The Union Health Ministry has released the draft ‘Drug, Medi­cal Devices, and Cosm­etics Bill-2022’ that seeks for the first time to regulate e-pharmacies.

The Bill aims to amend and consolidate the law relating to the import, manufacture, distribution and sale of drugs, medical devices and cosmetics to ensure their quality, safety, efficacy, performance and clinical trial of new drugs and clinical investigation of investigational medical devices and for matters connected therewith or incidental thereto.

The draft Bill has separate definition for medical devices that bring under its ambit diagnostic equipment, its software, implants, devices for assistance with disabilities, life support, instruments used for disinfection, and any reagents or kits. The previous 1940 Act regulated the medical devices as one of the four categories of “drugs”.

But the Bill doesn’t stop at just defining medical devices, it makes provision for creation of a ‘medical devices technical advisory board’ on the lines of the existing drugs technical advisory board. This board will not only include medical professionals, but also people with technical knowledge of the devices. Other than officials from the Health ministry, the board will also include people from the department of atomic energy, department of science and technology, ministry of Electronics, DRDO, and experts in the field of biomedical technology, biomaterials, and polymer technology.

There will be Medical Devices Technical Advisory Board along with Drug Technical Advisory Board. And The Central Government may remove any member nominated from office in above mentioned boards.

Central Government shall constitute a consultative committee to be called the Drugs, Medical Devices and Cosmetics Consultative Committee to advise the Central Government, the State Governments, the Drugs Technical Advisory Board and the Medical Devices Technical Advisory Board on any matter tending to secure uniformity in the country in the administration of this Act and the rules.

Central Government will also establish one or more special courts in consulation with states high court for trial of offences relating to adulterated drugs or spurious drugs and punishable under clauses.

Health ministry also specifies Fee payable for license, permission, registration certificate and approval of medicines in the country. 

The government has sought comments, objections, and suggestions on the draft Bill over the next 45 days.