In a major move to curb drug misuse and protect public health, the Union Ministry of Health and Family Welfare has brought the widely used medicine Pregabalin under the stricter Schedule H1 category of the Drugs Rules, 1945.

The decision comes after several states reported increasing misuse and abuse of the drug, especially among young people. Officials also flagged recent seizures of illegally stocked and unauthorisedly sold Pregabalin from different parts of the country, raising concerns over its growing misuse outside medical supervision.

Pregabalin is commonly prescribed for chronic pain, nerve-related disorders, fibromyalgia, and certain neurological conditions. However, health authorities said the medicine has increasingly been misused for its sedative and euphoric effects.

The new rule was officially notified through Gazette Notification G.S.R. 377(E) dated May 13, 2026, and published in the Gazette of India Extraordinary on May 20, 2026.

With this change, Pregabalin will now move from Schedule H to the far stricter Schedule H1 category under the Drugs and Cosmetics Rules, 1945.

Under Schedule H1 regulations, the medicine can only be sold on the prescription of a Registered Medical Practitioner (RMP). Retail chemists will now be required to maintain a separate register recording details of prescriptions and sales of the drug.

Manufacturers have also been directed to prominently display the mandatory “Schedule H1 Drug Warning” label on all product packaging.

The government has warned that any violation of the new rules could attract penal action under the Drugs and Cosmetics Act, 1940 and related rules.

Officials said the stricter classification is aimed at improving accountability across the pharmaceutical supply chain, preventing unauthorised access to the drug, strengthening prescription monitoring, and curbing illegal trafficking.

The Health Ministry has advised all stakeholders — including manufacturers, distributors, wholesalers, pharmacists, and retailers — to ensure strict compliance with the revised regulations.

The move is being seen as part of a broader effort by authorities to tighten control over medicines with abuse potential and prevent substance misuse among vulnerable groups, particularly youth.