What the draft medical devices Bill says and what it does not

GS Paper 2

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

Source: Indian express

Context:

• The Union Health Ministry last week released a draft of a proposed Drugs, Medical Devices and Cosmetics Bill, 2022 to replace the existing Drugs and Cosmetics Act, 1940, and several sets of Rules by which the industry is currently run.
• The draft focuses on regulating medical devices as a separate entity, makes provision for fines and imprisonment for injury and death related to clinical trials or investigations, and seeks to regulate e-pharmacies.

Key Provisions:

• Online pharmacies: No provisions to regulate online pharmacies exist in the 1940 law or any of the Rules.
  • No person shall himself or by any other person on his behalf sell, stock or exhibit or offer for sale, or distribute, any drug by online mode except under and in accordance with a license or permission issued in such manner as may be prescribed.
• Clinical trials and investigations: The draft Bill makes provisions for compensation to participants or their legal heirs for injury or death suffered in clinical trials and investigations for drugs and medical devices.
  • The draft also lays the onus on providing medical management for any injury arising due to the trial of the investigators.
• Imprisonment and fine: It amounts to double the compensation amount if the compensation is not paid.
  • If the draft Bill becomes law, these provisions will be part of it, and will not be restricted to just clinical trial Rules.
• Prohibits clinical trials: The draft Bill prohibits clinical trials or clinical investigations of drugs and medical devices without permission from the central licensing authority.
  • While companies have to seek permission from the regulator to conduct trials even now, this is not specifically mentioned in the existing law.
• Medical devices: Under the ambit of medical devices defined by the draft Bill are diagnostic equipment, their software, implants, devices for assistance with disabilities, life support, instruments used for disinfection, and reagents or kits.
  • The 1940 Act has medical devices as one of four categories of “drugs”.
• Medical Devices Technical Advisory Board: To make decisions on regulating medical devices, the draft Bill provides for creating a Medical Devices Technical Advisory Board on the lines of the existing drugs technical advisory board, with people who have technical knowledge of the engineering of these devices, and members of the industry.
  • Other than officials of the Health Ministry, the board will have officials from:
    • Department of Atomic Energy
    • Department of Science and Technology
    • Ministry of Electronics and Information Technology
    • Defense Research and Development Organization
    • Experts from the fields of biomedical technology, biomaterials, and polymer technology
  • Imprisonment or fines for adulterated or spurious medical devices: It defines provisions for imprisonment or fines for “adulterated” or “spurious” medical devices.
    • The draft states that a medical device will be considered to be adulterated if it is rusted, corroded, filthy, putrid, decomposed, packed or stored in unsanitary conditions, contains harmful or toxic substances, or has any component or software removed making it unsafe.
  • Medical devices to be spurious: The draft Bill deems a medical device to be spurious if it carries the label of a fictitious company or is purported to be of a manufacturer that has not manufactured it.

Insta Links:

Drugs and Cosmetic Rules, 1945

Practice Questions:

Q. Critically analyze the provisions of the Drugs and Cosmetics Act, 1940 and discuss the key changes suggested in the Drugs, Medical Devices and Cosmetics Bill, 2022.