Indian API maker voluntarily halts shipments to the U.S.

While a raft of India's largest drugmakers have had their shipments to the U.S. banned by the FDA over quality concerns, Ipca Laboratories has decided to do that on its own.

The drugmaker reported to the Bombay stock exchange that it was halting shipments of active pharmaceutical ingredients (APIs) from a plant in Ratlam after it scored a Form 483 following an inspection by the FDA. It said it "had voluntarily decided to temporarily suspended API shipments from this manufacturing facility for the US markets till this issue is addressed." The step has broader consequences because it uses APIs from the plant to make finished drugs at plants in Silvassa and Indore.

According to Reuters, Ipca exports to the U.S., Canada, Europe and Australia, but didn't indicate it was interrupting API or drug shipments to any other markets. The company did not delineate what kinds of problems inspectors noted in the report. but said it was fully committed to resolving the issues as quckly as possible.

India produces about 40% of the generic and over-the-counter drugs used in the U.S. and the FDA has been expanding its inspections there after finding that plants operated by some of the most noted drugmakers, as well as some other international players, had been cutting corners, faking data to indicate that APIs passed quality tests and also had sanitation concerns. Ranbaxy Laboratories had been found out years ago and had two plants operating under a consent decree. In the last year, the FDA has banned two more Ranbaxy facilities, as well as two plants owned by Wockhardt and one by Sun Pharmaceutical, as well as a number of smaller players.

During a visit to the country in February, FDA Commissioner Margaret Hamburg said she had found that many of the country's company's had modern, well-run manufacturing facilities and that problems at a few were casting a shadow over the industry. She urged regulators there to do more to insure quality by all of the companies. The FDA last year also brought in an Indian-born director for its expanded office there but Altaf Lal left the post and the FDA in May for undisclosed reasons. Another top official in the office also returned to the U.S., setting back FDA efforts to oversee and work with drugmakers there.

- here's the BSE announcement (PDF)
- read the Reuters story