Indian authority withdraws Ranbaxy plant export permit

Indian authorities, who have been criticized for turning a blind eye to serious problems at Ranbaxy Laboratories plants there, have stopped a Ranbaxy API plant in Toansa from being able to sell products outside of India.

The European Medicines Agency (EMA) said Wednesday in an emailed statement that "On 26 March 2014, Indian authorities withdrew the site's 'Written Confirmation,' effectively making the suspension of the exports official for the time being. The Written Confirmation is a document that accompanies all APIs exported to the EU (and elsewhere) to certify that relevant manufacturing standards have been met."

The news comes only days after India's Sun Pharmaceutical announced it would buy Ranbaxy in a $3.2 billion all-stock deal and would make its top priority getting Ranbaxy plants compliant.

It turns out that in January, Ranbaxy voluntarily halted shipments to Europe from the Toansa plant, as well as from a plant in Dewas, after actions by the FDA raised serious questions about their operations. In September, the FDA banned the Dewas plant from exporting to the U.S. and then cut off exports from the Toansa facility in January after a follow-up inspection there. Warning letters for the plants said they had faked analytical data and then covered it up by deleting audit trails from computer systems. Serious sanitation issues were also identified. The EMA said Ranbaxy notified the agency that a company investigation had found "GMP failings" at Dewas. Ranbaxy had issued a statement in January that the FDA had banned the Toansa facility but did not say that it also had voluntarily suspended shipments to the EU.

The EMA said Wednesday that a team of inspectors from Germany, the U.K., Ireland, Switzerland and Australia did their own "unannounced" inspection of Toansa following the FDA ban and are planning an inspection at the Dewas plant in June. The EMA said that it will not permit any imports from the two facilities until it has confirmed that problems at the facilities have been fixed. But it also said there isn't any evidence that any Ranbaxy products in Europe pose a risk to patients.

Indian authorities in the past have said they looked over the Ranbaxy facilities but didn't see anything that warranted stopping production. They claimed Ranbaxy's finished products met Indian requirements. But a lawyer in India has been pushing a public service lawsuit to force an investigation of Ranbaxy for the problems that led it to plead guilty last year in the U.S. to felony charges and pay $500 million in penalties. The Indian Supreme Court last month agreed to examine the complaints. State regulators in India assume oversight of drug manufacturing facilities from the central government after they have been open for four years. In March, one state FDA inspected Wockhardt plants that the U.S. FDA and the EU have also banned and said it had found problems. There have been no reports yet of any actions taken.

In February, FDA Commissioner Margaret Hamburg made her first trip to India and met with government and industry leaders. India produces 40% of the generic and over-the-counter drugs used in the U.S., and the FDA is enlarging its staff there to do more inspections and to educate the industry about its expectations. Hamburg returned with promises of more cooperation between the two countries, but she also urged officials to do more to ensure drug safety--not only for U.S. consumers but also for consumers in India.

- here's the EMA statement