The World Health Organization dealt another blow to the active pharmaceutical ingredients (API) industry in India with the suspension of prequalified status of Mumbai-based Anuh Pharma for pyrazinamide and sulfadoxine. Both are compounds used to treat malaria.
It’s the second such action against Anuh’s Boisar facility located in the western state of Maharashtra. The company had previously pledged to fix a number of issues cited during an inspection that found failure in adequately detailing the sources of antibiotic APIs as well as sourcing one product, azithromycin, from a Chinese plant that was banned by the European Union in 2014 for violating good manufacturing practices.
Anuh Pharma announced the WHO suspension in a notice to the Bombay Stock Exchange that said the WHO action followed a ban by the European Medicines Agency (EMA) for shipping antibiotic APIs from the Boisar plant pending an inspection.
“In view of the EDQM suspension, the WHO prequalification authorities have suspended pyrazinamide and sulfadoxine from the WHO list of prequalified APIs until the WHO led inspection,” the company said in the notice.
Indian pharmaceutical manufacturing companies have come under intense scrutiny by U.S. and European regulatory agencies in recent years due to inspections that have uncovered unsanitary manufacturing conditions and data collection violations.
Last month, the WHO cited Cadila Healthcare for rabies vaccine manufacturing deficiencies its inspectors found at the company’s Moraiya plant.
- see the Bombay Stock Exchange notice