New Delhi : HL September 17, 2026
The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, aimed at strengthening regulatory oversight over the sale and distribution of Schedule H, H1 and X drugs.
The proposed changes have been outlined in the Draft Gazette Notification G.S.R. 791 (E), dated September 8, 2026. A key proposal is the introduction of mandatory CCTV surveillance at medical stores, intended to improve transparency and accountability in the retail sale of medicines covered under these schedules.
Focus on prescription-based medicines
Schedule H, H1 and X medicines are subject to specific regulatory requirements because of the potential risks associated with their misuse, inappropriate access or sale without proper medical authorization.
The proposed amendment seeks to strengthen safeguards against the unauthorized sale and access of these medicines, particularly where valid prescriptions and other regulatory requirements are involved.
Proposal examined by DCC and DTAB
According to the Ministry, the proposal was first deliberated upon by the Drugs Consultative Committee (DCC). It was subsequently circulated among members of the Drugs Technical Advisory Board (DTAB) for consideration.
Following its deliberations, the DTAB recommended approval of the proposal.
If implemented, the amendment could provide regulators with an additional mechanism to monitor the handling and sale of Schedule H, H1 and X medicines at medical stores.
CCTV surveillance proposed as an additional safeguard
The proposed CCTV requirement is intended to strengthen accountability at the point of sale. Surveillance footage could provide an additional record of transactions and activities at medical establishments, supporting regulatory monitoring.
The Ministry has stated that the measure is expected to help curb the unauthorized access and sale of regulated medicines without valid prescriptions.
The proposal also forms part of broader efforts to strengthen oversight of the pharmaceutical supply chain and improve safeguards for public health.
Public and stakeholder feedback invited
The Health Ministry has invited objections and suggestions from stakeholders and members of the public regarding the proposed amendment.
Comments can be submitted to:
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
Suggestions and objections may also be emailed to drugsdiv-mohfw@gov.in.
The proposed changes will be subject to the applicable regulatory process before any final amendment to the Drugs Rules, 1945 is notified.
Key Takeaways
Draft amendment concerns Schedule H, H1 and X drugs.
Mandatory CCTV surveillance at medical stores has been proposed.
The proposal seeks to strengthen monitoring of medicine sales.
It aims to address unauthorized access and sale without valid prescriptions.
The proposal was considered by the DCC and subsequently by the DTAB.
DTAB recommended approval of the proposal.
The Ministry has invited public and stakeholder objections and suggestions.
