Switzerland-based Global Fund, which financially supports various disease eradication programmes, will not source malaria drug from Ipca Laboratories as the company has received a warning letter from the US health regulator for lapses in manufacturing norms at three of its facilities.
In a regulatory filing, Ipca Laboratories said the Geneva-based organisation that provides financial aid against AIDS, tuberculosis and malaria, has informed the company about its decision on Wednesday via a letter.
"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.
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.
Founded in 2002, the Global Fund is a partnership between governments, civil society, the private sector and people affected by the diseases.
It raises and invests nearly USD 4 billion a year to support programmes run by local experts in countries and communities most in need.
The USFDA in its observation has found major anomalies -- including systemic data manipulation and manufacturing norm violations -- at the three plants of Ipca Laboratories.
According to the warning letter sent by the USFDA over the three plants, its inspectors observed systemic data manipulation and other current good manufacturing practices (CGMP) violations and deviations at the company's three facilities.
The three plants are located at Ratlam, Pithampur (Madhya Pradesh) and Piparia (Silvassa).
Discover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!
Find the best of Al News in one place, specially curated for you every weekend.
Stay on top of the latest tech trends and biggest startup news.
