Drug Regulator's Advisory Over Lapses Amid Outrage Over Cough Syrup Deaths

India's top drug regulator has issued an advisory over serious lapses in pharmaceutical manufacturing practices, amid growing outrage over child deaths allegedly linked to contaminated cough syrups. 

In an advisory issued on October 7, the Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, said inspections at several factories revealed that companies were not testing every batch of raw materials and active ingredients before using them to make medicines - a mandatory requirement under Indian drug laws.

The advisory from the Central Drugs Standard Control Organisation (CDSCO) stated that manufacturers had failed to comply with Rule 74(c) and Rule 78(c)(ii) of the Drugs Rules, which require every batch of both raw materials and finished formulations to be tested for quality either in-house or at an approved laboratory.  

"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," the regulator said. 

The CDSCO directed all state and union territory drug controllers to intensify inspections, ensure manufacturers test every batch before release, and verify that raw materials are sourced only from approved and reliable vendors.

The admission comes in the shadow of the recent tragedy in Madhya Pradesh's Chhindwara, where at least 20 children died after being administered a cough syrup suspected to be contaminated. Public health experts warn that the credibility of India's drug manufacturing system, once praised as the 'pharmacy of the world', faces a crisis of trust. Investigations have focused on Coldrif, a brand produced by Sresan Pharmaceuticals in Tamil Nadu.

Inspections at the plant revealed unhygienic and unsafe conditions-rusted machinery, open heating of chemicals, and inadequate protective measures. While samples from the Tamil Nadu unit tested positive for toxic diethylene glycol (DEG), those collected in Madhya Pradesh were found free of DEG and ethylene glycol contamination, deepening the mystery and highlighting gaps in quality control across states.

NDTV investigations revealed that production and distribution lapses likely combined to create the fatal chain of events. Similar cough syrup-linked deaths have been reported in Rajasthan, prompting the suspension of certain products by Kayson Pharma. 

In response, several states have tightened controls: Kerala has banned the sale of cough syrups to children under 12 without a doctor's prescription, while the Indian Pharmacists Association has urged chemists nationwide to stop dispensing cough syrups to infants under two. 

The tragedy has reignited memories of earlier global scandals in which Indian-made syrups were implicated in child deaths in The Gambia and Uzbekistan in 2022, following contamination with the same toxic solvents. Those incidents triggered international outrage and forced India to mandate pre-export testing of cough syrups, but domestic enforcement appears to have lagged. 

The National Human Rights Commission has also issued notices to Madhya Pradesh, Rajasthan, and Uttar Pradesh, seeking detailed reports on the deaths.

The Union Health Ministry has ordered risk-based inspections across several pharmaceutical sites, while production has been suspended at multiple facilities found in violation.