India's Drug Regulator Issues Critical Advisory Following Fatal Cough Syrup Contamination Cases

Inspections at the Coldrif manufacturing facility revealed serious deficiencies in protective protocols. (Representational)

India's primary drug regulatory authority has released an advisory highlighting critical deficiencies in pharmaceutical production standards, as public outrage intensifies over children's deaths allegedly connected to contaminated cough medications.

On October 7, DCGI Rajeev Raghuvanshi issued an advisory noting that factory inspections had uncovered companies failing to examine each batch of raw materials and active components before incorporating them into medicinal products—a mandatory requirement under Indian pharmaceutical regulations.

The CDSCO's advisory emphasized that manufacturers were not adhering to Rules 74(c) and 78(c)(ii) of the Drugs Rules, which mandate quality testing of every batch of both raw ingredients and completed formulations, either internally or at certified laboratories.

"Observations indicate manufacturers are not conducting testing on each batch to verify compliance with prescribed standards before utilizing them in production and 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 every batch prior to distribution, and verify that raw materials are procured exclusively from approved and trustworthy suppliers.

This acknowledgment comes amid the recent tragedy in Madhya Pradesh's Chhindwara, where approximately 20 children died after receiving cough syrup suspected of contamination. Public health specialists caution that the reputation of India's pharmaceutical manufacturing industry, previously lauded as the 'pharmacy of the world,' faces a significant crisis of confidence. Investigations have centered on Coldrif, a product manufactured by Sresan Pharmaceuticals in Tamil Nadu.

Facility inspections revealed unsanitary and hazardous conditions—including corroded equipment, exposed chemical heating processes, and insufficient protective measures. While samples from the Tamil Nadu facility tested positive for toxic diethylene glycol (DEG), those collected in Madhya Pradesh were found to be free of DEG and ethylene glycol contamination, further complicating the investigation and highlighting inconsistencies in quality control across different states.

NDTV investigations uncovered that failures in both production and distribution likely combined to create the deadly sequence of events. Similar fatalities linked to cough medications have been reported in Rajasthan, resulting in the suspension of certain products manufactured by Kayson Pharma.

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

The incident has rekindled memories of previous international scandals where Indian-manufactured syrups were implicated in child fatalities in The Gambia and Uzbekistan in 2022, following contamination with identical toxic substances. Those incidents prompted global indignation and compelled India to mandate pre-export testing of cough syrups, though domestic enforcement appears to have remained inadequate.

The National Human Rights Commission has issued notices to authorities in 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 sites found in violation of regulations.