Indian regulators have launched an investigation into Balaji Amines, a major specialty chemicals manufacturer, after discovering that it produced pharmaceutical-grade propylene glycol (PG) without the required drug manufacturing license. The probe was triggered when government tests found a batch of PG contained excessive water and failed to meet pharmaceutical standards, though no toxic contamination was detected.
Balaji Amines, which supplies chemicals to agricultural, food, and pharma sectors, states that it has not sold PG for pharmaceutical use since it began production in 2022, stressing its manufacturing permission is only for technical and food-grade products. The company adds that it tested its PG according to U.S. and Indian pharma standards only at the request of non-pharma clients, resulting in the appearance of these standards on certain product labels.
Regulatory scrutiny follows a wider crackdown on India’s pharmaceutical supply chain, exacerbated by recent scandals involving contaminated cough syrups linked to over 150 child deaths globally. Indian federal and state drug inspectors visited Balaji’s facility in March 2025, but as of now, no formal actions have been confirmed against the company. Balaji has since applied for a license to manufacture pharma-grade PG and awaits regulatory approval.
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