NHRC Recommends a National Drug Registration Certificate and QR Track-and-Trace to Fight Spurious Medicines

The news

New Delhi. The National Human Rights Commission (NHRC) has recommended a centralised registration system for medicines sold in India, a portal to track their movement through supply chains in real time, and dynamic QR codes to authenticate them, as part of a broad set of measures to curb spurious and counterfeit drugs, The Economic Times reports. In plain terms, a spurious drug is a fake: it imitates another medicine, carries a false manufacturer’s name, or has been substituted in whole or in part. The central proposal is a National Drug Data Registration Certificate, a centralised and authenticated system under which every medicine would be compulsorily registered through a central government portal. This covers branded, branded generic and unbranded generic products, whether made by a third party or for domestic use or export. A branded generic is an off-patent medicine sold under a company’s own brand name, and third-party manufacturing means one firm has its product made by another under contract. The NHRC also proposed a trace-and-track portal holding each medicine’s manufacturer identity, composition, batch information and distribution chain, allowing real-time tracking of drugs entering each State or Union Territory, starting with life-saving and high-risk medicines. Under a centrally regulated digital authentication protocol, QR codes on medicine packs would be dynamic and uniquely serialised to prevent duplication and to standardise data governance across manufacturers. In simple terms, each pack would carry its own code, so a copied code would show up as a duplicate. The commission recommended a centralised national database of counterfeit-medicine cases, covering offenders, products, emerging patterns and enforcement outcomes, which could be used with artificial intelligence tools to identify organised networks and repeat offenders. It also proposed a uniform standard operating procedure for forensic protocols, sampling, residue and laboratory analysis, supply-chain investigation, digital evidence extraction and legal strategies. The proposals follow an open house discussion on ‘Measures to Curb Spurious Medicines in India’, held earlier this year and chaired by NHRC member Justice Bidyut Ranjan Sarangi, with central and State drug authorities and other stakeholders taking part. The NHRC forwarded the recommendations to the Central Drugs Standard Control Organisation (CDSCO) in August. The regulator referred them to the drug consultative committee, which ET describes as an expert committee under the CDSCO, for its advice. The syllabus link is GS2 on health and statutory bodies, and GS3 on technology in governance.

Static syllabus linkage

1. The Drugs and Cosmetics Act, 1940 sorts bad medicine into three legal categories, with the harshest penalties for fakes that injure. Section 17 of the Drugs and Cosmetics Act, 1940 defines a misbranded drug, for instance one that is coloured or coated to hide damage or carries a false claim on its label. Section 17A defines an adulterated drug, for instance one made in insanitary conditions or containing a harmful substance. Section 17B defines a spurious drug: one sold under another drug’s name, made to imitate another drug, or labelled with a fictitious manufacturer. A drug that is simply below the prescribed standard is called ‘not of standard quality’, which is a separate and lesser category. The Drugs and Cosmetics (Amendment) Act, 2008 raised the penalties. Under Section 27(a), an adulterated or spurious drug likely to cause death or grievous hurt carries at least ten years’ imprisonment, which may extend to life, and a fine of at least ₹10 lakh or three times the value of the drugs confiscated, whichever is more. Some offences were made cognizable and non-bailable, and special courts were provided for.
2. Drug regulation is split between the Centre and the States, and the Act sets up two central advisory bodies. The Central Drugs Standard Control Organisation, headed by the Drugs Controller General of India, sits under the Directorate General of Health Services in the Union Health Ministry. It approves new drugs and clinical trials, regulates imports and sets standards. State drug controllers license the manufacture and sale of most drugs and do most of the enforcement, and ‘drugs and poisons’ is Entry 19 of the Concurrent List. The Drugs Technical Advisory Board, under Section 5 of the Act, gives technical advice. The Drugs Consultative Committee, under Section 7, includes representatives of the Centre and of every State and advises on securing uniformity in how the Act is administered. The Mashelkar Committee (2003) examined drug regulation, including the problem of spurious drugs, and argued for stronger central oversight and tougher penalties.
3. Traceability and manufacturing standards are already being tightened step by step. According to a PIB release of August 12, 2025, the Drugs Rules, 1945 were amended on January 18, 2022 to require a QR code on every active pharmaceutical ingredient (API) manufactured or imported in India. An amendment of November 17, 2022 required a barcode or QR code on the primary packaging of the brands listed in Schedule H2, the top 300 brands, from August 1, 2023. Revised Schedule M, which sets Good Manufacturing Practices, was notified on December 28, 2023. It applied from June 29, 2024 to manufacturers with a turnover above ₹250 crore, with a conditional extension to December 31, 2025 for smaller firms. A PIB release of June 25, 2026 says Schedule H2 has been expanded to all vaccines, antimicrobials, narcotic and psychotropic drugs, and anti-cancer medicines. The deadline is July 1, 2027 for vaccines, narcotic drugs and anti-cancer drugs and July 1, 2028 for antimicrobials, and the code carries nine data elements, including batch number and manufacturing licence number.
4. The NHRC is a statutory, recommendatory body, and it treats access to safe medicine as part of the right to life. The NHRC was set up under the Protection of Human Rights Act, 1993. Its chairperson must have been Chief Justice of India or a judge of the Supreme Court. Its members include a serving or former Supreme Court judge, a serving or former High Court Chief Justice, and three members with knowledge of human rights, at least one of them a woman. The chairpersons of several national commissions are ex officio members. Section 12 lets it inquire into violations, review safeguards and promote research, and its recommendations under Section 18 are advisory rather than binding. The Supreme Court has read the right to health into Article 21, notably in Paschim Banga Khet Mazdoor Samity v. State of West Bengal (1996), and Article 47 makes improving public health a primary duty of the State.

Why UPSC loves this

1. GS2 covers both the institution and the service. The syllabus asks about statutory, regulatory and quasi-judicial bodies, and about issues relating to health. Here a human rights body is designing regulatory architecture for a health regulator, a good case for questions on institutional coordination and the limits of recommendatory bodies.
2. Prelims regularly tests NHRC composition and drug-law categories. The composition, appointment and powers of the NHRC are standard Prelims material. So are the definitions under the Drugs and Cosmetics Act and the roles of CDSCO and the DCGI. Schedule M and Schedule H2 of the Drugs Rules are the likely next set, given their recent revisions.
3. GS3 frames it as technology in governance and India’s standing as a pharmaceutical exporter. Serialised QR codes, national registries and AI-assisted enforcement fit the syllabus theme of applying technology in everyday life. India’s reputation as a supplier of affordable generics depends on the integrity of its supply chain, so drug quality is also an economic question.

Analysis

1. The central proposal shows what is missing today: a complete national list of what is legally on sale. The recommendation that every medicine be compulsorily registered through a central government portal, including export-only and third-party products, implies that no such complete national list exists now. Without a master list, a QR code can say what a pack claims to be, but not whether that product is legally licensed. Bringing in export and contract-made products closes a real gap, because products licensed for one purpose can be diverted to another market. The registry is therefore the foundation, and the QR code only works on top of it. The objection is administrative: registering every product of every licensee is a large exercise, and a registry that is incomplete or out of date would give false assurance.
2. A QR code stops copying only if it is unique and someone actually scans it. A static code printed on a pack can be photocopied onto a thousand fakes, which is why the NHRC wants codes that are dynamic and uniquely serialised, so that a second scan of the same code raises a flag. That protection works only if scanning happens at the wholesaler, the pharmacy and ideally the patient’s phone, with every scan recorded centrally. Starting with life-saving and high-risk medicines is sensible, and it matches the Centre’s June 2026 expansion of Schedule H2 to vaccines, anti-cancer medicines, antimicrobials and narcotic drugs. Serialisation costs money, and small manufacturers will pass some of it on. But the counterfeit cancer injections and rabies vaccines this magazine reported earlier this month show what the absence of such checks costs.
3. The hardest part is federal, not technical. Because State drug controllers issue most manufacturing and sale licences, a central registry and a real-time map of drugs entering each State depend on State departments, which vary widely in staff and laboratory capacity. Sending the proposals to the drug consultative committee, where every State is represented, is the correct channel. It also means the pace will be set by the slowest State. A national system needs central funding for State laboratories and inspectors, not just a central portal, or it will produce data that no one on the ground acts on.
4. The forensic SOP may do more for convictions than the technology. Drug prosecutions often turn on procedure: how a Drugs Inspector drew and sealed a sample under Section 23 of the Act, and whether the Government Analyst’s report under Section 25 was properly served. A uniform standard operating procedure for sampling, laboratory analysis and digital evidence would make cases harder to defeat on technicalities. A national database of offenders, which AI tools can search, would let enforcement treat counterfeiting as the organised crime it often is, rather than as a string of unrelated seizures. This is the least glamorous recommendation and possibly the most valuable, because the deterrent effect of the 2008 penalties depends on convictions that actually follow.
5. A rights body designing regulation shows both the reach and the limits of the NHRC. The NHRC has approached fake medicines as a violation of the right to life, which fits its mandate under Section 12 to review safeguards and promote research. Its open house brought central and State regulators to one table, which the fragmented regulatory system rarely does on its own. But its recommendations are advisory, it has no power to make CDSCO act, and its technical proposals will be judged by a committee of the very regulators whose gaps they expose. The fair view is that the NHRC can set the agenda and keep public attention on it, while accountability for delivery has to remain with the Health Ministry and CDSCO.

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