Government Clarifies Stance on Schedule H Drugs Regulation

The Indian government addressed concerns in Parliament regarding potential changes to Schedule H under the Drugs and Cosmetics Act. The Drugs Technical Advisory Board discussed this in their April meeting. For now, no new digital tools are planned for tracking Schedule H drug sales, though label amendments are being implemented.


Devdiscourse News Desk | New Delhi | Updated: 12-08-2025 17:19 IST | Created: 12-08-2025 17:19 IST
Government Clarifies Stance on Schedule H Drugs Regulation
This image is AI-generated and does not depict any real-life event or location. It is a fictional representation created for illustrative purposes only.
  • Country:
  • India

The Indian government addressed queries in Parliament concerning potential changes to the list of drugs under Schedule H of the Drugs and Cosmetics Act. During the 92nd meeting of the Drugs Technical Advisory Board (DTAB) in April, the agenda to review Schedule H was considered, a government statement revealed on Tuesday.

Minister of State for Health Anupriya Patel responded to the Rajya Sabha, noting that the DTAB, a statutory body, advises on technical matters related to the Act. Patel stated that state licensing authorities (SLAs) currently regulate the sale and distribution of Schedule H drugs, which require a prescription from a registered medical practitioner.

Unauthorized sale of such drugs is a punishable offense, with SLAs empowered to enforce this. While digital tracking tools are not yet in consideration, recent amendments to the Drugs Rules, 1945, require barcodes or QR codes on the packaging of Schedule H2 drugs to ensure proper authentication of products.

(With inputs from agencies.)

Give Feedback