Amid concerns over contaminated paediatric cough syrups leading to the deaths of several children, the Centre has launched a sweeping crackdown on drug quality compliance across the country. More than 700 cough syrup manufacturers have been subjected to intensive audits by central and state drug regulators, Minister of State for Health Anupriya Patel informed the Rajya Sabha in a written response on Tuesday.
In addition to regulatory inspections, market surveillance sampling of cough syrup formulations has been significantly scaled up nationwide to prevent circulation of substandard medicines.
Trigger: Cluster of child deaths in Madhya Pradesh
The government’s action was prompted by reports of child fatalities in Chhindwara district of Madhya Pradesh. Immediately after the incident surfaced, a multidisciplinary expert team from the National Centre for Disease Control (NCDC), National Institute of Virology (NIV) and the Central Drugs Standard Control Organisation (CDSCO) visited Chhindwara and Nagpur for a detailed field investigation in coordination with state authorities.
The team collected 19 samples of medicines consumed by the affected children from private clinics and neighbouring pharmacies. Analysis later revealed that:
Contents
Trigger: Cluster of child deaths in Madhya PradeshThe deadly contaminant: 46% Diethylene Glycol in Coldrif SyrupFactory inspections reveal gross GMP violationsStricter national guidelines to prevent future tragediesIndian Pharmacopoeia upgraded: DEG & EG testing mandatoryGovernment emphasises zero tolerance for drug safety breaches
- 15 samples met standard quality requirements
- 4 samples were declared Not of Standard Quality (NSQ)
The deadly contaminant: 46% Diethylene Glycol in Coldrif Syrup
Chemical testing identified a shocking issue with ‘Coldrif Syrup’, manufactured by Sresan Pharmaceuticals based in Kancheepuram, Tamil Nadu. The product contained a dangerously high concentration of Diethylene Glycol (DEG) — 46.28% w/v.
DEG and Ethylene Glycol (EG) are industrial-grade toxic chemicals, exposure to which may cause acute kidney failure, neurological impairment and death, especially in children.
Factory inspections reveal gross GMP violations
Following the lab findings, CDSCO inspected the manufacturer’s premises. Officials flagged serious Good Manufacturing Practices (GMP) lapses, including unhygienic production and poor storage conditions.
Consequently:
- The manufacturing licence of Sresan Pharmaceuticals was cancelled
- A criminal case was registered in Madhya Pradesh and Tamil Nadu
- Arrests of those responsible have been made
Additionally, Madhya Pradesh, Tamil Nadu, Odisha and Puducherry where the faulty batches were supplied imposed an immediate recall and sales ban.
Stricter national guidelines to prevent future tragedies
To tighten oversight and safeguard paediatric health, the Central Drugs Controller issued multiple directives:
Date Directive
- 3 October Ensure rational prescription of paediatric cough syrups
- 7 October Strict enforcement of drug testing regulations under Drugs Rules, 1945
- 21 October Heightened vigilance against spurious and substandard medicines
Indian Pharmacopoeia upgraded: DEG & EG testing mandatory
The Indian Pharmacopoeia Commission (IPC), Ghaziabad has amended IP-2022 to mandate. DEG and EG testing not only in raw materials, but also at the finished product stage, prior to market release. This aligns domestic norms with global safety protocols, especially in the wake of international recalls and alerts involving India-made syrups over the last two years.
Government emphasises zero tolerance for drug safety breaches
Minister Patel reiterated that the Centre remains committed to “zero tolerance” toward pharmaceutical negligence affecting patient safety — particularly children who are most vulnerable to adverse drug reactions.
