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Regulatory Focus™ > News Articles > WHO Raises Serious Concerns With Indian TB Drugmaker

WHO Raises Serious Concerns With Indian TB Drugmaker

Posted 04 September 2015 | By Zachary Brennan 

WHO Raises Serious Concerns With Indian TB Drugmaker

World Health Organization (WHO) inspectors earlier this week released a letter uncovering a number of safety issues at a Mumbai-based manufacturer of tuberculosis drugs.

WHO said its inspection at the facility of Svizera Labs, which is part of Maneesh Pharmaceuticals, from June 2015 uncovered several critical and major deviations from WHO Good Manufacturing Practice standards and this latest Notice of Concern letter includes deficiencies that are still a problem for the company.

The list of deficiencies includes possible manipulation of dissolution tests, a lack of contamination controls, rusty and unclean surfaces on drug packaging lines, defective seals and black mold in a cleaning area as well as inadequate data surveillance.

The deficiencies cited are only related to pre-qualified products.

Svizera is one of four manufacturers contracted to supply drugs to the Stop TB Partnership, a WHO-backed organization, according to Reuters. Svizera Managing Director Vinay Sapte told the media outlet that he disagreed strongly with the content of the report and that independent consultants visiting the factory since the WHO inspection had found it to be up to standard.

A quality manager of Svizera Europe also told Outsourcing-Pharma.com that the company disagrees with WHO’s decision to publish the letter.

The Notice of Concern comes as more than a dozen Indian drugmakers continue to struggle with data integrity issues.

The data are intended to ensure products meet pre-established specifications for purity, potency, stability and sterility, among other important markers to determine the drugs are safe and effective. In the absence of credible data, the concern is that these products cannot be trusted. And FDA has subjected many of these companies to import alerts, which means their products are refused entry into the US.

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