WHO Raises Serious Concerns With Indian TB Drugmaker.

WHO Raises Serious Concerns With Indian TB Drugmaker:

World Health Organization (WHO) inspectors earlier this week sent a letter to discover a series of security problems to a manufacturer of anti-tuberculosis drugs, based in Mumbai.

Who said inspection at the facility Svizera Labs, part of Maneesh Pharmaceuticals, in June 2015 revealed a number of important differences and major WHO standards GMP and the final notification of the menu consists of Concern gaps still are a problem for society.

The list of deficiencies includes the possible manipulation of dissolution testing, lack of pollution controls, oxidized and contaminated packaging lines of drugs, broken seals and black mold in an area cleaning surfaces and inadequate supervision data .

The aforementioned deficiencies are related to prequalified products.
Svizera is one of four contract manufacturers to provide drugs for the Stop TB Partnership, an organization supported by the WHO, according to Reuters. Vinay Sapte Svizera CEO told the media that he disagreed strongly with the content of the report and the independent consultants who visit the plant since the WHO inspection keep up was discovered.

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

The Notice of concern is that more than a dozen manufacturers of medicines from India continue to struggle against data integrity issues.

The data is intended to ensure that products meet predetermined specifications for purity, potency, stability and sterility, among other important markers to determine they are safe and effective medicines. A lack of reliable data, the concern is that these products can not be trusted. FDA and presented several of these companies to import alert, which means that their products entry into the United States refused.