CDSCO Orders Nationwide Audit of Cough Syrup Makers After Fatal Toxic Syrup Scare

Earlier, the Medical Dialogues Team had reported the WHO had requested clarification from Indian authorities regarding whether the cough syrup linked to the deaths of children in India had been exported to other countries, official sources said, as reported by PTI.

In response to questions raised by the World Health Organization (WHO), the Central Drugs Standard Control Organization (CDSCO) has confirmed that three cough syrups, namely Coldrif, RespifreshTR, and ReLife, have been recalled, and none of the products were exported from India.

The children died in India over the past month after consuming cough medicine containing toxic diethylene glycol in quantities nearly 500 times the permissible limit, officials told Reuters. The deaths were all linked to the Coldrif medicine, which was banned after a test confirmed the presence of the chemical on October 2.

The Respifresh and RELIFE syrups also contain diethylene glycol, according to a public alert by Gujarat and other states on Wednesday that described it as "a toxic chemical that can cause serious poisoning, including kidney failure, neurological complications and even death, especially among children".

The World Health Organization told Reuters it had received confirmation from India on Wednesday that three contaminated syrups had been identified, and none had been exported.

"WHO expresses deep concern over these developments and emphasizes... the regulatory gap in DEG/EG screening for domestically marketed medicines in India," a spokesperson added by email, referring to diethylene glycol and ethylene glycol.

Details of the three tainted cough syrups:

COLDRIF

Linked to the deaths of children from Madhya Pradesh, who mostly died of kidney failure in a government hospital in another state.

Manufactured by Sresan Pharmaceuticals, based in Tamil Nadu.

Found to contain 48.6% of the toxic substance diethylene glycol (DEG), far exceeding the 0.1% permissible limit set by India and the WHO.

Produced in May 2025, with an expiry date of April 2027.

The syrup has been banned, and the company owner has been arrested.

RESPIFRESH TR

Not linked to any reported deaths.

Manufactured by Rednex Pharmaceuticals, based in Gujarat.

Contaminated with 1.342% DEG.

Produced in January 2025, with an expiry date of December 2026.

The syrup has been recalled, and the company has been ordered to halt production of all medical products.

RELIFE

Not linked to any reported deaths.

Manufactured by Shape Pharma, based in Gujarat, in January 2025, with an expiry date of December 2026.

Contaminated with 0.616% DEG.

The syrup has been recalled, and the company has been directed to stop production of all medical products.

“The CDSCO has now recommended cancellation of the manufacturing license for the company. If the raw material and the finished product were tested, we could have avoided the situation, an official told The Hindu.

The official further clarified that the recent child deaths in Rajasthan were not linked to contaminated cough syrup. “Child deaths in Rajasthan have been under scrutiny and have been medically attributed to meningitis, mucositis, and acute respiratory distress syndrome (ARDS),’’ he added.