Ranbaxy, which on Monday said that it did not receive any letter regarding import warning from the US Food and Drug Administration, on Tuesday confirmed having received such letter.
In a communication to the BSE, the company said that it had received a communication from the USFDA during late hour of Monday (September 16) that the regulator has imposed an import alert on its Mohali facility.
The USFDA has also advised that the Mohali facility will be subject to certain terms of the consent decree signed in January 2012.
Meanwhile, the stock recovered 3.9 per cent to Rs 331.20. On Monday, the stock had crashed 30 per cent following the import warning.
"Ranbaxy will review the details and will continue to fully cooperate with the USFDA and take necessary steps to resolve the concerns at the earliest," it said in a release to the BSE.
Meanwhile, the US Food and Drug Administration (USFDA) has confirmed that it has banned the manufacture of FDA-regulated drugs from Ranbaxy’s Mohali plant.
It has asked the company to hire a “third-party expert’’ to conduct a thorough inspection of the Mohali facility and certify to the FDA that the “facilities, methods, processes, and controls are adequate to ensure continuous compliance with CGMP (Current Good Manufacturing Practices)’’.
In a news release posted on the agency’s Web site >www.fda.gov , the agency has confirmed that on September 16 it had issued an import alert under which “US officials may detain at the US border drug products manufactured at Ranbaxy Laboratories Ltd’s facility in Mohali, India’’.
Several brokerages including HSBC, Anand Rathi, Angel Broking, Karvy and Antique, have said that the new development is "significantly negative" for the company.
Import alert
The USFDA said that the company would “remain on the import alert’’ till it complied with the US drug manufacturing requirements known as CGMP.
The release quoted Howard Sklamberg, Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, as saying that the FDA was “committed to using the full extent of its enforcement authority’’ to ensure that drugs made for the US market met federally mandated quality standards and wanted to ensure that the American consumers were confident that the “drugs they are taking are of the highest quality, and the FDA will continue to work to prevent potentially unsafe products from entering the country’’.
CGMP compliance
The USFDA also ordered that Ranbanxy’s Mohali facility be subjected to “certain terms of the consent decree of permanent injunction’’ entered against Ranbaxy in January 2012, which contained provisions to ensure CGMP compliance at some of Ranbaxy facilities, including in Paonta Sahib and Dewas, as well as provisions addressing data integrity issues at those two facilities.
Ranbaxy’s Paonta Sahib and Dewas facilities have been on FDA import alert since 2008, the release said.
FDA inspections
USFDA said that in September and December 2012, the FDA inspections had “identified significant CGMP violations’’ at Ranbaxy’s Mohali facility. They included failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality.
The decree prohibited the company from manufacturing “FDA-regulated drugs at the Mohali facility and introducing drugs into interstate commerce, including into the United States, from the Mohali facility until the “methods, facilities, and controls’’ used to manufacture drugs were “established, operated, and administered in compliance with CGMP’’.
Hiring 3rd party expert
The decree said that Ranbaxy was required to “hire a third-party expert to conduct a thorough inspection of the Mohali facility and certify to the FDA that the facilities, methods, processes, and controls are adequate to ensure continuous compliance with CGMP’’.
After USFDA was “satisfied that Ranbaxy has come into compliance with CGMP’’, the company would be permitted to resume manufacturing and distribution of FDA-regulated drugs at the Mohali facility, the notification said.
Drugs shortage
USFDA did not expect this action to cause a “supply disruption or shortage of drugs in the United States’’. It has recommended to patients not to “disrupt their drug therapy’’ as this could “jeopardise their health’’ and advised the patients concerned about their medications to consult their healthcare professionals.
Ranbaxy had, in a clarification issued yesterday afternoon after the shares were hammered, said that it had “so far not received any communication from the USFDA on this subject’’ and was “seeking information from the USFDA in this regard. But the FDA’s announcement would put at rest any speculation on its action.
Stock movement
Surprisingly, the stock was up in the morning trade on the NSE today. After yesterday's carnage when the stock lost about 30 per cent, Ranbaxy shares were up by Rs 17.40 or 5.46 per cent at Rs 335.90 on the NSE. Trading volume was about 37 lakh shares in the first 30 minutes.
In the previous session, shares of Ranbaxy lost over 30 per cent, eroding Rs 5,855 crore from its market value.
DGCI view
Drug Controller General of India G.N. Singh said that as far as the Mohali plant is concerned, the Indian regulator will not inspect the plant since "it is totally export-oriented'.
However, the Indian authority had already started looking into the safety of medicines from Ranbaxy that are being sold in India after the company pleaded guilty to violations in the US, and had to pay a $500-million fine for the same.
“From the regulatory point of view, we are looking into the matter (from an Indian perspective), Singh said.
“The investigation is in process and if there are some alarming findings we’ll take preventive actions,” he said.