So what are the corresponding legal provisions in the process of generic drugs in India?
First of all, as we all know, India is a country with a large number of poor people, many of whom lost their lives and health because they could not afford to take such expensive medicines, thus leading to a lack of livelihood. In 1970, Indira Gandhi, the Prime Minister of India at that time, solved this problem by utilizing a change in the patent law. The amended patent law stated that for food and drugs, only patents on the process were granted, not the product, which then meant that India gave up the protection of intellectual property rights on pharmaceutical compounds. This system is more lenient, so that the country's enterprises can obtain a large number of licenses for the production of generic drugs, thus providing room for the rapid growth of generic drugs in India. And at the same time, the Indian government has mandated that drug companies' pre-tax profits cannot exceed 15 percent of the selling price of a drug. Between 1970 and 1995, India eliminated patents on pharmaceutical products, making it the lowest priced country in the world, and in 2005, the Indian Patent Act was amended to allow Indian generics to be exported even to regions and countries without the relevant manufacturing capacity under compulsory licensing. What does compulsory licensing mean? India's patent law provides that in the event of unavailability or unaffordability or inability to provide properly, local drug companies can apply to the Indian government for a compulsory license of intellectual property rights, which means that the Indian government will compulsorily license their own drug companies to obtain the right to produce and sell generic drugs.
Theoretically, patented drugs have a 20-year patent protection period according to the laws of the world, but the Indian government can't even wait for the 20-year protection period, and has implemented a special patent compulsory license system. That is, under special circumstances, without the consent of the patentee, the Indian government grants a license to other companies that do not hold the patent to use a patent. In other words, the Indian government is allowing drugs to be directly copied.
This saves a lot of time accordingly. Then, as long as the drug is copied and meets the appropriate regulations, it can be legally marketed and sold in India. From a legal point of view, Indian law also provides some protection for generic drugs in judicial practice.