Ranbaxy Laboratories-Consent Decree-Indian Plants-Regulators

Ranbaxy reportedly hits bump with Indian regulator

Ranbaxy Laboratories, which is operating under an extensive consent decree with U.S. regulators, has now run afoul of authorities in India, which reportedly slapped it with a four-day suspension for "flouting" rules on product storage.The suspension, issued by the Maharashtra Food and Drug Administration, was prompted by a complaint by the Maharashtra Chemists & Distributors Federation (MCDF), reports Pharmabiz. Narendra Jain, general secretary of the MCDF, tells the publication he thinks Ranbaxy is getting off too easy for practices that expose products to potential contamination. A Ranbaxy spokesman told Pharmalot that the company was checking into the accuracy of the report.While this appears to be a local fight, even the hint of a suggestion of any manufacturing or handling shortcomings is sensitive for the drugmaker. It has only recently gotten FDA approval to ship products from three of its Indian plants and is under unprecedented scrutiny as part of a 5-year, 55-page consent decree announced earlier this year. In 2008, regulators uncovered a list of issues, including faked drug quality data, and banned 30 products from the U.S. Among other provisions, the decree requires the company to set up an independent oversight group that can take in complaints from employees and elsewhere. The auditors are to report all of their findings and recommendations to the FDA as well as the company. Ranbaxy has taken full advantage of its ability to ship products from its upgraded plants to the North American market. As a result of the FDA approval for Ranbaxy's generic of Pfizer's ($PFE) Lipitor, the company has seen its sales here surge. In its first full quarter selling copycat Lipitor, the Indian genericsmaker reported sales in North America doubled to $375 million.- check out the Pharmabiz story
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source:http://www.fiercepharmamanufacturing.com/

Price Controls-Drug Shortages-The Government-Formal Price

Drug shortages deepen as Pakistan debates price controls

Shortages of some drugs in Pakistan are mounting as the government continues to dither over whether to keep price controls on a host of drugs.Both domestic and Western drug manufacturers have urged the government to act, saying shortages could become extensive and some foreign companies may just decide it is not worth doing business there, reports The Express Tribune. Citing sources, it says there has not been a formal price increase since 2001.There already have been shortages of some drugs, The Express Tribune reports, because margins got so thin that domestic drugmakers quit producing them. Last month, the American Business Council, which represents 65 American drug manufacturers in Pakistan, warned authorities that if matters are not sorted out soon, Pakistan could face shortages of more than 800 drugs. The ABC said its three largest clients--Pfizer Pakistan ($PFE), Johnson & Johnson ($JNJ) and Abbott Laboratories ($ABT)--are already being affected by the supply chain disruptions. The organization played the economic development trump card, saying Western companies might reconsider their commitment to Pakistan if problems persist.Meanwhile, analysts are warning the government that a price control policy will not be healthy for the industry in the long run, reports The Economic Times. Analysts say experience elsewhere shows price controls will not improve health access but will limit drug innovation in the country at a time when rising life expectancy calls for new varieties of pharmaceuticals.David Taylor, a professor at the University of London, points to his experience in India, which is currently debating the expansion of price controls on drugs. "Price caps have the opposite effect, though, by disincentivising the sale of innovative drugs or drug research in India. Patients with incurable endemic diseases will continue to suffer in silence since cures for such diseases may no longer be actively researched," he said.- read The Economic Times story
- more from The Express TribuneRelated Articles:
Pfizer, J&J, Abbott facing shortages of crucial ingredients in Pakistan
Even some domestic firms rail at India's price control plan read more..

source:http://www.fiercepharmamanufacturing.com/

Intellectual Property-Compulsory License-Indian Government-Natco Pharma-Patent Case

U.S. questions India's IP regime after Nexavar move

Is intellectual property safe in India? That's the question drugmakers--and now U.S. officials--are asking, as the country's top court considers a landmark patent case, and after the government ordered its first compulsory license on a Big Pharma-patented drug.The issue drives to the heart of pharma's push into emerging markets; after all, if innovative drugs aren't protected, then how can the makers of those drugs profit? But, at the same time, developing countries--and the citizens who can barely pay for food, much less medication--can't afford to pay the prices demanded in mature markets. And what good is a lifesaving drug if only a tiny fraction of patients can use it?Not surprisingly, U.S. Commerce Secretary John Bryson came down on Big Pharma's side, The Economic Times reports. During a visit with Indian Commerce Minister Anand Sharma, Bryson protested the government's order that Bayer ($BAY) allow domestic drugmaker Natco Pharma to knock off its cancer drug Nexavar at a vastly reduced price.Bryson told Sharma that "(a)ny dilution of the international patent regime was a cause for deep concern for the U.S.," a government official told the ET. But Sharma countered, saying the World Health Organization's compulsory licensing provisions were established for cases just like this--life-threatening illness treated by a drug out of reach at brand-name prices.Meanwhile, India's Supreme Court is hearing arguments in Novartis' ($NVS) long-running patent dispute. The fight involves the Swiss drugmaker's groundbreaking cancer treatment Gleevec, which India's patent officials deemed unworthy of market exclusivity. The case not only determines the fate of Gleevec--and the patients who need it--but could affect access to HIV drugs and other treatments now produced and sold at low cost.If Novartis succeeds in striking down the Indian patent provision in question, "it will open a flood of patents," Leena Menghaney, a lawyer with Médecins Sans Frontières, told the Globe and Mail. And that could make many drugs suddenly inaccessible.But Novartis maintains that access to medicines depends on patent protection. The company "is seeking clarity on whether we can rely on patents in India and whether we as a research-based organization can continue to invest in the development of better medicines for India," Novartis' top official in India, Ranjit Shahani, told the newspaper. We'll soon see how the Indian justices feel.- see the ET story
- get more from The Globe and MailRelated Articles:
Indian government forces Bayer to accept generic Nexavar competition
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Natco wants OK to copy patented Pfizer HIV drug read more..

source:http://www.fiercepharma.com