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India’s Drug Regulator Mandates Nationwide Audit of Cough Syrup Manufacturers Following Tragic Child Deaths

October 9, 2025
in National, Politics
Reading Time: 3 min

The Central Drugs Standard Control Organisation (CDSCO) has instructed all State governments to provide a comprehensive list of cough syrup manufacturers, simultaneously initiating a joint audit of these companies. This significant move, announced by a senior Health Ministry official on Thursday (October 9, 2025), follows a tragic month where over 20 children reportedly died due to contaminated cough syrups.

CDSCO has also informed the World Health Organisation (WHO) that it has identified three specific contaminated cough syrups – Coldrif, Respifresh, and ReLife – linked to the recent child deaths in India, as containing Diethylene Glycol (DEG). Crucially, the CDSCO clarified that none of these particular contaminated products had been exported from India.

Authorities have since recalled these dangerous products and issued orders for the identified manufacturers to cease production of all medical items immediately.

The WHO had initially reached out to the CDSCO on October 1, seeking urgent clarification on any potential connections to contaminated medicines and inquiring about the export status of such products.

The UN health agency highlighted that the CDSCO’s findings indicated Coldrif from Sresan Pharma (Tamil Nadu) contained a shocking 48.6% DEG; Respifresh TR from Rednex Pharmaceuticals (Gujarat) showed 1.342% DEG; and ReLife from Shape Pharma (Gujarat) had 0.616% DEG.

The tragic symptoms observed in the affected children, including acute renal failure and acute encephalitis syndrome, were deemed consistent with the use of these oral syrup medicines.

The WHO reiterated its readiness to assist national authorities in investigating and responding to these heartbreaking incidents. However, it also noted that it had not yet received official information regarding the exact source of the DEG contamination or if any other contaminated pharmaceutical materials were still in circulation.

Furthermore, the WHO pointed out a “regulatory gap” in screening for DEG/EG in medicines marketed domestically within India. It emphasized the critical need to pinpoint the contamination source and ensure all tainted pharmaceutical materials are identified and removed from circulation.

Meanwhile, a Health Ministry official clarified that Coldrif, produced by Sresan Pharma (Tamil Nadu), had not been under the Central Government’s radar when it was first licensed in 2011 or even during its renewal in 2016.

“The CDSCO has now recommended the cancellation of the manufacturing license for the company. If the raw material and the finished product had undergone proper testing, this tragic situation could have been avoided,” the official stated.

The official also confirmed that child deaths in Rajasthan, which had been under scrutiny, were medically attributed to meningitis, mucositis, and acute respiratory distress syndrome (ARDS), and were unrelated to contaminated cough syrup.

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