What Has Changed?

The Ministry of Health and Family Welfare (MoHFW) published G.S.R. 506(E) in the Gazette of India Extraordinary on 22 June 2026, formally enacting the Drugs (Seventh Amendment) Rules, 2026. The notification amends Schedule H2 of the Drugs Rules, 1945 — which governs prescription-only medicines requiring additional recordkeeping obligations — by inserting a new Table 2 covering four broad therapeutic categories.

Until now, Schedule H2 principally covered specific identified drugs (Table 1). The amendment introduces a category-level inclusion, bringing entire classes of medicines under the same stringent dispensing regime.

The New Table 2: Four Categories Now Covered

Background: What Is Schedule H2?

Schedule H2 is a restrictive category under the Drugs Rules, 1945, sitting above Schedule H. It imposes additional obligations on retail pharmacists: prescriptions for Schedule H2 drugs must be retained, recorded in a register, and can only be dispensed against a valid prescription from a registered medical practitioner.

The drugs currently listed in Table 1 of Schedule H2 (pre-amendment) include specific high-risk medicines such as third-generation cephalosporins, carbapenems, and other critical medicines identified individually. The new Table 2 operates at a category level — any formulation falling within the described therapeutic class is automatically covered, removing the need for item-by-item listing.

Legislative Background & Consultation Process

The regulatory journey for this amendment began with a draft notification (G.S.R. 757(E)) published on 16 October 2025, inviting public objections and suggestions within 30 days. Gazette copies were made available to the public on 18 October 2025. The Central Government reviewed all received objections and suggestions before finalising the amendment in consultation with the Drugs Technical Advisory Board (DTAB).

Implementation Timeline

Who Is Affected?

This amendment has far-reaching implications across the pharmaceutical supply chain:

• Retail Pharmacists & Chemists: Must maintain a separate register for Schedule H2 dispensing, retain prescriptions, and refuse supply without valid prescriptions for all covered categories.
• Pharmaceutical Manufacturers: Labels, package inserts, and promotional materials for all products in Table 2 categories must comply with Schedule H2 labelling requirements.
• Wholesalers & Distributors: Record-keeping requirements extend to the distribution chain for covered formulations.
• Hospital Pharmacies: Institutional dispensing practices for oncology, vaccines, and NDPS-listed substances must be reviewed against the updated Schedule H2 framework.
• Marketing Authorisation Holders: Must ensure all covered products are correctly classified and labelled before the effective dates.

Compliance Checklist for Stakeholders

Policy Significance

This amendment reflects India's ongoing effort to tighten prescription discipline for high-risk therapeutic categories. The inclusion of all antimicrobials under Schedule H2 is particularly significant in the context of India's National Action Plan on Antimicrobial Resistance (AMR) — placing every antibiotic, antifungal, and antiviral behind a prescription-only wall is a major structural move against over-the-counter antibiotic misuse, a recognised driver of resistance.

Similarly, extending Schedule H2 to all vaccines (rather than relying on individual state vaccination programme frameworks), all anticancer drugs, and all NDPS-listed narcotics and psychotropics closes previous interpretive ambiguities about exactly which products required Schedule H2 treatment.