Indian drug regulator reaches out to other countries as issues mount

The top drug regulator in India has decided it is time to confer with some of his peers around the world after a run of tough regulatory actions by Western countries against Indian drugmakers. Just last week the FDA issued a new import ban against yet another plant of the country's largest generic drugmaker, Ranbaxy Laboratories.

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."

The FDA issued the import ban on the Mohali plant, the fourth 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 from 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. The Mohali ban, announced last week, leaves Ranbaxy with only a plant in New Jersey currently allowed to market drugs in the U.S.

But the ban may have even broader implications. After the U.S. issued an import ban against a Wockhardt Indian plant in May, U.K regulators piled on with an import alert that affected Wockhardt drugs throughout the EU. Now regulators in the U.K. and Australia are trying to assess whether the ban the U.S. just put on the 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 UK 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 said essentially the same thing. 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."

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.

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