The Union health ministry has taken decisive action against the growing misuse of Pregabalin, a widely prescribed medication for pain and neurological disorders, by reclassifying it under the stricter Schedule H1 category. This move tightens regulations on its sale and prescription, effective 180 days after official publication.
Government Action and Notification
The Drugs (Second Amendment) Rules, 2026, amending the Drugs Rules, 1945, were finalized on May 13 and published in the Gazette of India on May 20. The decision follows reports from multiple states detailing Pregabalin abuse, including seizures of illegally stocked and unauthorized supplies.
Reasons for Reclassification
Pregabalin is prescribed for chronic pain, nerve-related disorders, fibromyalgia, and certain neurological conditions. However, officials note its increasing recreational misuse, particularly among young people, due to its sedative, euphoric, and dissociative effects. Dr. Rajesh Sagar from AIIMS's psychiatry department highlights that many users wrongly perceive it as safe, overlooking its abuse potential.
Warning signs of misuse include unusual sleepiness, slurred speech, dizziness, behavioral changes, declining academic or work performance, and mixing the drug with alcohol or other sedatives. Dr. Sagar emphasizes that while tighter prescription control helps, regulation alone cannot curb misuse.
New Rules Under Schedule H1
- Pregabalin can now only be sold against a valid prescription from a registered medical practitioner.
- Pharmacies must maintain a separate register recording prescription and sales details.
- The amendment aims to prevent unauthorized access, strengthen prescription monitoring, and curb illegal trafficking.
The change was made after consulting the Drugs Technical Advisory Board (DTAB). Pregabalin is now listed as serial number 51 under Schedule H1 of the Drugs Rules, 1945.
Expert Commentary
Dr. Sagar calls Pregabalin misuse a serious public health concern, especially among youth. He urges families to watch for warning signs and stresses the need for public awareness alongside regulatory measures.
The revised rules will come into force 180 days after publication in the Official Gazette, giving stakeholders time to comply.
