NEW DELHI (Reuters) - India’s IPCA Laboratories Ltd said on Thursday that the Global Fund to Fight AIDS, Tuberculosis and Malaria, would no longer buy the company’s anti-malarial treatments after a U.S. regulatory warning about quality lapses at its factories.
IPCA said in February that the U.S. Food and Drug Administration had issued it with a warning letter outlining manufacturing quality lapses observed at three of its Indian factories. Those plants had already been banned from supplying to the United States after earlier inspections.
The Global Fund will no longer source Artemisinin-based Combination Therapy (ACTs), an anti-malarial treatment, from IPCA following a “risk consideration exercise”, the drugmaker said.
The Global Fund “will not allocate any volume of ACTs to the company and ... will only source ACTs from other pre-qualified suppliers that have no outstanding issues with the regulators,” IPCA in a statement to the Indian stock exchange.
IPCA has 16 manufacturing plants in India from where it supplies to more than 120 countries. The three sites with U.S. bans also supply to India, UK and Canada.
Several drug factories in India have been cited by the FDA over the last two years for violating manufacturing quality standards, as the regulator has increased its oversight of the industry, which is a key supplier to the United States.
Geneva-based, the Global Fund is a public-private partnership set up in 2002 that has made considerable progress in tackling epidemics of deadly infectious diseases. No one at the organization was immediately available for comment.
Reporting by Tommy Wilkes; Editing by Greg Mahlich