U.K., Australia gather FDA intel on Ranbaxy ban

After the U.S. issued an import ban against a Wockhardt Indian plant in May, U.K. regulators followed up with an import alert that affected Wockhardt drugs throughout the EU. Now regulators in the U.K. and Australia are trying to assess whether a new ban the U.S. just put on a Ranbaxy Laboratories plant might suggest issues for drugs manufactured for their countries.

"We are currently working with the FDA and other European regulators to assess the impact the FDA action has on the medicines from the Mohali site that are destined for the U.K. and European market," a spokesperson with the Medicines and Healthcare Products Regulatory Agency (MHRA) told The Economic Times. A spokesperson for Australia's Therapeutic Goods Administration echoed those thoughts. The MHRA spokesperson cautioned that patients should continue to take their meds because at this point there is "no evidence that medicines on the U.K. and EU market manufactured at this site are defective."

The FDA issued a import ban on a Ranbaxy plant in Mohali, the third against a Ranbaxy plant that markets to the U.S., after inspectors found a host of problems during inspections last year. According to reports, they found toilets without running water. They also discovered a drug tablet that appeared to have a human hair sticking to it; others had oil spots on them. And plant managers were not getting to the root cause of the problems. The plant was manufacturing generic Lipitor for the U.S. market until manufacturing issues created problems for that drug. CEO Arun Sawhney has said the company has taken steps since that last FDA inspection to get the issues in hand. In 2009, the U.S. issued bans against two other Ranbaxy plants. In 2012 they fell under a consent decree the company signed with the FDA, and the Mohali plant has been added to the provisions of the decree. Ranbaxy now has only a plant in New Jersey currently allowed to market drugs in the U.S.

India is a major manufacturer, particularly of generic drugs, for the U.S. and global markets. The FDA has beefed up its in-country inspection team there, and the result has been a host of recent actions against Indian drugmakers. In May, the agency tagged a Wockhardt plant with a ban after inspectors found serious manufacturing lapses and doctored documents. The company acknowledged that the ban could cost it $100 million in sales. That was before regulators in the U.K. and Europe followed suit, asking the company to recall products, as well as stopping imports from the plant. But India's office of the Drug Controller General of India (DCGI) decided the problems at the facility are not bad enough to take any punitive action after inspections of its own.

Now the the top drug regulator in India has decided it is time to confer with some of his peers around the world about the run of tough regulatory actions by Western countries against Indian drugmakers. According to the Business Standard, with problems for its drugmakers mounting, Drug Controller General of India G. N. Singh is confabbing with regulators in Europe this week about the cGMP standards that they expect. His agency might invite officials from the U.S. for discussions as well. "India is a developing country and we are evolving each day. The global standards are also changing and getting stricter with increasing generic penetration and competition," Singh told the newspaper. "Since our companies are major players in the sector, they are under stringent scrutiny."

- read the Business Standard story
- more from the Economic Times story