Health Ministry Proposes Tighter Prescription Monitoring for 4 CNS Drugs

The draft notification has been issued by the Central Government in exercise of the powers conferred under sub-section (1) of Section 12 and sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board (DTAB).

Once the amendment is finalised and brought into force, formulations containing these drugs will be subjected to the stricter prescription, labelling, dispensing and record-maintenance requirements applicable to medicines listed under Schedule H1.

The proposed inclusion covers four medicines used across different therapeutic areas. Flupentixol is primarily used in the management of psychiatric conditions, while Zopiclone is used for the short-term management of insomnia. Gabapentin is prescribed for conditions including epilepsy and neuropathic pain, whereas Carisoprodol is a centrally acting skeletal muscle relaxant.

The proposed regulatory change assumes significance because these medicines act on the central nervous system, and inappropriate or unsupervised consumption may be associated with adverse effects, dependence, misuse or other medication-related risks. Their proposed placement under Schedule H1 would strengthen regulatory oversight at the level of both prescribing and retail dispensing.

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.

Drugs listed under Schedule H1 cannot be sold without a valid prescription from a registered medical practitioner.

The Ministry has clarified that the present notification contains draft rules and does not immediately place the four medicines under Schedule H1. The proposed amendment will be considered on or after the expiry of 30 days from the date on which copies of the Gazette notification are made available to the public.

The notification states:

"The following draft of certain rules further to amend the Drugs Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public."

The Ministry has invited objections and suggestions from persons likely to be affected by the proposed amendment. Representations received within the prescribed 30-day period will be considered by the Central Government before the rules are finalised.

Objections or suggestions 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.

Setting out the proposed amendment, the draft notification states:

"1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2026.

(ii) They shall come into force after one eighty days of publication of the final rules in the Official Gazette.

2. In the Drugs Rules, 1945, in Schedule H1 after serial number 52 and entries relating thereto, the following serial numbers and entries shall be inserted, namely:-

“53. Flupentixol”

“54. Zopiclone”

“55. Gabapentin”

“56. Carisoprodol”

To view the official notice, click the link below: