Drafts Published to Amend Rules Drafts Published to Amend Rules
Several Drafts Published to Amend Rules Under D & C Act.
The Ministry of Health and Family Welfare, has issued notifications and published Draft Rules to amend Rules issued under Drugs and Cosmetics Act, 1940 through notifications dated 10.10.2025 and 16.10.2025 as follows:
- Medical Devices Rules - Rules 18A & 18B – The qualifications of Inspector (Medical Device) and Government Analyst under said rules are proposed to be inserted to include qualifications as B. Tech in Biomedical, Chemical, Mechanical, Electrical, Electronics etc.
- Drugs Rules – Schedule H2 – All drugs covered under therapeutic categories such as Vaccines, Antimicrobials, Anticancer and NDPS are proposed to be inserted under Schedule H2.
- Drugs Rules – Rules 75, 75A, 76, 76A, Forms 27D, 27DA, 28D and 28DA – Cell or Stem Cell derived products, Gene therapeutic products or Xenografts proposed to be regulated.
- Drugs Rules – Schedule K & Schedule H1 – Oral formulations containing more than 12% alcohol with packing of more than 30ml to be brought out of exemption from licensing. Such formulations proposed to be covered by Schedule H1.
- Drugs Rules – Schedule K – Separate exemptions with conditions proposed for sales licence for (a) Liquid Antiseptics for Household Use and for (b) Hospital and other than household use and they are to be labelled accordingly.
Objections and suggestions may be sent within thirty days of publication to Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 545, A Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in.