Indian generic anti-cancer drugs have a reputation of being “Super A” in the pharmaceutical industry, as they are sold at a tenth or even less of the price of legal “foreign drugs”, making patients who can’t afford them The price is only one tenth of the legal “foreign drugs” or even lower, so that patients who can not afford to take drugs are rushing to. However, these generic drugs are considered “fake” because they do not have approvals in China. Recently, a Nanjing couple was prosecuted by the prosecutor’s office for buying and selling Indian anti-cancer drugs.
Indian generic drugs, which usually flow into the domestic market through underground channels because they are not patented, bring hope to the poor at low prices while causing profit losses to pharmaceutical giants. How to break the dilemma of life and death?
The price/quality ratio tempted to buy cancer “fake drugs” in India.
For businessmen who frequently travel to and from India, it seems that “Indian medicines” have become a must-have “souvenir”. These “Indian medicines” are certainly not the so-called mysterious massage oil or ointment, but mainly refers to several small molecular weight generic anti-cancer drugs, such as Gleevec, Erysal and Doxorubicin.
These drugs were originally developed by European and American pharmaceutical companies, in India because of the local companies were copied, benefit from the cheap “Indian cost”, the same course of treatment can be up to ten to fifteen percent cheaper than the original price, so in the community has a considerable influence. Generally, only one strip (10 boxes) per person is allowed on the plane.
The overseas buyers have apparently found business opportunities in the huge price difference between imported drugs and Indian generics, extending their tentacles from everyday items such as clothing, shoes and bags, digital and food, to the field of medicine that saves lives.
Recently, the media reported that a Nanjing couple borrowed the convenience of working in India to purchase and sell Indian generic anti-cancer drugs through the Internet, selling 320,000 yuan in two years. The couple was prosecuted by the prosecutor’s office for allegedly selling counterfeit drugs.
The so-called “fake drugs” refers to the efficacy level of fake drugs; the other refers to the legal level of fake drugs. In the case of the Nanjing couple, the Indian generic anti-cancer drugs were sold because they did not have China’s drug import registration number.
Putting aside all the artificial factors that may occur in the process of purchasing drugs, in terms of efficacy, “authentic” Indian generic drugs are almost identical to patented “foreign drugs” in terms of dosage, safety, efficacy, quality, action and indications, and are not bound by patents in India. It is a regular drug that is not bound by patents. (The
It is ten times cheaper than the “patent medicine”.
In fact, this is not the first time that a case like the Nanjing couple’s happened. At the end of last month, the State Food and Drug Administration released 10 illegal drug selling websites, including four selling anti-cancer drugs mainly “India ERSA” and “India Gleevec”.
At present, the Indian generic drugs purchased in China are usually targeted therapies such as Gleevec for leukemia, Herceptin for breast cancer, ERSA for lung cancer, and Doxorubicin for renal cell cancer and liver cancer. The so-called targeted therapy refers to the design of therapeutic drugs targeting the identified cancer-causing sites, which will select the cancer-causing sites for action in the body and kill the tumor cells without affecting the surrounding normal cells, thus helping patients to achieve high-quality “survival with tumor”.
These anti-cancer drugs are not produced in China at present, but are imported from European and American pharmaceutical companies. According to a regular state-run pharmacy, ERSA costs more than 5,400 yuan per box, requiring at least 15,000 yuan for three boxes a month; Gleevec costs more than 11,500 yuan per box, requiring at least 23,000 yuan for two boxes a month.
In contrast, the “Indian version” of the anti-cancer drug is much cheaper. For example, the price of the “Indian version” of ERSA is about 1,800 yuan a box, that of Troche is 4,500 yuan a box, and that of Gleevec is 1,800 yuan a box, and each box is a 30-day supply. The price is about 1,800 yuan for a box, 4,500 yuan for a box of Troche and 1,800 yuan for a box of Gleevec, and each box is a 30-day supply.
Many foreigners go to India for medical treatment
Every year, a large number of tourists from Europe, the United States, the Middle East and India’s neighboring countries to India to see the doctor, known as “medical tourism”, because the same medical services, the price in India is sometimes cheaper than in the West 1/10, the price advantage of Indian generic drugs is one of the important reasons.
Of course, many private hospitals in India are also world class in terms of technology, and they have developed effective and cost effective treatments in the most economical way, based on the low cost of medical care in India, with some procedures costing 1/10th of the cost in the West, and with considerate service. Like the famous Apollo Hospitals, which attracts nearly 30,000 foreigners to India for medical treatment every year, which includes many patients from Europe, America and the Middle East.
According to a statement by the Confederation of Indian Industry, about 150,000 people came to India for medical treatment last year, and the number will increase significantly this year, and the growth rate may be about 15%. A study by McKinsey & Company and the Confederation of Indian Industry shows that in 2012, the annual revenue of medical tourism in India reached $1 billion to $2 billion. Some industry insiders predict that the industry will be able to generate $50 billion in annual revenue for India, based on the fact that a small fraction of the world’s spending on healthcare, even if 2% of it can be spent in developing countries, India can achieve this goal.
The loss of patents
India becomes the world’s pharmacy
Since India entered the fast lane of economic development in the 1990s, it has relied not on the expansion of the processing industry, but on several industries based on the original domestic technological base, of which the biological and pharmaceutical industry is one. India’s pharmaceutical industry stands out among Asian countries for its internationalization and the quality of its pharmaceutical products.
Major Drug Exporters
India is the world’s leading drug exporter, with a large number of internationally certified drugs. 650 Indian pharmaceutical companies have been permitted by the FDA to export drugs and related raw materials to the U.S., while only 300 Chinese companies are permitted to export to the U.S. According to Indian government statistics, in 2008-2009, the total value of India’s pharmaceutical and pharmaceutical industry services exports reached $8.3 billion.
India has always been known as the “world’s pharmacy”, drug prices are the lowest in the world, has been welcomed by poor patients and humanitarian medical organizations. In particular, the generic drug industry is well developed, and generally speaking, once expensive drugs are available in Western countries, Indian pharmaceutical companies can copy the same products under the protection of their own patent laws.
For international humanitarian organizations, such as Médecins Sans Frontières, the Global Fund, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), UNITAID and UNICEF, all have to rely on inexpensive Indian generic drugs to run their programs. The medical humanitarian organization Médecins Sans Frontières (MSF) notes that 80 percent of its anti-HIV drugs are purchased from India.
Recognized by the United Nations
On September 16, 2012, UN Secretary-General Ban Ki-moon launched the UN Millennium Development Goals Gap Worker Annual Report at UN Headquarters in New York. In this annual report, the importance of generic drugs is recommended at considerable length, and the development of generic drug industry is considered to be an important guarantee for third world countries to improve their health and the health status of their people, and the efforts of countries such as India to strengthen the production of low-cost generic drugs are appreciated and affirmed. According to the report, “Indian generic pharmaceuticals are mainly export-oriented and thus have become the pharmacy of the third world during the transition period.”
Ignoring European and American drug patents
Leaving aside the phenomenon of shoddy imitation by adulterers, why are cancer drugs so cheap in India? In addition to India’s unique technological cost advantage, this is also due to India’s unwavering implementation of the “compulsory drug licensing system”. Simply put, this means that Western patent protection regulations are being tossed aside to produce the latest and most effective drugs for low-income people.
Rapid genericization is possible
In the 1970s, the Indian government did not recognize patents on drugs in Western countries. The Patent Act enacted in India granted only process patents, not product patents, for food, drugs, etc. In the 20 years or so after the enactment of the Patent Act, Indian generic drugs grew rapidly. A drug approved by the US FDA could be found in the Indian market as a generic only 3 months later.
It was only in 2005, as part of an agreement with the World Trade Organization, that India began to reinstate drug patents.
It was also difficult to cut off generic drugs that violated the Patent Act because the poor were already enjoying the benefits of generic drugs, especially in South Asia and Africa. the Indian Patent Act, which came into force in January 2005, only provides patent protection for new drugs invented after 1995 or improved drugs that substantially improve their efficacy, and does not support patents on mixtures or derivatives of original drugs. At the same time, the Indian government can implement “compulsory licensing” as needed.
European and American drug companies often lost the lawsuit
To this day, many Indian generic drugs are being sold while fighting legal battles with the original R&D manufacturers. However, most of the patent lawsuits by European and American pharmaceutical companies in India have ended in failure.
On September 4, 2009, India withdrew the patent protection of Tenofovir; on September 7, 2012, the Indian court rejected the patent infringement lawsuit of Roche’s anti-cancer drug Tarceva; ten days later, Bayer’s petition was rejected by the Indian Intellectual Property Rights Appellate Board; in 2013, the Indian Supreme Court recently rejected the Swiss pharmaceutical giant Novartis’ request for patent protection of the new and improved anti-cancer drug Glivec The Supreme Court of India recently rejected Swiss pharmaceutical giant Novartis’ claim for patent protection for its improved anti-cancer drug Glivec. The Supreme Court of India recently rejected Swiss pharmaceutical giant Novartis’ claim for patent protection for its improved anti-cancer drug Glivec, holding that the Indian generic version of the cancer drug could continue to be sold. The lawsuit has been hailed as a game of “human rights versus intellectual property” in India.
Confusion over legality
Patented drug development under threat
Most drugs are extremely cheap to produce. The most important cost for foreign pharmaceutical companies is the cost of research and development, from the development and synthesis of drugs, to the long phase IV clinical trials, and then through the approval of national drug regulatory agencies, all need to invest a lot of money, almost every new drug that can finally reach the market is behind billions of dollars of investment, only a few multinational giants with strong capital can afford.
Since the discovery of penicillin in 1928, the pharmaceutical industry has entered the industrial era and inevitably has become an integral part of business activities. Drugs are also a special commodity, and often the research and development process for a drug such as an antibiotic often takes years, involves huge investments, and is unpredictable, with many drug developments ending in failure. In the past, it was generally believed that the average cost of developing a new drug was about $1 billion. However, a recent data suggests that the cost of developing a new drug is much more than that.
With such a high risk of investment, high returns are inevitably sought, so it’s hard to imagine how profitable new drugs can be. At the same time, drug companies can only use these profits to continue to invest in subsequent research, in order to continue to advance the progress of medical technology.
While bringing a boon to poor patients, inexpensive Indian generics have made European and American pharmaceutical giants suffer losses and become their sworn enemies. For many patients, they are grateful for both patented and generic drugs – patented drugs give them the hope of life, but they can hardly afford the high cost of drugs and are discouraged; while generic drugs give them the possibility of life and make the advanced human medical technology truly benefit the general public. Here is the paradox of the dilemma: without the innovative research and development of patented drugs, how can generic drugs save life and death? Therefore, from the perspective of the pharmaceutical giants who invented the patented drugs, I am afraid that selling expensive drugs is a choice that has to be made.