Indian company Svizera Labs has drawn a rebuke from the World Health Organization (WHO) for flawed manufacturing standards and testing procedures of tuberculosis drugs made for export to developing countries, the latest in a string of regulatory rebukes facing drugmakers in the country.
The company, owned by Mumbai-based Maneesh Pharmaceuticals faces the prospect of suspension on the approval and use of its products if "critical and major observations are not corrected within a reasonable time frame," Reuters news agency reported, citing a "notice-of-concern" from the WHO.
WHO prequalifies companies as suppliers for vaccines and medicines for a variety of global programs. In this case, the company is one of four manufacturers with a long-term contract to supply medicines to the Stop TB Partnership, Reuters said.
Reuters quoted Svizera Managing Director Vinay Sapte as saying he disagreed strongly with the report. "We are convinced that ... we can resolve this issue in short time," Sapte said in an emailed statement to Reuters.
A European-wide ban was put in place this summer on more than 700 drugs that were bioequivalency-tested by India's GVK BioSciences and in August, the WHO put India's CRO Quest Life Sciences on notice over falsified ECGs in an HIV drug trial.
The deficiencies cited by WHO included rusty and unclean surfaces and black mold in a cleaning area, as well as poor record-keeping.
The GVK issue began in May when investigators from France's Agency for Medicines and Health Products Safety examined 9 trials conducted at GVK's Hyderabad facility. The inspection found GVK employees repeatedly switched outpatient ECG scores with those of healthy volunteers.
The inspectors also criticized the quality of drug testing and said some of the results may have been manipulated.
At a wider level, top Indian generics makers including the fifth largest globally, Sun Pharmaceutical Industries, face a slew of U.S. FDA manufacturing sanctions over poor quality and record-keeping.
- here's the story from Reuters