CDSCO Circular Warns Against Self-Medication With Antibiotics and Painkillers, Citing Risk of Kidney Damage

The news

New Delhi. The Central Drugs Standard Control Organisation (CDSCO), India’s national drug regulator, has cautioned against the indiscriminate or prolonged use of painkillers and antibiotics, citing the associated risk of kidney damage, The Hindu reports. In a circular dated September 21, the regulator said that non-steroidal anti-inflammatory drugs (NSAIDs) and antibiotics are regulated under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, and should be sold only on the prescription of a registered medical practitioner. It advised the public not to self-medicate with antibiotics and not to use them for conditions where they are not clinically indicated, including most uncomplicated viral infections. The paper does not say which specific drugs, retailers or incidents prompted the circular. Some terms need explaining. NSAIDs are the common class of painkillers and fever-reducers that act by blocking inflammation; they are widely sold without any prescription in practice. Antibiotics are drugs that kill bacteria or stop their growth; they have no effect on viruses, which is why the regulator singles out viral infections such as the common cold as cases where they are not indicated. “Self-medication” means taking medicine without a doctor’s advice, often on the pharmacist’s suggestion or from an old prescription. Kidney damage matters because the kidneys clear many drugs from the body, and certain painkillers and antibiotics are known to be harmful to kidneys when used for long periods or in high doses. The second, larger concern behind any warning on antibiotics is antimicrobial resistance (AMR): when bacteria are repeatedly exposed to antibiotics that are taken without need or taken incompletely, the resistant strains survive and multiply, so that common infections become harder and costlier to treat. The circular is a reminder of an existing legal rule rather than a new one — the requirement of a prescription already exists for these medicines. Its significance lies in the gap it admits between that rule and the practice at India’s chemist counters. The syllabus link is GS2 on health, and GS3 on science and technology in everyday life and on biotechnology-related public health risks.

Static syllabus linkage

1. CDSCO is the central drug regulator, but most retail enforcement lies with the States. The Central Drugs Standard Control Organisation, headed by the Drugs Controller General of India (DCGI), functions under the Directorate General of Health Services in the Ministry of Health and Family Welfare. It approves new drugs and clinical trials, regulates imports, and licenses certain categories such as vaccines and blood products jointly with the States. Licences to manufacture most drugs and to sell drugs at wholesale and retail are granted and enforced by State drug controllers. A CDSCO advisory on retail sale therefore depends on State drug inspectors for its effect.
2. The Drugs and Cosmetics Act, 1940 sorts medicines into schedules that decide how they may be sold. The Drugs and Cosmetics Act, 1940 is the parent law on the import, manufacture, distribution and sale of drugs; the rules under it, earlier called the Drugs and Cosmetics Rules, 1945, were renamed the Drugs Rules, 1945 after cosmetics got separate rules in 2020. Schedule H lists drugs that may be sold at retail only on the prescription of a registered medical practitioner and must carry the “Rx” symbol and a warning. Schedule H1, in force since 2014, covers higher-generation antibiotics, anti-tuberculosis drugs and certain habit-forming drugs; the chemist must keep a separate register of such sales, with the prescriber’s and patient’s details, for three years. India has no statutory definition of “over-the-counter” drugs, so anything outside the prescription schedules can in effect be sold without one.
3. Antimicrobial resistance is treated globally as a One Health problem. Antimicrobial resistance occurs when bacteria, viruses, fungi and parasites evolve so that medicines no longer work against them. The World Health Assembly adopted a Global Action Plan on AMR in 2015, and the UN General Assembly held high-level meetings on AMR in 2016 and 2024; the 2024 political declaration set a target of reducing global deaths associated with AMR by 10% by 2030. The WHO’s AWaRe classification divides antibiotics into Access, Watch and Reserve groups, with Reserve drugs kept as a last resort. AMR is a One Health problem because antibiotic use in animals, poultry, aquaculture and the environment feeds resistance in humans.
4. India’s National Action Plan on AMR builds on earlier campaigns. India launched its National Action Plan on Antimicrobial Resistance (NAP-AMR) in 2017, aligned with the Global Action Plan, with strategic priorities on awareness, surveillance, infection prevention, optimised use of antimicrobials, research and international collaboration. The Health Ministry’s “Medicines with the Red Line” campaign of 2016 asked people not to use medicines whose pack carries a vertical red line, which marks prescription-only antibiotics, without a doctor’s advice. The Chennai Declaration of 2012, by medical societies, was an early professional call for a national AMR policy. ICMR runs the Antimicrobial Resistance Surveillance and Research Network of laboratories that tracks resistance trends.

Why UPSC loves this

1. AMR is a standing GS2 and GS3 theme. UPSC has asked in Mains about the causes of antibiotic resistance in India and the measures needed to contain it, and in Prelims about the misuse of antibiotics and the reasons for resistance. The CDSCO circular is a fresh peg for an answer, because it names both drivers — self-medication and use for viral infections — in a regulator’s own words.
2. Regulatory architecture of drugs is a recurring Prelims area. Questions test the distinction between the Drugs and Cosmetics Act and other laws, the role of the DCGI and CDSCO, and what Schedule H and H1 mean. The renaming of the rules as the Drugs Rules, 1945 and the separate Cosmetics Rules, 2020 is the kind of detail a statement-based question can use.
3. Governance angle: a law on paper, weak at the counter. GS2 includes government policies and issues arising from their implementation. The prescription-only rule is a textbook example of a well-designed law that fails at the last mile, and it lets a candidate discuss State capacity, the number of drug inspectors and the role of behaviour change.

Analysis

1. A circular that restates the law is also an admission that the law is not working. Nothing in the September 21 circular is new law: NSAIDs and antibiotics were already prescription-only. When a regulator reminds the public of an existing rule, it signals that enforcement at the point of sale has failed. The rational next step would be inspections, penalties and audits of Schedule H1 registers by State drug controllers, not only public advice. The counter-view is that awareness is itself an intervention in a country where many people genuinely do not know that antibiotics do not treat viral illness. Both are true, but advice without enforcement tends to fade within a news cycle.
2. Self-medication is often a rational response to the cost of seeing a doctor. For a daily-wage worker, a visit to a doctor can mean a lost day’s earnings, a queue and a fee, while a chemist is a few steps away and will suggest a medicine for free. Seen this way, over-the-counter antibiotic use is a symptom of weak primary care, not only of ignorance. Strict enforcement without better access could push people towards unlicensed sellers or delay care. That is why the Ayushman Arogya Mandirs and teleconsultation are part of the AMR answer: they lower the cost of getting a prescription honestly.
3. Kidney harm is the immediate risk; resistance is the collective one. The circular leads with kidney damage, which is a harm to the individual user and therefore more persuasive to the public. Resistance is different: it is a harm to everyone, created by each person’s use, which makes it a classic negative externality. People do not weigh a cost that falls on others, so information alone will under-correct the behaviour. This is the economic case for regulation of sale rather than reliance on individual choice. The framing of the circular is smart communication, but policy has to address the externality.
4. The absence of an over-the-counter category makes enforcement harder, not easier. Because India has no legal list of medicines that may be sold freely, the line between what a chemist may and may not sell without a prescription is blurred in practice. A formal over-the-counter list of safe, low-risk medicines, with clear labelling and dose limits, would let enforcement focus on the prescription categories that matter. Many countries use such a two-tier system. The risk is that a badly drawn list could legitimise the casual sale of painkillers, which the circular itself warns about, so dose and pack-size limits would be essential.
5. Human use is only half of the antibiotic problem. The circular is addressed to people, but antibiotics are also used in poultry, dairy and fish farming, often as growth promoters, and residues from manufacturing reach rivers. Under a One Health approach, a campaign aimed only at patients treats one tap while others run. India has taken some steps on animal-use antibiotics, but monitoring is thin. A credible AMR strategy needs the Health, Animal Husbandry, Fisheries and Environment ministries working to a common plan, which is what the National Action Plan envisaged.

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