The Centre has taken a decisive step to address the misuse of medicinal products that contain high levels of ethyl alcohol by amending existing drug regulations. The revision involves revoking a longstanding exemption that allowed certain alcohol-based preparations to evade licensing and prescription controls, despite possessing significant alcohol content. These changes come in response to widespread concerns about the potential for these products to be abused as intoxicants.

On 10 July 2026, the Union Health Ministry modified Schedule K of the Drugs Rules, stipulating that any medicinal preparation with more than 12% volume by volume (vv) of ethyl alcohol can no longer claim exemption based solely on the presence of ingredients like cardamom or ginger. This amendment targets formulations that previously had unregulated sales, which enabled products containing ethyl alcohol of up to 80% to be marketed without the safeguards typical of most prescription medicines.

Changes to Licensing and Prescription Requirements

The revised regulations dictate that any medicinal formulation containing over 12% vv ethyl alcohol, and in quantities exceeding 30 ml, will now necessitate manufacturing and sales licences under the Drugs and Cosmetics Act of 1940. Furthermore, such products will fall under Schedule H1 of the drug regulations, meaning they cannot be dispensed without a prescription from a registered medical practitioner.

This amendment aims to standardise regulatory practices for alcohol-based medicinal preparations, closing exploitative loopholes that had allowed certain products to navigate around defined alcohol limits. Government sources noted that the Drugs Rules have already stipulated permissible alcohol limits for traditional systems of medicine—Ayurvedic, Siddha, and Unani syrups have a 16% alcohol cap, while homoeopathic medicines are restricted to 12%.

By positioning high-alcohol products under stricter guidelines, the latest amendments align with the overall regulatory framework designed to ensure that all medicinal products containing ethyl alcohol adhere to appropriate licensing and prescription mandates.

Addressing Concerns Over Product Misuse

The decision to implement these regulations follows ongoing reports of the diversion and misuse of specific medicinal products, including tinctures and aromatic formulations that are marketed with ethyl alcohol concentrations ranging from 80% to 90% vv. Various state governments had brought attention to cases of these products being consumed for intoxication due to their unregulated availability.

Officials reiterated that the amendments aim to ensure that high-alcohol medicinal products remain accessible for legitimate therapeutic uses while curbing their distribution in unregulated market segments. Through these changes, authorities intend to reinforce the integrity of the medicinal supply chain, significantly reducing the potential for misuse.

The Health Ministry emphasised that the modifications represent a concerted effort to strengthen oversight, ensuring that genuine medicinal formulations are appropriately monitored within the framework of the revised drug regulations. Government sources reaffirmed that surveillance measures will be enacted to secure the manufacturing, distribution, and retail processes for these high-alcohol medicines, thereby enhancing regulatory compliance in the pharmaceutical sector.

Long or Short, get news the way you like. No ads. No redirections. Download Newspin and Stay Alert, The CSR Journal Mobile app, for fast, crisp, clean updates!

App Store –  https://apps.apple.com/in/app/newspin/id6746449540 

Google Play Store – https://play.google.com/store/apps/details?id=com.inventifweb.newspin&pcampaignid=web_share