Haryana FDA Tightens Vigil on Propylene Glycol in Ayurvedic Drugs

The Food and Drug Administration (FDA) in Haryana has intensified its efforts to counter the issue of adulteration of pharmaceutical ingredients, and recently issued a "Most Urgent" alert to increase scrutiny of propylene glycol (PG), which is used to solubilize medications, in allopathic and ayurvedic medicines.

Lalit Kumar Goel, State Drugs Controller, has ordered quality tests and checks in the manufacturing process to reduce the potential for toxic adulteration related to diethylene glycol (DEG) and ethylene glycol (EG), which are industrial chemicals that have caused toxic poisoning and death around the world.

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The action was initially directed to allopathic manufacturers in the form of an advisory issued on October 5, and the alert has recently been extended to ayurvedic manufacturers, recognizing that PG-like solvents may also be used extensively in formulations in traditional medicine. The State Licensing Authority (ASU) for the Directorate of Ayush has been ordered to ensure that all ayurvedic drugs manufacturers follow up with the same level of scrutiny in terms of safety and testing.

The FDA has made pre-use testing of PG mandatory in which each batch must be analyzed for DEG and EG using gas chromatography (GC). It is essential that manufacturers only purchase certified pharmaceutical-grade PG while adhering to strict storage conditions and using only licenced (certified) dealers.

Also, finished liquid oral dosage forms must undergo GC testing for purity and companies must test retained control samples on a regular basis. If any levels of contaminant(s) are detected, the product would be recalled immediately. Clearly, Haryana has zero tolerance for drug adulteration and wishes to advance a contaminants free drug ecosystem.