CHENNAI: Indian officials are investigating whether safety lapses in the supply of a pharmaceutical ingredient were responsible for contaminating cough syrup that has killed at least 24 children in recent months, according to three people familiar with the matter.
The three health and drug safety officials from Tamil Nadu state told Reuters they believe the solvent used to make a batch of Coldrif cough syrup could have been contaminated with a toxic chemical around the time it was supplied to the drugmaker, Sresan Pharmaceutical Manufacturer.
Sresan acquired 50 kg of the propylene glycol (PG) solvent from local chemicals distributor Sunrise Biotech on March 25, which had purchased it the same day from Jinkushal Aroma, a small company that makes fragrance blends for liquid detergents and other chemicals, according to interviews with the suppliers and an October 3 investigation report by the Tamil Nadu pharmaceutical regulator.
The Tamil Nadu Drugs Control Department didn’t respond to repeated requests for comment about its investigation.
Authorities have said the Coldrif syrup was heavily contaminated with a known industrial toxin, diethylene glycol (DEG). They are investigating how the chemical was added to the solvent, which is used in cough syrup as a base for dissolving its active ingredients.
The fatalities, which began in September, have revived concerns about safety standards in India’s $50 billion pharmaceutical sector, which was tarnished by the deaths of more than 140 children in Africa and Central Asia in 2022 and 2023 from Indian-made cough syrups made with contaminated solvents.
Indian health officials say DEG is sometimes fraudulently or unintentionally used in medicines in place of pricier PG. Ingesting high levels of it has been linked to acute kidney damage and death in children.–Reuters
Comments are closed.