India’s largest drug maker Ranbaxy Laboratories faces the possibility of major restrictions in the US market for medicines produced from some of its plants, if it violates a slew of quality-related conditions laid down by the US Justice Department including permission for third-party reviews of its facilities.
The Justice Department filed a proposal in a federal court in Maryland on Wednesday to settle a three-year old dispute with Ranbaxy Laboratories.
Under the settlement, Ranbaxy must allow third-party conduct reviews of its facilities, as well as audits of the data it provides to the US Food and Drug Administration (FDA).
The FDA has placed Ranbaxy on permanent injunction until it makes these changes.
Ranbaxy, majority-owned by Japanese pharmaceutical company Daichii, has been on USFDA alert since 2008 after facing charges of quality control violations at some of its Indian manufacturing facilities in Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh The FDA had banned the import of more than 30 generic drugs, including Zocor, a generic antibiotic to treat high cholesterol, and popular diabetes drug Metformin, citing serious manufacturing deficiencies in these two plants.
In a statement on Thursday, Ranbaxy said that it had agreed to “comply with current good manufacturing practices.”
The consent decree filed on Wednesday is unprecedented in its scope and can hold out lessons for other Indian generic drug manufacturers who thrive on manufacturing cheap copies of original medicines after the patent expires.
The company didn’t admit or deny the accusations detailed in the settlement, which requires approval by a federal judge.
“Today’s announcement is the next step in the process of finalising our agreement with the FDA to resolve this legacy issue,” said Arun Sawhney, managing director & CEO, Ranbaxy.
Last month, the drug maker had said that it has set aside $500 million ( about R2,500 crore) to resolve all potential civil and criminal liability related to the US investigation.
“Because this company continued to violate current good manufacturing practice regulations and falsify information on drug applications, the FDA took these actions to protect consumers,” said Dara Corrigan, associate commissioner for regulatory affairs, FDA.
However, the legal proceedings do not affect the US sale of Ranbaxy’s generic version of the best-selling drug in the world, cholesterol pill Lipitor.
Dr Reddy’s also in trouble
Dr Reddy’s Laboratories has run into trouble with the US health authorities again, this time for not highlighting important risk information on a promotional website for injectable generic fondaprinux sodium, a drug that it launched in the US market recently.
The failure to provide adequate warning about the risk of using the USP for injections was raised by the department of health and human services, under the USFDA.Last year, the US health regulator imposed an import ban on products made at Dr Reddy’s Laboratories’ Mexican plant for violation of current good manufacturing practices.