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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:
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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.
