India's generic drug industry has brought three major changes to China. How can local enterprises cope?

Indian pharmaceutical companies with early awareness of international operation and strong ability of generic drug development, occupy a more obvious leading position in the European and American market According to statistics, only in 2017-2018, India's drug exports amounted to US $17.3 billion, 75% of which were pharmaceutical preparations and biological drugs, totaling US $12.9 billion, and 60% were exported to high-end markets such as Europe and the United States Since last year, a series of reform and implementation of China's domestic drug supervision and new policy of centralized procurement have created more and more favorable conditions for India's generic drugs to enter the Chinese market At the same time, it is inevitable to bring impact and changes to the domestic pharmaceutical market When we see that foreign generic drugs inject fresh blood into the domestic competition system, how can domestic generic drugs confront it? India's generic drugs in China: the development is relatively slow due to the fierce competition in China's generic drug market, the preferential policy for the use of imported generic drugs passing the consistency evaluation is limited, a large number of Indian generic drugs certified by Europe and the United States have not been deeply involved in the Chinese market, and the market share is even smaller Mr Vijay, a former representative of lupin pharmaceutical company in China, wrote a review entitled "why Indian pharmaceutical companies can't succeed in China" He believed that the main factors that make it difficult for Indian pharmaceutical companies to enter China are three aspects: First, there are biases on the understanding of the Chinese market, and they think that the operation is difficult; second, they feel good about themselves and don't try their best; third, the attention of senior managers is not enough, and the team motivation is not enough The direct consequence of this is that Indian pharmaceutical companies are in a hurry to invest in China, mainly in APIs, with little involvement in the pharmaceutical market Ranbaxy's abandonment of its shares in the mainland joint venture, the tangled investment of DRL in Kunshan, and the short-lived joint venture between Aurobindo and orchid in China are the real portraits New policy of market access: promote the gradual "Dongfeng season" of imported generic drugs registered in Europe and the United States Since last year, a series of drug supervision and new policy reforms have created more and more favorable conditions for Indian generic drugs to enter China In April 2018, the general office of the State Council issued the opinions on the reform and improvement of the supply guarantee and use policy of generic drugs, which clearly proposed to promote the research and development of generic drugs, formulate the catalogue of generic drugs that are urgently needed in clinical practice, strengthen the tackling of generic technology, accelerate the consistency evaluation of the quality and efficacy of generic drugs, improve the supporting policies, promote the substitution of generic drugs, and promote generic drugs The internationalization of industries encourages overseas enterprises to establish R & D centers and production bases in China In May, the State Food and Drug Administration and the health care Commission issued the announcement on the optimization of drug registration, review and approval In July, the State Food and Drug Administration issued the technical guidelines for the acceptance of overseas clinical trial data of drugs For those who have complete and evaluable bioequivalence data for the research and development of generic drugs abroad in accordance with the ICH and GCP management specifications, they will be included in the overseas clinical trial data recognized in the domestic register conditionally In December, the state organized the "4 + 7" city pilot implementation of drug volume centralized procurement bidding Generic drugs that passed the consistency evaluation won the bid with the help of price advantage, and clinical substitution of original drugs accelerated The products that have been listed in China or Japan by the original research manufacturers corresponding to the imported generic drugs will be approved preferentially, so as to promote further price reduction of the expired original research drugs India's generic drugs, which have clinical value and price competitive advantage, are expected to accelerate the import and win the domestic market Declaration of generic drugs imported from India: according to statistics of Xianda, since 2016, the countries and regions that have declared the largest imports of generic drugs of category 5.2 are India, Switzerland, Taiwan and Greece The enterprises with the largest number of application products are redI, India The application products include tiralos dispersible tablets for the treatment of rare anaemia, abiolone acetate tablets for the treatment of refractory prostate cancer, fluvistrane injection for the treatment of breast cancer, rivaroxaban tablets for the anticoagulant, and spiramycin tablets for the treatment of chronic kidney disease and hyperphosphatemia In the context of the long-standing trade friction between China and the United States, China's import demand for India's priority developed and approved heavy-duty generic drugs registered in Europe and the United States will continue to increase At the end of 2018, the acquiescence system of domestic clinical trials was implemented, and the imported generic drugs entered the era of filing system After "4 + 7", Indian pharmaceutical companies also see great potential to enter the Chinese market If they get new opportunities to speed up import approval and centralized procurement and win the bid, they will expand the international revenue of Indian generic drugs, and reduce the pressure brought by their participation in the sales competition in the US market International competition: actively respond to China as the world's second largest drug market after the United States, and the growing health demand makes Indian pharmaceutical companies have to re-examine the huge potential of Chinese drugs Especially for the first generic drugs or generic drugs with high technical barriers, large market demand and less competitive products that are urgently needed in the clinical market, Indian drugs have comparative advantages It is true that the entry of Indian generic drugs into the Chinese market will inevitably bring impact and changes to the domestic pharmaceutical market First, it will push the price of original research drugs down and inject fresh vitality into the domestic competition system Second, we will improve the driving force of domestic generic drugs, boost the reshuffle of the pharmaceutical industry, and accelerate the development of generic innovation, transformation and upgrading of pharmaceutical enterprises The third is to meet the needs of clinical diversification, reduce the medical burden of patients, and benefit the health needs of the people But after all, the competitiveness of imported generic drugs ultimately depends on the technical barriers of specific varieties, sales price, demand, number of manufacturers and the strength of domestic access policy reform and other comprehensive factors Whether to exempt under the filing system of bioequivalence research on imported generic drugs, how much shorter the time limit for approval can be, and whether the over dependence on imported generic drugs may affect the security of domestic drug supply are all important factors affecting the development process of imported generic drug market With the trend of internationalization of domestic and international competition in the generic market, the import of generic drugs registered in Europe and the United States and urgently needed in clinical practice is surging Domestic generic drugs should be prepared in advance and quickly surpassed -- especially focusing on clinical need, rushing to imitate drugs for treatment of major diseases, chronic diseases of the elderly, women and children and rare diseases; developing slow controlled release, transdermal absorption, mucosal absorption and gas The high-tech barriers such as aerosols, etc are to extend the production cost advantage of upstream raw materials and auxiliary materials of generic drugs and the innovation ability of downstream dosage forms, and upgrade the internal technical quality of drugs and the external competitive speed of industrial chain differentiation.