IPC To Launch Nationwide Drive To Strengthen Drug Quality Testing

In the wake of recent infant deaths in Madhya Pradesh and Rajasthan linked to contaminated cough syrups, the Indian Pharmacopoeia Commission (IPC), under the Union Health Ministry, will from next month roll out a nationwide initiative to bolster drug quality surveillance and laboratory testing across the country.

As part of the drive, scientists and analysts from public drug testing laboratories in 10 States, including Maharashtra, will undergo intensive training to detect toxic industrial chemicals — ethylene glycol (EG) and diethylene glycol (DEG) — in cough syrups and other liquid pharmaceutical formulations.

The move comes after several tragic incidents reported last month from Madhya Pradesh, Rajasthan, and other States, where newborns and infants succumbed to acute kidney failure after consuming cough syrups adulterated with these lethal substances. Both EG and DEG are commonly used in industrial solvents and antifreeze and are known to cause serious renal and neurological damage even in trace quantities.

Under the new initiative, the IPC will conduct hands-on training sessions on Gas Chromatography (GC) — a globally recognised analytical method used to identify and quantify EG and DEG contamination in medicines.

Each participating State laboratory will nominate two officials for the first phase of training, which will be held in Tamil Nadu, Rajasthan, Madhya Pradesh, Haryana, Telangana, and Maharashtra, among others. A second phase will subsequently expand coverage to other States and Union Territories to establish a uniform national standard for chemical detection and drug safety.

In parallel, the IPC has developed a comprehensive free toolkit for stakeholders across the pharmaceutical supply chain. The toolkit includes pharmacopoeial standards, regulatory guidelines, and international testing protocols, aimed at helping raw material suppliers, manufacturers, and regulators identify contamination early in the production process.

“The goal is to build permanent capacity and not just respond to crises. Every preventable death reflects a failure of systems that must be corrected,” an IPC official said.

The urgency of this intervention has been reinforced by the Central Drugs Standard Control Organisation (CDSCO)’s September Drug Alert Report, which flagged one batch of cough syrup and 112 other drugs as substandard.

According to the CDSCO, the current measures form part of a broader effort to curb the spread of spurious and substandard medicines and restore public confidence in India’s pharmaceutical quality standards — a key global concern following multiple incidents of DEG-related fatalities over the past two years.

The World Health Organisation (WHO) has also flagged the risk that contaminated products might be exported through unregulated channels, even though officially “none of the contaminated medicines have been exported from India” at present, according to reports.