Why in the News
The Union Health Ministry has proposed mandatory closed circuit television (CCTV) surveillance at medical stores, with recordings retained for three months. The stated purpose is stricter control over prescription medicines, and the draft notification frames it as addressing “unauthorised access to and sale of Schedule H, H1 and X drugs” under the Drugs and Cosmetics Rules, 1945. The measure was first proposed in 2021 to prevent the abuse of drugs by children, and the Drugs Consultative Committee of the Central Drugs Standard Control Organisation (CDSCO) cleared it this year alongside an application based system. The All India Organisation of Chemists and Druggists has objected on cost, on rural power and connectivity, and on patient privacy. What is contested is whether a camera at the counter reaches the behaviour the rule is aimed at, or only records the transaction while leaving the prescription itself unverified.
What do Schedules H, H1 and X cover?
- Schedule H: These medicines cannot be sold without a prescription from a registered medical practitioner, and they include many antibiotics and steroids.
- Schedule H1: These are subject to additional record keeping requirements and include certain antibiotics and anti tuberculosis medicines.
- Schedule X: This is the more tightly controlled category carrying additional requirements, and it includes some psychotropic medicines.
Why has the government proposed camera surveillance?
- The original trigger: The measure was first proposed in 2021 to prevent the abuse of drugs by children.
- Deterrence is the stated mechanism: Round the clock surveillance is intended to create apprehension among medical store owners and pharmacists, so they are not inclined to sell these medicines to children without a prescription.
- What the footage is meant to establish: It is meant mainly to verify whether a sale was made to a minor without a prescription, and not all sales can be verified this way.
- Retrieval rather than inspection: Routine inspection every three months is difficult, so the data is to be retrieved when a complaint is received.
- Paired with a digital system: The Drugs Consultative Committee decided earlier this year to implement the application based system alongside the CCTV plan.
How common is prescription drug addiction among children?
- Opioid use ranks second: Opioid use, covering heroin, opium and pharmaceutical opioids found in strong painkillers, is the second most common form of addiction among children and affects nearly 1.8 per cent of them.
- Cannabis leads: Cannabis use affects 19 per cent of children, according to one of the most comprehensive studies of drug use in India, conducted by the All India Institute of Medical Sciences (AIIMS) and published in 2019.
- Alcohol and inhalants: Alcohol use affects 1.3 per cent and inhalant use 1.17 per cent of children, and inhalant use is the only form of addiction more common in children than in adults.
- Where pharmaceutical opioids sit: Of an estimated 2.3 crore opioid users of all ages, 25 lakh are dependent on pharmaceutical opioids while the largest group of 63 lakh is dependent on heroin.
What do chemists object to?
- Capital cost against turnover: A store may have to spend nearly Rs 1 lakh to put the system in place, which is not viable for a store with daily sales of Rs 5,000 to Rs 10,000.
- Rural power and connectivity: Power failures and connectivity problems in rural areas make continuous recording and retention impractical.
- Patient privacy: Recording every purchase captures identifiable patients buying identifiable medicines, which the organisation treats as its most important objection.
Challenges to CCTV surveillance at medical stores
- The prescription itself stays unverified: A camera records who bought a medicine and not whether the prescription produced at the counter was genuine or valid. Eg. Most retail prescriptions in India remain handwritten and are not checked against any prescriber registry at the point of sale.
The Fix: Mandate electronic prescriptions linked to a verified practitioner registry, so validity is checked at dispensing rather than reconstructed from footage afterwards. - Enforcement capacity is the binding constraint: A rule generating three months of footage at every store needs inspectors and laboratories that the drug regulatory system does not have. Eg. The Mashelkar Committee report of 2003 flagged severe shortages of drug inspectors and testing laboratory capacity.
The Fix: Fill sanctioned drug inspector posts and tie retail licence renewal to a documented compliance record rather than to a periodic fee. - Surveillance without a data protection scaffold: Footage of a patient buying a specific medicine is sensitive personal data, and the draft names a retention period without naming who may access it or for what. Eg. The Digital Personal Data Protection Act, 2023 requires purpose limitation and security safeguards for personal data held by any entity.
The Fix: Specify in the notification the authority empowered to demand footage, the permitted purpose, and a mandatory access audit log. - Sales migrate to unmonitored channels: A rule that binds the physical counter pushes unprescribed demand toward online and unlicensed sellers that no store camera reaches. Eg. Draft rules to regulate e pharmacies have been under consideration since 2018 without final notification.
The Fix: Apply the same prescription verification and record keeping obligations to online dispensing before the retail rule takes effect.
Conclusion
The proposal is at the draft notification stage and has cleared the Drugs Consultative Committee, so the next step is the final notification and the compliance window given to retailers. The dispute it exposes is narrower than it appears. The state is regulating the place of sale because the prescription behind the sale is not yet auditable, and until it is, a camera records evidence of a transaction rather than evidence of a violation.
Back2Basics: Central Drugs Standard Control Organisation (CDSCO)
- Status: It is India’s national drug regulatory authority, functioning under the Ministry of Health and Family Welfare and headed by the Drugs Controller General of India.
- Statutory basis: It operates under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.
- Functions: It approves new drugs and clinical trials, lays down standards for drugs, and licenses notified categories such as vaccines and blood products.
- Drugs Consultative Committee: This is a statutory advisory body under the Act that advises the Centre and the States on securing uniformity in the administration of the Act.
Matching Previous Year Question
“[2014, GS3, 12.5 marks] Can overuse and the availability of antibiotics without doctor’s prescription, the contributors to the emergence of drug-resistant diseases in India? What are the available mechanisms for monitoring and control? Critically discuss the various issues involved.”
