Follow Up Of 325 Million Day Price Ticket For Raw Material Enterprises: Multi Province Special Rectification Industry To Accelerate Shuffle

Not long ago, the State Administration of market supervision and administration investigated and dealt with a case of abuse of dominant position in the field of major raw material drugs, and imposed administrative penalties on monopoly practices of 3 calcium gluconate raw material distribution enterprises. The total amount of fines was 325 million 500 thousand yuan. After this price ticket, recently, Jiangxi, Hubei and other provinces and drug administration asked to strengthen the special supervision of raw materials production, full coverage supervision and inspection.

API is in the upstream of the pharmaceutical industry chain, which is the basis for ensuring the supply of drugs and meeting the needs of medicine. In April 21st, an analyst who had long followed the API said to the twenty-first Century economic report that the State Administration of market supervision and administration had investigated and dealt with the monopoly of raw material drugs to ensure market fairness and prevent the price inflation of raw materials from affecting the preparations.

Chen Li Chen, the head of Beijing Ding Chen medical management consulting center, also pointed out that with the stricter supervision, the trade barriers will continue to improve. In the future, the backward production capacity of API will be eliminated and the industrial layout will be optimized. Green and stable production will become the top priority for the development of API. Not long ago, the four departments such as the Ministry of industry and Commerce jointly issued the "guiding opinions on promoting green development of the bulk drug industry", clearly stated that it will promote green production technology transformation, increase the proportion of green products of bulk API, speed up the development of specialty raw materials and high-end custom-made raw materials, and eliminate backward technologies and products in accordance with the law.

API has great impact on downstream pharmaceutical enterprises. - Song Wenhui photo

Strengthening quality supervision

Shi Lichen told the twenty-first Century economic analysis reporter that under the background of state gathering, API is the key, which has an important impact on pharmaceutical enterprises, and its price and quality problems are particularly critical. It is understood that the National Health Insurance Bureau of medicine prices and bidding procurement Guidance Center recently issued the main points of 2020, including the next round of implementation of the new round of state procurement, local version of centralized procurement arrangements.

"With the reform of the organization, the anti monopoly duty has been closed to the State Administration of market supervision and administration. Recently, the monopoly of three APIs has been fined, and a heavy blow has been launched to rectify the market behavior. The State Administration of drug supervision is to strengthen quality supervision and management. The quality and price of API can be well handled by multiple departments. Shi Lichen pointed out.

Following the State Administration of market supervision, local enterprises are further strengthening the quality supervision of raw material medicines.

    The Jiangxi Provincial Drug Administration said that it should further urge enterprises to implement the main responsibility of product quality, strictly control the production and management of pharmaceutical raw materials and accessories, ensure that the raw materials and pharmaceuticals meet the requirements of the production quality management standards, crack down on illegal and illegal activities in the production process of pharmaceutical raw materials, and improve the level of drug safety protection and control in the whole province from the source, and formulated the Jiangxi pharmaceutical raw materials. Special supervision and inspection work plan for production.

The above plan requires that all chemical raw materials and pharmaceutical excipients produce enterprises to get related reviews and production reports before the end of April 2020, and then report to the Provincial Bureau of drug production, and conduct self-examination according to the relevant laws and regulations of the pharmaceutical industry and the requirements of the national production quality management standard and the contents of the special inspection, and conduct the wind inspection on the risks that may affect the quality of drugs found in the process of self-examination. Risk assessment, cause analysis, formulation of corrective measures, self-examination and rectification report will be formed, and the self inspection and rectification report (with official seal) will be submitted to the Provincial Bureau of drug production before June 30, 2020.

Among them, the Jiangxi provincial food and drug administration also pointed out that it is necessary to report on illegal activities, especially the export of chemical raw materials, protein assimilation and peptide hormones, which do not conform to the conditions and requirements of certification, and fail to comply with the standards of drug production quality management in China.

Following the Jiangxi Province, the Hubei provincial drug administration also announced the 2020 annual plan for drug production supervision and inspection. The plan calls for a focus on the compliance of raw materials and raw materials, and implements the supervision and inspection of raw materials and pharmaceutical packaging enterprises.

"Raw material medicine is in the upstream of the pharmaceutical industry chain, and has a huge impact on downstream pharmaceutical enterprises. It is the basis for ensuring the supply of drugs and meeting the needs of the public. The quality of raw materials directly affects the safety of people's medication. Especially the procurement of the national third tire is coming. Besides Jiangxi, Hubei and other provinces, there will be a regulatory storm in the whole country. "The analysts pointed out.

Ye Weiping, founder and CEO of Guangdong Raffles Pharmaceutical Technology Co., Ltd. also pointed out that the price of the generic drug market is bigger and the cost control requirements are higher because of the quantity purchase. For generic generic drugs, the main cost is in fact the cost of raw materials, which requires enterprises to have higher technological development capability and to meet the market competition with lower cost on the basis of meeting the requirements of green environmental protection.

Transformation of green high-end raw materials

"With the stricter supervision, the trade barriers will continue to improve. In the future, the backward production capacity of API will be eliminated, and the industrial layout will be optimized. Green and stable production will become the top priority for the development of API." Shi Lichen pointed out that although domestic APIs are in the stage of rapid development, they still have problems such as serious homogenization of products, low concentration of industries and high environmental costs.

In fact, in order to further promote the green upgrading of the bulk drug industry, a series of measures have been introduced in recent years to help the high quality development of the pharmaceutical industry. For example, in recent years, the four departments jointly issued by the Ministry of industry and the Ministry of Commerce jointly issued the "guiding opinions on promoting green development of the bulk drug industry" clearly indicated that it will promote green production technology transformation, increase the proportion of green products of bulk API, speed up the development of specialty raw materials and high-end custom-made raw materials, and eliminate backward technologies and products in accordance with the law.

The above opinions also listed the green development targets of API. By 2025, the industrial structure was more reasonable, the proportion of raw materials used in green process production was further improved, the market share of high-end specialty raw materials increased significantly, the industrial layout was optimized, the technology level was effectively promoted, the green standards were continuously improved, and the level of cleaner production was improved significantly. In this regard, the industry generally believes that under the policy push, the future environmental protection compliance with the characteristics of raw materials and high-end customized raw materials companies will usher in positive.

The industry agreed that affected by the epidemic, the supply chain of many countries was disrupted, and the opportunity for Chinese pharmaceutical companies to expand to the market, Southwest Securities pointed out that through the epidemic, FDA and the EU also re understood the quality of Chinese characteristic API and intermediates in the global pharmaceutical industry. But the quality is also particularly critical. For example, the Jiangxi drug administration also mentioned the quality supervision of the export of API.

At the same time, Jiang Yangzhi, Capital Partners of de Lian, pointed out to the twenty-first Century business reporter that the competitiveness of China's low and medium end raw materials can still be achieved, but some production processes are complex, and the technical threshold of equipment is high. The international competitiveness of high-end API for purity requirements is not strong, and there are still many gaps with foreign countries, but in recent years it has been shrinking and has certain advantages in some subdivision fields.

It is understood that in recent years, some enterprises in China have begun to actively promote the transformation and upgrading of the bulk drug industry. For example, at present, many domestic pharmaceutical companies have been carrying out production and marketing of characteristic raw materials and intermediates against various kinds of drugs, such as virus, anti infection, cardiovascular, cerebrovascular and endocrine, and have made certain achievements.

Among them, Jingxin pharmaceutical company plans to build a new raw material drug production base to expand the market share of the company's raw material medicine. The company recently announced that the board passed the "motion on the establishment of wholly owned subsidiary in foreign investment". It agreed that the company invested 120 million yuan with its own capital to set up a wholly owned subsidiary, and invested in the new drug production base of the new company in Weifang, Shandong, to enhance the market competitiveness of the company in the field of API and advanced pharmaceutical intermediates.

In recent days, Jinhua has released a notice to change part of its fundraising purposes. It plans to invest 426 million 880 thousand yuan in the planned capital raising project, the international advanced pharmaceutical base production line block project in Jinhua, and all of the changes will be invested in the implementation of the relocation project of the international pharmaceutical raw materials base in the world. The international advanced pharmaceutical base project two Period). This means that on the basis of its original industrial advantages, it will further increase the supply of specialty raw materials, so as to lay a solid foundation for enhancing the company's position and market share in the global API industry.