On 10 July 2026 the Union Health Ministry amended the Drugs Rules, 1945, removing the Schedule K exemption for certain medicinal formulations containing ethyl alcohol and notifying new controls via G.S.R. 607(E).
Key changes
- Thresholds: Oral formulations with >12% v/v ethyl alcohol and quantities exceeding 30 mL fall outside Schedule K exemption.
- Licensing: Such products now require manufacturing and marketing licences under the Drugs and Cosmetics Act, 1940.
- Reclassification: These products are shifted to Schedule H1 of the Drugs Rules, 1945.
- Sale conditions: Schedule H1 medicines may be sold only against a prescription issued by a Registered Medical Practitioner.
- Record-keeping: Pharmacies must preserve sales/dispensing records relating to these drugs for at least three years.
- Notification & commencement: G.S.R. 607(E) dated 8 July 2026 published in the Gazette on 9 July 2026; rules come into force six months from publication (from 9 July 2026).
- Risk context: Some medicated preparations subject to the change contain 80–90% v/v ethyl alcohol, a factor cited by states for tighter controls.
IASPOINT Booster Facts
- Parent law: Drugs and Cosmetics Act, 1940 governs manufacture, sale and distribution of drugs in India; Rules under it are the Drugs Rules, 1945.
- Schedules: Schedule K previously exempted specified medicated preparations from licensing; Schedule H1 prescribes prescription-only sale and record maintenance.
- Legal effect: Reclassification subjects affected formulations to regulatory provisions applicable to prescription drugs, including inspection and compliance obligations under the Act.