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FDA warns 2 Indian companies for manufacturing lapses

PTI     August 26, 2013
In its latest action against Indian drug makers, the US health regulator FDA has red-flagged "significant deviations" from good manufacturing practices at two Indian pharmaceutical companies.

In the case of Hyderabad-based Posh Chemicals, the US Food and Drug Administration said that lapses found at its manufacturing facility may cause the Active Pharmaceutical Ingredients (APIs) manufactured by it to get adulterated.

During an inspection of the company's facilities, FDA found failure to protect computerised data from unauthorised access, failure to ensure that test procedures are scientifically sound and failure to follow and document quality-related activities at the time they are performed.

With regard to the second company, Himachal Pradesh-based Sentiss Pharma (formerly Promed Exports), the FDA said the company failed to establish adequate systems for monitoring environmental conditions and for cleaning and disinfecting the room and equipment in aseptic processing areas.

Besides, Sentiss allegedly failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, FDA has alleged.

In separate warning letters issued to the two companies, the FDA said that their deviation from "good manufacturing practices" could cause their products to be adulterated as per the US regulations.

The FDA said it may withhold approval of any new applications or supplements of the two companies, until they put in place necessary corrective measures and get those corrections approved as per the US regulations.

At least six Indian drug makers have been issued such warning letters so far this year by the FDA, which has also ordered recall of certain drugs manufactured in India.

Wockhardt and Fresenius Kabi received warning letters last month, while Hospira Healthcare India and RPG Life Sciences got such letters in May.

Besides, the FDA recently also clamped down on 15 companies globally, including Gujarat-based Amrutam Life Care, for illegal sale of drugs labelled as dietary supplements and ayurvedic products for treating diabetes.

Others having faced FDA action for non-compliance with various US regulations include Ranbaxy, Dr Reddy's Labs, Sun Pharma, Cadila, Aurobindo Pharma and Glenmark.

Known for making cheaper generic versions of expensive well-known drugs, India enjoys about 10 per cent share in the finished-dose product market in the US.

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