- When German regulatory inspectors from the Federal Institute for Drugs and Medical Devices visited Artemis Biotech's Hyderabad, India-based API facility, they found close to three dozen violations, reports FiercePharma. Most of the violations fall under the category of 'a lack of QA oversight,' including several major violations.
- Although the Federal Institute for Drugs and Medical Devices said that it does not think a product recall is necessary, however, the institute recommended that Artemis not be allowed to ship any simvastatin APIs to EU member countries.
- Artemis Biotech, which is headquartered in Mumbai, is a division of Themis Medicare—a joint venture between India-based Themis and Geodon Richter in Hungary.
It's a hard time to be an Indian drug or API manufacturer, because the heat is on. Inspectors are spilling in from the FDA, the European Medicines Agency (EMA) and even the World Health Organization. From API manufacturing facilities, to generic drug factories, to government-level institutes, inspectors who come to India to ensure that cGMP is intact are having to report back numerous deficiencies, violations and observations.
Last month for example, the EMA recommended the suspension of marketing authorization for dozens of generic drugs that relied on bioequivalence studies from the India-based Semler Research Centre, after concluding the center's studies were flawed. The European Commission is currently weighing that recommendation.
As for the violations at Artemis Biotech's API facility, they included failure to keep important GMP data in the quality management system, data integrity problems and abysmal record-keeping. And although the likelihood of recalls is low, there is a chance that the EMA will pull the facility's manufacturing certificate.
The challenge is manifold as companies try to police far-flung production facilities, while regulators attempt to implement GMP and work with companies that are in violation. At the same time, it's pharma companies that are caught in the cross-hairs, including most recently, Sandoz, Teva and Mylan.