2010 year-end inventory of raw material industry in the future pressure is approaching

Business News Agency January 5th The raw material medicine industry in China in 2010 can be said to be intertwined with good news and bad news. Challenges and opportunities coexist. Among them, there are serious excess production capacity, environmental protection standards are increasingly stringent and other factors that test the development of pharmaceutical companies, but also some countries are planning to promote the management of raw and auxiliary materials DMF and encourage and increase the company to transfer methods, adjust the structure and other favorable factors.

The raw material medicine industry in China in 2010 is still on the road.

Keywords: raw and auxiliary materials DMF system

2010 process: entering the consultation stage

On September 19, SFDA issued the "Notice on Soliciting the Opinions on the Administration of Filing of Raw Materials for Pharmaceutical Use (Exposure Drafts)". SFDA said that the implementation of the DMF (Pharmaceutical Raw Material Registration) system, the first person responsible for more clarified product quality is the formulation company, and the formulation companies are embodied in practical aspects such as how to select raw and auxiliary materials and supplier audits. Responsibilities of the company, but also stressed the pharmaceutical raw materials manufacturers of raw materials for the authenticity of raw materials and other aspects of the responsibility.

【Comment】

Entering the solicitation stage marks the brewing of the standardization and standardization of pharmaceutical excipients for a long time.

Although it is an "imported product," DMF is not new to China's bulk drug companies. At present, most API companies have implemented or explored DMF management for their key export products.

The formal promotion of the DMF system in China began in 2002. The progress made in recent years has been very rapid. Consensus has also been reached at the levels of supervision, production, and export. In March 2008, the first draft of the DMF system framework was completed; in July 2009, the SFDA announced that “China is exploring the implementation of the DMF management system for medicinal excipients”. As of January 12, 2010, the number of DMF documents for APIs registered by the US FDA has also reached 674. Until now, China has been implementing registration management for medicinal excipients, and there have been drawbacks such as higher administrative costs and insufficient regulatory power.

Obviously, this is in response to international regulations, especially in Europe and the United States and other regulatory markets, to attach greater importance to the safety of the raw material supply chain, and in particular to strengthen the audit of overseas raw material pharmaceutical factories. Europe will also introduce relevant certification standards for excipients to strengthen the circulation of raw materials and accessories. Use regulatory actions such as supervision. After the implementation of the system, it will bring reshuffle opportunities to China's pharmaceutical packaging materials and raw and auxiliary materials manufacturing enterprises. Enterprises with poor product quality, unregulated operations, and inadequate management will be expelled.

Keywords: Quality Risk Management

Process of 2010: New GMP implements quality risk management concept

The 2010 edition of the Chinese Pharmacopoeia was enacted on October 1. The 2010 version of GMP will also be released soon. The new GMP is different from the past. It draws on the successful experience of ICH-Q9 and EU GMP, and highlights the concept of quality risk management for APIs. At present, this concept has not yet been fully realized in the domestic raw material drug companies, and is implemented in 100% of production. This concept is an important and critical interface between domestic companies and the international community. It is reported that, due to the concept of the reasons, there are many domestic raw material companies COS certificate was suspended.

【Comment】

Drug quality risk management has become the subject of mandatory inspections and key examinations by the US FDA and the EU EDQM for on-site inspection and production supervision of Chinese pharmaceutical companies. Needless to say, this is also the weakness of domestic pharmaceutical companies. To strengthen quality risk management, we must make efforts in the compliance and efficient operation of the quality system (especially the main document system of change control, deviation control, etc.), and make great efforts in the quality consciousness and risk awareness of personnel at all levels. Good efforts have been made in the integration of good quality, design, and risk management.

In addition to competing in the research and development and listing of new products, the other main battlefield for domestic API companies is international market certification. This includes two parts: One is the quality audit of the US FDA, the COS certification of the European Pharmacopoeia Commission, which belongs to the government-level official certification, and the other is the quality audit of large customers targeted at the company and belongs to the customer certification. Passing international certification means that the product has obtained a pass to the international market, and taking the first step means occupying an opportunity to seize the international market.

Developing international certification is the only way for the internationalization of China's bulk drug companies. It is also the only way for production to shift from extensive to sophisticated, and from low-end intermediates to high-end products. According to statistics, as of September 12, 2009, the number of COS certificates that China's raw material medicines obtained European EDQM certification was 206. As of January 12, 2010, the number of DMF documents for raw material medicines registered by the US FDA has also reached 674.

2010 Process: Exports Move to Downstream Products

Penicillin industrial salt is another bulk raw material drug that has a severe excess capacity in China. As the vicious competition has intensified, China's penicillin products have been repeatedly investigated for anti-dumping in the international market. The most recent one was on February 11, 2010. The Indian Ministry of Commerce and Industry had made a preliminary ruling. In the past two years, the Ministry of Commerce and Industry of India had filed two cases, but due to the active defense of Chinese companies, the initial ruling failed to be formed. Affected by this, in 2009, China's export of penicillin salt to India showed volume, price, and volume. To effectively avoid this situation, the export focus of penicillin industrial salt began to shift to downstream products and high-end products, and the export of APIs such as 6-APA and amoxicillin showed an upward trend.

【Comment】

Although it is passive, the efforts of the export of penicillin exports to downstream and high-end products are still worthy of recognition. This means that Chinese pharmaceutical companies have taken a favorable step in the export of low-value-added APIs, which is in accordance with the "2010" issued in October 2010. "Guiding Opinions on Accelerating the Structural Adjustment of the Pharmaceutical Industry" is required. It should be pointed out that high-end products must be based on high-end markets, supplemented by high-end market competition and development strategies. In the past, the old road of "international competition domestication" could not be followed.

Keywords: "Pharmaceutical industry water pollutant discharge standards"

2010 process: officially implemented on July 1

On July 1, 2010, the new "Emission Standards for Water Pollutants in the Pharmaceutical Industry" was enforced in the entire industry. The new “Standard” stipulates that the water pollutant emission targets are all stricter than the US standards, and the fermentation enterprises’ COD (chemical oxygen demand), BOD (biochemical oxygen demand), and total cyanide emission requirements are close to the most stringent EU standards. It has the greatest impact on heavily polluted chemical synthesis, fermentation, and extraction APIs. In 2010, a number of bulk drug products such as erythromycin thiocyanate had been restricted production due to environmental pressure, resulting in tight market supply.

【Comment】

The new "standard" has undoubtedly become the lifeline of raw material drug companies. As the "standard" has been greatly improved, and many companies' existing waste water pollution prevention facilities' capabilities and effects are very different from the new "standards," pharmaceutical companies urgently need large investments to improve this situation. It is roughly estimated that the increase in environmental protection operating costs for general enterprises to meet the requirements of the new "Standard" is above 100%. The technologies, capabilities, and environmental protection costs for companies to prevent and control pollution have become an important core competitiveness of API companies.

Keywords: low-carbon economy

Process of 2010: Important Tasks for the Twelfth Five-Year Plan

At the end of the year, the 2010 UN Cancun Climate Conference ended, and low-carbon economic topics such as carbon emissions, carbon tariffs, and carbon trading have once again become the focus of China's bulk drug companies. China has determined that the carbon dioxide emissions per unit of GDP will be 40% to 45% lower than in 2005, and carbon emission reduction will become one of the important indicators for the assessment of the “Twelfth Five-year Plan”. The task is particularly arduous. Stress and assessment will be implemented in raw materials and other related industries.

【Comment】

Carbon emissions in 2010 is only a hot topic. During the “Twelfth Five-Year Plan” period, it is very likely that it will become the second sword of Damocles that hangs on raw material medicine in China, becoming one of the common new barriers to international trade. Domestic API companies should take precautions and make early plans to do key tasks such as energy conservation, emission reduction, environmental protection, clean technology, and cleaner production. At present, special efforts should be made to integrate low-carbon medicine, green technology, and the “turning mode and structure” of enterprises. stand up.

Keywords: Capacity

2010 process: the country brewing overcapacity governance policy "big stick"

Affected by the sluggish international demand and the surge in domestic production capacity, the vitamin C market that was still maintained at the high US$10/kg level has been diving over the past few years and has entered a new downturn. Cai Dongchen, chairman of Shijiazhuang Pharmaceutical Group, proposed that the competent authority should change the export of some APIs such as vitamin C and penicillin to quota management, so as to curb low-price competition in the deteriorating API industry. In September 2010, the top five vitamin C manufacturers held a coordination meeting to stop the single quote from the foreign ministers and announced that they would stop the insured price from September 20th. The National Development and Reform Commission, together with the Ministry of Industry and Information Technology, introduced strict control measures such as the implementation of export quota management. In October, industry experts gathered at the inaugural Vitamin Industry Innovation and Development Summit and unanimously called for the expansion of the vitamin C domestic demand market. It is reported that the Ministry of Industry and Information Technology is taking the lead in formulating the "admission requirements for vitamin C industry."

【Comment】

Every major raw material drug product with a severe excess of production capacity means a close competition for the Red Sea. Regrettably, there are more and more raw material medicines that have fallen into a serious overcapacity in China, and the domestic market's raw material medicines have "more and more control, more surpluses, more excesses, and more vicious competition". To get out of this dilemma, it is inseparable from the strict control and control of the relevant departments, especially the local authorities’ excessive emphasis on the shift in the concept of GDP. At the same time, it requires the strict self-discipline of industry associations and related companies. Otherwise, it is not only the profits of individual pharmaceutical companies that are lost, but the losses. The international competitiveness of domestic raw materials and pharmaceuticals.