India can produce generic drugs but other countries cannot. This is not because India’s pharmaceutical technology is extremely advanced, but because the Indian government pursues a policy of “I am poor and I am justified” and ignores patent rights for drug research and development. If India's drug development technology is really advanced to an incredible level, it should directly develop new drugs instead of following the world's leading pharmaceutical companies and copying their research results.
Many people may not know how much money and manpower it costs to launch a new drug, how many failures and repeated experiments it takes, and the clinical trial stage. This cost is extremely huge, and ordinary companies simply cannot afford it. The world's leading pharmaceutical companies, such as Pfizer of the United States, Novartis of Switzerland, and Bayer of Germany, spend billions or even tens of billions of dollars to develop a specific drug. This investment will be amortized into the drug price after the new drug is launched, so new specific drugs are often very expensive because they include research and development expenses.
However, Indian generic drugs directly bypass the research and development stage, and can be made into biosimilars within 3 months of the original drug being launched. This kind of generic drug may be only about 80% as effective as the original drug, but the price is only 1/10 of the original drug.
For example, the specific drug for the treatment of chronic myelogenous leukemia is "Gleevec" developed by the Swiss company Novartis, which costs about 23,000 yuan per box, while its generic drug VEENAT only costs more than 200 yuan and is produced by the Indian pharmaceutical company Natco Produced by the company, the active ingredient of both is imatinib, but the price gap is huge.
In addition to Gleevec, other specific drugs such as Herceptin for the treatment of breast cancer, Iressa for the treatment of lung cancer, and Nexavar for the treatment of renal cell carcinoma and liver cancer have their generic drugs in India.
In fact, many countries can produce generic drugs, but generally, generic drugs can only be produced after the patent protection period of the original drug has expired.
In 1983, the U.S. FDA (U.S. Food and Drug Administration) passed the Waxman Act, which stipulates that after the 20-year patent protection period of the original drug, manufacturers do not need to repeat preclinical animal research and human clinical research. It only needs to prove that the biological activity of the generic drug is equivalent to that of the original drug before it can be approved for marketing.
However, the Indian government did not even bother to wait for the 20-year patent protection period. They have implemented a special "patent compulsory licensing" system, which means that under special circumstances, the government can grant and license other companies to use a certain patent without the consent of the patentee. In other words, when poor people cannot afford high-priced patented drugs, India allows the drugs to be copied directly regardless of whether the patent protection period expires. It is said that the Indian government did this to break the European and American pharmaceutical monopoly and make life-saving medicines for the poor. However, this is actually an act that ignores the intellectual property rights of drugs. The underlying philosophy is "I am poor, so I am justified, and you are rich, so you should let me The gangster logic of "imitation".
Patent right protection is a universal norm and a law that everyone abides by. Of course, other countries can produce generic drugs, but India is not so confident in not abiding by the rules. However, the direct beneficiaries of its non-compliance are ordinary people who cannot afford high-priced drugs. This puts generic drugs in a dilemma: ethically it is certainly impeccable, but legally it is illegal.
In addition, India has no quantitative restrictions on taking medicines abroad, and medicines are also open to customers. In 2015, India's generic drug sales reached US$300 million, of which 250 million were domestic sales, while 51 million were exported to various parts of the world.