The Ministry of Health and Family Welfare has published a draft notification proposing an amendment to Schedule H2 of the Drugs Rules, 1945, to expand the list of medicines covered under the category of drugs that require specific prescription and monitoring controls.
The proposed amendment, titled the Drugs (… Amendment) Rules, 2025 has been published for public consultation under the Drugs and Cosmetics Act, 1940. Stakeholders and the public have 30 days to submit their comments or objections to the Ministry before the rules are finalised.
New Categories for Enhanced Scrutiny
The draft rules introduce a new structure under Schedule H2 by designating a Table 2, which lists specific therapeutic categories of drug formulations. These categories are generally deemed critical, high-risk, or subject to strict control due to public health or misuse concerns.
| Serial Number | Therapeutic Category of drug formulations |
| 1 | All Vaccines |
| 2 | All Antimicrobials |
| 3 | All Narcotic and Psychotropic drugs listed under the Narcotic and Psychotropic drugs Act, 1985 |
| 4 | All Anticancer drugs |
Commencement and Public Consultation
The draft rules are published for public information, and the Central Government is soliciting objections and suggestions from all affected persons.
The draft rules will be taken into consideration after the expiry of a period of thirty days from the date the official Gazette copies are made available to the public (published on October 16, 2025).
Objections and suggestions may be addressed to the Director (Drugs regulation), Ministry of Health and Family Welfare, or emailed to drugsdiv-mohfw@gov.in.