The Union Health Ministry has added Pregabalin to Schedule H1 of the Drugs Rules, 1945, through a Gazette Notification dated May 22, 2026. The decision follows reports from several states about misuse of the medicine, especially among young people.
Pregabalin is prescribed for chronic pain, nerve disorders, fibromyalgia and certain neurological conditions. It has been misused for its sedative and euphoric effects, prompting seizures of unauthorized stocks in parts of the country.
The drug will now be governed by the tighter controls of Schedule H1 instead of the previous Schedule H. Retailers must keep separate records of prescriptions and sales, while manufacturers are required to display the mandated warning label on packaging. Violations can lead to action under the Drugs and Cosmetics Act, 1940.
The ministry said the measure will improve supply-chain accountability, limit unauthorized access, strengthen prescription monitoring and reduce illegal distribution. All manufacturers, distributors, wholesalers and pharmacists have been directed to comply.
Pregabalin belongs to the gabapentinoid class and acts on the central nervous system. In India it is widely used for pain linked to diabetes, spinal injuries and nerve problems. Over the past decade, non-medical use has risen, particularly in Punjab, Haryana and other northern regions where opioid dependence is already a concern. Similar regulatory steps have been taken in countries such as the United Kingdom.
