Generic drugs manufactured in India are not "counterfeit" products
Firstly, it needs to be clarified that the expensive newly approved drugs mentioned earlier are patented drugs, and the research and development investment for new drugs is huge. When new drugs are developed, they enjoy patent protection in order to protect innovation. Most of the "bargains" produced in India are generic drugs, that is, drugs produced by other manufacturers are identical to patented drugs after the expiration of the drug patent (the patent protection period of drugs is generally 20 years).
The so-called "identical" refers to "having the same bioequivalence and effectiveness". The generic drugs do not need clinical trials, but are consistent with the original drugs in terms of dose, safety and efficacy, quality, effect, indications and other factors. So, once the generic drugs manufactured in India pass the "bioequivalence experiment", their production management standards are also certified by the US FDA. If one thinks that "generic drugs" are counterfeit and shoddy products, it is a big mistake.
Due to the lack of high research and development costs in the early stages, the prices of these generic drugs are generally only 20% -40% of those of patented drugs, and some varieties vary several times. As a result, low-cost generic drugs have a considerable competitive advantage in the market.
Indian generic drugs are considered "conditional and legal" and are popular among poor people and charitable organizations
While rapidly expanding the market, Indian pharmaceutical companies are also being questioned: have their actions violated intellectual property rights and disrupted the pharmaceutical market?
In the 1970s, India's first patent law was enacted, which clearly stated: "The Indian patent law protects the entire production process and process, but if the process and process change, the corresponding product is not bound by the original patent." This provision was criticized for decades after it essentially denied the patent rights of drugs as products themselves. With the support of such lenient legal policies, Indian pharmaceutical companies have begun to manufacture a large number of generic drugs.
In 1994, India reached an agreement (TRIPS clause) with India before joining the WTO, agreeing to provide product patent protection in all technical fields, but enjoying a transitional period of ten years before 2005. Over the past decade, India has been making slow progress in the field of patents, but this has also provided valuable time for local pharmaceutical companies, making India the home of generic drug manufacturers.
It was not until 2005 that the Indian Parliament passed the National Patent Law, which was in line with international standards. However, even the new law only provided patent protection for new drugs invented after 1995 or drugs that could significantly improve their efficacy after improvement, and did not support patents for existing drug mixtures or derivative drugs. This provision provided a legal exemption for Indian pharmaceutical companies that were later plagued by lawsuits. European and American pharmaceutical companies, which later regarded Indian pharmaceutical companies as fierce enemies, were almost impossible to sue Indian pharmaceutical companies into bankruptcy under the name of patents.
Indian generic drugs sold to Americans, reshaping the global pharmaceutical landscape
When Chinese people are still facing high domestic drug prices while mocking India as a drug counterfeiting country, India is beginning to show a higher level in the pharmaceutical industry. Indian pharmaceutical companies, who used to wear the hat of market disruptors and wandered in the gray zone of national protection, did not waste the opportunities they had won during the transition period: Indian generic drug manufacturers have moved up the global value chain and are attempting to gain a foothold in regulated markets such as the United States and Europe.
Between 2004 and 2014, the total sales of generic drugs in India increased from $4 billion to $17 billion, an average annual growth of 16%, while sales abroad grew even faster, with an average annual growth of 22%, soaring from $1.7 billion to $12 billion. By 2014, foreign sales had accounted for 70% of the total, and over half of the drugs were sold to the international market, with developed countries such as Europe and America, especially the United States, being the main market for generic drugs in India.
