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China news tagged with: pharmaceuticals (23)

• China’s Pharmaceutical Market Primed to Explode

  

  Reuters reports that reforms in China’s health care system may be a boon for global pharmaceutical companies:

  As growth in the U.S. and European markets remains sluggish, many giant pharmaceutical companies are expanding their sales forces, distribution channels and research operations in China to tap into the country’s robust drug market — expected to expand at about 22 percent annually over the next five years, said Mandy Chui, senior principal of IMS Health Inc.

  Chui is the China expert at IMS Health, which provides market data on the pharmaceutical and healthcare industries.

  “We see companies continuing to invest in China because the other markets are not growing,” Chui said in an interview. “For companies, (China’s growth) is certainly a good story to tell to the Street, right?”

  With a huge and aging population, rapid urbanization and adoption of Western lifestyles that give rise to hypertension, obesity and other diseases, China is poised to become the world’s third biggest pharmaceutical market by 2013, up from its current No. 5 spot, said Chui.

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  • July 22, 2009 5:13 PM

• Beijing Sends Inspectors to Check on Factories Making “Made in India” Fake Drugs

  

  As reported in the Times of India, the government of Nigeria has claimed that imported pharmaceuticals that were labeled “Made in India” were actually created in China:

  The matter came to light after The Times of India reported that Nigeria’s Drug Regulatory Authority has seized a large consignment of fake anti-malaria drugs that were made in China but stamped ‘Made in India’ to escape blame. The TOI report resulted in the Indian government lodging a protest with China. 

  “We are highly concerned about the case and are sending investigating officials to the Chinese provinces involved, including Guangdong,” SFDA spokesperson Yan Jiangying told a press conference. 

  The statement shows that SFDA headquarters is Beijing does not fully trust its provincial units to carry out monitoring and investigation into the concerned company. It came soon after the SFDA hit out against a report in a British daily saying that fake Chinese drugs are flooding the United Kingdom. 

   

  See also past posts on counterfeit medicine.

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  • June 13, 2009 9:14 AM

• Big Pharmaceutical Companies Rely on India, China for R&D

  

  The IndUS Business Journal reports on the Ewing Marion Kauffman Foundation’s study, “The Globalization of Innovation: Pharmaceuticals – Can India and China Cure the Global Pharmaceutical Market?”

  …Indian and Chinese scientists are rapidly developing the ability to innovate and create their own intellectual property as a result of Western companies shifting their research and development operations to the two countries. In fact, several non-Indian firms with business units in India and China are performing advanced discovery and have begun to move into the “highest-value segments of the pharmaceutical global value chain,” according to the study.

  “Globalization is happening faster than people think. Having India and China conduct such sophisticated research and participate in drug discovery was unimaginable even five years ago,” report author Vivek Wadhwa, an executive in residence and adjunct professor Duke University’s Pratt School of Engineering, and a fellow at the Labor and Worklife Program of Harvard Law School, said in a statement. “The challenge is for America to understand this trend and realize the potential of globalization”…But, it is too early to tell if India and China will eventually rival the United States as important sources of novel drugs, and not just as the world’s top producers of generic medications. Whereas high-tech sectors such as software development and electronics manufacturing have experienced tremendous growth in Asia – the former in India and the latter in China – in the pharmaceutical industry, new products take years to emerge from the research and development stage and then must still clear regulatory hurdles. According to Wadhwa, most of the new risk-sharing agreements between Western and Asian drugmakers are relatively new, dating to 2005, so it could be another decade before they produce concrete results.

  See also past CDT posts on pharmaceuticals.

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  • February 20, 2009 7:01 PM

• Roger Bate: A ‘Green’ Olympics at Any Cost

  

  Written by Roger Bate, a resident fellow at the American Enterprise Institute, from Far Eastern Economic Review:

  Beijing is taking Draconian measures to clean up for the Olympic Games which start next month. In the past week, 300,000 high-emission or yellow-labeled vehicles, mainly freight trucks, have been banned from the city until Sept. 20 to ensure a “green” Olympics.

  Du Shaozhong, deputy director of the Beijing municipal environmental protection bureau, announced the auto restrictions in an attempt to ensure acceptable air quality for the Olympic athletes. Beijing residents are familiar with such bans–during conferences and for periodic “blue sky” days–but how they will cope with such a long-term ban is difficult to imagine.

  Another concern of the clean-up was revealed two weeks ago when the Chinese authorities revoked licenses for three pharmaceutical manufacturers, punishing 125 other companies (mainly retail pharmacies) for making, selling or distributing performance-enhancing drugs.

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  • July 15, 2008 6:18 AM

• China Cracks Down on Drug Companies

  

  In the run-up to the Olympics, China is cleaning up its pharmaceutical industry, which the U.S. has accused of exporting tainted drugs and manufacturing the worldwide supply of illegal performance enhancing drugs. From the New York Times:

  Chinese officials said Wednesday that licenses had been revoked for three drugmakers, including one that sent human growth hormone to the United States, and that they had punished 125 other companies, mostly pharmacies, for making, selling or distributing performance-enhancing drugs.

  The move was heralded as evidence that China was determined to live up to its promise to host a clean Olympics.

  Officials also challenged claims by the United States that China accounted for 99 percent of the illicit performance-enhancing drugs in the largest drug-enforcement action in United States history, known as Operation Raw Deal, last year. The United States had asked China to investigate 37 drug manufacturers.

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  • June 19, 2008 8:51 AM

• Drug Tied to China Had Contaminant, F.D.A. Says

  

  The New York Times continues its reporting on the heparin scandal with news that the drug sold in the U.S., which has been linked to 19 deaths, was contaminated with a counterfeit fake version of the real thing:

  Routine tests failed to distinguish the contaminant from the drug, heparin. Only sophisticated magnetic resonance imaging tests uncovered that as much as 20 percent of the product’s active ingredient was a heparin mimic blended in with the real thing. Federal officials said they did not know what the contaminant was.

  …Heparin is made from pig intestines. Scientific Protein Laboratories, based in Waunakee, Wis., bought raw heparin produced in some cases in small, unregulated family workshops in China and processed it in plants in Wisconsin and China, according to heparin traders and producers in China. Baxter International purchased the active ingredient from Scientific Protein and sold the finished drug.

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  • March 13, 2008 8:03 PM

• A Blood Thinner Might Be Linked to More Deaths

  

  From the New York Times, more bad news for the manufacturers of the blood thinner Heparin:

  Amid indications that more people may have died or been harmed after being given a brand of the blood thinner heparin, federal drug regulators said Thursday that they had found “potential deficiencies” at a Chinese plant that supplied much of the active ingredient for the drug.

  …The Food and Drug Administration said the number of deaths possibly associated with the drug, made from pig intestines, had risen to 21 from 4. But it cautioned that many of those patients were already seriously ill and that the drug might not have caused their deaths.

  The F.D.A. emphasized that it had yet to identify the root cause of the problem, and that it had not concluded that the Chinese plant was responsible. The agency also said it was investigating two Chinese wholesalers — also called consolidators — that supplied crude heparin to the Chinese plant, Changzhou SPL, as well as those that sold raw ingredients to the consolidators.

  Read more about the Heparin case from CDT.

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  • February 29, 2008 12:09 AM

• China SFDA: Buyers Must Vet Drug Safety

  

  After the international spotlight focused on the safety of the drug Heparin, produced in China, the State Food and Drug Administration has said that the responsibility to check a drug’s safety lies with the importing country. From AP:

  The State Food and Drug Administration, in a statement on its Web site, said it was cooperating with a U.S. probe into a factory that makes heparin, a blood-thinning drug by Baxter International that is subject to a massive recall due to adverse patient reactions.

  “We attach high importance to this,” the agency said in its first comment on the heparin recall. SFDA officials have not responded to repeated inquiries about the case.

  But the SFDA said that based on international practice, “safeguarding the legality, safety and quality of raw materials imported for use in pharmaceuticals is the responsibility of the importing country.”

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  • February 27, 2008 10:59 PM

• Drug Plant Name Confusion Prevented China Factory Inspection

  

  The U.S. Food and Drug Administration confused the name of a Chinese factory that made the tainted blood-thinning drug Heparin with another factory, an error that prevented the inspection of the right facility and resulted with 300 people experiencing deadly allergic reactions. The factory was also not inspected by Chinese regulators. The Chicago Tribune reports on how the Chinese and the FDA are trying to come up with an agreement on how regulate factories that produce pharmaceuticals for the U.S.

  The FDA’s explanation, by Joseph Famulare, deputy director of compliance for the FDA’s center for drug evaluation and research, comes amid questions about the safety of different types of goods made in China and the adequacy of the FDA’s inspection procedures for drugs entering the U.S. from China.

  More than 300 people have reported potentially deadly allergic reactions after taking the blood-thinning drug heparin, which includes a key active ingredient produced in China for Deerfield-based Baxter International Inc. by Scientific Protein Laboratories of Waunakee, Wis.

  While the cause of the allergic reactions remains unknown, the FDA said it plans to visit the Chinese plant this week as part of an investigation that the agency on Monday deemed “one of its top priorities.”

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  • February 19, 2008 2:40 PM

• China Didn’t Check Drug Supplier, Files Show

  

  Curtains are up. Here is more about the Chinese drug factory linked to four deaths in the States. From The New York Times:

  A Chinese factory that supplies much of the active ingredient for a brand of a blood thinner that has been linked to four deaths in the United States is not certified by China’s drug regulators to make pharmaceutical products, according to records and interviews.

  Because the plant, Changzhou SPL, has no drug certification, China’s drug agency did not inspect it. The United States Food and Drug Administration said this week that it had not inspected the plant either — a violation of its own policy — before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States…

  China provides a growing proportion of the active pharmaceutical ingredients used in drugs sold in the United States. And Chinese drug regulators have said that all producers of those ingredients are required to obtain certification by the State Food and Drug Administration. However, some of the active ingredients that China exports are made by chemical companies, which do not fall under the Chinese drug agency’s jurisdiction.

  See also related articles: Heparin Trail: Pig Intestines From China Via Wisconsin from the Wall Street Journal and Wisconsin firm tied to troubled blood drug from Chicago Tribune.

  » Read more
  • February 15, 2008 10:33 PM

• Chinese Factory Linked to Drug Under Inquiry in U.S.

  

  After the Trader Joe’s and pet food cases, now the spotlight is on Chinese drugs, from The New York Times:

  A Chinese factory that has not been inspected by the Food and Drug Administration is the source for the active ingredient of a critical blood-thinning drug whose production was suspended this week after 350 patients reported ill effects from it.

  At least four people died after being given the drug, heparin.

  An F.D.A. spokeswoman, Heidi Robello, said Wednesday that the agency was making plans to inspect the Chinese factory as well as a finishing plant in New Jersey “as soon as possible.”

  See also “China scrutinized in blood thinner problems” from the Los Angeles Times.

  » Read more
  • February 14, 2008 12:10 AM

• The F.D.A. in Crisis: Another Danger Made in China

  

  The New York Times follows up on their expose of tainted cancer drugs with an editorial calling for a stronger Federal Drug Administration in the U.S. to monitor imported pharmaceuticals:

  When Chinese regulators began to investigate the cause of the adverse reactions, plant workers tried to cover up what had happened, delaying corrective action. The government has now closed the factory and detained two company officials in a criminal investigation.

  The same company is the sole supplier to the United States of the abortion pill known as RU-486. That pill is made at a different factory that passed an F.D.A. inspection in May and was inspected three times in recent months by Chinese drug regulators. Still, in light of the company’s current difficulties, the F.D.A. would be wise to reinspect the plant promptly to ensure that the RU-486 production facility is adhering to rigorous quality control procedures.

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  • February 2, 2008 11:07 PM

• Tainted Drugs Linked to Maker of Abortion Pill

  

  The New York Times reports on tainted cancer medicine produced in China for export. According to the article, the same company is the sole producer for the U.S. of the abortion drug mifepristone, or RU-486:

  A huge state-owned Chinese pharmaceutical company that exports to dozens of countries, including the United States, is at the center of a nationwide drug scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise harmed last summer by contaminated leukemia drugs.

  Chinese drug regulators have accused the manufacturer of the tainted drugs of a cover-up and have closed the factory that produced them. In December, China’s Food and Drug Administration said that the Shanghai police had begun a criminal investigation and that two officials, including the head of the plant, had been detained.

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  • January 30, 2008 7:55 PM

• Big Pharma Eyes the China Market – Bloomberg

  

  In the latest version of the China-as-untapped-market story, U.S. and European pharmaceutical companies see a changing China as the place to maintain sales growth, writes Bloomberg’s Shannon Pettypiece:

  Penetrating the Chinese market is crucial for the drugmakers as China’s middle class of 300 million already matches the entire U.S. population and will double in three years. At the same time, prosperity is fueling an explosion in Western-style diseases, including an epidemic of obesity that now affects 90 million Chinese. With poor air quality and 350 million smokers, China’s rates of asthma, cancer and lung disease are surging. [Full text]

  And that spells opportunity. Still, Western companies know they have to compete with traditional medicines. For example, Pettypiece describes the marketing strategy for the allergy drug Claritin:

  » Read more
  • December 26, 2007 1:28 AM

• China’s Drug Addiction – Kathleen Kingsbury

  

  From Time:

  As an oncologist, Dr. Jiang Zefei is trained to save lives. Working in China’s mediocre health system, this is rarely an easy task. Patients typically cannot afford basic care, and up-to-date medicine often isn’t even available. Recently, though, Jiang has gained an unexpected helping hand: global clinical drug trials.

  Lured by immense patient populations ailing from both chronic and infectious diseases, Big Pharma has turned to China to test its newest products. Jiang’s cancer patients are the beneficiaries. “They’re getting advanced care without worrying about the price,” says Jiang, a staff physician at Beijing’s No. 307 Hospital. “It’s the difference between life and death.”

  Asia has become the next frontier for pharmaceutical firms desperate to find their next blockbuster drug while keeping research costs low. In 2006, big drug companies doubled R&D investment in China and India over the previous year, to $2.2 billion. Nearly all of that went into China, thanks to generous government support and strong infrastructure. Beijing wants to attract more than 2% of the world’s R&D budget, or about $10 billion, by 2010. [Full Text]

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  • November 15, 2007 10:32 PM

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