New Pharmacopeia Significantly Improves Pharmaceutical Quality Standards Accelerates Pharmaceutical Industry Reshuffle

Business Club September 30 hearing "2010 version of the "Chinese Pharmacopoeia"" will begin on October 1. Industry sources said that the new version of the Pharmacopoeia significantly raises the quality standards for pharmaceuticals, which will inevitably lead to a reshuffle of the domestic pharmaceutical industry, and the market position of dominant companies will become even more prominent.

It is understood that the new edition of the Pharmacopoeia is the 9th edition of the Pharmacopoeia since the founding of New China. In view of the fact that the total number of varieties collected in the past was relatively low and the quantity of various categories was not balanced, the new edition of the Pharmacopoeia further expanded the scope of collection, and basically formed the categories of Chinese medicinal materials, Chinese medicines, Chinese patent medicines, chemical medicines, pharmaceutical excipients, and biological products. Complete drug standards system. The new edition of the Pharmacopoeia also pays particular attention to the systemic improvement of the standard. Not only has the collection variety increased by more than 40%, but the original standard of 70% has been improved or improved.

Zhou Fucheng, the deputy secretary-general of the State Pharmacopoeia Committee, used the quality standard of Xiaoyan Lidan Tablets as an example to illustrate the difference: In the new edition of the Pharmacopoeia, the new quality standard for Xiaoyan Lidan Tablets has been revised and updated in 11 items, including the standardization of the method of manufacture. Film-coated tablets; identification items removed chemical reactions, new and more specific thin-layer chromatography identification, leachables examination, andrographolide and dehydroandrographolide content determination. One of the key items is "Andrographolide Content", which is nearly 5 times higher than the original standard.

"Xiaoyanlidan tablets are relatively simple varieties in the existing Chinese medicine preparations, but the time, energy, and financial resources invested in comprehensively raising the standards are still relatively large. Other more complex traditional Chinese medicine compound preparations need to raise the standard and cost them. Time, energy and financial resources will be greater," he said.

The industry expects that the implementation of the new Pharmacopoeia standards will inevitably lead to the suspension of production of some non-compliant enterprise products, accelerate changes in the product mix and changes in the status of the company. For example, due to the introduction of the new version of the standard, there will be dozens of production companies in the field of anti-inflammatory and anti-cholesterol tablets because the technology is not up to standard or eliminated or integrated.

The person in charge of the State Pharmacopoeia Commission stated that the new pharmacopoeia standard aims to promote the survival of the fittest and to ensure the rejuvenation of Sinopharm in the system. He pointed out that there are many problems with the use of basic drugs and bidding. If there is no tender for the tender price, on the one hand, ordinary drugs with low prices may be tendered below the cost in a vicious competitive bidding. Enterprises can only reduce production requirements in order to ensure the market; on the other hand, foreign companies, joint ventures and individually priced products often Winning bids at high prices.

Relevant personnel said that “the use of medical products has been reshuffled in the use of medical institutions: generic drugs have gradually disappeared, medical institutions have used imported drugs, joint venture drugs, and bid-winning high-priced drugs.” said Liu Hongqiong, deputy general manager of Luofushan Guoyao in Guangdong. In the basic medication, the quality of domestic drugs varies. In the process of grassroots use, because the bid price is too low, the quality of products provided by some enterprises is low, resulting in insecure grass-roots drug use and switching to high-quality, high-priced foreign drugs.

Wu Hao, the deputy director of the State Food and Drug Administration, said that they will use the new pharmacopoeia to strengthen the supervision of inspections, in order to urge drug production and operation companies to carry out equipment transformation and technological innovation to ensure that the development and production of qualified in line with the new pharmacopoeia standards product.