3 Oral cough syrups found contaminated with DEG, India informs WHO; medicines recalled

New Delhi: India on Wednesday informed the World Health Organisation that three oral cough syrups - made by firms in Tamil Nadu and Gujarat - have been found to be contaminated with toxic diethylene glycol (DEG) but the medicines have been recalled from the market with the manufacturers being instructed to stop production of all medicines.

“On October 8, WHO received confirmation from the Central Drug Standard and Control Organisation that DEG had been detected in at least three oral syrup medicines. These medicines were among those consumed by children in the reported cluster of cases,” WHO sources told DH.

The CDSCO has identified the contaminated products as Coldrif manufactured by Sresan Pharmaceuticals in Tamil Nadu; Respifresh TR made by Rednex Pharmaceuticals in Gujarat and ReLife produced by Shape Pharma Private Limited in Gujarat.

While Coldrif has 48.6% contamination of DEG, the levels of adulteration in Resprifesh and ReLife are 1.34% and 0.616% respectively.

The CDSCO response comes a week after the UN health body approached the Indian government seeking clarification on reports of children’s deaths in Madhya Pradesh and Rajasthan reportedly after consuming contaminated cough syrups.

As many as 20 kids have died in Chhindwara district of Madhya Pradesh allegedly after consuming contaminated cough syrups.

The UN health body said it approached the Indian authorities on Oct 1 after media reports regarding clusters of peadiatric illnesses and deaths in Madhya Pradesh and Rajasthan. These reports describe symptoms consistent with acute renal failure and acute encephalitis syndrome, with suspected links to the use of oral syrup medicines.

The global body contacted the CDSCO for clarification regarding the deaths’ potential links to contaminated medicines and whether the products were exported to other countries. The world body said it would support national authorities in investigating and responding to these tragic events.

In its response, the Indian regulator said the products have been recalled and manufacturers have been ordered to stop production of all medical products. Also none of the products were exported from India.

WHO has not received any official information as to the source of the DEG contamination or if contaminated pharmaceutical material has been identified.

The UN agency that raised global alerts on India-made cough syrups in 2023 also flagged the potential risk of contaminated products being exported to other countries, particularly via unregulated channels besides the regulatory gap in DEG/EG screening for domestically marketed medicines in India.

“WHO recognizes the gravity of these incidents and stands ready to support national authorities in investigating and responding to these tragic events. It remains committed to supporting India in safeguarding public health and ensuring the safety of medical products,” sources said.

DEG, a toxic solvent used in industrial products, has been linked to fatal poisoning in several countries. It is not used for drug making and its adverse effects are known to the pharmaceutical industry. There have been at least five major cases of DEG poisoning in India since 1972.

Health Ministry sources said inspections were carried out at the premises of manufacturing units in six states – Madhya Pradesh, Tamil Nadu, Himachal Pradesh, Uttarakhand, Gujarat and Maharashtra.