Daily News Analysis » New Drugs, Medical Devices and Cosmetics Bill, 2022

New Drugs, Medical Devices and Cosmetics Bill, 2022

Why in the News?

Recently, the Ministry of Health and Family Welfare (MoHFW) released a draft of the New Drugs, Medical Devices and Cosmetics Bill, 2022.  

Drugs and Cosmetics Act, 1940:

  • It regulates the manufacture, import and distribution of drugs in India.
  • Objective: To ensure that the drugs and cosmetics sold in India are effective, safe and conform to state quality standards.
  • Section 3 of the Drugs and Cosmetics Act, 1940:
    • After consulting with the Drugs Technical Advisory Board (DTAB), the Central Government specifies the devices intended for use as drugs in humans or animals.
 

Key Points:

About the Bill:

  • It will replace the Drugs and Cosmetics Act, 1940, and many rules.
  • It will regulate online pharmacies,medical devices and clinical trials.
  • Focuses on regulating medical devices as a distinct entity.
  • Makes provision for imprisonment and fines for injury and death related to clinical trials.
 

Key Provision of the Bill:

  • Online pharmacies
    • There was no provisions to regulate online pharmacies exist in the 1940 law or any of the Rules.
    • It prohibits any person from selling, keeping stock, exhibiting or offering for sale or distributing any drug by online mode, except with a license.
 
  • Medical Devices:
    • Creating a Medical Devices Technical Advisory Board
    • Provisions for fines or imprisonment for “adulterated” or “spurious” medical devices.
 
  • Clinical trials and investigations
    • It makes provisions for compensation to participants or their legal heirs for injury or death suffered in clinical trials.
    • The draft Bill prohibits clinical trials without permission from the central licensing authority.
 
  • AYUSH Drugs:
    • It also includes a chapter on Ayurveda, Siddha, Unani, Sowa-Rigpa, and Homeopathy, and their respective Drug Technical Advisory Boards.
    • It has a separate chapter for AYUSH drugs which proposes to regulate Sowa Rigpa and Homeopathy for the first time.
  • Penalty:
    • There is a new provision for imprisonment and fine.

Criticism:

  • The provisions for imprisonment under the draft Bill might act as a deterrent.
  • Even the clinical trial Rules have fines, but a few lakhs is not enough to deter a big pharma company.
  • There should also be a mechanism for recalling medicines or devices if any issues are detected.
  • The draft Bill misses post-marketing surveillance, especially for medical devices, because implants can remain within a patient’s body for years.

Conclusion:

  • The bill has been drafted to keep pace with the changing needs, times, and technology as the existing is a pre-independence legislation.
  • Separate chapters for medical devices will raise standards, consumer assurance, and stakeholder expectations.