Balaji Amines Under Scrutiny Over Unlicensed Propylene Glycol Production: Report

The probe began when a 2023 batch failed quality checks due to excess water content. The firm has denied selling the chemical for pharma use.

Indian authorities have reportedly accused Balaji Amines of manufacturing pharmaceutical-grade propylene glycol (PG) without a valid drug license, after a batch of its product was found to be substandard.

The probe began when a 2023 batch failed quality checks due to excess water content. However, no contamination, such as toxic ethylene glycol or diethylene glycol, was detected, according to a report by Reuters.

However, test reports have confirmed that Balaji’s PG was free of contaminants.

What Is Propylene Glycol Used For?

Propylene glycol is a solvent used in food, cosmetics, and medicines. However, it has been under scrutiny following contamination incidents in Indian-made cough syrups linked to child deaths. Earlier this month, the World Health Organization (WHO) had raised serious concerns about regulatory shortcomings that enabled toxic substitutes to enter medicines.

The company stated that it only produces technical and food-grade PG and has not sold any material “intended for pharmaceutical applications” since beginning production in 2022.

Balaji said some non-pharma customers had requested tests based on U.S. and Indian pharmacopoeia standards (USP/IP), which is why such labels appeared on certain batches. The firm has already applied for a licence to manufacture pharma-grade PG and is awaiting approval, the report added.

In March, the Central Drugs Standard Control Organization (CDSCO) inspected the company’s facility and sealed some samples for further verification. Balaji confirmed the visit but said there was no ongoing investigation at present.

Stock Watch

Balaji Amines’ stock closed 1.25% lower at ₹1,349 on Tuesday.

Year-to-date, the shares have declined nearly 25%.

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