In the U.S., the furor over Ranbaxy Laboratories' misdeeds has largely settled down, but the generics drugmaker is having trouble getting past it at home in India. Authorities, who took little notice in the 5 years leading up to Ranbaxy's May settlement with U.S. authorities, today confirmed that it has ordered a review of the manufacturing standards of the drugmaker.
"The DCGI [Drug Controller General of India] has already been ordered to review the good manufacturing practices compliance of the manufacturing facilities of Ranbaxy in India as well as to ascertain the quality, safety and efficacy of drugs manufactured for the domestic market at these facilities," Minister of State of Chemicals and Fertilizers Srikant Kumar Jena told The Economic Times. Government officials earlier had indicated they were deciding whether to probe the manufacturing practices at Ranbaxy based on problems identified in the U.S. settlement.
U.S. inquiries into problems at two of the Indian plants operated by the generics maker began in 2006 and resulted in an FDA import alert on products from the two plants in 2008. India reportedly looked at the issues at the time but took no action, leaving it to U.S. regulators. Ranbaxy entered into a consent decree in 2012 that put it under special FDA oversight, and then in May agreed to plead guilty to three felony charges and pay $500 million in penalties, in the largest-ever federal settlement with a maker of copycat drugs.
It was then, after Ranbaxy had reportedly cleaned up its act for several years, that consumers in India seemed to take notice and started asking officials there what they were doing about it. Some of the country's largest hospitals and a pharmacy chain temporarily stopped using Ranbaxy drugs in response to patient questions.
Ranbaxy has tried to quell concerns by announcing after the plea agreement that it is a different company with a different culture than the one caught making bad products. Ranbaxy CEO Arun Sawhney publicly declared that he stands by every pill the company makes. And he probably can, given that Ranbaxy is in the second year of the stringent 5-year consent decree that requires outside consultants to keep close tabs on Ranbaxy and report any problems to the FDA.
- here's the Economic Times story