- The World Health Organization (WHO) has suspended approval of all tuberculosis (TB) products produced by Svizera Labs at its Mumbai, India site, according to Reuters.
- During an inspection of Svizera Labs last fall, the WHO found dirty surfaces, black mold, poor-hygiene situations and faulty record-keeping.
- Poor record-keeping has been at issue with a number of Indian manufacturers, and is often cited in warning letters sent by the U.S. FDA.
Svizera Labs is a subsidiary of Maneesh Pharmaceuticals and has a large presence in both India and Europe. The company manufactures 25 different combination medication-based treatment regimens for TB. Products include varying combinations of rifampicin, isoniazid, ethambutol and pyrazinamide.
According to the WHO Tuberculosis Report for 2015, 9.6 million people contracted TB in 2014, and 12% of those people were HIV-infected. What this means is that for patients who have TB and HIV, their treatment regimens must be modified in order to take their immune-compromised status into account. Tainted medical supplies are a direct threat to their health.
India has been besieged by quality-control issues for the last several years, and despite increased FDA and WHO oversight, the problems continue to mount. For its parts, Svizera Labs claims they have rectified the problems.