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Ever since the new management has taken over Ranbaxy Laboratories, the company has been faced with many challenges and delays in approvals from the US Food and Drugs Administration (USFDA) for some of its major drugs.
In the past few years, the firm, the Indian arm of Japanese drug maker Daiichi Sankyo, lost some key first-to-file opportunities that could have earned it a potential revenue through 180 days of exclusive marketing in the US - the world’s biggest drug market.
The latest where the company is faced with a delay in securing the US regulator’s approval is generic Diovan. The firm claims it has 180 days’ exclusive marketing rights for the drug. However, the USFDA approval for the anti-hypertension drug, which was expected to come in September 2012, is still pending.
Meanwhile, a lot of other players have entered the US market with their generic version of Diovan HCT, a combination of valsartan with hydrochlorothiazide.
Recently, Indian companies such as Lupin and Aurobindo launched their generic versions of Diovan HCT. Last year, Mylan had also launched a generic of the drug after losing a legal fight with USFDA to launch Diovan.
The total US market for Diovan, a patented product of Novartis AG, is estimated at around $1.5 billion annually.
No evidence at present against Ranbaxy drugs: WHO
The World Health Organisation (WHO) said that at present it has no evidence that Ranbaxy manufactured medicines, that are currently prequalified by WHO, are of unacceptable quality.
However, it is closely monitoring all cases of substandard medicines and will take action if required based on merit.
“At present, there is no evidence that any of the Ranbaxy products currently included on the WHO list of Prequalified Medicinal Products are of unacceptable quality,” WHO said in a statement.
The agency also said that in 2004, three antiretroviral products manufactured by Ranbaxy had come under the WHO scanner and were removed from its list of prequalified products.
“The removal came after WHO-PQP reported deficiencies during inspections of a number of contract research organizations(CROs), including Vimta Labs, based in India, that had conducted bioequivalence (BE) studies for pharmaceutical companies,” WHO said. Following this Ranbaxy voluntarily withdrew seven products.
Thereafter, Ranbaxy conducted new studies and submitted new applications, the statement said.
“These applications were evaluated, and the CROs or BE studies were inspected and found to have been conducted in accordance with WHO good clinical practice,” it said.
