Indian authorities are investigating whether serious safety failures in the supply chain of pharmaceutical ingredients contributed to the contamination of a cough syrup that has killed at least 24 children in recent months, sources familiar with the inquiry told Reuters.
Health and drug safety officials in Tamil Nadu believe that propylene glycol (PG), a solvent used in the production of Coldrif cough syrup by Sresan Pharmaceutical Manufacturer, may have been contaminated with the industrial toxin diethylene glycol (DEG). The contamination is suspected to have occurred around the time the solvent was supplied.
According to an investigation report seen exclusively by Reuters, Sresan acquired 50 kg of PG on March 25 from local distributor Sunrise Biotech, which had purchased it the same day from Jinkushal Aroma — a small chemical company supplying fragrance blends. Neither company is licensed to handle pharmaceutical-grade ingredients, contravening Indian law.
Further complicating the case, Sunrise confirmed it repackaged the solvent without a seal before delivering it to Sresan. Typically, PG intended for medical use is delivered in sealed containers to prevent contamination.
Authorities say the syrup was heavily tainted with DEG, a toxic substance sometimes fraudulently or mistakenly substituted for PG due to its lower cost. High DEG intake has been historically linked to acute kidney failure and death in children.
The fatalities, recorded since September, have reignited concerns over safety standards in India’s US$50 billion pharmaceutical sector, already under scrutiny following similar incidents that led to child deaths in Africa and Central Asia in 2022 and 2023.
Sresan’s manufacturing licence has now been revoked, and its founder, G. Ranganathan, is in custody. A 105-page inspection report dated October 3 revealed “critical” operational failings at the factory near Chennai, including data falsification and unhygienic storage, although regulators stopped short of directly linking these breaches to the deaths.
Further investigations are underway to determine how the contamination occurred and who was responsible. The Central Drugs Standard Control Organisation is increasing inspections nationwide and reviewing paediatric cough syrup usage.
SK picglobal, the South Korean manufacturer of the original solvent, confirmed it prohibits repackaging or subdivision of its products, warning that quality cannot be guaranteed once seals are broken. The PG barrel supplied to India was originally sealed and should not have been redistributed.
Despite previous penalties issued to Sresan in 2020, 2021, 2022 and 2023, the facility had not undergone inspection since last year, officials said.
Authorities continue to assess whether negligence or fraudulent handling led to the deaths, as the investigation widens into supply practices and regulatory oversight.
