Drug, Medical Devices, And Cosmetics Bill-2022:
The Union Health Ministry has released the new draft ‘Drug, Medical Devices, and Cosmetics Bill-2022’ that separately defines medical devices.
- The government has sought comments, objections, and suggestions on the draft Bill over the next 45 days.
Key Highlights:
- Separate expert group: It has provision for the constitution of a separate expert group on medical devices.
- Central and state testing laboratories: It calls for the setting up of central and state medical device-testing laboratories on the lines of the network of drug-testing laboratories.
- Rules for online pharmacy: The draft Bill also suggests that the Central government formulate rules for regulating online pharmacies.
- Separate definitions for medical devices: The draft Bill has a 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 medical devices as one of the four categories of “drugs”.
- ‘Medical devices technical advisory board’: It makes provision for the creation of a ‘medical devices technical advisory board’ on the lines of the existing drugs technical advisory board.
- This board will include medical professionals and also people with technical knowledge of the devices.
