The Cough Syrup Catastrophe

UPSC Syllabus Topic: GS Paper 2 –Issues relating to development and management of Social Sector/Services relating to Health. The Cough Syrup Catastrophe.

Introduction

India has seen repeated child deaths from contaminated cough syrups. In October 2025, 27 children died in Madhya Pradesh and Rajasthan after consuming Coldrif and another dextromethorphan-based syrup. WHO confirmed diethylene glycol (DEG) up to 48.6% in Coldrif. The pattern is not new. Indian-made syrups were earlier linked to deaths in The Gambia and Uzbekistan, with similar crises in Indonesia and Cameroon. The crisis exposes deep failures in regulation, enforcement, and medical practice.

Reasons for Recurrent Child Deaths from Cough Syrups

1. Toxic solvent substitution: Some manufacturers replace safe solvents like propylene glycol or glycerin with diethylene glycol (DEG) or ethylene glycol to cut costs. These chemicals damage kidneys and the nervous system. Children are highly vulnerable, so poisoning is rapid and often fatal.
2. Uneven enforcement: Action varies across states. Tamil Nadu shut Sresan Pharmaceuticals and cancelled its licences. Gujarat recalled syrups without arrests. This inconsistency lets rogue firms exploit gaps.
3. Underpowered national regulator: The CDSCO oversees a $50-billion industry but is understaffed, underfunded, and compromised. Inspections were reactive, not preventive. Pharmacovigilance exists but is underused and overwhelmed.
4. Perverse incentives in prescribing: A doctor was arrested for prescribing Coldrif and admitting to commissions from the company. Such incentives promote overprescription despite paediatric safety guidance, which is poorly enforced.
5. Flawed licensing and surveillance: The 2021 online drug licensing system has not curbed adulteration. Signals from hospitals and citizens rarely trigger swift recalls, targeted audits, and prosecution.
6. Light penalties, slow justice: The Drugs and Cosmetics Act, 1940 imposes paltry penalties—fines as low as ₹1 lakh, low compared to profits. Sresan Pharmaceuticals‘s owner faces manslaughter charges, but delayed trials blunt deterrence.
7. Export–domestic double standard: India tightened export scrutiny after deaths abroad, but domestic markets remain poorly policed. Poor families relying on cheap generics carry the highest risk from untested potions.

Initiatives Taken to Curb Contamination.

1. Rapid bans: Madhya Pradesh first banned Coldrif on October 2. The ban became nationwide by October 11, removing the suspect syrups from shelves.
2. Expert committee: Rajasthan set up an expert committee. The Indian Council of Medical Research joined a multidisciplinary investigation to trace sources and failures.
3. Digital monitoring system: In October 2025, the CDSCO launched a digital monitoring system on the Online National Drug Licensing System (ONDLS) portal. This system tracks the supply chain of high-risk solventslike propylene glycol, requiring manufacturers to obtain licenses and upload batch details for real-time monitoring.
4. Strengthened manufacturing practices: The government has mandated strict compliance with revised Schedule M of the Drugs and Cosmetics Act by December 31, 2025. The new rules align with global GMP and require manufacturers to enhance quality systems, supply chain traceability, and testing for DEG and EG.
5. Increased testing and surveillance: The Indian Pharmacopoeia Commission (IPC) is launching a nationwide training program for drug laboratories to improve their ability to detect toxic contaminants using advanced techniques like gas chromatography.
6. Targeted inspections: The CDSCO has ordered nationwide, risk-based inspections and audits of all cough syrup manufacturing units.
7. Traceability measures: The government plans to mandate QR code-based traceability for specific drugs, including cough syrups, to strengthen the fight against counterfeit and substandard medicines.
8. Restrictions on use: In response to contamination risks, advisories were issued to states and union territories against prescribing cough-cold syrups for children under five years old.
   9. Export checks: Following deaths in The Gambia and Uzbekistan, export scrutiny was tightened. USFDA and the US embassy confirmed no implicated exports reached the United States.
9. Global coordination: WHO offered investigative support and termed the contamination criminal. Engagement with WHO remains essential for standards and alerts.

Way forward

1. Strengthen regulation and testing: Empower CDSCO with independent funding, a larger inspectorate, and transparent governance. Mandate verifiable batch-wise quality certificates from accredited labs before release.
2. Accountability and deterrence: Raise penalties for adulteration to meaningful levels. Blacklist and prosecute negligent firms. Protect whistleblowers to surface malpractice early.
3. Clinical practice and surveillance: Disclose doctor commissions, enforce paediatric guidelines, and penalise non-compliance.
4. Strengthen pharmacovigilance: Create and promote a robust adverse drug reaction reporting system that allows healthcare facilities and patients to report negative outcomes promptly.
5. Raise public awareness: Educate caregivers and the public about the risks of contaminated medicines, the importance of only buying from verified sources, and how to spot a dubious product.
6. Close the domestic–export gap: Apply the same strict standards at home that are used for exports. Uniform state enforcement must replace fragmented action to end regulatory arbitrage.
7. Foster global collaboration
   • Strengthen international cooperation: Partner with the World Health Organization (WHO) and other global bodies to create faster alert systems for contaminated products and to build capacity in low-resource settings.
   • Enforce global standards: Adhere to and benchmark against WHO guidelines for manufacturing and testing to ensure consistently high standards for both domestic and exported medicines.

Conclusion

This is a systemic failure, not an accident. Profit-driven adulteration, weak laws, fragmented enforcement, and perverse prescribing incentives created a deadly chain. Manufacturers and policymakers share responsibility for the 27 child deaths. India’s pharmaceutical success cannot rest on domestic neglect. Only independent regulation, rigorous testing, real deterrence, ethical prescribing, and uniform enforcement can prevent the next cough syrup tragedy.

Question for practice:

Discuss the reasons behind recurrent child deaths from contaminated cough syrups in India and the key initiatives taken to curb such contamination.

Source: The New Indian Express