The financial turmoil has affected the global economy. The pharmaceutical industry has not been spared this time. For the emerging markets of China and India, opportunities are emerging everywhere in the crisis. Multinational companies need to cut costs and improve efficiency more than ever before. They must outsource many R&D and production tasks to Asian countries. India and China should be the biggest beneficiaries of this global outsourcing flow. However, at this critical juncture, India’s shocking Mumbai terrorist attacks occurred. Before that, several Indian pharmaceutical companies were subjected to rigorous inspections and penalties by the FDA, which provided an ambitious Indian pharmaceutical industry that entered the international pharmaceutical market. A layer of ominous shadows.
FDA’s iron fist hit India and North America
The global operation of the Indian pharmaceutical industry has been going on for many years and it has been quite successful. In Europe and the United States, India's pharmaceutical companies are second only to the United States in number of DMF registrations and ANDA applications. India hopes to win at least 10% of the grand industry of the US generic market will see it happen, but suddenly met with the FDA's strong blow, was suddenly suppressed to a low point. According to India’s “Economic Times†report, the US FDA recently discovered that there were some problems in manufacturing and quality control at the surprise inspection of three Indian pharmaceutical companies. The industry sources said that this incident even constituted the entry of Indian drugs into the US market. obstacle.
An industry veteran who did not want to reveal his identity stated that the FDA will seize on these minor flaws and take certain measures. “This will detract from the reputation of the Indian pharmaceutical industry and become a non-tariff barrier to trade. Despite the fact that There is no evidence that any drugs or drugs produced by Indian pharmaceutical companies have any efficacy or safety issues."
In October of this year, the US FDA banned the entry of 30 drugs from two production plants in Lamberts into the US market and issued two warning letters. Earlier this month, the United States decided not to issue marketing licenses for drugs manufactured by the Sun Pharmaceuticals plant in Detroit, India. In late November, Mandideep Pharmaceuticals was identified by the FDA as having 15 defects.
"When the incoming Obama administration considers purchasing generic drugs, there are so many incidents that are unfavorable to Indian pharmaceutical companies. This may be related to the intentions of the brand-name pharmaceutical companies, questioning the quality of Indian pharmaceutical production and preventing the entry of their drugs. "Daara Patel, the secretary general of the Indian Pharmaceutical Manufacturers Association, has complained about this. However, Sanjiv Kaul, an expert in medicine, believes that big Indian pharmaceutical companies should be ready to accept FDA inspections and “prick†at any time.
Perhaps because of urgency, perhaps because it was too smooth in the past, or because the competition among generic companies was too intense, Indian pharmaceutical companies seemed to have relaxed their vigilance in the development of the North American market in recent years. Production and quality control. The FDA has been under the pressure of criticism from domestic public opinion and big pharmaceutical companies. It just needs to explain to some Chinese people through the discovery of certain problems in foreign pharmaceutical companies. According to the routine, once the FDA finds a problem, especially a systemic problem, it will send a large number of personnel to conduct more thorough verification. The more detailed the verification may be, the easier it will be to pick out the problems. This has a large market penetration rate for Indian pharmaceutical companies in the United States. Negative impact. India's pharmaceutical industry, which is seriously injured, needs rethinking. It also needs a new quality control system to make up for various loopholes.
Mumbai terrorist attacks scare off overseas customers
In addition to the FDA’s iron fist, the worst hit for the Indian pharmaceutical industry was the terrorist attacks in Mumbai on the evening of November 25. These terrorist attacks targeting foreigners will seriously damage India's pharmaceutical industry and outsourcing services. The attack made people feel that India's counter-terrorism measures are not in place. This has caused foreign investors and pharmaceutical customers to worry. The countless agreements that have been signed may also be postponed indefinitely if they are not abandoned in accordance with commercial practices.
Currently, as one of the world's largest industry events, the PhiI India 2008, originally scheduled for November 28-30 at the Mumbai Exhibition Center, has been postponed. The exhibition of pharmaceutical equipment and instruments at the local P-MEC India It has also been postponed. ArchPharmalabs is an Indian raw material pharmaceuticals manufacturer. Ajit Kamath, chairman and general manager of the company, told the media: “India must take strong anti-terrorism measures to ensure domestic security, and at the same time demonstrate to the international community on the economic front its ability to govern the current situation. problem."
The commercial losses of the Indian pharmaceutical industry may be a surprise for Chinese counterparts, especially in R&D outsourcing. In China, people do not have to worry about terrorist attacks. In the current global financial crisis, China is also more stable and full of confidence. In addition, the Chinese government intends to build a bio-pharmaceutical industry and increase investment in the next few years. There are good opportunities for expansion. The question is whether Chinese pharmaceutical companies are fully prepared for the internationalization process. Is there a rich talent pool and a viable operating plan? To expand the export of APIs, break through the export of pharmaceutical preparations to European and American markets, improve the status of the domestic pharmaceutical industry, and strive to gain market share and high-end product market share. This is the direction and historical mission of Chinese pharmaceutical companies.
Indian enterprises increase in contrarian
The double blow will indeed bring immeasurable losses to the Indian pharmaceutical industry in the short term, but the foundation of the Indian pharmaceutical industry will not be shaken. Its R&D production and clinical trials still have a strong competitive advantage in the world. In addition, India's domestic emerging markets are favored by major pharmaceutical companies. As a result, the local pharmaceutical companies and multinational companies in India have been expanding their local business and staffing establishments.
Last year, Merck established a branch in India and it is now necessary to increase the number of employees to 1,600. Naveen Rao, Managing Director of Merck East India, told the Economic Times that the company will employ 400 people in 2009 and 400 in 2010. It plans to launch 6 new drugs in the next few years and become the largest in India by 2015. One of the five pharmaceutical companies. It is estimated that by the end of this year, the company will have 800 employees and now employ 700, 80% of whom are sales representatives. However, Merck headquarters announced in November that it would cut 7,200 people.
Pfizer has already cut 10% of its employees worldwide. However, at the local Pfizer branch in India, the number of employees has only increased. Currently, there are 2,000 employees and plans to increase 200 to 250 employees.
Similarly, a GSK spokesperson told the New York Times that GSK’s Indian subsidiary is also expanding its enrollment to prepare for the company’s planned launch of new drugs. The branch currently has a team of more than 3,000. “About 100 more people will be recruited to meet the needs of the expansion plan.â€
Novartis will create about 100 jobs in India, and the company will transfer some of its clinical trials and financial related back office work to India. Novartis plans to lay off 3,750 people worldwide.
While MNCs continue to lay off employees, they have continuously increased R&D and sales staffing in India and China, reflecting the new pattern and changes in the global pharmaceutical industry. It is hoped that this shift will not only be the inevitable result of the dynamic changes in the global pharmaceutical market and the redistribution of resources in order to save labour costs.
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Pharmaceutical Internationalization, India Goes Fast
In the internationalization of the pharmaceutical industry, India has always gone faster than China. The most worthwhile places for Chinese colleagues to learn are: 1. Pay attention to talent; 2. Pay attention to research on international markets and regulations; 3. Make good use of international capital and cross-border mergers and acquisitions 4. Dare to challenge the patents of the branded drug companies. In the field of APIs, outsourcing services of Indian pharmaceutical companies are more sophisticated and professional than many Chinese companies. They do not compete with people in terms of price and time, but rather do articles on processes and independent innovation. Compared with Chinese pharmaceutical companies, Indian pharmaceutical companies have a large number of DMFs and are of good quality. Many of them use low-cost Chinese raw materials to produce high-value raw materials that meet GMP specifications and are exported to Europe and the United States. In the field of formulation development and production, Indian pharmaceutical companies appear to have stronger advantages. Guang Lanxi has more than 30 products entering the US market. This depends on many years of hard work and accumulation.
In the first three quarters of this year, the cooperation between Indian pharmaceutical companies and foreign pharmaceutical companies in the development of new drugs has doubled from last year, from 6 items in last year to 12 items (see Table 1 for details). If this terrorist attack is not encountered, the study Development cooperation should also increase. It is reported that about 40 billion to 50 billion U.S. dollars of R&D expenditures for multinational pharmaceutical companies are spent on outsourcing services.
The October report by PricewaterhouseCoopers pointed out that India, China and Singapore and other countries will maintain their position in the Asian pharmaceutical industry, and most of the outsourcing of new drug development will fall into these countries. Experts in the industry believe that since the beginning of this year, the number of new drug development projects signed by Indian pharmaceutical companies and multinational companies has increased, reflecting the trust of multinational corporations in India to a certain extent, allowing them to use the most advanced methods for new drugs that have not been screened. The initial basic research was outsourced from the initial drug screening to structural transformation and optimization. This is a model that completely starts from scratch and the parties share risks and future benefits. It may play a very important role in the future.
Dr. Rashmi Barbhaiya, CEO and managing director of India's research and development company Advinus Therapeutics, said that the company has signed a contract with Merck in just two months. "Three years later, we have successfully completed the results of three milestones, and compared the industry average to identify a clinical candidate drug. The time is much faster."
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