Centre notifies Drugs (Seventh Amendment) Rules, 2026

The Ministry of Health and Family Welfare has notified the Drugs (Seventh Amendment) Rules, 2026, introducing significant changes to the Drugs Rules, 1945 by expanding Schedule H2 to cover additional therapeutic categories of medicines.

Issued on June 22, 2026, the amendment follows the publication of draft rules in October 2025 and the consideration of stakeholder feedback after consultation with the Drugs Technical Advisory Board (DTAB).

Under the amendment, the existing table in Schedule H2 will be redesignated as Table 1, and a new Table 2 will be inserted. The new table includes four therapeutic categories of drug formulations:

• All vaccines
• All antimicrobials
• All narcotic drugs and psychotropic substances covered under the Narcotic Drugs and Psychotropic Substances Act, 1985, and the rules made thereunder
• All anticancer drugs

The Drugs (Seventh Amendment) Rules, 2026 will come into effect from July 1, 2027.

However, Serial Number 2 (All Antimicrobials) in Table 2 will come into force a year later, on July 1, 2028.

According to the notification, the amendments were introduced after the government invited public comments on the draft rules published on October 16, 2025, with the consultation process concluding after stakeholders’ suggestions were examined.

The amendments have been made in exercise of the powers conferred under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.

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