Global Fund stops sourcing IPCA's anti-malaria drug
08 Apr 2016
IPCA Laboratories Ltd on Thursday said the Global Fund to Fight AIDS, Tuberculosis and Malaria, which supports disease eradication programmes across the world, has stopped sourcing the company's anti-malarial drugs after a US regulatory warning about quality lapses at its plants in India.
Switzerland-based Global Fund stopped sourcing malaria drug from Ipca Laboratories after the company received warning letter from the US health regulator for lapses in manufacturing norms at three of its facilities.
The US Food and Drug Administration (FDA) had, in February, issued IPCA with a warning letter pointing to manufacturing quality lapses observed at three of its factories in India. Those plants already are banned from supplying to the United States.
Global Fund's action would vastly limit sales of IPCA's Artemisinin-based Combination Therapy (ACTs), an anti-malarial treatment, following a "risk consideration exercise", the drugmaker said.
"In the light of the warning letter issued to the company by the USFDA on January 29, 2016, they (The Global Fund) have re-assessed the situation and following a risk consideration exercise, will not allocate any volume of Artemisinin based Combination Therapy (ACTs) to the company," Ipca Laboratories said in a statement issued to stock exchanges.
The Global Fund will only source ACTs from other pre-qualified suppliers that have no outstanding issues with the regulators, it added.
WHO recommends Artemisinin-based Combination Therapies (ACTs) for the treatment of uncomplicated malaria.
IPCA has 16 manufacturing plants in India from where it supplies to more than 120 countries. The three sites banned by the US also supply to India, the UK and Canada.
FDA has been raising quality issues with several Indian drug manufacturers in India citing violation of manufacturing quality standards, as the regulator has increased its oversight of the industry, which is a key supplier to the United States.
Global Fund, a Geneva-based public-private partnership set up in 2002, has made considerable progress in tackling epidemics of deadly infectious diseases.