Many people may not know how much money and manpower a new drug will cost, how many failures and repeated experiments it will go through, and the clinical trial stage of the drug. This kind of cost is huge, and ordinary companies simply can't afford it. Several well-known pharmaceutical companies in the world, such as Pfizer in the United States, Novartis in Switzerland and Bayer in Germany, have to invest billions or even billions of dollars to develop a specific drug. This kind of investment will be allocated to the drug price after the new drug goes on the market, so new specific drugs are often very expensive because they include research and development expenses.
Indian generic drugs directly bypass the research and development stage, and can be made into biosimilars within three months after the original drug is listed. This generic drug may only be about 80% of the original drug, but the price is only110 of the original drug.
For example, the specific drug for the treatment of chronic myeloid leukemia is Gleevec developed by Novartis, Switzerland, which costs about 23,000 yuan per box, while its generic drug VEENAT costs more than 200 yuan, which is produced by Indian pharmaceutical company Natco. The active ingredient of both is imatinib, but the price gap is huge.
Besides Gleevec, other specific drugs, such as Herceptin for breast cancer, Iressa for lung cancer, nexavar for renal cell cancer and liver cancer, all have their generic drugs.
In fact, many countries can produce generic drugs, but generally speaking, generic drugs can only be produced after the patent protection period of the original drug.
1983, the FDA of the United States passed a Waxman bill, stipulating that after the patent protection period of the original drug is 20 years, the manufacturer does not need to repeat preclinical animal research and human clinical research, but only needs to prove that the biological activity of the generic drug is equivalent to that of the original drug.
However, the Indian government does not even bother to wait for a 20-year patent protection period. They have implemented a special "compulsory patent licensing" system, that is, under special circumstances, the government can grant or license other enterprises to use a patent without the consent of the patentee. In other words, when the poor can't afford expensive patented drugs, India allows drugs to be directly copied, regardless of whether the patent protection period ends. It is said that the Indian government did this in order to break the drug monopoly in Europe and America and make life-saving drugs for the poor, but this is actually an act of ignoring the intellectual property rights of drugs. The robber logic behind it is "I am poor, so I am right, and you have money, so you should let me copy".
Patent protection is a universal norm and a law that everyone abides by. Of course, other countries can also copy drugs, but they don't follow the rules as confidently as India. But its disobedience directly benefits ordinary people who can't afford high-priced drugs. This puts generic drugs in a dilemma: morally speaking, it is impeccable, but legally speaking, it is illegal.
In addition, there is no limit to the number of medicines India can take abroad, and customers can also buy medicines. In 20 15, the sales of generic drugs in India reached USD 300 million, of which 250 million were sold at home and 510 million were exported to all parts of the world.