Pharmaceutical companies are not taking Indian and foreign laws very seriously. As a result both domestic and international pharmaceutical authorities are taking punitive actions against these companies. For instance, the illegal online pharmacies of India are on hit list of Google and United States federal authorities. Similarly, the Maharashtra Food and Drugs Administration (FDA) has also raided many online pharmacies operating in Mumbai, Thane and Pune and has seized drugs worth Rs. 2 Crore.
Meanwhile the U.S. Food and Drug Administration (U.S. FDA) has issued the Import Alert 66-40- Detention Without Physical Examination Of Drugs From Firms Which Have Not Met Drug GMPs (PDF). It has banned import of pharmaceutical products from many Indian pharmaceutical companies. The notification would allow the detention without physical examination of drugs from firms which have not met drug good manufacturing practices (GMPs).
There are many Indian pharmaceutical companies on this list. Obviously, they cannot afford to get their products detained and forfeited and the only choice seems to be to recall the products that fail to meet the prescribed standards and criteria. It has been reported that Lupin Ltd is recalling 9,210 bottles of infection-preventing drug Suprax which failed a purity test in the United States.
The Suprax recall is the second for India’s fourth-largest drugmaker by sales, after pulling nearly 65,000 bottles from the U.S. in January last year because of discoloration. Other companies like Ranbaxy Laboratories Ltd, Sun Pharmaceutical Industries Ltd and Dr. Reddy’s Laboratories Ltd have also recalled their products in the past.
The latest recalled bottles of Suprax, used to prevent or treat bacteria-related infection, “did not meet specification in total impurities”, the FDA said on its website on Monday. The FDA classified the incident as a Class III recall, meaning use of or exposure to the drug is unlikely to cause any adverse health consequences.