In yet another regulatory blow to generic drugs maker Ranbaxy Laboratories, the US Food and Drug Administration (FDA) has banned imports from its plant in Toansa, Punjab that manufactures active pharmaceutical ingredients (APIs).
This is the fourth unit of Ranbaxy to be proscribed by the FDA – and it means that all of the company's Indian plants have been banned by the FDA. Its other units at Paonta Sahib in Himachal Pradesh, Dewas in Madhya Pradesh and Mohali in Punjab have already been banned from supplying any products to the US.
"Ranbaxy Laboratories is prohibited from manufacturing and distributing APIs from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012," a USFDA release today said. Its three other Indian plants are also under 'consent decree'.
The unit at Toansa was Ranbaxy's main unit for producing API, a primary raw material used in manufacturing a medical formulation. It comprises of a major chunk of the production cost incurred by any pharmaceutical company. The US import alert means that the company will now have to source API from outside to manufacture medicines for the US market.
Controversially, the US is increasingly cracking down on generics made in India; many critics believe that this is mere disguised protectionism for its own pharmaceutical giants who are major contributors to political parties as well as the American economy.