The World Health Organization (WHO) has suspended its approval of all tuberculosis drugs manufactured by Svizera Labs, saying the Indian drugmaker's production standards and quality management were unreliable.
The action, reported by Reuters, comes after several inspections of the company's Mumbai plant that resulted in a warning letter issued in September. Svizera, which is part of Maneesh Pharmaceuticals, touts itself as one of the largest suppliers of generic TB medicines to more than 70 countries.
In its suspension, the United Nations health agency urged that all existing batches of TB drugs made at the facility should be checked by independent experts as they may need to be recalled. In its September letter, the agency warned the company of the suspension if "critical and major observations are not corrected within a reasonable time frame."
False and inadequate drug manufacturing data and plant hygiene issues were among 10 major problems cited by inspectors in the September letter to Svizera, which is one of four drugmakers with long-term contracts to supply WHO-supported agencies battling tuberculosis globally.
|Boudewijn Ploos van Amstel, managing director of Svizera Europe|
"The letter of suspension is very misleading," Boudewijn Ploos van Amstel, managing director of Svizera Europe, told Reuters. He said WHO ignored information from Svizera that showed its operations were up to standards.
The suspension is yet another mark against generic drug manufacturers in India, which have been under heavy scrutiny by U.S. and European regulators in the past few years.
Last week, the European Medicines Agency (EMA) slapped Indian drugmaker Marksans Pharma's plant in Goa with a noncompliance report in the wake of a reinspection of the facility in November that found critical problems with the facility's data integrity system, including the destruction of parts of records of prime data and missing and deleted lab data.