🗞️ Why in News The Central Drugs Standard Control Organisation (CDSCO), in a circular dated 21 September 2026, warned against the indiscriminate, repeated or prolonged use of painkillers (NSAIDs) and antibiotics, citing the risk of chronic kidney disease, and directed pharmacists not to facilitate self-medication. On 22 September, a Supreme Court Bench of Justices Vikram Nath and Sandeep Mehta called the tenfold gap between the retail price and the price to retailers of an essential cancer drug “broad daylight dacoity” with patients.
What the CDSCO Circular Says
The circular reminds everyone in the supply chain that these medicines are prescription drugs under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
| Drug class | Where it sits in the Drugs Rules | What that means |
|---|---|---|
| Most non-steroidal anti-inflammatory drugs (NSAIDs) | Schedule H | Cannot be sold at retail without a prescription |
| Most antibiotics, in the circular’s words | Schedule H1 (by statute, mainly third- and fourth-generation antibiotics, anti-TB drugs and some habit-forming drugs) | Carry a warning not to be taken except on medical advice; sold only on prescription |
Its directions, by stakeholder:
| Stakeholder | Direction |
|---|---|
| Public | Do not self-medicate with antibiotics or take them for conditions where they are not indicated, including most uncomplicated viral infections; take prescribed antibiotics exactly as advised; never share them or use leftovers; people with kidney disease should tell their doctor before taking NSAIDs |
| Doctors | Consider age, other illnesses and other medicines; use the lowest effective dose for the shortest duration for NSAIDs; follow antimicrobial stewardship and avoid unnecessary combinations, wrong drug choice, wrong doses and prolonged courses |
| Pharmacists and retailers | Comply strictly with Schedule H and H1 requirements; do not facilitate self-medication |
| Hospitals | Strengthen rational prescribing, prescription review, stewardship and patient counselling |
| State and UT drug controllers | Build awareness of the risks and the rules |
Why the kidneys. NSAIDs such as ibuprofen and diclofenac block prostaglandins, which help keep blood flowing to the kidneys. Repeated or long use, especially with dehydration, old age or existing kidney disease, can injure the kidney. Several antibiotics are also toxic to the kidney at high doses or over long courses.
The Supreme Court on Cancer-Drug Prices
Hearing two petitions on drug pricing and generic prescribing, the Bench was shocked that an essential cancer drug carried a printed maximum retail price (MRP) of Rs 27,000 while its price to retailer (PTR) was Rs 2,700. “The MRP is 10 times the rate at which it is provided to the retailers. If this is not extortion, then what it is? People sell their houses, ornaments to get treatment,” the Bench said, adding that the silence of the authorities was “very surprising”.
| Petition | What it seeks |
|---|---|
| First | Directions to stop unethical overpricing of essential medicines by companies and retailers, and strict enforcement of the Drugs (Prices Control) Order, 2013 |
| Second | Disciplinary action against doctors who do not prescribe generic medicines |
Status. These were oral observations, not an order. The Centre, through Additional Solicitor General K.M. Nataraj, said it was not treating the matter as adversarial. The case is listed for further hearing on 29 September 2026.
The Regulatory Framework
Who regulates what.
| Body | Role |
|---|---|
| CDSCO, headed by the Drugs Controller General of India (DCGI) | Approves new drugs and clinical trials, regulates imports, sets standards; under the Directorate General of Health Services, Ministry of Health and Family Welfare |
| State drug licensing authorities | License the manufacture and sale of drugs, and inspect chemists |
| National Pharmaceutical Pricing Authority (NPPA), set up in 1997 | Fixes and enforces drug prices under the DPCO; under the Department of Pharmaceuticals |
How prices are controlled. The Drugs (Prices Control) Order, 2013, issued under the Essential Commodities Act, 1955, works on two tracks:
| Category | Rule |
|---|---|
| Scheduled formulations (medicines in the National List of Essential Medicines, NLEM 2022 lists 384) | NPPA fixes a ceiling price; all brands must sell at or below it |
| Non-scheduled formulations | Companies set the launch price, but may raise the MRP by no more than 10 per cent a year |
NPPA has also used Trade Margin Rationalisation: in February 2019 it capped the trade margin on 42 non-scheduled anti-cancer medicines at 30 per cent, cutting the MRPs of hundreds of brands. The gap the Court described, between PTR and MRP, is the retailer’s part of the trade margin; NPPA measures the full trade margin from the price at the first point of sale (to the stockist) up to the MRP.
Antimicrobial resistance (AMR). Misuse of antibiotics breeds resistant bacteria. India’s first National Action Plan on AMR (2017-21) has been followed by NAP-AMR 2.0 (2025-29), launched in November 2025; the Red Line campaign (2016) asked that prescription-only antibiotics carry a red vertical line on the pack; and the World Health Organization’s AWaRe classification sorts antibiotics into Access, Watch and Reserve groups to guide use.
Why It Matters
Public health. Self-medication with antibiotics for viral fevers and routine use of painkillers are common where doctors are far and chemists near. The result is both drug resistance and avoidable kidney damage. The circular restates the rules; enforcement at the chemist’s counter is the weak link.
Affordability. Out-of-pocket spending remains a large share of health spending in India, and medicines are its biggest part. Cancer drugs, often non-scheduled, carry high trade margins. The Court also noted, as LiveLaw and Bar and Bench reported, that when hospitals charge inflated MRPs under insurance schemes such as Ayushman Bharat PM-JAY, the taxpayer pays. PM-JAY completed eight years on 23 September 2026.
The generic debate. Generic prescribing lowers costs but depends on reliable quality across manufacturers. The National Medical Commission’s 2023 regulations requiring generic prescribing were put in abeyance within weeks after objections about quality assurance.
UPSC Relevance
GS Paper 2. Issues relating to the development and management of health; statutory and regulatory bodies. GS Paper 3. Science and technology: antimicrobial resistance; issues in drug regulation.
A question worth preparing. India’s drug regulation must address both the misuse of medicines and their affordability. Discuss with reference to antimicrobial resistance and drug price control. (250 words)
The Mains framing. Open with the twin problem: over-use (self-medication, AMR, kidney harm) and over-pricing (trade margins, non-scheduled drugs). Explain the legal tools: Schedules H, H1 and X; DPCO 2013 and NPPA; trade margin rationalisation. Identify gaps: weak enforcement at retail, fragmented Centre-State regulation, quality concerns that slow generic adoption. Way forward: digital prescription and dispensing records, wider trade margin caps for cancer and critical drugs, a stronger single regulator, stewardship programmes in hospitals, and expansion of Jan Aushadhi outlets.
📌 Facts Corner, Knowledgepedia
Prelims, statement-ready facts:
- CDSCO circular dated 21 September 2026 warned that misuse of NSAIDs and antibiotics risks chronic kidney disease.
- Most NSAIDs are in Schedule H; Schedule H1 lists newer-generation antibiotics, anti-TB drugs and some habit-forming drugs.
- Schedule H1 drugs need a separate register at the chemist, recording prescriber, patient, drug and quantity.
- CDSCO is headed by the DCGI and works under the Ministry of Health and Family Welfare.
- NPPA, set up in 1997, enforces the Drugs (Prices Control) Order, 2013 under the Department of Pharmaceuticals.
- DPCO 2013 is issued under the Essential Commodities Act, 1955.
- Non-scheduled drug prices may rise by at most 10 per cent a year.
- NLEM 2022 lists 384 medicines, whose ceiling prices NPPA fixes.
- In February 2019 NPPA capped trade margins on 42 anti-cancer drugs at 30 per cent.
- WHO’s AWaRe groups antibiotics as Access, Watch and Reserve.
Prelims, the traps:
- CDSCO regulates new drugs, trials and imports; State authorities license manufacture and sale.
- Price control is under the Department of Pharmaceuticals (Ministry of Chemicals and Fertilizers), not the Health Ministry.
- The Supreme Court’s “daylight dacoity” remark was an oral observation, not a judgment.
- Schedule X covers narcotic and psychotropic drugs; H1 covers mainly newer-generation antibiotics and anti-TB drugs.
Mains, arguments and keywords:
- Over-use (AMR, kidney harm) and over-pricing (trade margins) are twin failures of the medicines market.
- Enforcement at the chemist’s counter and Centre-State fragmentation are the weak links.
- Keywords: antimicrobial stewardship, Schedule H1, DPCO, NPPA, trade margin rationalisation, NLEM, generics, out-of-pocket expenditure.
Interview, be ready for:
- “Should all antibiotics be banned from over-the-counter sale?” They already need prescriptions; the task is enforcement, digital tracking and access to doctors in rural areas.
Source: Medicines Under Scrutiny: CDSCO Warns Against Self-Medication with Painkillers and Antibiotics; Supreme Court Flags Cancer-Drug Mark-Ups — Ujiyari.com | Free UPSC & State PCS Current Affairs
