Key Details
Draft amendment: The Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945 through Draft Gazette Notification G.S.R. 791(E) dated 8 September 2026.
Drugs covered: The proposal focuses on Schedule H, H1 and X drugs, which are subject to prescription and other regulatory requirements, with the stated objective of strengthening oversight over their sale and distribution.
Mandatory CCTV: The proposed amendment would require medical stores to install CCTV surveillance, creating an additional mechanism to monitor the sale and handling of these medicines.
Preventing unauthorised sales: The measure is intended to strengthen monitoring and help curb the unauthorised access to and sale of regulated medicines without valid prescriptions.
Regulatory process: The proposal was initially considered by the Drugs Consultative Committee (DCC) and subsequently circulated among members of the Drugs Technical Advisory Board (DTAB). Following its consideration, the DTAB recommended approval.
Supply-chain accountability: The Ministry states that CCTV surveillance could improve transparency and accountability across the pharmaceutical supply chain and strengthen safeguards for public health.
Public consultation: The amendment remains a draft proposal. The Ministry has invited objections and suggestions from stakeholders and members of the public before further action.
Strengthening Pharmacy-Level Oversight
Schedule H, H1 and X medicines are subject to tighter controls because of the risks associated with their inappropriate or unauthorised use. The proposed amendment adds CCTV surveillance as an additional monitoring mechanism at the point of sale.
The measure would complement existing prescription and record-keeping requirements by creating a visual record of activities within medical stores, with the stated aim of improving regulatory oversight.
From Prescription Controls to Traceability
The proposal addresses not only access to regulated medicines but also accountability in their distribution. By strengthening monitoring at medical stores, regulators could have an additional mechanism to identify and address instances of unauthorised sale.
The Ministry positions the measure as part of broader efforts to improve transparency across the pharmaceutical supply chain and strengthen public-health safeguards.
Regulatory Oversight and Consultation
The proposal has progressed through the DCC and DTAB before being issued as a draft Gazette notification. DTAB's recommendation provides a technical input into the proposed regulatory change.
However, the amendment has not yet become a final requirement. Stakeholders and members of the public have been invited to submit objections and suggestions to the Ministry for consideration.
What Are Schedule H, H1 and X Drugs?
Schedule H, H1 and X are categories under India's Drugs Rules that carry specific controls on their sale and dispensing. The categories include medicines subject to prescription requirements and, particularly for H1 and X, additional controls relating to their sale and records.
Policy Relevance
Strengthen monitoring of Schedule H, H1 and X drug sales at the retail level.
Assess the implementation and compliance requirements associated with mandatory CCTV systems.
Ensure monitoring mechanisms complement existing prescription and record-keeping requirements.
Consider data-protection, storage and access protocols for CCTV footage as implementation frameworks are developed.
Use stakeholder feedback to assess operational implications for pharmacies before finalising the amendment.
Relevant Question for Policy Stakeholders: How can stronger retail-level monitoring of prescription medicines be implemented while ensuring proportionate compliance requirements for medical stores?
Follow the Full Release here: Union Health Ministry Proposes Amendments to Drugs Rules, 1945 to Strengthen Regulatory Oversight of Schedule H, H1 and X Drugs