Corrective Actions "Inadequate," U.S. FDA Warns Ranbaxy; Threatens Seizure And Injunction

MUMBAI - Ranbaxy's four-year-long tangle with U.S. FDA over the Indian firm's troubled manufacturing sites took one more serious turn as the world's most powerful regulatory agency fired another salvo saying: "It is apparent that Ranbaxy's attempts to make global corrections after past regulatory actions by the FDA have been inadequate."

As part of a Warning Letter issued to Robert Patton, Vice President at the Ohm Labs facility at Gloversville, and posted on its site recently, the FDA noted in a strongly worded statement, "We remind you that Ranbaxy is responsible for ensuring that all Ranbaxy drug manufacturing operations comply with applicable U.S. requirements, including the cGMP regulations."

"FDA expects Ranbaxy immediately to undertake a comprehensive assessment of its global manufacturing operations to ensure that all sites manufacturing drugs for the U.S. market conform to U.S. requirements," the agency concluded in the notice served on the Ohm Lab's facility that manufactures liquid formulations.

Since 2006, Ranbaxy has been undergoing scrutiny after the FDA charged the company with the falsification of data for drugs manufactured at Paonta Sahib and Dewas in India. Eventually, Ranbaxy had to bear a ban imposed on more than 30 of its products sold in the U.S. and a freeze on future approvals from the implicated manufacturing sites (Also see "Ranbaxy Woes Continue With 30-plus Product Import Alert" - Scrip, 16 Sep, 2008.).

Ranbaxy's Paonta Sahib has been cleared by other regulatory agencies like Health Canada, the UK's MHRA and Australia's Therapeutic Goods Administration.

U.S. FDA had cleared two other units of Ohm Labs as part of inspections conducted last July and August, but pointed at significant cGMP violations at Gloversville, which allegedly caused the drug products to be "adulterated."

In comments to PharmAsia News, Ranbaxy maintained that it is comprehensively cooperating with the FDA, but declined to share details of how Ranbaxy planned to resolve the issues.

In an indication of the wide range of issues at Ohm Labs aside from just manufacturing, FDA found that Ohm manufactured and distributed a prescription drug without an approved application - in violation of certain sections of U.S. interstate commerce laws.

FDA also slammed Ohm Labs for its inadequate response: "We received your firm's September 11, 2009 response, and we note that it lacks sufficient corrective actions."

One of the FDA findings centers on visible black particles in metformin. "The investigation did not include an assessment to determine whether the use of such defective equipment affected the quality of other batches of your product and other products that utilize the same filling machine," it said. The agency nailed the Ohm Labs site on other important manufacturing issues such as inadequate stability studies and lack of laboratory control mechanisms.

The agency sent out a harsh signal to Ranbaxy and cautioned that, "Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts."

It further notes: "Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected."

Reacting to the points outlined in the FDA warning letter, Citigroup's Prashant Nair wrote to Ranbaxy investors: "We are not sure whether the comments reflect the FDA's thoughts on the progress being made on the Indian plants but the cautionary tone of the letter bears highlighting, in our view. We would be concerned if the two larger units in the U.S. are affected. However, given that these were also inspected at the same time as the Gloversville unit without material observations, this appears unlikely."

- Vikas Dandekar ([email protected])