Govt makes Pregabalin a strict prescription-only drug amid rising misuse cases
Babushahi Bureau
New Delhi, May 23, 2026: The Ministry of Health and Family Welfare has brought the widely used medicine Pregabalin under the stricter Schedule H1 category of the Drugs Rules, 1945, in a move aimed at curbing its growing misuse nationwide.
The decision, announced through an official gazette notification on Friday, introduces tighter regulations on the sale and distribution of the drug, which is commonly prescribed for chronic pain, nerve-related disorders, fibromyalgia and certain neurological conditions.
Officials said the move was prompted by increasing reports from several states regarding the abuse of Pregabalin, particularly among young people seeking its sedative, euphoric and dissociative effects.
Authorities have also reported multiple seizures involving illegally stocked supplies and unauthorised sales of the medicine.
With the new classification, Pregabalin can now only be sold against a valid prescription issued by a registered medical practitioner. Chemists and pharmacies will also be required to maintain a separate register documenting prescriptions and details of every sale involving the drug.
The health ministry has further instructed pharmaceutical manufacturers to clearly print the mandatory “Schedule H1 Drug Warning” on product packaging. The label will caution consumers that the medicine should only be consumed under medical supervision and cannot be purchased without a prescription.
Authorities warned that any violation of the revised rules could invite strict action under the Drugs and Cosmetics Act, 1940 and related regulations.
The ministry has urged manufacturers, wholesalers, distributors, retailers and pharmacists to ensure full compliance with the new directives to prevent misuse and safeguard public health.