The Union Health Ministry has proposed mandatory CCTV surveillance at medical stores as part of a new regulatory effort to curb the unauthorised sale of prescription medicines and strengthen oversight of Schedule H, H1 and X drugs across India.
The proposal forms part of draft amendments to the Drugs Rules, 1945, and is aimed particularly at preventing medicines falling under these controlled prescription categories from being sold without valid prescriptions.
The Ministry of Health and Family Welfare issued the proposal through Draft Gazette Notification G.S.R. 791(E), dated September 8, 2026. If implemented, CCTV surveillance would become an additional regulatory safeguard at premises selling these medicines, giving authorities another mechanism to monitor compliance with existing prescription requirements.
Focus on Schedule H, H1 and X Medicines
Schedule H, H1 and X contain medicines whose sale is subject to prescription and other regulatory requirements under India’s drug-control framework. The degree and nature of restrictions differ between the schedules, with some categories subject to additional record-keeping and dispensing controls.
The latest proposal does not convert these medicines into newly controlled drugs. Instead, it seeks to strengthen enforcement of restrictions that already govern their sale by improving oversight at the retail level.
The Health Ministry said the amendment is intended to address concerns over unauthorised access to Schedule H, H1 and X medicines and their sale without valid prescriptions.
This distinction is important because the proposal is fundamentally an enforcement measure. The government is seeking to improve its ability to determine whether prescription-only medicines are being dispensed in accordance with existing regulations rather than introducing prescription requirements for the first time.
CCTV Proposed as an Additional Regulatory Safeguard
The most significant element of the proposed amendment is the mandatory installation of CCTV surveillance systems at medical stores.
According to the Health Ministry, surveillance would strengthen monitoring of the sale and distribution of Schedule H, H1 and X medicines and help curb unauthorised access and sales without valid prescriptions.
The government also expects the surveillance mechanism to improve transparency and accountability in the pharmaceutical supply chain. For regulators, CCTV records could provide an additional layer of oversight at the point where medicines are actually dispensed to consumers.
The measure therefore shifts part of drug-control enforcement directly to the retail environment. Rather than relying entirely on inspections, documentation and other existing compliance mechanisms, regulators would have an additional means of examining activities taking place at medical stores.
Proposal Examined by India’s Drug Regulatory Bodies
The CCTV proposal has already passed through important stages of India’s drug-regulatory consultation process.
According to the Health Ministry, the proposal was initially considered by the Drugs Consultative Committee, or DCC. It was subsequently circulated among members of the Drugs Technical Advisory Board, or DTAB, for further deliberation.
Following its consideration, the DTAB recommended approval of the proposal.
The involvement of the DCC and DTAB is significant because these bodies play important advisory roles in the administration and technical evaluation of India’s drug regulatory framework.
The proposal has now moved into the draft-notification and public consultation stage before any final regulatory change is implemented.
Government Targets Sale Without Valid Prescriptions
The underlying objective of the amendment is to strengthen enforcement against the sale of medicines that should not be freely dispensed without the required prescription.
Prescription controls exist partly because certain medicines require medical supervision, may cause significant adverse effects when used incorrectly, or carry risks associated with inappropriate or prolonged use. Some medicines covered by tighter regulatory schedules also require greater control because of their potential for misuse.
Unauthorised access can undermine these safeguards by allowing consumers to obtain medicines without appropriate medical assessment or supervision.
The proposed surveillance requirement therefore forms part of a wider effort to ensure that the legal distinction between prescription medicines and freely available medicines is actually observed at the point of sale.
Schedule H1 Has Already Been Strengthened in 2026
The latest proposal comes during a period of broader regulatory activity surrounding controlled prescription medicines.
Earlier in 2026, the Health Ministry brought pregabalin and its formulations under Schedule H1 of the Drugs Rules. The government said the decision followed reports from some States concerning misuse and abuse of the medicine, particularly among young people.
Pregabalin is legitimately prescribed for several medical conditions, including certain forms of neuropathic pain and neurological disorders. Its inclusion in Schedule H1 subjected its sale to stronger prescription and record-keeping requirements.
The government has also moved to consider additional medicines for inclusion under Schedule H1, demonstrating a broader effort to strengthen controls where emerging patterns of misuse or inappropriate access are identified.
The proposed CCTV requirement represents a different approach to the same regulatory challenge. Rather than changing the classification of an individual medicine, it seeks to improve enforcement across several existing categories of controlled prescription drugs.
Draft Rules Are Not Yet Final
The proposed CCTV requirement has not yet become a final nationwide rule.
The Health Ministry has invited objections and suggestions from stakeholders and members of the public regarding the draft amendment. Feedback received during the consultation process will be considered before the government proceeds with the final regulatory framework.
This means the details of the proposal can still be modified before the final rules are notified.
The distinction between a draft notification and a final rule is particularly important for pharmacies and medical-store operators because compliance obligations will arise from the final notified provisions rather than from the announcement of the proposal itself.
Greater Accountability at the Retail End of the Drug Supply Chain
India has an extensive network of pharmacies and medical stores that forms the final link between pharmaceutical manufacturers, distributors and patients. Effective prescription regulation therefore depends heavily on compliance at this retail stage.
The government’s proposal attempts to strengthen that point in the supply chain by introducing a surveillance mechanism alongside the existing licensing, prescription and record-keeping framework.
If the draft amendment is ultimately notified, mandatory CCTV surveillance would represent a significant change in the way compliance involving Schedule H, H1 and X medicines is monitored at medical stores.
The larger objective is not to restrict legitimate access to medicines prescribed for patients who need them, but to make it more difficult for controlled prescription medicines to move through retail channels without the safeguards already required under Indian drug regulations.
For consumers, pharmacies and regulators alike, the proposal signals a move towards greater accountability at the point of sale as India strengthens enforcement of its prescription-drug framework.
REFERENCES
- Press Information Bureau (PIB), Ministry of Health and Family Welfare, Government of India. “Union Health Ministry Proposes Amendments to Drugs Rules, 1945 to Strengthen Regulatory Oversight of Schedule H, H1 and X Drugs.” Published 17 September 2026.
https://www.pib.gov.in/PressReleasePage.aspx?PRID=2311184 - Akashvani News / News On AIR. “Govt proposes amendments to Drugs Rules (1945) to strengthen oversight of Schedule H, H1 and X drugs.” Published 17 September 2026.
https://newsonair.gov.in/govt-proposes-amendments-to-drugs-rules1945-to-strengthen-oversight-of-schedule-h-h1-and-x-drugs/ - Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare. Gazette Notifications — G.S.R. 791(E), dated 8 September 2026: Draft notification for amendment to the Drugs Rules, 1945 regarding mandatory installation of CCTV surveillance systems at sales premises.
https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/ - Press Information Bureau (PIB), Ministry of Health and Family Welfare. “Union Health Ministry Brings Pregabalin Under Schedule H1 to Strengthen Regulation and Prevent Misuse.” Published 22 May 2026.
https://www.pib.gov.in/PressReleasePage.aspx?PRID=2263975
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