Government amends Drugs Rules, 1945 to strengthen regulation of high alcohol-containing drug formulations
The Drugs Rules, 1945 have been amended to withdraw Schedule K exemption for certain high-alcohol formulations and place them under stricter licensing and prescription control.
AI generated- The Drugs and Cosmetics Act, 1940 is the principal law under which licences are required for regulated drug products in India.
- The Drugs Rules, 1945 were amended to change the regulatory status of certain high-alcohol medicinal formulations.
- Schedule K earlier exempted certain medicinal products from licensing requirements.
- Schedule H1 requires sale against a Registered Medical Practitioner’s prescription and stricter record-keeping.
The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945 to tighten regulation of certain medicinal formulations containing high levels of ethyl alcohol. The change matters because products earlier exempted under Schedule K can now be subject to licensing and prescription-based sale.
The government said some exempted products, including tinctures of cardamom, ginger and other aromatic preparations, contain up to 80–90% v/v ethyl alcohol in some cases. According to the ministry, such formulations were vulnerable to misuse for intoxication, and references were also received from some State Governments.
Under the amended framework, formulations containing more than 12% v/v ethyl alcohol in quantities exceeding 30 mL will no longer enjoy the exemption under Schedule K. These products must obtain the required licences under the Drugs and Cosmetics Act, 1940.
UPSC may link this amendment to regulatory governance, the balance between access and control in drug policy, and the role of prescription-only systems in preventing substance misuse.
