The Ministry of Health and Family Welfare has released a draft notification proposing significant changes to Schedule H2 of the Drugs Rules, 1945. This amendment aims to include more medicines under a category that mandates strict prescription and monitoring protocols. The Drugs (Amendment) Rules, 2025, the draft has been issued under the Drugs and Cosmetics Act, 1940, and is open for public consultation.
The proposal introduces a new Table under Schedule H2, identifying specific therapeutic categories of drugs that are considered high-risk, critical, or vulnerable to misuse. These additions are meant to strengthen regulatory oversight and ensure safer use of potent medications.
Stakeholders, healthcare professionals, and the public have 30 days from the Gazette publication date (October 16, 2025) to submit feedback or objections. The Ministry will review all suggestions before finalizing the amendment.
This move underscores the government’s focus on public health and the responsible distribution of sensitive drug formulations through tighter legal controls.