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Dated: 04.06.2025
MoHFW Proposes Key Amendments to Drugs Rules, 1945
The Ministry of Health and Family Welfare has issued Draft Notification G.S.R. 345(E) dated 28th May 2025, proposing critical amendments to the Drugs Rules, 1945 under the Drugs and Cosmetics Act, 1940. The proposed changes aim to strengthen quality assurance, streamline regulatory compliance, and ensure responsible sale of drugs for both medicinal and certain non-medicinal uses.
This draft notification is open for public comments and suggestions for 30 days from the date of its availability in the Gazette.
Key Highlights of the Proposed Amendments
1. Testing Standards Enhanced (Rule 121A)
- Substitution of existing Rule 121A to mandate that solutions for parenteral administration, along with any aqueous solvents, must pass the bacterial endotoxins or pyrogens test.
- Testing must conform to the latest Indian Pharmacopeia (IP) standards.
2. Supervision by Competent Persons
- In Forms 20B, 20BB, 20G, and 21B:
- Sale of drugs must be conducted under the personal supervision of a “competent person”.
- Any change in the designated competent person must be reported to the licensing authority within one month.
3. Sale Conditions for Non-Medicinal Manufacturers Modified
- Provisos deleted and revised for manufacturers of beverages, confectionery, biscuits, and hydrogenated vegetable oils:
- The general sale restrictions will not apply to such manufacturers except in the case of antimicrobial drugs.
- This revision allows more flexibility while maintaining a check on the distribution of sensitive antimicrobial substances.
4. Clarification to Schedule H
- A new entry added to Schedule H:
- Drugs listed under Serial No. 15 of Schedule K are excluded from Schedule H restrictions, thereby resolving regulatory overlap.
Public Feedback Invited
Stakeholders—including pharmaceutical companies, drug distributors, industry associations, and healthcare professionals—are encouraged to send objections or suggestions:
- By Post:
To Under Secretary (Drugs),
Ministry of Health and Family Welfare,
Room No. 545, A Wing, Nirman Bhavan, New Delhi – 110011 - By Email: drugsdiv-mohfw@gov.in
Deadline: Within 30 days of the publication in the Gazette.
Implications for Stakeholders
- Pharma Retailers and Wholesalers must comply with the “competent person” clause and update records with regulatory authorities in case of staff changes.
- FMCG and Food Processing Units utilizing drugs for processing (non-therapeutic) purposes get regulatory relief, except for antimicrobials.
- Manufacturers of injectables and parenterals will face tighter quality control mandates aligned with global pharmacopoeial practices.
Conclusion
The draft amendment under G.S.R. 345(E) is a timely move towards fortifying India’s drug regulatory framework. It strikes a balance between quality enforcement, regulatory transparency, and industrial flexibility. Stakeholders should take this opportunity to participate in the consultative process and help shape the final policy.
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Source: MoHFW
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