Drugs Rules, 1945 amended: high-alcohol formulations lose Schedule K exemption, move to Schedule H1
The Health Ministry announced on 10 July 2026 that formulations with more than 12% v/v ethyl alcohol in quantities above 30 mL will need licences and be sold only on prescription under Schedule H1.
Summary
The Union Health Ministry announced on 10 July 2026 an amendment to the Drugs Rules, 1945 to curb misuse of medicinal products with high alcohol content. All formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL are no longer covered by the licensing exemption under Schedule K and must obtain licences under the Drugs and Cosmetics Act, 1940. These products are also moved to Schedule H1, which requires sale against a registered medical practitioner's prescription and stricter record-keeping. Some exempted tinctures, such as those of cardamom and ginger, contained up to 80â90% v/v alcohol, and certain State Governments had raised the issue.
Key facts
- Announced
- 10 July 2026, Ministry of Health and Family Welfare
- Rule amended
- Drugs Rules, 1945
- Threshold
- >12% v/v ethyl alcohol in quantities >30 mL
- Change 1
- Removed from Schedule K licensing exemption
- Change 2
- Moved to Schedule H1 â prescription-only, stricter records
- Licence under
- Drugs and Cosmetics Act, 1940
Practice MCQs 3 questions
Under the July 2026 amendment to the Drugs Rules, 1945, high-alcohol formulations were moved to which schedule requiring prescription sale?
Show answer
Correct answer: C â Schedule H1
The amendment shifts these products to Schedule H1, which mandates sale against a registered medical practitioner's prescription.
What threshold triggers the new licensing requirement for alcohol-containing formulations under the July 2026 amendment?
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Correct answer: A â More than 12% v/v ethyl alcohol in quantities above 30 mL
Formulations with more than 12% v/v ethyl alcohol in quantities exceeding 30 mL are no longer covered by the Schedule K exemption.
Consider the following statements about the July 2026 amendment to the Drugs Rules, 1945: 1. It removes certain alcohol-containing formulations from the licensing exemption under Schedule K. 2. Affected products must now obtain licences under the Drugs and Cosmetics Act, 1940. 3. The amendment bans the manufacture of all tinctures containing ethyl alcohol. Which of the statements given above are correct?
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Correct answer: D â 1 and 2 only
Statements 1 and 2 are correct. Statement 3 is wrong: there is no ban; the products need licences and prescriptions so they remain available for legitimate therapeutic use.