Popular Re 1 Ayurvedic Digestive Tablet Fails Maharashtra FDA Test, Listed Among 239 NSQ Drugs By CDSCO

Mumbai: A popular Ayurvedic digestive tablet, widely sold in small Re 1 sachet, has been declared Not of Standard Quality (NSQ) during a quality check conducted by the Maharashtra Food and Drug Administration (FDA). The product has also figured in the Central Drugs Standard Control Organisation’s (CDSCO) July NSQ list, which names 239 products found to have failed prescribed quality parameters across the country.

Maharashtra FDA Finds Broken Tablets In Tested Batch

The Maharashtra-linked sample was tested at the FDA laboratory in Chhatrapati Sambhajinagar. The batch, identified as BM1250, was submitted for analysis with 120 tablets. Of these, 13 tablets were found broken, with some powder also present inside the container.

An NSQ declaration means that the tested sample failed one or more specified quality parameters. It does not, by itself, establish that every unit in the entire batch is defective. Regulatory authorities undertake further action based on the test findings.

13 Maharashtra-Linked Products Feature In CDSCO July List

The July CDSCO surveillance list includes 13 products from Maharashtra. Besides the digestive tablet, several commonly used medicines were flagged for quality-related failures.

As per the list, a Telmisartan 20 mg sample failed the dissolution test at the CDSCO laboratory in Mumbai. An Azithromycin oral suspension (200 mg/5 ml) contained only 65.76% of the labelled azithromycin content and also showed fungal growth.

Aspirin Batches Found With Low Drug Content

Two batches of Aspirin 75 mg were found to contain only 0.32% of the labelled aspirin content. The tablets were also described as brittle and showed shiny, needle-shaped crystals.

A Glimepiride 2 mg sample, used in diabetes treatment, failed the dissolution test, while samples of Cefixime 200 mg and Telmisartan 40 mg were reported to have physical defects.

Meanwhile, Diabetis-All Powder, manufactured in Nashik district, was declared spurious after laboratory testing detected pioglitazone hydrochloride at 0.32 mg/gm.

A Sodium Chloride Injection 0.9% failed the Indian Pharmacopoeia requirement for particulate contamination, while Diclofenac gastro-resistant tablets failed the test for related substances.

The CDSCO's July surveillance exercise identified 239 NSQ products nationwide, including 13 linked to Maharashtra, highlighting continuing regulatory scrutiny of medicines and pharmaceutical products available in the market.

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