American market challenges keep India's generic pharmaceutical manufacturers facing big test

Source: China medicine daily, January 22, 2014 source: China Chamber of Commerce for import and export of medical insurance, in recent years, the overseas strategy of Indian generic pharmaceutical manufacturers has achieved great success On the one hand, Indian pharmaceutical companies have obtained more than 150 FDA certifications, laying the foundation for the production and sales of generic drugs; on the other hand, Indian pharmaceutical companies have acquired the sales path by acquiring local pharmaceutical companies in the United States to enter the United States pharmaceutical marketing network Most importantly, India's generic pharmaceutical companies have launched patent challenges to the original research drugs in the United States through simplified new drug application (anda), and gradually have their own core businesses and key products, occupying a place in the U.S generic pharmaceutical market With the arrival of the second patent expiration climax in the new century starting from 2012, there will be more than 250 billion dollars of drugs sold worldwide losing patent protection India's generic pharmaceutical companies focus on the expired drug patents and carry out research and development in advance, and the number of Anda applications increases year by year In 2012, FDA passed 505 anda applications, 206 of which were obtained by Indian pharmaceutical companies, accounting for 41% In the first quarter of 2013, FDA issued 121 anda certificates for enterprises in 12 countries, of which 19 Indian companies won 60, accounting for half of the total The growth in the number of Anda certificates indicates the rapid development of Indian generic pharmaceutical enterprises However, under the surface of the scenery, Indian generic pharmaceutical companies are facing a big test In recent years, FDA inspection warnings are frequent, and the control of drug production standards by FDA is more and more strict, which also indicates that it will conduct more and more continuous inspections on enterprises Through the inspection, FDA found many problems in the production process of pharmaceutical enterprises, usually in the form of warning letters to warn enterprises and promote their rectification In recent years, the number of warning letters issued by FDA has been increasing, from 152 in 1996 to 753 in 2012 By the end of October 2013, the FDA had issued 544 warning letters in the first 10 months of 2013 A considerable number of these warning letters were sent to Indian generic pharmaceutical companies Most of FDA's warnings to Indian enterprises are due to the fact that their pharmaceutical plants fail to strictly implement cGMP production standards in the long-term production process, such as insufficient equipment cleanliness, lack of production records, and lack of current cGMP training for employees The result is usually a ban on the factory from exporting the drugs it produces to the United States until the next pass Although the punishment is not serious, it highlights the problems of management, ethics and integrity in Indian generic pharmaceutical enterprises According to statistics, many Indian pharmaceutical companies have data reliability problems Concealing failure results, conducting informal analysis, deleting electronic data, disabling audit tracking in electronic data collection system, fabricating training data, repeatedly analyzing unqualified samples until they pass, back testing past data, and not publishing stability failure reports, etc., seem to be the secret of Indian pharmaceutical industry Most of the senior managers and the company's management support this practice secretly or openly, and even encourage it in some cases If Indian generic companies do not actively correct their business attitude, it can be predicted that the FDA will send more and more warning letters to Indian generic companies, and the Indian pharmaceutical industry will have more and more stains Not long ago, the Indian Pharmaceutical Alliance (IPA), on behalf of Indian pharmaceutical companies, appealed to the FDA for an active dialogue around the pharmaceutical industry to solve the problem of frequent FDA warnings and prohibitions on the export of drugs to the United States According to FDA data, more than 20 drug manufacturing plants across India have been blacklisted for banning the supply of drugs to the U.S market Patent infringement dispute lost in June 2013, Indian Multinational generic pharmaceutical company Sun pharmaceutical company and Israeli Teva pharmaceutical company encountered a major setback in the U.S generic business The two companies were ruled by the court of New Jersey of the U.S to infringe Pfizer's protonix drug patent, and were awarded compensation of $550 million and $1.6 billion respectively Sun pharmaceutical has set aside about US $100 million in October 2012 for possible compensation to Pfizer, and the rest of the compensation must be paid in full within 2013 The huge amount of compensation has seriously weakened the competitiveness of sun pharmaceutical, which has to postpone the negotiation of its acquisition of Sweden MEDA pharmaceutical and Israel taro Pharmaceutical Co., Ltd The active patent challengers in the US generic drug market favor "the fourth anda" This is because the approval of "the fourth anda" indicates that the challengers have not infringed the challenged original research patent or its patent is invalid The successful enterprises can ignore the original research patent constraints, market their generic products and obtain 6 Months of market monopoly This can earn a lot of market share and profits for the generic enterprises, and it is the sharpest weapon for the generic enterprises to compete for the original research drug market However, there is no doubt that there are great risks in doing so Most of the original research drug companies that are challenged before the patent expires will rise up and accuse the patent challengers of infringing the patent of the original research drug Once the patent of the original research drug is maintained, the listed generic drugs will become a heavy burden for the patent challengers However, it is often seen that the original pharmaceutical companies will eventually choose to reach a settlement with the generic companies, or postpone the listing time of the generic drugs, or narrow the listing scope of the generic drugs As a compensation, generic pharmaceutical enterprises can obtain certain benefits from the original research enterprises, while avoiding the high cost of long-term litigation It is the compromise of the original drug research enterprises and all the advantages brought by it that impels Indian generic drug enterprises to increase the research and development of generic drugs again and again, and the application volume of Anda is increasing year by year However, the failure of sun pharmaceutical company's patent infringement case indicates that Pfizer's insistence on the lawsuit may be imitated by other original pharmaceutical companies with strong strength It is necessary for Indian generic companies to reassess the risk-taking costs, weigh the costs and benefits, and make a prudent decision before applying for the "fourth anda" In the future, Indian generic pharmaceutical companies will still encounter more and more patent infringement lawsuits How to avoid repeating the mistakes of sun pharmaceutical company will be a big problem lingering on Indian generic pharmaceutical companies