The U.S. Food and Drug Administration released an import alert Wednesday, tagging more than 40 drug companies to ban their imports from India.
One of the drugmakers in question is Sun Pharmaceutical Industries Ltd., which produces generic medication out. In particular, the FDA is banning imported medications made from the company's Karkhadi plant in the Gujarat state. In the last year as well, the agency has imposed a number of sanctions on India's generic drug makers, triggering worries over the quality of medications supplied by the country.
Generic drugs is a $14 billion industry and the United States is India's biggest market. However, the top supplier of generics to the U.S. is Canda, which accounts for 40 percent of over-the-counter and generic drugs sold to Americans.
According to Rohit Bhat, an analyst for B&K Securities, the FDA is becoming stricter, which is just right. He said drugmakers will have to invest more, pulling up quality standards to meet requirements to distribute generic drugs in the U.S.
It's not clear in the import alert what infractions Sun Pharmaceuticals is guilty of but it shows growing concern over the quality of medications manufactured in India. The country is considered the "pharmacy to the world," offering low-cost generic drugs in demand in various countries and not just the U.S.
Sun Pharmaceuticals has acknowledged the ban but said that restrictions on its products made from the Karkhadi plant will not drastically affect its operations. In fact, a spokesperson for the company referred to the ban as negligible since it will only affect less than a percent of Sun Pharmaceuticals' overall sales. However, the company has still launched corrective steps to address the problems that gave the FDA cause for concern.
The race to come out with generic versions of drugs coming off patent is tight, pushing pharmaceutical companies to rush to release their own before the competition. It is necessary to be the first to launch a generic drug because doing so will give the company a period of six months in which it can exclusively sell its product.
Pharmaceutical companies are aware of their lapses and are working towards addressing these, most especially if they want to continue tapping into the billion-dollar market in the U.S.
Photo: Erich Ferdinand | Flickr
