The Health Ministry announced the addition of Pregabalin to Schedule H1 of the Drugs Rules, 1945, due to concerns over its misuse, especially among the youth. Pregabalin, typically prescribed for chronic pain and certain neurological conditions, has been misused for its sedative and euphoric effects.
This decision means that Pregabalin will now fall under the more stringent regulations of Schedule H1, compared to its previous classification under Schedule H. Stakeholders in the pharmaceutical supply chain are urged to adhere strictly to the new notification to prevent violations.
Under the revised classification, Pregabalin can only be dispensed with a valid prescription from a Registered Medical Practitioner. Retailers are required to maintain a separate register for prescriptions and sales, while manufacturers must display a warning label on the product packaging. These measures aim to enhance accountability and curb illegal trafficking of the drug.
