The Union Health Ministry has brought pregabalin under Schedule H1 of the Drugs Rules, 1945 through a gazette notification on May 20. According to reports from PTI, the drug was previously regulated under Schedule H under the Drugs and Cosmetics Rules, 1945. The stricter classification requires the drug to be sold only against a valid prescription issued by a registered medical practitioner. The decision was officially notified through a gazette notification issued on May 20 under the Drugs Rules, 1945, as confirmed by PTI reports. The ministry has now directed manufacturers, distributors, wholesalers, retailers, and pharmacists to ensure strict compliance with the new notification.
The ministry cited reports from several states regarding the increasing misuse and abuse of pregabalin, particularly among youth. As reported by PTI, officials stated that the drug has been increasingly abused for its sedative, euphoric and dissociative effects. The ministry also cited seizures of illegal stocks and unauthorised sales of the medicine in various parts of the country as contributing factors to the decision. The ministry stated that the decision has been taken 'in view of reports received from certain states regarding the misuse and abuse of Pregabalin, particularly among youth.'
Under the revised classification, retail chemists will be required to maintain a separate register containing details of prescriptions and sales related to the medicine, while manufacturers must display the mandatory 'Schedule H1 Drug Warning' label prominently on product labels and packaging. According to the ministry statement reported by PTI, any violation of the revised regulations would invite action under the Drugs and Cosmetics Act, 1940 and associated rules. The notification specifically mentions that companies that sell the product in India include Pfizer, Sun Pharma, Torrent Pharma, Intas Pharma and Micro Labs, among others.
The ministry stated that the move is aimed at strengthening accountability across the supply chain, preventing unauthorised access, enhancing prescription monitoring, curbing illegal trafficking, and safeguarding public health from drug misuse and abuse. As reported by PTI, the drug is prescribed for the treatment of chronic pain, neuropathies, fibromyalgia, and certain neurological conditions. The ministry emphasized that the decision is part of broader efforts to improve accountability across the supply chain, strengthen prescription monitoring, prevent unauthorised access and illegal trafficking, and protect public health from drug abuse.
