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    Home > Active Ingredient News > Drugs Articles > China India drug regulatory exchange conference holds pressure on domestic generic pharmaceutical industry

    China India drug regulatory exchange conference holds pressure on domestic generic pharmaceutical industry

    • Last Update: 2019-06-25
    • Source: Internet
    • Author: User
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    On June 21, the official website of the drug administration released a news that in order to strengthen the exchange and cooperation between the drug regulatory authorities of China and India and between the drug industries of the two countries, "China India drug regulatory exchange meeting" was held in Shanghai Leaders from the State Food and drug administration, the Ministry of foreign affairs, the development and Reform Commission, the Ministry of Commerce, the state health insurance bureau, the Shanghai Drug Administration, the China Chamber of Commerce for the import and export of medical and health products, the central drug standard control bureau of India, the Ministry of health and family welfare, the Ministry of Commerce, the Embassy in China, the Consulate General of India in Shanghai and other relevant departments attended the meeting First of all, from the level of participants It's important at the level Looking at the contents of the meeting, the FDA said, "in this exchange meeting, the two sides have conducted extensive exchanges on the topics of relevant laws and regulations, policies and technical requirements for the registration of imported drugs from China and India, guidelines for overseas inspection and compliance of drugs, policies and bidding processes for bidding and purchase of Chinese drugs, and cooperation in the pharmaceutical industry between China and India." In addition, according to the Indian times, the Chinese and Indian drug regulatory agencies discussed the issue of Indian drug exports to China during the meeting, which lasted for 9 hours Tang Yongsheng, India's ambassador to China, wrote that China needs to work out a clear road map to increase the share of Indian drugs in the Chinese market Xu Jinghe, deputy director of the State Food and drug administration, also said at the meeting that he hopes to take more actions to solve the problem Based on the above information, it seems that the process of pharmaceutical companies from India, a big generic pharmaceutical country, entering China to seize the market will obviously accelerate At the same time, once India's generic drugs are released into the Chinese market, it will bring more pressure to the Chinese generic drug industry and enterprises, and then drive the overall improvement of the quality of the Chinese generic drug industry 1 India has been planning for China's market layout for a long time in May According to industry rumors, Indian generic pharmaceutical companies are negotiating with the state to participate in the "4 + 7" bidding And some Indian generic pharmaceutical companies say that their drug prices can drop another 20% - 30% based on the bid price of 4 + 7 The content of this Sino Indian exchange meeting also involves the relevant content of China's drug bidding and procurement As the second largest drug consumption market in the world, the Chinese market is undoubtedly very attractive to India, which has been making efforts to increase drug imports to China According to the IPA and McKinsey, the Indian pharmaceutical industry hopes to occupy 7% of the global pharmaceutical market by 2030, but its current market share is 3.6% To achieve the 7% target, it is estimated that the growth rate must reach 11% - 12% per year by 2030 Under the pressure of pricing and regulation in the U.S market, the competitiveness of Indian pharmaceutical companies in the U.S market has been reduced compared with the past Previously, on April 23, 2018, the Chinese government announced to cancel the import tariff of anticancer drugs and other drugs in the form of provisional tax rate from May 1 At that time, the news excited Indian pharmaceutical companies The heads of several Indian pharmaceutical companies publicly said that the reduction of drug import tariffs would benefit many Indian pharmaceutical companies China will speed up the introduction of Indian drugs, which has long been said According to a Reuters report in July 2018, the head of an Indian Trade Promotion Agency said, "China is ready to quickly approve drugs made in India." Another Indian government official involved in promoting trade with China said, "we do feel that China is very willing to accept this time as long as the price is competitive", but said that the two sides have not signed a specific agreement In addition, with the movie "I am not the God of medicine" sweeping across the country, it also deepened the impression of the Chinese people on the "low price" of Indian drugs, which also gave birth to a new phenomenon: it is reported that many Chinese tourists now like to buy some drugs by the way when they travel to India Obviously, this has further stimulated the demand of Indian pharmaceutical companies to enter the Chinese market Since 2018, Indian pharmaceutical companies have been trying to open up the Chinese market in various ways In July 2018, enrovita, the second largest pharmaceutical company in India, invested US $100 million to establish enrovita pharmaceutical Taizhou Co., Ltd in China Pharmaceutical city; in December 2018, India arabindu Pharmaceutical Co., Ltd and rohin Pharmaceutical Co., Ltd jointly established a joint venture in China to jointly invest in R & D and production system to introduce respiratory products; in February 2019, the sulfuric acid of Dr redI, an Indian Pharmaceutical Company The bioequivalence test of hydrochloclopidogrel tablets was applied in China to prepare for entering the Chinese market In addition, large Indian pharmaceutical companies such as arabindu, redI and sunpharma are successively applying for drugs in China It can be seen that after Indian drugs enter China, the price will be the key way for Indian drug companies to seize the market, and also adapt to the current requirements of the Chinese government for reducing drug prices 2 "High quality and low price" is a long-standing standard put forward by the government in the process of the great reform of China's generic pharmaceutical industry From the recent actions of the government departments to promote the development of the generic pharmaceutical industry, "quality improvement" and "price reduction" are the key words throughout On June 20, in accordance with the spirit requirements of the work plan on accelerating the implementation of the supply guarantee and use policy of generic drugs and other documents, the drug administration department of the health and Health Commission officially publicized the list of the first batch of recommendations on encouraging generic drugs catalogue, which is also clear, accelerating the improvement of the quality of listed drugs, and releasing the list of drugs encouraging generic drugs before the end of each year from 2020, and the drugs in the catalogue Will enjoy a series of preferential policies This also means that the country is taking practical actions to encourage and guide the development of generic pharmaceutical industry Whether to pass the consistency evaluation has become an important standard to measure the quality of domestic generic drugs, and promoting the consistency evaluation of generic drugs is also one of the current priorities of the drug regulatory bureau In addition, the 4 + 7 volume purchase of generic drugs is the first threshold to pass the consistency evaluation, and the goal of 4 + 7 is to reduce the price of drugs on the premise of ensuring the quality of drugs, so as to save medical insurance funds 4 + 7 also led to linkage price reduction outside the pilot cities, and even the enterprises declared their own price reduction From the results of the first batch of pilot procurement with volume, the drug price reduction effect is obvious Recently, the medical insurance bureau, together with the Ministry of finance, has carried out accounting information quality inspection for 77 pharmaceutical enterprises, focusing on the sales expenses of pharmaceutical enterprises, which is considered as a way for the medical insurance bureau to determine the cost structure of pharmaceutical enterprises The next step will inevitably affect the drug price Not only the trend of the medical insurance bureau, but also the importance of reducing the false high drug price in the process of medical reform was emphasized again in the press conference held by the health care Commission on June 14 The entry of Indian drugs into the local market will undoubtedly force the local generic drugs to consolidate the market, improve the quality and reduce the price, or it will become one of the driving forces to stimulate the upgrading of the local generic drug industry However, India's access to China may not be as fast as expected Although India's drugs have a strong appeal in price, the quality problem has always been an important issue to be considered by national drug regulatory agencies In recent months, for example, the FDA has issued several announcements, pointing out that there are production quality problems in famous Indian pharmaceutical companies such as sun pharmaceutical and lupin It is worth noting that according to the information of China Chamber of Commerce for the import and export of pharmaceutical and health care products, the conference also made a detailed interpretation on the registration procedure of APIs in China from the background documents, application scope, registration process, data requirements, common problems in the process of acceptance and review, etc The monopoly of APIs and the rising prices of APIs have always been a problem for local pharmaceutical companies, and also regarded as an important factor affecting the prices of pharmaceuticals Increasing the import of API is a breakthrough to solve this problem.
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