European authorities have slapped Indian drugmaker Marksans Pharma's plant in Goa with a noncompliance report in the wake of a reinspection of the facility in November. The move is just the latest in a parade of crackdowns by Western regulators to improve the quality of drugs coming from Asia.
The European Medicines Agency (EMA) recently posted the notice on its website, citing shortcomings found during a reinspection by the U.K. that followed a March 2015 inspection. According to the notice in the EudraGMDP, inspectors identified critical problems with the facility's data integrity system that included the destruction of parts of records of prime data and missing and deleted lab data.
The agency didn't request a recall of any products from the plant. It did, however, recommend the withdrawal of Marksans' GMP certificate, and urged Indian government agencies to evaluate the products supplied at the Marksans Goa facility and enact measures to ensure a continued supply.
The action by the agency comes in the wake of a similar crackdown last summer when Italian regulators recommended bans for two plants in China and one in India for issues related to data falsification.
U.S. and European regulators have been ramping up their enforcement in recent years to correct manufacturing problems at plants in India and China and make sure the pharmaceuticals produced there are safe. According to a recent Bloomberg report, more than 80% of main APIs for the world's drugs are manufactured in those two countries.
Local drugmakers in India and China aren't alone in being scrutinized by the regulators. Last year, plants in China owned by GlaxoSmithKline ($GSK) and Pfizer ($PFE) were cited for problems. Indian generic drugmakers like Wockhardt, Sun Pharmaceutical, Ranbaxy Laboratories, and Dr. Reddy's ($RDY) have all been hit hard by FDA sanctions that have included numerous warning letters and bans on products coming from a number of plants.
- see the EudraGMDP report