**Executive Summary**
The Union Ministry of Health and Family Welfare has reclassified the drug “Pregabalin” from Schedule H to the stricter Schedule H1 under the Drugs Rules, 1945, via Gazette Notification dated 13th May 2026. This regulatory shift aims to curb the rising misuse, illegal trafficking, and unauthorized sale of the drug, particularly among youth. The notification mandates enhanced prescription monitoring, specific labeling, and rigorous record-keeping across the supply chain.
**Key Points / Main Content**
* **Regulatory Reclassification:** Pregabalin is now governed by Schedule H1 of the Drugs Rules, 1945, moving away from its previous Schedule H classification to ensure stricter oversight.
* **Rationale for Stricter Control:** The decision follows reports of drug abuse for sedative, euphoric, and dissociative effects, as well as recent seizures of illegally stocked supplies.
* **Prescription Requirements:** The drug can only be sold to consumers who present a valid prescription issued by a Registered Medical Practitioner (RMP).
* **Mandatory Record-Keeping:** Retailers are legally required to maintain a separate register to record all details regarding the prescription and sale of Pregabalin.
* **Labeling Mandates:** Manufacturers are required to prominently display a "Schedule H1 Drug Warning" on the packaging of the drug.
* **Penal Provisions:** Any violation or non-compliance with these new regulations will attract penal action under the Drugs and Cosmetics Act, 1940.
**Impact Analysis**
**Manufacturers**
**Impact:** Required to modify product packaging to meet new legal standards.
**Action Required:** Prominently display the prescribed “Schedule H1 Drug Warning” label on all Pregabalin product packaging.
**Retailers and Pharmacists**
**Impact:** Subject to stricter sales protocols and increased administrative documentation.
**Action Required:** Must ensure the drug is sold only against a valid RMP prescription and maintain a dedicated register specifically for Pregabalin sales and prescription details.
**Registered Medical Practitioners (RMPs)**
**Impact:** Increased accountability regarding the issuance of prescriptions for this medication.
**Action Required:** Issue valid prescriptions only for legitimate medical conditions (such as chronic pain or neuropathies) in accordance with medical advice.
**Distributors and Wholesalers**
**Impact:** Heightened responsibility for supply chain accountability.
**Action Required:** Ensure strict compliance with the Schedule H1 provisions and prevent unauthorized access or illegal trafficking within the supply chain.
Key Entities Referenced
Schedule H1: The specific regulatory category under which Pregabalin has been reclassified to mandate stricter prescription monitoring, sales record-keeping, and warning labels.
Drugs Rules, 1945: The governing rules amended by the Union Health Ministry to shift Pregabalin from Schedule H to the more restrictive Schedule H1.
Union Ministry of Health and Family Welfare: The central government body responsible for issuing the notification to strengthen the regulation of Pregabalin and prevent its misuse.
Drugs and Cosmetics Act, 1940: The primary legislation under which violations of the new drug classification and sale mandates will attract penal action.
Ministry of Health and Family Welfare
Union Health Ministry Brings Pregabalin Under
Schedule H1 to Strengthen Regulation and
Prevent Misuse
Measures to Curb Easy Access, Enhance Prescription
Monitoring, Strengthen Supply Chain Accountability, and
Safeguard Public Health
Posted On: 22 MAY 2026 10:30AM by PIB Delhi
The Union Ministry of Health and Family Welfare has notified the inclusion of the drug “Pregabalin”
under Schedule H1 of the Drugs Rules, 1945 vide Gazette Notification G.S.R. 377(E) dated 13th May
2026, published in the Gazette of India Extraordinary on 20th May 2026.
The decision has been taken in view of reports received from certain States regarding the misuse and
abuse of Pregabalin, particularly among youth. 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. Recent seizures of illegally stocked and unauthorisedly sold
Pregabalin have also been reported from some parts of the country.
With this notification, 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.
Schedule H1 Prescription Drug-CAUTION:
-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;
Violations and non-compliance will attract penal action under the Drugs and Cosmetics Act, 1940 and
Rules thereunder.
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.All stakeholders, including manufacturers, distributors, wholesalers, retailers, and pharmacists, are
advised to ensure strict compliance with the provisions of the notification.
The e-Gazette can be accessed through the following link - https://egazette.gov.in/(S(rqa3ekkjb0kpe5pwg
0vwdyg4))/ViewPDF.aspx
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HFW–Pregabalin Classified Under Schedule H1of the Drugs Rules, 1945/22nd May 2026/1
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