South China Drug Makers Differ on Impact of Product Safety

UNCLAS SECTION 01 OF 02 GUANGZHOU 001049 SIPDIS SENSITIVE SIPDIS STATE PASS TO USTR STATE FOR EAP/CM E.O. 12958: N/A TAGS: ETRD ECON PGOV CH SUBJECT: South China Drug Makers Differ on Impact of Product Safety Issues ¶1. (SBU) SUMMARY: Several pharmaceutical companies in South China appear to have taken steps to improve their quality assurance (QA) procedures and put them more in line with international standards. Product safety and integrity problems interestingly are reinforcing for Chinese companies the need to address IPR violations so as to protect brands and clamp down on counterfeits and fakes. Drug Industry executives have also expressed interest in obtaining U.S. Food and Drug Agency approval for their products, but they claim to be confused about the approval process - not just in the United States, but in China as well. END SUMMARY. Snapshots of Three PRC Drug Companies -------------- ¶2. (SBU) Baiyunshan Pharmaceutical Company: According to Managing Director Qi Zhaoji, Baiyunshan mainly produces antibiotics and over-the-counter medications. It also has a Hong Kong-based subsidiary that specializes in traditional Chinese medicines (TCM). Founded in 1992 and listed on the Shenzhen Stock Exchange in 1993, Baiyunshan ranks as China's 25th largest pharmaceuticals company by sales volume. In August 2007, one of Baiyunshan's 11 subsidiary companies formed a joint-venture with U.S. Baxter, an American medical device company. ¶3. (SBU) Hua Hong Pharmaceutical: Board of Directors Secretary Liang Song told us that his firm - founded in 1971 and restructured in the late 1990s - has been transformed from a failing state-owned enterprise into a multi-million dollar company. Today it is a household name in China. Hua Hong's TCM products are mostly aimed at women. The company claims that its most popular product - the Hua Hong Tablet - is the first oral TCM designed to treat gynecological inflammation. Hua Hong's market is primarily domestic, with some exports going to South East and East Asian countries. ¶4. (SBU) Ranbaxy (Guangzhou) Ltd.: This subsidiary of India's largest pharmaceutical manufacturer produces active pharmaceutical ingredients (APIs) which are primarily exported to U.S.-based drug makers and used in the manufacture of finished drug products such as antibiotics and cardiovascular medications. The United States accounted for 80 percent of its sales. Improving Quality Assurance Procedures or... -------------- ¶5. (U) Two of the pharmaceutical companies visited by Congenoffs reported that they had strengthened their quality assurance systems in response to recent media reports about product safety problems. Baiyunshan implemented a new quality assurance regime in 2006 in response to several high profile drug scandals in Anhui province that led to deaths around China. The firm provided detailed information on its "5 S Quality Assurance System," which mandates quality control reviews at each phase of production and by each level of the company. It has also established an independent QA department and an extensive customer service response system, including a hotline to report potential quality issues. ¶6. (SBU) Hua Hong's Liang said that the recent spate of consumer safety scandals had prompted the company to reexamine its QA processes. Liang's candid statements were "clarified" by the local Foreign Affairs Office official, who also attended the meeting with Congenoff and who averred that Hua Hong had not changed or improved its QA regime as a result of media reports. Rather, he emphasized, Chinese enterprises and government officials had "continuously stressed the necessity of adherence to product safety regulations and will continue to do so in the future." Satisfied with Status Quo -------------- ¶7. (SBU) The Ranbaxy executive, in contrast, told us that recent news had not had an impact on the company's already strict safety and control procedures. He explained that Ranbaxy Guangzhou had received Good Manufacturing Practice (GMP) clearance, a standard introduced by the World Health Organization (WHO) in 1968, ensuring that products are manufactured and tested in compliance with WHO prescribed quality standards. The Ranbaxy executive claimed the GMP audit and certification process is accepted by 90 percent of countries around the world. In addition, he said 70-80 percent of Ranbaxy Guangzhou's operating costs go toward monitoring and GUANGZHOU 00001049 002 OF 002 maintenance of proper air pressure, humidity controls, and air quality. The executive also said that regulations enforced by China's State Food and Drug Administration (SFDA) regulations are quite strict. His facility is regulated by the Guangdong Province as well as the Guangzhou FDA; they conduct unannounced annual site over several days. Quality Assurance Problems Still Persist for Some -------------- -------------- ¶8. (SBU) Baiyunshan's Qi Zhaoji told Congenoff that despite its strengthened QA regime, its U.S. joint-venture partner, Baxter, had asked the Guangzhou plant to stop production until it could conclude a thorough investigation to ensure that QA procedures met global standards. Hua Hong showed Congenoff a flashy media presentation, which claimed Hua Hong is "refining Chinese medicine in a western way" by taking old folk remedies and mass producing them with the help of modern science. However, the factory tour was less convincing. At one point during the tour, the floor manager firmly led Congenoff away from a room where a machine was spitting brown medicine tablets into a dirty plastic bucket and onto the floor. Conditions in the room clearly did not reflect the modern science advertised in the media presentation. Renewed Focus on IPR -------------- ¶9. (U) Baiyunshan managers stressed to us that combating counterfeit drugs is one of their top priorities, especially in light of concerns about product safety. To that end, Baiyunshan has a special office devoted to IPR protection. This office works with the pharmaceutical professional association, public security bureaus and other law enforcement agencies. Customers can also use the customer service hotlines to report counterfeit products. ¶10. (U) Hua Hong's manager said that concern about counterfeit products had been heightened due to the risk of unsafe copies. He said that in July 2007, Chinese drug inspectors from SFDA found four batches of Hua Hong's most popular medicine - the Hua Hong tablet - that did not meet nationally mandated safety standards. Further investigation revealed that the medicines did not originate from the Hua Hong plant but were instead very convincing fakes. ¶11. (U) Ranbaxy is known in the U.S. for the high-profile patent law suit filed against it by Pfizer Pharmaceuticals. The ongoing law suit resulted in Pfizer's Lipitor drug patent being reduced by 15 months. The Ranbaxy executive informed us that the firm spends about 10% of corporate sales on research and development and employs 1,200 scientists who work on new drug applications. However, he noted that there had not yet been any discoveries of Chinese counterfeit versions of Ranbaxy products. Seeking Approval in the U.S. and China -------------- ¶12. (U) Baiyunshan and Hua Hong executives both told us that an important goal for them is to obtain U.S. Food and Drug Administration (FDA) approval for their drugs. Although one motive for FDA approval is access to the U.S. market, managers also seem believe that an FDA "seal of approval" would bring international legitimacy to their products that could boost sales in China and elsewhere. However, both firms complained of confusion over the FDA approval process. Pharmaceutical managers said they would welcome more communication with the U.S. FDA as well as with U.S. pharmaceutical associations so as to better understand the path to FDA approval. ¶13. (SBU) The Ranbaxy executive, on the other hand, complained to us about the drug approval process in China, which he said takes too long. He said the process takes one to two years and blamed delays on the high volume of applications. He pointed out that China has 4,000 GMP approved pharmaceutical manufacturers each submitting multiple approval requests per year. Thailand, in comparison, has only 170. GOLDBERG