also has a separate segment which proposes to regulate Sowa Rigpa and Homeopathy, under AYUSH, encouraging the use of modern science and technology to develop innovative drugs and devices across the AYUSH branch of medicines. The current bill regulates Ayurveda, Siddha and Unani drugs and cosmetics.
A copy of the new Draft bill has been uploaded on the Ministry of Health and Family Welfare (MoHFW) website for review, suggestions, comments and objections from the public and stakeholders for a period of 45 days from the date of issue (08 July).