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Govt Amends Drugs Rules: High Alcohol Formulations (>12% v/v, >30ml) Now Under Schedule H1, Require Prescription

Target:UPSC GS-IIMPSCSSC GATeachingPrelims HighMains MediumStatic GK Link
10 Jul 2026
~2 min
Source: The Hindu
Key Data:>12% v/v ethyl alcohol>30 mlSchedule H1Schedule KDrugs Rules, 1945Drugs and Cosmetics Act, 1940
Bodies:Ministry of Health and Family Welfare
Practice MCQs from today's news ▸
What This Article Covers

1.Government amends Drugs Rules, 1945 to regulate high-alcohol formulations (more than 12% v/v ethyl alcohol and quantity exceeding 30 ml).

2.Such products are removed from Schedule K (exempt from licensing) and placed under Schedule H1 (sale by prescription only).

3.Examiner’s angle: Focus on the exact thresholds (12% v/v, 30 ml), the two schedules involved (K and H1), and the Acts (Drugs Rules, 1945 and Drugs and Cosmetics Act, 1940).

The Big Picture
Prelims · HighMains · Medium

The government has tightened rules for drug formulations with high ethyl alcohol content. Products exceeding 12% v/v alcohol in quantities over 30 ml are moved from Schedule K exemption to Schedule H1, requiring a prescription and stricter record-keeping. This targets misuse of tinctures and similar products for intoxication, while ensuring their legitimate medical use. Key for prelims: threshold percentages, schedule names, and the legal framework (Drugs Rules, 1945 and Drugs and Cosmetics Act, 1940).

Exam Lens

Quick Exam Facts From News

Alcohol Threshold>12% v/v ethyl alcohol
Quantity Trigger>30 ml
New ScheduleH1 (prescription required)
Parent ActDrugs and Cosmetics Act, 1940
Rules AmendedDrugs Rules, 1945 (Schedule K exemption removed)
MinistryMinistry of Health and Family Welfare
Date of AmendmentJuly 10, 2026

1-Minute Revision

  • ›Alcohol Threshold: >12% v/v ethyl alcohol
  • ›Quantity Trigger: >30 ml
  • ›Target this Data: Threshold - more than 12% v/v ethyl alcohol and quantity exceeding 30 ml.
  • ›Target this Nodal Body: Ministry of Health and Family Welfare (responsible for drug regulation).
  • ›Target this Legal Point: Drugs Rules, 1945 - Schedule K vs Schedule H1; Drugs and Cosmetics Act, 1940.

Mastered this topic? Test your knowledge with a full MCQ quiz.

Practice exam-style questions, track your score, and strengthen your recall.

Q1Static LinkageEasy

Which ministry/department is primarily responsible for administering the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945?

Q2Statement-basedHard

Consider the following statements regarding the recent amendment to the Drugs Rules, 1945:

1. Formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 ml are now required to be sold only under prescription.

2. All formulations of tinctures containing ethyl alcohol are now prohibited from sale.

3. The amendment moves these formulations from Schedule K to Schedule H1.

Which of the statements given above is/are correct?

Q3Data-centricMedium

What is the minimum ethyl alcohol concentration (in % v/v) above which a drug formulation's exemption under Schedule K is removed and it requires prescription under Schedule H1?

Q4Application/ImpactMedium

What is the primary objective of moving high-alcohol drug formulations from Schedule K to Schedule H1?

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