WHO Raises Serious Issues with Big Indian Supplier of Tuberculosis Drugs
World Health Organization (WHO) personnel this September released a letter uncovering a number of safety problems at a Mumbai-based producer of tuberculosis medicines.
WHO stated its examination at the facility of Svizera Labs, which is part of Maneesh Pharmaceuticals, from June 2015 discovered various crucial and major deviations from WHO Good Manufacturing Practice requirements and this recent Notice of Concern letter contains inadequacies that are still a problem for the company.
The list of inadequacies consists of possible manipulation of dissolution assessments, a lack of contamination controls, rusty and dirty surfaces on drug packaging lines, faulty seals and black mold in a cleaning area along with insufficient data monitoring.
The inadequacies mentioned are only relevant to pre-qualified products.
Svizera is one of four manufacturers contracted to supply medicines to Stop TB Partnership, a WHO-backed organization. Svizera Managing Director Vinay Sapte informed the media people that he did not agree strongly with the content of the report and that independent professionals visiting the factory since the WHO examination had identified it to be up to standard.
A quality manager of Svizera Europe also informed Outsourcing-Pharma.com that the organization doesn’t agree with WHO’s decision to publish the letter.
The Notice of Issue comes as over a dozen Indian drug-makers continue to have difficulty with data integrity problems.
The data are designed to make sure products fulfill pre-established requirements for purity, potency, stability and sterility, among other significant markers to figure out the medicines are safe and effective. In the absence of reliable data, the worry is that these products can’t be trustworthy. And FDA has subjected many of these organizations to import alerts, which indicates their products are rejected entry into the US.