Regulation of medical devices: The draft Bill suggests a separate expert group, check on online pharmacies

GS paper 2

Syllabus: Issues related to the social sector involving healthcare, schemes for vulnerable sections of society etc

Context:

• 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.
  • Other than officials from the Health ministry, the board will also include people from:
    • Department of atomic energy,
    • Department of science and technology,
    • Ministry of Electronics,
    • DRDO
    • Experts in the field of biomedical technology, biomaterials, and polymer technology.

Insta Links:

Drugs and Cosmetic Rules 1945

Practice Questions:

Q. Consider the following statements:

1. Medical devices were categorized separately under the drugs and cosmetics act, 1940.
2. The drugs and cosmetics act, 1940 did not provide for a drug technical advisory board.

Which of the statements given above is/are correct?

• 1 only
• 2 only
• Both 1 and 2
• Neither 1 nor 2

Ans: (d)

Justification:

• The 1940 Act regulated medical devices as one of the four categories of “drugs”.
• Section 3 of the Drugs and Cosmetics Act, 1940: The Central Government, after consultation with the Drugs Technical Advisory Board (DTAB), specifies the devices intended for use in human beings or animals as drugs.

Source: Indian express