India's Drug Regulator Acknowledges Pharmaceutical Manufacturing Lapses Following Fatal Cough Syrup Incidents

Inspections at the Coldrif plant revealed inadequate protective measures. (Representational)

India's principal drug regulatory authority has acknowledged significant deficiencies in pharmaceutical production standards, as public anger intensifies over child fatalities allegedly connected to tainted cough medications.

In a directive released October 7, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi revealed that facility inspections uncovered companies failing to examine each batch of raw materials and active components before incorporating them into medicinal products - a mandatory procedure under Indian pharmaceutical legislation.

The Central Drugs Standard Control Organisation (CDSCO) advisory highlighted manufacturers' non-compliance with Rules 74(c) and 78(c)(ii) of the Drugs Rules, which mandate quality testing of every batch of both raw materials and completed formulations either internally or at approved testing facilities.

"It has been observed that manufacturers are not carrying out testing of each batch for verification of compliance with the prescribed standards before using them in manufacture and also in finished products," stated the regulatory body.

The CDSCO has instructed all state and union territory drug authorities to enhance inspection protocols, ensure manufacturers test each batch prior to distribution, and confirm raw materials originate only from approved and trustworthy suppliers.

This acknowledgment follows the recent tragedy in Madhya Pradesh's Chhindwara, where approximately 20 children died after receiving a cough syrup suspected of contamination. Public health specialists caution that India's pharmaceutical manufacturing system's reputation, once celebrated as the 'pharmacy of the world,' confronts a severe credibility crisis. Investigations have centered on Coldrif, a product manufactured by Sresan Pharmaceuticals in Tamil Nadu.

Facility inspections revealed unsanitary and dangerous conditions—corroded equipment, uncontained chemical heating processes, and insufficient protective protocols. While samples from the Tamil Nadu facility tested positive for toxic diethylene glycol (DEG), those collected in Madhya Pradesh were found free of DEG and ethylene glycol contamination, complicating the investigation and exposing quality control inconsistencies across states.

NDTV investigations discovered that manufacturing and distribution failures likely combined to create the fatal sequence of events. Similar cough medication-related fatalities have been reported in Rajasthan, prompting the suspension of certain Kayson Pharma products.

In response, several states have implemented stricter controls: Kerala has prohibited cough syrup sales to children under 12 without prescription, while the Indian Pharmacists Association has encouraged chemists nationwide to cease dispensing cough syrups to infants under two years.

The tragedy has rekindled memories of earlier international incidents where Indian-manufactured syrups were implicated in child deaths in The Gambia and Uzbekistan in 2022, following contamination with identical toxic substances. Those events triggered international condemnation and compelled India to mandate pre-export testing for cough syrups, though domestic enforcement appears inadequate.

The National Human Rights Commission has issued notices to Madhya Pradesh, Rajasthan, and Uttar Pradesh, requesting comprehensive reports on the fatalities.

The Union Health Ministry has mandated risk-based inspections across numerous pharmaceutical facilities, while production has been suspended at multiple locations found violating regulations.