Re 1 Ayurvedic Tablet Fails Maharashtra FDA Test

A popular Ayurvedic digestive tablet, widely sold in small Re 1 sachets, has been declared Not of Standard Quality (NSQ) by the Maharashtra Food and Drug Administration (FDA). The product was tested at the FDA laboratory in Chhatrapati Sambhajinagar, where 13 out of 120 tablets were found broken, with some powder also present inside the container.

The batch, identified as BM1250, was submitted for analysis and failed one or more specified quality parameters. This declaration does not necessarily mean that every unit in the entire batch is defective, but rather that the tested sample did not meet the required standards.

The Central Drugs Standard Control Organisation (CDSCO) has also listed the product in its July NSQ list, which names 239 products found to have failed prescribed quality parameters across the country. The list includes 13 products from Maharashtra, including several commonly used medicines that were flagged for quality-related failures.

One Telmisartan 20 mg sample failed the dissolution test at the CDSCO laboratory in Mumbai, while an Azithromycin oral suspension (200 mg/5 ml) contained only 65.76% of the labelled azithromycin content and also showed fungal growth. Two batches of Aspirin 75 mg were found to contain only 0.32% of the labelled aspirin content and were described as brittle, with 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. Additionally, a Diabetis-All Powder manufactured in Nashik district was declared spurious after laboratory testing detected pioglitazone hydrochloride at 0.32 mg/gm.

The CDSCO's July surveillance exercise highlights the ongoing regulatory scrutiny of medicines and pharmaceutical products available in the market. The FDA and CDSCO are responsible for ensuring that drugs and pharmaceutical products meet the required standards of quality and safety.

The declaration of these products as NSQ is a reminder of the importance of regulatory oversight in the pharmaceutical industry. It is essential for manufacturers to adhere to the required standards of quality and safety to ensure that their products are effective and safe for consumption.

The Maharashtra FDA has taken steps to address the issue, and further action will be taken based on the test findings. The CDSCO's surveillance list is a valuable tool for regulatory authorities to identify and address quality-related issues in the pharmaceutical industry.

In conclusion, the declaration of the popular Ayurvedic digestive tablet as NSQ is a significant development that highlights the importance of regulatory oversight in the pharmaceutical industry. It is essential for manufacturers to adhere to the required standards of quality and safety to ensure that their products are effective and safe for consumption.

The ongoing regulatory scrutiny of medicines and pharmaceutical products available in the market is crucial to ensuring public health and safety. The FDA and CDSCO will continue to monitor the situation and take necessary actions to address any quality-related issues.

The CDSCO's July surveillance exercise has identified 239 NSQ products nationwide, including 13 linked to Maharashtra. This highlights the need for continued vigilance and regulatory oversight in the pharmaceutical industry to ensure that products meet the required standards of quality and safety.

Overall, the declaration of the popular Ayurvedic digestive tablet as NSQ is a reminder of the importance of regulatory oversight in the pharmaceutical industry. It is essential for manufacturers to adhere to the required standards of quality and safety to ensure that their products are effective and safe for consumption.