India Issues Alert Over Toxic Cough Syrups After 17 Child Deaths; WHO Flags Regulatory Lapses

Indian health authorities have urged the public to avoid three locally manufactured cough syrup brands after the deaths of 17 children under the age of five were linked to toxic contamination. The syrups — Coldrif, Respifresh, and RELIFE — were found to contain diethylene glycol (DEG) in dangerously high concentrations, nearly 500 times above the permissible limit, according to state health officials.

The fatalities occurred over the past month in India, prompting Gujarat and several other states to issue urgent public warnings describing DEG as a “toxic chemical that can cause severe poisoning, kidney failure, neurological damage, and even death, especially in children.”

The World Health Organization (WHO) confirmed that India had identified the three contaminated products and said none appeared to have been officially exported. However, the agency cautioned that unofficial shipments could not be ruled out and expressed concern over what it termed a “regulatory gap” in screening domestically marketed cough syrups for DEG and ethylene glycol (EG).

“WHO expresses deep concern over these developments and emphasizes the need for stronger testing protocols for medicines sold within India,” the agency said in an emailed statement to Reuters.

Manufacturers Under Scrutiny

The contaminated Coldrif syrup, produced by Sresan Pharmaceutical Manufacturer in Tamil Nadu, has been banned following laboratory confirmation of the toxic ingredient on October 2. The firm’s factory and offices have since been sealed, with police launching a manslaughter investigation. Central regulators have also recommended the cancellation of its manufacturing licence.

Two other Gujarat-based firms — Shape Pharma (maker of RELIFE) and Rednex Pharmaceuticals (maker of Respifresh) — are under investigation after state and federal inspectors declared their syrup samples “not of standard quality.” Both companies have been ordered to halt production and distribution pending further inquiry.

The Drug Controller General of India (DCGI), Rajeev Raghuvanshi, said recent factory inspections uncovered serious lapses, including failure to test every batch of raw materials and final products as required by law.

Regulatory and Global Implications

The incident echoes earlier international tragedies linked to Indian-made syrups, which caused the deaths of over 140 children in Gambia, Uzbekistan, and Cameroon between 2022 and 2023, and 12 children in India in 2019. These recurring cases have once again raised concerns over India’s pharmaceutical oversight, despite its position as the world’s third-largest drug producer by volume, valued at $50 billion.

India supplies nearly 40% of generic medicines used in the United States and over 90% of all pharmaceuticals in many African nations. Following past contamination cases, exports of cough syrups have required additional government laboratory testing since 2023.

As authorities intensify inspections across 19 manufacturing units in six states, WHO has reiterated its standing advisory against the use of cough and cold medicines in children, emphasizing the need for immediate corrective measures to prevent further loss of life.

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