The Ministry of Health and Family Welfare on July 10th issued the Draft Drug Rules (….Amendment),2024, to further amend the Drugs and Cosmetics Rules ,1945.
Proposed Amendments
The proposed amendments focus on introducing a new Schedule G, which is expected to list specific drugs under heightened regulatory scrutiny. The inclusion of drugs in this schedule will necessitate additional compliance measures and potentially stricter oversight.
Schedule G drugs include critical medications that play a pivotal role in public health, such as antibiotics like Ceftriaxone and Amoxicillin used to treat severe infections, vaccines crucial for preventing diseases like Tetanus and Hepatitis B, and life-saving drugs for chronic conditions such as insulin and metformin for diabetes management and hypertension.
Key Amendments :
- Rule 74: This rule will now include Schedule G drugs in clause (p), which deals with specific regulatory requirements.
- Rule 74A: Clause (i) of this rule will also be amended to include Schedule G drugs, outlining additional guidelines for their manufacture and distribution.
- Rule 74B: Amendment in clause (7) will specify regulatory measures concerning Schedule G drugs, ensuring stringent adherence to safety protocols.
- Rule 78: Clause (q) will now encompass Schedule G drugs, strengthening oversight during the licensing and registration process.
- Rule 78A: This amendment in clause (8) will further outline the responsibilities and requirements related to Schedule G drugs for manufacturers and distributors.
Public Consultation
Objections and suggestions if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011
E-mailed: drugsdiv-mohfw@gov.in.
Deadline For Submission Of Reponses : 45 days from date of notification (August 24th, 2024).
