Centre brings Pregabalin drug under Schedule H1 to prevent misuse, boost regulation
New Delhi, May 22
Health Ministry on Friday said it has notified the inclusion of the drug 'Pregabalin' under Schedule H1 of the Drugs Rules, 1945. The decision has been taken in view of reports received from certain states regarding the misuse and abuse of Pregabalin, particularly among youth.
Violations and non-compliance will attract penal action under the Drugs and Cosmetics Act, 1940 and Rules thereunder.
The drug, which is prescribed for the treatment of chronic pain, neuropathies, fibromyalgia, and certain neurological conditions, has reportedly been misused for its sedative, euphoric, and dissociative effects, informed the ministry.
All stakeholders, including manufacturers, distributors, wholesalers, retailers, and pharmacists, are advised to ensure strict compliance with the provisions of the notification, the ministry said.
Recent seizures of illegally stocked and unauthorisedly sold Pregabalin have also been reported from some parts of the country.
With the notification, published in the Gazette of India Extraordinary, Pregabalin will now be regulated under the stricter provisions of Schedule H1, instead of the existing Schedule H, under the Drugs and Cosmetics Rules, 1945.
The Schedule H1 prescription 'Drug-CAUTION' says that it is dangerous to take this preparation except in accordance with the medical advice - not to be sold by retail without the prescription of a Registered Medical Practitioner.
The revised classification mandates that Pregabalin can be sold only against a valid prescription issued by a Registered Medical Practitioner (RMP); retailers must maintain a separate register recording details of prescriptions and sales; manufacturers shall prominently display the prescribed 'Schedule H1 Drug Warning' label on product packaging.
"The measure 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," said the ministry.
— IANS
Reader Comments
Makes sense, but hope this doesn't create unnecessary hurdles for genuine patients. My wife has fibromyalgia and getting proper pain management is already a hassle here. Need to balance regulation with access.
As a pharmacist, this is much needed. We've been raising concerns about Pregabalin misuse for years. The Schedule H1 register will help track every sale. But the government should also run awareness campaigns about drug abuse among youth. Medicine is not a recreational substance!
Good step but implementation is key. I've seen Schedule H drugs being sold without prescription in small towns. If the enforcement is weak, this will just stay on paper. Hope the state drug control departments are serious about inspections.
Finally! This drug was becoming the new 'party pill' in college circles. I know friends who took it just to get high and ended up with serious side effects. The youth need to understand that no medicine is safe without doctor's supervision. 🙏
I'm a chronic pain patient and this worries me. Pregabalin is the only thing that helps my neuropathy. I hope the new rules don't make it impossible to get refills on time. Doctors should be able to provide repeat prescriptions without making patients visit every month.
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