- The Global Fund to Fight AIDS, Tuberculosis and Malaria, a major NGO, will no longer be buying anti-malarials from IPCA Labs due to continued concerns over quality concerns at several of the company's facilities in India, reports Reuters.
- Specifically, the NGO will no longer source artemisinin-based combination therapy (ACTs) from IPCA, and will therefore rely on other suppliers which have not been flagged by the FDA.
- IPCA has 16 manufacturing plants in India, and supplies over 120 countries. Three of IPCA's plants have been banned from exporting to the US, however the decision to not source drugs from IPCA extends to all of its plants.
India's quality-control related problems have been going on for several years; however, the world still relies on India's generic drug industry. Problems range from data-related issues, to packaging mix-ups, evidence of contamination and API problems. The FDA currently lists 42 Indian firms on its import ban alert.
Nonetheless, the Indian pharmaceutical market is one of the fastest-growing in the world. Estimates peg its 2020 valuation at anywhere between $40 billion to $55 billion.
The US alone receives 40% of its generics from India, and other countries rely on India even more heavily. Given the anticipated rate of growth and the world's reliance on India's manufacturing prowess, additional steps, above and beyond the FDA's stepped-up inspection schedule in India, are needed to fully put quality concerns to rest.