The Union Health Ministry on Friday included the widely prescribed drug Pregabalin under the stricter Schedule H1 category of the Drugs Rules, 1945, and imposed stricter controls on its sale and distribution amid growing concerns over its misuse and abuse, especially among youth.
Pregabalin, which is commonly prescribed to treat chronic pain, neuropathies, fibromyalgia, and some neurological conditions, was previously regulated under Schedule H.
The ministry cited reports from the states and said they highlighted the growing misuse of the drug due to its sedative, euphoric and dissociative effects. Authorities have reported the seizure of illegally stored and undeclared pregabalin in parts of the country.
Pregabalin can now only be sold after a prescription from a registered doctor, the ministry said in a notice in the Official Gazette. Retail chemists will be required to keep a separate register recording details of prescriptions and sales of the drug.
The ministry directed manufacturers to prominently display the mandatory “Schedule H1 Drug Warning” label on the product packaging, saying the drug should only be taken under medical advice and cannot be sold without a prescription.
It said violations and non-compliance with the new provisions would result in penal action under the Drugs and Cosmetics Act 1940 and related rules.
The Ministry of Health advised manufacturers, distributors, wholesalers, retailers and pharmacists to ensure strict compliance with the notification.
