These proposed draft rules have been issued in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board (DTAB).
Issued under the Drugs and Cosmetics Act, 1940, the draft notification seeks to amend Schedule H1 by inserting a new entry for Pregabalin, a medicine widely used in neuropathic pain, epilepsy, fibromyalgia, and certain anxiety disorders, in view of growing regulatory concern over its misuse potential and non-medical consumption.
Schedule H1 drugs are a restricted category in India under the Drugs & Cosmetics Rules, primarily for antibiotics, anti-TB drugs (like Rifampicin, Isoniazid, Ethambutol), and some psychotropic meds, requiring strict prescription, record-keeping (for 3 years), and red "Rx" labeling to combat antibiotic resistance and misuse. They are a stricter subset of Schedule H, demanding pharmacists maintain a separate register with prescriber/patient details for every sale, a key difference from regular Schedule H drugs.
In line with this regulatory approach, the recent draft gazette notification proposes to place Pregabalin under this stricter framework to ensure that the drug is dispensed only against a valid prescription and that its supply chain is traceable.
The draft amendment stated:
1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2025.
(ii) They shall come into force after the 3 months of publication of the final rules in the Official Gazette.
2. In the Drugs Rules, 1945, in Schedule H1 after serial number 50 and entries relating thereto, the following serial number and entry shall be inserted, namely: ―
“51. Pregabalin”
The draft rules will be taken into consideration after the expiry of 30 days from the date on which copies of the Gazette of India containing the draft rules are made available to the public.
"Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government." the gazette notice stated.
"Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1, New Delhi, 110001 or emailed at drugsdiv-mohfw@gov.in." the gazette added.
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