The Union health ministry on Friday brought the widely prescribed drug Pregabalin under the stricter Schedule H1 category of the Drugs Rules, 1945, imposing tighter controls on its sale and distribution amid growing concerns over its misuse and abuse, particularly among youth.
Pregabalin, commonly prescribed for chronic pain, neuropathies, fibromyalgia, and certain neurological conditions, was earlier regulated under Schedule H.
The ministry cited reports from states and said they highlighted the increasing misuse of the drug for its sedative, euphoric, and dissociative effects. Authorities have reported seizures of illegally stocked and unauthorised sale of Pregabalin from parts of the country.
In a gazette notification, the ministry said Pregabalin can now be sold only after a registered medical practitioner’s prescription. Retail chemists will be required to maintain a separate register recording details of prescriptions and sales of the drug.
The ministry has directed manufacturers to prominently display the mandatory “Schedule H1 Drug Warning” label on product packaging, saying the medicine should not be taken except under medical advice and cannot be sold without a prescription.
It said violations and non-compliance with the new provisions would attract penal action under the Drugs and Cosmetics Act, 1940, and related rules.
{{/usCountry}}It said violations and non-compliance with the new provisions would attract penal action under the Drugs and Cosmetics Act, 1940, and related rules.
{{/usCountry}}The health ministry advised manufacturers, distributors, wholesalers, retailers, and pharmacists to ensure strict compliance with the notification.