IGMPI India



US warned Indian suppliers for drug makers on plant practices

US regulators warned Indian companies that supplies ingredients for major drug makers for forging test results and failing to properly clean equipment.

The Food and Drug Administration is increasing enforcement in India due to the growth of quality issues. These Quality concerns have led FDA to ban US sales from some Indian factories. Canton Laboratories Pvt. Ltd of Vadodara was warned in a letter dated 27 February for a variety of manufacturing practices, including reporting results for tests it never performed to measure microorganisms in active ingredients and failing to ensure equipment was cleaned to prevent contamination.

Ranbaxy Laboratories Ltd and Wockhardt Ltd, both Indian companies, have been banned from supplying drugs to the US after being warned for manipulating test results and poor sanitation. The FDA has also issued a warning letter to Mumbai-based USV Ltd that accused the company of manipulating tests.