The implementation of the new edition of the Pharmacopoeia reduces the production of Xiaoyan Lidan Tablets by half

The implementation of the new Pharmacopoeia is speeding up the shuffling of the pharmaceutical industry. “There are a total of 129 production approvals for Xiaoyanlidan Tablets in the country. There are about 50 companies actually producing. After the 2010 Chinese Pharmacopoeia raised the quality standards for the drug, only 20 or more companies are now eligible to adopt the new standard. Production.” Li Chuyuan, general manager of Xiaoyan Libile’s annual sales volume – General Manager of Baiyunshan Hutchison Whampoa Chinese Medicine Co., Ltd. (“Baiyun Mountain and Huang”) recently announced to New Express that it was implemented on October 1 last year. The Chinese Pharmacopoeia raised the industry concentration of the drug.

The New Express reporter recently visited the mainstream pharmacies of Guangzhou, Neptunus, and Other major drugstores in the Guangzhou market. The sampling investigation found that only Baiyunshan Hehuang, Guangdong Luofushan Sinopharm Co., Ltd. (abbreviated as "Luofushan Guoyao") and Guangdong Wannianqing Pharmaceutical Co., Ltd. Four companies (referred to as "Evergreen") and Guangdong Tian Tian Pharmaceutical Co., Ltd. ("Yida Pharmaceutical" for short) are still on the market.

Product profits drop by 50%

Xiaoyan Lidan Tablets is a proprietary Chinese medicine for the treatment of acute cholecystitis and cholangitis. It has been listed on the domestic market for more than 30 years. Since it has a better curative effect and the price is less than RMB 10, it is very popular with the public. Because its ingredients mainly contain Andrographis paniculata, Radix szechuanica, etc., and the main origins of these raw materials are all from Guangdong, the drug is mainly produced in Guangdong pharmaceutical companies. The reporter found on the website of the State Food and Drug Administration that 129 enterprises had production approvals and Guangdong had 38, accounting for nearly 30%.

Prior to the implementation of the new Chinese Pharmacopoeia on October 1, 2010, the implementation standards of Xiaoyanlidan tablets were all based on the component indicators set in the 1997 edition of the Chinese Pharmacopoeia. The quality standards were relatively low and the quality controllability was poor. After the implementation of the new edition of the Pharmacopoeia, according to the new standard, the main drug in the anti-inflammatory gallbladder tablets - the content of andrographolide over the original standard increased by 3 times, the old standard containing andrographolide tablets 1mg, large 3mg; new standards were 5mg and 10mg . This will lead to increased costs for the business community. According to Zheng Chuanyu, minister of the Luofu Mountain State Pharmaceutical Marketing Department, the plant has invested more than RMB 5 million in research and equipment costs at one time.

Li Chuyuan told reporters that the contrast between new and old standards, coupled with the continuous increase in raw materials prices this year, as a whole, the profit margins of Xiaoyan Lidan narrowed by 50%.

Half of production companies

"Before the implementation of the new standard in October last year, although many enterprises with production approvals did not produce because they were not leading products, small quantities, and low market share, there were still about 50 companies producing anti-inflammatory and gallbladder tablets in China. Li Chuyuan said that after the implementation of the new version of the "Chinese Pharmacopoeia", only 20 or more were in line with the new regulations. One year later, the pattern of the drug market changes even more, and the degree of industrial concentration is getting higher and higher. Currently, Baiyun Mountain Huanghe, Luofushan Sinopharm and Evergreen have occupied 80% of the market.

The reporter also learned that in the implementation of the new standard for Xiaoyanlidan tablets, the related production companies presented three different situations: Some enterprises chose to increase input to meet the needs of the new standard; some enterprises chose to digest the inventory and comprehensively judge the cost performance. Afterwards, the next step is to be done; some companies are completely unable to meet the requirements of the new standard and can only opt out.

In fact, Xiaoyan Lidan Tablets is just a microcosm of the new edition of the Pharmacopoeia to accelerate the reshuffle of the pharmaceutical industry.

The 2010 edition of the “Chinese Pharmacopoeia” not only increased the number of varieties collected by more than 40%, but also improved or improved the original standard of 70%. Industry insiders said that this will inevitably lead to a more prominent market position of dominant companies.

Xie Zhijie, director of the Guangdong Provincial Institute of Drug Control, said that funds and R&D technology are the first threshold for pharmaceutical companies. For those companies with insufficient strength, they will be eliminated in the process of raising standards.

According to Guo Fanli, a research fellow in the pharmaceutical industry of China Investment Advisors, about 90% of drug companies in China are SMEs, with the best annual sales amounting to 100 million yuan, and the annual net profit of most SMEs is between 10 million and 20 million yuan. yuan. Take half of the annual net profit to do quality upgrade. Obviously, many SMEs simply cannot afford such costs.