What Happened
- At least 25 children died in Madhya Pradesh's Chhindwara district after consuming Coldrif cough syrup contaminated with diethylene glycol (DEG), a toxic industrial chemical.
- Laboratory analysis revealed one batch of Coldrif contained 48.6% DEG -- approximately 500 times the permissible limit -- causing acute kidney failure in children.
- The syrup was manufactured by Sresan Pharmaceuticals in Tamil Nadu, which was found to have 39 critical and 325 major violations of the Drugs and Cosmetics Act, including no qualified chemist on-site, untested raw materials sourced from paint dealers and chemical traders, pest infestations, zero ventilation, and broken equipment.
- Madhya Pradesh imposed a complete ban on Coldrif's sale and distribution; Tamil Nadu cancelled Sresan's manufacturing licence and ordered permanent shutdown.
- The company owner, Ranganathan Govindan, who had been absconding since September, was arrested and charged with adulteration, endangering child safety, and culpable homicide not amounting to murder.
- The incident follows a pattern of contaminated cough syrup tragedies, including the 2022 Gambia incident linked to another Indian manufacturer.
Static Topic Bridges
Drugs and Cosmetics Act, 1940 -- India's Drug Regulatory Framework
The Drugs and Cosmetics Act, 1940 (DCA) is the principal legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics in India. It establishes a dual regulatory structure where the Central Drugs Standard Control Organisation (CDSCO) under the Drugs Controller General of India (DCGI) handles regulatory approvals, while State Drug Regulatory Authorities (SDRAs) are responsible for manufacturing licences and routine inspections.
- Section 18: Prohibits manufacture, sale, or distribution of drugs that are not of standard quality, or are misbranded, adulterated, or spurious
- Section 27: Penalties for manufacture/sale of adulterated drugs -- imprisonment up to 5 years and fine (enhanced to 10 years to life if causing death under Section 27(d))
- Section 16: Empowers Central Government to appoint Drug Inspectors; Section 21: Powers of inspectors to enter, inspect, and take samples
- Drug regulation is a concurrent subject (Entry 19, List III, Seventh Schedule) -- both Centre and States have jurisdiction
- CDSCO: National Regulatory Authority under Directorate General of Health Services, Ministry of Health & Family Welfare
- State licensing authorities grant manufacturing licences, conduct factory inspections, and take samples for testing
- CAG 2024 report found that in Tamil Nadu, only about two-thirds of required drug inspections were carried out between 2016-2021, and as few as half the expected samples were tested
Connection to this news: The Sresan Pharmaceuticals case epitomises the regulatory failure where 364 combined violations went undetected until children died. The dual Centre-State structure creates accountability gaps, with state regulators often lacking accredited labs, qualified inspectors, and digital tracking systems.
Mashelkar Committee (2003) -- Unimplemented Drug Regulatory Reforms
In January 2003, the Ministry of Health and Family Welfare constituted the Expert Committee on a Comprehensive Examination of Drug Regulatory Issues, Including the Problem of Spurious Drugs, chaired by Dr R.A. Mashelkar, then Director General of CSIR. The Committee submitted its report in November 2003 with sweeping recommendations that remain largely unimplemented.
- Recommended converting CDSCO into an independent Central Drug Administration under the Ministry of Health
- Called for centralised licensing of drug manufacture (instead of state-level licensing) to ensure uniform standards
- Recommended strengthening State Drug Control Organisations with funds, competent personnel, and modern infrastructure
- Proposed death penalty for manufacture/sale of spurious drugs causing death or grievous hurt (currently maximum is life imprisonment)
- Called for mandatory coordination between pharmaceutical industry, trade associations, and consumer bodies to combat spurious drugs
- Implementation status: Most recommendations remain unimplemented over two decades later
- Subsequent reports (59th Parliamentary Standing Committee Report on Health, 2012) found CDSCO had systemic deficiencies and was biased towards drug companies
Connection to this news: The Sresan Pharmaceuticals tragedy is precisely the kind of incident the Mashelkar Committee's recommendations were designed to prevent. Had centralised licensing and strengthened state inspection infrastructure been implemented, the 364 violations at Sresan might have been detected before contaminated syrup reached the market.
Diethylene Glycol Contamination -- A Recurring Global Crisis
Diethylene glycol (DEG) is a toxic industrial solvent sometimes used as a cheaper substitute for pharmaceutical-grade propylene glycol or glycerine in liquid medications. Its ingestion causes acute kidney injury, liver failure, and neurological damage, often fatal in children. DEG contamination in medicines has caused mass casualty events globally since the 1937 Sulfanilamide disaster in the United States.
- DEG molecular formula: C4H10O3; lethal dose in humans: approximately 1 mL/kg body weight
- 1937 Sulfanilamide disaster (USA): 107 deaths; directly led to the passage of the Federal Food, Drug, and Cosmetic Act, 1938
- 2022 Gambia incident: 70 children died from cough syrups manufactured by Maiden Pharmaceuticals (Haryana, India); WHO issued Medical Product Alert No. 6/2022
- Maiden Pharmaceuticals had previously been flagged for substandard products by Kerala, Gujarat, Bihar, and Vietnam
- Common cause across incidents: use of industrial-grade (non-pharmaceutical) raw materials without quality testing
- Indian Pharmacopoeia specifies permissible DEG limits; manufacturers are required to test raw materials for DEG and ethylene glycol contamination
Connection to this news: The Coldrif contamination follows the same pattern as the Gambia tragedy -- industrial-grade raw materials substituted for pharmaceutical-grade ones, with no quality testing. The recurrence within three years of the Gambia incident indicates that the regulatory reforms triggered by that crisis were insufficient.
Key Facts & Data
- Deaths: At least 25 children in Chhindwara district, Madhya Pradesh
- Contaminant: Diethylene glycol (DEG) at 48.6% concentration (approximately 500 times permissible limit)
- Manufacturer: Sresan Pharmaceuticals, Tamil Nadu
- Violations found: 39 critical + 325 major under Drugs and Cosmetics Act, 1940
- Drugs and Cosmetics Act, 1940: Section 18 (prohibition of substandard drugs), Section 27 (penalties)
- Drug regulation: Concurrent subject (Entry 19, List III, Seventh Schedule)
- Mashelkar Committee: Constituted January 2003, report submitted November 2003; key recommendation of centralised licensing remains unimplemented
- 2022 Gambia incident: 70 children died; Maiden Pharmaceuticals (Haryana); WHO Alert No. 6/2022
- 1937 Sulfanilamide disaster: 107 deaths in USA; led to Federal Food, Drug, and Cosmetic Act, 1938
- CAG finding: Tamil Nadu conducted only two-thirds of required drug inspections (2016-2021)