**Executive Summary**
The Ministry of Health and Family Welfare amended the Drugs Rules, 1945, on July 10, 2026, to tighten regulations on drug formulations with high ethyl alcohol content. The amendment removes licensing exemptions for products exceeding 12% v/v alcohol in quantities over 30 mL and reclassifies them under Schedule H1. These measures aim to prevent the misuse of medicinal tinctures for intoxication and ensure a regulated supply chain for legitimate therapeutic use.
**Key Points / Main Content**
**Regulatory Reclassification**
* Formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL are no longer exempt under Schedule K.
* These products have been moved to Schedule H1 of the Drugs Rules, 1945.
* The change specifically targets high-concentration formulations, such as tinctures of cardamom, ginger, and other aromatic preparations, which can contain up to 80–90% v/v alcohol.
**Licensing and Distribution**
* All affected formulations must now obtain requisite licenses under the Drugs and Cosmetics Act, 1940.
* Products must be supplied exclusively through the regulated pharmaceutical supply chain to reduce the possibility of diversion.
**Sale and Record-Keeping**
* Retail sale of these formulations is restricted to prescriptions issued by a Registered Medical Practitioner.
* Stricter record-keeping is mandated for all transactions involving these products to ensure regulatory oversight and safeguard public health.
**Impact Analysis**
**Pharmaceutical Manufacturers and Distributors**
**Impact**
They can no longer rely on Schedule K exemptions for high-alcohol formulations and must operate within a more rigid regulatory framework.
**Action Required**
Obtain necessary licenses under the Drugs and Cosmetics Act, 1940, and ensure all distribution occurs through authorized pharmaceutical channels.
**Retailers and Pharmacists**
**Impact**
The sale of these products is now legally restricted, requiring valid medical authorization and enhanced documentation.
**Action Required**
Dispense affected formulations only against a prescription from a Registered Medical Practitioner and maintain precise sales records as required under Schedule H1.
**Registered Medical Practitioners**
**Impact**
They become the primary gatekeepers for patient access to high-alcohol medicinal products like specific tinctures.
**Action Required**
Issue formal prescriptions for these formulations when required for legitimate therapeutic purposes.
**Regulatory Authorities**
**Impact**
The government and state authorities gain increased oversight to prevent the misuse of medicinal products for intoxication.
**Action Required**
Enforce the new licensing, prescription, and record-keeping requirements through regular inspections and monitoring of the supply chain.
Key Entities Referenced
Drugs Rules, 1945: The primary regulatory framework being amended to strengthen oversight and licensing requirements for medicinal formulations with high alcohol content.
Schedule H1: A classification under the Drugs Rules that mandates the sale of medicines only against a medical prescription and requires strict record-keeping by pharmacists.
Schedule K: A schedule providing exemptions from licensing requirements, which is being restricted to exclude formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL.
Drugs and Cosmetics Act, 1940: The overarching legislation under which high alcohol-containing medicinal products are now required to obtain requisite licenses following the removal of their exemption.
Ministry of Health and Family Welfare: The primary regulatory body responsible for issuing this amendment to prevent the misuse of medicinal products for intoxication.
Ministry of Health and Family Welfare
Government amends Drugs Rules, 1945 to
Strengthen Regulation of High Alcohol-
Containing Drug Formulations
High Alcohol-Containing Formulations to Require Licenses
and to be dispensed only under Prescription
Formulations Containing More Than 12% v/v Ethyl Alcohol in
Quantities Exceeding 30 mL No Longer Covered Under
Schedule K Exemption; Included Under Schedule H1
Posted On: 10 JUL 2026 11:49AM by PIB Delhi
In a significant step towards strengthening regulatory oversight and preventing misuse of medicinal
products with high alcohol content, the Ministry of Health and Family Welfare has removed the existing
exemption (under Schedule K) from licensing requirements for formulations containing ethyl alcohol.
Certain medicinal products, including tinctures of cardamom, ginger and other aromatic preparations, have
been exempted from licensing requirements under Schedule K of the Drugs Rules, 1945. Some of these
formulations contain high concentrations of ethyl alcohol, in certain cases up to 80–90% v/v, making them
susceptible to misuse for intoxication. References were also received from certain State Governments in
this regard.
To address this concern, the Government has mandated that all formulations containing more than 12%
v/v ethyl alcohol, in quantities exceeding 30 mL, shall no longer be covered under the exemption provided
to them under Schedule K. Consequently, such products will be required to obtain the requisite licenses
under the Drugs and Cosmetics Act, 1940.
The amendment also shifts these products to Schedule H1 of the Drugs Rules, 1945, which mandates sale
against the prescription of a Registered Medical Practitioner and stricter record-keeping.
The amendment is expected to strengthen regulatory oversight over those medicinal products containing
alcohol, ensuring their supply only through the regulated pharmaceutical supply chain. It will significantly
reduce the possibility of diversion and misuse while ensuring their continued availability for legitimate
therapeutic use.
The initiative is in line with the Government's continued efforts to strengthen the regulatory framework for
drugs, promote the rational and responsible use of medicinal products and safeguard public health.
The Gazette Notification containing the detailed amendments is available on the website of the
Ministry/Department and may be accessed for ready reference at: https://egazette.gov.in/WriteReadData/2
026/274311.pdf***
SR
HFW/Drugs Rules, 1945 Amended to Strengthen Regulation of High Alcohol-Containing Drug
Formulations/10July2026/1
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