Drugs Rules 1945 Amendment: CCTV Proposed for Medical Stores Selling Schedule H, H1 and X Drugs

Why in News?

• The Union Ministry of Health and Family Welfare has proposed an amendment to the Drugs Rules, 1945 to strengthen regulatory oversight over prescription medicines.
• The proposal has been issued through Draft Gazette Notification G.S.R. 791(E), dated 8 September 2026. It proposes mandatory Closed-Circuit Television (CCTV) surveillance at licensed premises where prescription drugs are supplied.

Background

• The sale and distribution of medicines in India are regulated through the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
• Under the existing rules, medicines falling under Schedule H, Schedule H1 and Schedule X cannot generally be sold at retail except on the prescription of a Registered Medical Practitioner.
• However, concerns have continued regarding the sale of prescription medicines without valid prescriptions, misuse of habit-forming drugs and weak monitoring at the retail level.
• To address these concerns, the proposal was first discussed by the Drugs Consultative Committee (DCC). It was subsequently circulated among members of the Drugs Technical Advisory Board (DTAB), which recommended its approval.

Key Provisions of the Proposed Amendment

1. Mandatory CCTV Surveillance: The draft proposes inserting a new sub-rule (2A) under Rule 65 of the Drugs Rules, 1945. Supply of prescription medicines, other than wholesale transactions, would have to take place under a CCTV surveillance system installed and maintained at the licensed premises.
2. CCTV Recording Retention: The CCTV recordings would have to be preserved for a minimum period of three months. This could allow drug inspectors and other regulatory authorities to verify suspected violations relating to prescription-drug sales.
3. Licensed Premises Covered: The provision concerns licensed premises involved in supplying medicines against prescriptions, including retail medical stores and pharmacies covered by the relevant provisions of the Drugs Rules.
4. Wholesale Transactions Excluded: The proposed CCTV provision specifically excludes supply conducted by way of wholesale dealing.

What are Schedule H, H1 and X Drugs?

Schedule H: Schedule H broadly covers prescription-only medicines that cannot be sold at retail without a prescription from a Registered Medical Practitioner. Their labels carry the Rx symbol and prescribed statutory warnings.

Schedule H1: Schedule H1 was introduced to impose stricter controls on certain medicines, including several antibiotics, anti-tuberculosis medicines and some habit-forming drugs.

• Apart from prescription requirements, pharmacists have to maintain records containing details such as the prescriber, patient, medicine and quantity supplied. Such records are required to be preserved for three years.
• Schedule H1 is particularly important from the perspective of preventing irrational use of antibiotics and antimicrobial resistance (AMR).

Schedule X: Schedule X medicines are subject to comparatively stringent controls. Under the Drugs Rules, Schedule X medicines sold at retail require a prescription, and the prescription is required in duplicate, with one copy retained by the licensee for two years. Schedule X medicines kept at retail premises are also subject to special storage requirements, including storage under lock and key or in a restricted area.

Significance of the Proposed Amendment

• Better Monitoring of Prescription Medicines: CCTV footage can provide an additional mechanism for checking whether regulated medicines are being dispensed in accordance with prescription requirements.
• Prevention of Drug Misuse: Stronger surveillance could reduce unauthorised access to medicines that have potential for misuse, dependence or inappropriate consumption.
• Tackling Antimicrobial Resistance: Stronger enforcement relating to Schedule H1 medicines may help discourage the indiscriminate sale and consumption of antibiotics. India faces a significant public-health challenge from antimicrobial resistance, making rational use of antibiotics an important policy priority.
• Greater Accountability: CCTV surveillance could improve accountability among pharmacy owners, pharmacists and other persons involved in the dispensing of regulated medicines.
• Better Regulatory Enforcement: Drug inspectors could potentially use CCTV records as an additional source of evidence while investigating suspected violations.
• Strengthening the Pharmaceutical Supply Chain: The measure complements other regulatory initiatives aimed at improving traceability, transparency and safety in India's pharmaceutical sector.

India Relevance

India has one of the world's largest pharmaceutical markets and a very large network of retail pharmacies. Easy access to medicines is important for healthcare delivery, but unrestricted availability of prescription drugs can contribute to:

• Self-medication.
• Antibiotic misuse.
• Antimicrobial resistance.
• Drug dependence and abuse.
• Adverse drug reactions.
• Irrational consumption of medicines.

Therefore, the proposed CCTV mechanism represents an attempt to balance access to medicines with stronger regulatory compliance and patient safety.

Challenges

• Compliance Cost for Small Pharmacies: Installation, maintenance, storage systems and servicing of CCTV equipment may create additional costs, particularly for small medical stores.
• Privacy Concerns: CCTV systems may capture patients, prescriptions and other sensitive information. Appropriate safeguards would therefore be necessary to protect privacy and prevent misuse of recordings.
• Data Security: Stored CCTV footage could become vulnerable to unauthorised access or cyber incidents if adequate security standards are not followed.
• Enforcement Capacity: Merely installing cameras may not be sufficient unless State Drug Control Departments have adequate manpower and systems to inspect premises and act on violations.
• Rural and Remote Areas: Small pharmacies in remote regions may face infrastructure, electricity, internet or storage-related constraints.
• Need for Clear Operational Guidelines: Detailed standards may be required regarding camera positioning, storage, access to recordings, inspections, data protection and responsibility for system failures.

Way Forward

• The government should develop clear and uniform CCTV compliance standards for pharmacies across States and Union Territories.
• Financial and technical support may be considered for smaller pharmacies to ease the transition.
• Access to CCTV recordings should be clearly defined and restricted to authorised persons and regulatory authorities.
• The surveillance system should be integrated with broader reforms such as digital prescriptions, electronic pharmacy records, QR-based medicine traceability and stronger pharmacist supervision.
• At the same time, public awareness campaigns should discourage self-medication and highlight the dangers of consuming prescription medicines without medical advice.

Conclusion

• The proposed amendment to the Drugs Rules, 1945 represents a shift towards stronger technology-based monitoring of prescription-drug sales in India.
• Mandatory CCTV surveillance and preservation of recordings for at least three months could help regulators detect unauthorised sale of medicines, strengthen prescription compliance and improve accountability.
• However, effective implementation will require appropriate safeguards relating to privacy, data security, compliance costs and enforcement capacity.
• If combined with digital prescriptions, QR-based traceability, better pharmacy records and stronger awareness against self-medication, the reform could contribute significantly to safer and more responsible use of medicines in India.

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