The FDA’s goals in India are to obtain robust information to help FDA officials make decisions about the products from India that are being developed for the U.S. market.

The U.S. Food and Drug Administration (FDA) has banned the sale of generic medicines and ingredients from several manufacturing plants in India after drug quality concerns surfaced, reports Bloomberg.  Last month, for example, FDA inspectors learned that drugs were being retested to gain the favorable results needed to sell.  Indian facilities for Ranbaxy Laboratories Ltd. and Wockhardt Ltd. have been banned from selling drugs in the U.S.

According to a press release from the FDA, Ranbaxy is prohibited from distributing drugs made at certain Indian facilities.  Additionally, even if the drug is made at Ranbaxy’s New Jersey facility, it may not be sold if it contains components called active pharmaceutical ingredients (API) from Ranbaxy’s banned Indian facilities.  The FDA has also banned manufacture of API for any FDA-regulated product, export of API to the U.S. for any purpose, and provision of API to any other company or facility that makes products for American consumers.

The FDA concluded inspecting the Ranbaxy Toansa facility on Jan. 11, 2014, identifying significant violations of manufacturing standards.  These included Toansa staff retesting raw materials, intermediate drug products, and finished API after those items failed analytical testing and specifications, in order to produce acceptable findings, and subsequently not reporting or investigating these failures.

Ranbaxy states that they manufacture over 500 molecules and combinations for generic versions of pharmaceutical products.  Some of their most popular products include the hypolipidemic simvastatin and the anti-bacterial amoxicillin.  The company website touts their approval by numerous regulatory bodies in the U.S., Europe, Africa, Asia Pacific and Latin America.

The U.S. Embassy website states that the FDA’s goals in India are to obtain robust information to help FDA officials make decisions about the products from India that are being developed for the U.S. market. This includes products that are being reviewed for marketing authorization in the USA, and that are presently already on the U.S. market.

There are concerns about the ramifications of this prohibition on Indian firms, reports Economic Times.  Given that the U.S. generics market is a $35 billion industry, firms cannot afford to be banned.  Additionally, 40 percent of generic drugs in the U.S. come from an Indian facility and non-compliance may harm the patients that need access to their drugs.  The FDA will be monitoring access issues and may modify their prohibition if there is a shortage.