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Foundation note: Who regulates medicines in India, and the drug schedules
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Cough syrups and Schedule K
Copy link to Cough syrups and Schedule KPrelims and Mains
LeadRegulating medicines: cough syrups, fixed dose combinations and QR codesJune 2026
Why in news
In June 2026 the Health Ministry announced four changes to how medicines are regulated: cough syrups may be sold only by licensed pharmacies, sixteen fixed dose combinations were banned, QR codes were notified for vaccines, antimicrobials and cancer drugs from 2027 and 2028, and minor offences under the health laws were decriminalised.
Background
- Medicines are regulated under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
- The Central Drugs Standard Control Organisation (CDSCO) approves new drugs; State drug controllers license manufacture and sale.
- The Drugs Technical Advisory Board (DTAB) advises the government on technical matters.
- The Rules carry Schedules that sort drugs: Schedule H drugs need a prescription; Schedule K lists exemptions.
- In October 2025 at least 20 children in Madhya Pradesh died after taking a cough syrup adulterated with diethylene glycol, an industrial solvent.
1. Cough syrups: Schedule K
- Schedule K exempts named classes of drugs from parts of the Act. One entry had let cough syrups be sold in small villages without a retail licence.
- The word "syrup" has been removed from that entry, so cough syrups may be sold only through licensed pharmacies, on a doctor's prescription; lozenges, pills and tablets stay exempt.
- Critics call it defensive: the deaths came from failures in manufacturing and in testing raw material, not from where the syrup was sold.
2. Fixed dose combinations
- A fixed dose combination (FDC) holds two or more active drugs in fixed proportions in one dose.
- It is rational only if each drug adds to the effect. An irrational FDC exposes the patient to needless drugs, and in antibiotics it breeds resistance.
- Sixteen FDCs were banned under Section 26A of the Act, after an expert committee found them irrational.
3. QR codes: Schedule H2
- Schedule H2 requires a bar code or QR code on the label, so that each pack can be traced from factory to shop.
- It first covered the top 300 brands. It now covers all vaccines, anti cancer drugs and narcotic and psychotropic drugs from July 2027, and antimicrobials from July 2028.
- The shift is from regulating by sales to regulating by risk.
4. Jan Vishwas: decriminalising minor lapses
- The Jan Vishwas (Amendment of Provisions) Act, 2026 turns minor procedural offences in many laws into administrative penalties.
- In the health laws, lapses in paperwork now draw a penalty after a hearing, while offences that endanger health stay criminal.
The way forward
- Strengthen State drug controllers, who are understaffed, since rules made at the Centre are enforced in the States.
- Test raw materials and finished batches, which is where the cough syrup deaths began.
- Make traceability work through real time State databases that work across States, and habitual scanning by pharmacists.
- Enforce bans at the pharmacy counter, where banned stocks have kept selling in the past.
Prelims facts
- A drug can be banned in the public interest under Section 26A of the Drugs and Cosmetics Act, 1940.
- Schedule H2 concerns QR codes; Schedule K concerns exemptions.
- DTAB is the Drugs Technical Advisory Board.
- Diethylene glycol and ethylene glycol are the contaminants tested for in oral liquids.
Schedule K of the Drugs Rules, 1945 exempts named classes of drugs from certain provisions of the Drugs and Cosmetics Act, 1940. Entry 13 had allowed cough syrups to be sold in villages of fewer than 1,000 people without retail licensing. Diethylene glycol and ethylene glycol are industrial solvents and antifreeze agents, fatal even in small amounts, which enter medicines through adulterated excipients such as glycerin, propylene glycol, sorbitol and polyethylene glycol; the Indian Pharmacopoeia mandates tests for them in all oral liquids, but State drug controllers are understaffed. The same schedule's exemption was withdrawn in July 2026 for formulations with more than 12 per cent alcohol in packs above 30 ml, tinctures that were being diverted for intoxication, which moved to Schedule H1 and prescription only sale.
Syrup deaths to the rule
October 2022
WHO alert on contaminated syrups: The Gambia
November 2022
WHO alert: Indonesia
January 2023
WHO alert: Uzbekistan; WHO reports over 300 deaths, mostly children under five
October 2025
At least 20 children die in Madhya Pradesh after taking Coldrif syrup
December 2025
Amendment to Schedule K issued
16 June 2026
Rule in force: cough syrups only through licensed pharmacies
What changed
See also: Indian Pharmacopoeia Commission