India Regulates Pregabalin to Curb Misuse and Abuse
Union Health Ministry Brings Pregabalin Under Schedule H1 to Strengthen Regulation and Prevent Misuse

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The Union Ministry of Health and Family Welfare in India has classified Pregabalin under Schedule H1 of the Drugs Rules to combat its misuse, particularly among youth. This regulation mandates prescriptions for sales and aims to enhance accountability in the drug supply chain.
- 01Pregabalin is now classified under Schedule H1, which imposes stricter regulations compared to the previous Schedule H.
- 02The drug is commonly prescribed for chronic pain, neuropathies, and fibromyalgia but has been misused for its sedative effects.
- 03Retailers must maintain a register of prescriptions and sales for Pregabalin.
- 04Manufacturers are required to label products with a 'Schedule H1 Drug Warning' to inform consumers about the risks.
- 05Violations of these regulations will result in penalties under the Drugs and Cosmetics Act of 1940.
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The Union Ministry of Health and Family Welfare in India has announced the inclusion of Pregabalin under Schedule H1 of the Drugs Rules, 1945, effective from May 13, 2026. This decision, published in the Gazette of India Extraordinary on May 20, 2026, aims to address the rising misuse and abuse of Pregabalin, particularly among the youth. The drug, used for treating chronic pain and certain neurological conditions, has been reported to be misused for its sedative and euphoric effects. The new classification imposes stricter regulations, requiring Pregabalin to be sold only with a valid prescription from a Registered Medical Practitioner (RMP). Retailers will need to maintain detailed records of prescriptions and sales, while manufacturers must display a 'Schedule H1 Drug Warning' label on packaging. Non-compliance with these regulations will attract penalties under the Drugs and Cosmetics Act of 1940. This initiative is part of a broader effort to enhance accountability in the drug supply chain and safeguard public health by preventing unauthorized access and curbing illegal trafficking.
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This regulation aims to protect public health by reducing drug misuse and enhancing accountability in the pharmaceutical supply chain.
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