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Govt Tightens Cough Syrup Sale Rules Under Schedule K, Drugs Rules 1945, After WHO Alerts on DEG/Child Deaths

Target:MPSCUPSC GS-IISSC GATeachingPrelims HighMains MediumStatic GK Link
23 Jun 2026
~2 min
Source: The Hindu
Key Data:Schedule KDrugs Rules, 1945Drugs and Cosmetics Act, 1940Entry 13Population less than 1,000Diethylene Glycol (DEG)
Bodies:CDSCOMinistry of Health and Family WelfareWHOTamil Nadu Drugs Control DepartmentTamil Nadu Chemists and Druggists AssociationKanchi Kamakoti CHILDS Trust HospitalTamil Nadu Health Development Association
Practice MCQs from today's news ▸
What This Article Covers

1.India omitted 'syrup' from Entry 13, Schedule K of Drugs Rules, 1945, ending the exemption for cough syrup sale in villages with population <1000 without a pharmacy license.

2.The reform follows WHO alerts (2022-2025) on contaminated Indian cough syrups containing DEG/ethylene glycol linked to 300+ child deaths globally; latest: Coldrif by Sresan Pharmaceuticals in MP (Oct 2025).

3.Experts call the amendment 'superficial' and demand stronger manufacturing quality control, mandatory pre-market batch testing, and certification by state drug control laboratories.

The Big Picture
Prelims · HighMains · Medium

India has amended Schedule K of the Drugs Rules, 1945 to remove the exemption that allowed cough syrup sales in small villages without a pharmacy license. This comes after multiple WHO alerts linking Indian-manufactured cough syrups contaminated with Diethylene Glycol (DEG) to over 300 child deaths globally, including recent deaths in Madhya Pradesh. For exam aspirants, this is a high-impact regulatory reform with strong static GK linkage to the Drugs and Cosmetics Act, WHO alerts, and public health governance.

Exam Lens

Quick Exam Facts From News

Key Legal ChangeOmission of 'syrup' from Entry 13, Schedule K, Drugs Rules, 1945
Contaminant Linked to Child DeathsDiethylene Glycol (DEG) and Ethylene Glycol
Latest Incident (2025)20+ children died in MP linked to Coldrif syrup by Sresan Pharmaceuticals
WHO Alert ScopeOver 300 fatalities in 7+ countries (Gambia, Indonesia, Uzbekistan etc.) since 2022
Regulatory BodyCentral Drugs Standard Control Organisation (CDSCO) under MoHFW

1-Minute Revision

  • ›Key Legal Change: Omission of 'syrup' from Entry 13, Schedule K, Drugs Rules, 1945
  • ›Contaminant Linked to Child Deaths: Diethylene Glycol (DEG) and Ethylene Glycol
  • ›Target this Data: Omission of 'syrup' from Entry 13, Schedule K, Drugs Rules, 1945
  • ›Target this Nodal Body: Central Drugs Standard Control Organisation (CDSCO) under Ministry of Health and Family Welfare
  • ›Target this Legal Point: Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945; Schedule K exemptions; Contaminants: Diethylene Glycol (DEG) and Ethylene Glycol

Mastered this topic? Test your knowledge with a full MCQ quiz.

Practice exam-style questions, track your score, and strengthen your recall.

Q1Static LinkageEasy

Which ministry is primarily responsible for the Central Drugs Standard Control Organisation (CDSCO)?

Q2Statement-basedHard

Consider the following statements:

1. The recent amendment omitted the word 'syrup' from Entry 13 of Schedule K of the Drugs Rules, 1945.

2. Schedule K of the Drugs Rules, 1945 provides exemptions from certain provisions of the Drugs and Cosmetics Act, 1940.

3. The amendment now allows cough syrups to be sold in villages with population less than 1000 without a pharmacy license.

Which of the statements given above is/are correct?

Q3Data-centricMedium

What was the population threshold in villages below which cough syrups were earlier exempted from retail licensing provisions under Schedule K?

Q4Application/ImpactMedium

Why do health experts consider the recent amendment to Schedule K 'superficial'?

All 25 MCQs ▸
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