To resolve manufacturing and data integrity issues
The US Department of Justice has filed an injunction in a court in Maryland against Indian generic drug manufacturer Ranbaxy to resolve allegations of improper manufacturing practices at its plants in India and the US.
The consent decree will address outstanding current good manufacturing practice (cGMP) and data integrity issues at Ranbaxy’s Paonta Sahib, Batamandi and Dewas facilities in India, as well as cGMP issues at Ranbaxy’s wholly owned subsidiary Ohm Laboratories plant in Gloversville, NY, US. Ranbaxy is majority owned by Japanese pharmaceutical firm Daichii Sankyo.
The three Indian plants have been on FDA import alert since 2008 and Ranbaxy has closed its Gloversville facility.
The consent decree requires that Ranbaxy complies with detailed data integrity provisions before the FDA will resume reviewing drug applications containing data or other information from them.
Ranbaxy must hire a third party expert to review the plants and audit applications containing data from the affected facilities; adopt policies to ensure data integrity; and withdraw any applications containing untrue statements.
Failure to meet the requirements by a specific date could result in the company losing its 180-day marketing exclusivity for several generic drug applications. Ranbaxy has already agreed to relinquish the exclusivity it may have for three pending generic drug applications.
Further penalties will be imposed on Ranbaxy if it distributes any drugs from the affected plants or makes any untrue statements in its applications to the FDA.
The FDA can also make other Ranbaxy facilities part of the consent decree if they do not comply with cGMP practices or they have serious data integrity issues.
‘Because this company continued to violate current good manufacturing practice regulations and falsify information on drug applications, the FDA took these actions in an effort to protect consumers,’ said Dara Corrigan, FDA associate commissioner for regulatory affairs.
Ranbaxy has committed to further strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices.
Arun Sawhney, Ranbaxy’s ceo and md said: ‘This is the next step in the process of finalising our agreement with the FDA to resolve this legacy issue.
‘We are pleased with the progress we have made in upgrading and enhancing the quality of our business and manufacturing processes and remain committed to ensuring that all of our facilities and products meet the high standards that patients, prescribers and the public have come to expect from Ranbaxy.’