In recent years, a film called "I Am Not the God of Medicine" has caused huge repercussions and discussions in China. The film tells the story of an ordinary leukemia patient who risks his life to smuggle cheap generic drugs from India in order to save himself and other people with the same disease. The film not only sheds light on China's healthcare system and social issues, but also instills curiosity and concern about India's generic drug industry. Why is India able to produce generic drugs during the patent period?What is the impact of generic medicines in India on global access to medicines and public health?What are the challenges and risks faced by generic drugs in India?This article will analyze and analyze these issues from multiple perspectives such as history, law, economy, and society.
The development of generic drugs in India can be traced back to 1970, when India amended the patent law in order to protect the domestic pharmaceutical industry, canceled the product patent of the drug, and only granted the process patent for the production process. This means that as long as a pharmaceutical company in India is able to produce the same or similar drug through different manufacturing methods, there will be no patent infringement. This move has led to the rapid development of India's generic drug industry, which has become one of the world's largest producers of generic drugs, also known as the "Pharmacy Country".
However, with the process of globalization, India is also facing international pressure and requirements, in order to join the World Organization (WTO), India had to restore the product patent protection system for drugs in 2005, that is, for drug patents applied after January 1, 2005, India will give a 20-year patent term, prohibiting any unauthorized imitation and sale. This change has had a huge impact on India's generic drug industry, with many new drugs not being able to be imitated, resulting in lower drug prices** and drug accessibility.
In response to this challenge, India has implemented a number of special legal provisions and measures to ensure the legitimacy and sustainability of generic drugs in India, while restoring patent protection for medicines. The most important of these are compulsory patent licenses and restrictions on the granting of patents for some compounds.
Compulsory patent licensing means that under certain circumstances, the state may authorize a third party to use, produce or sell a patented product or process without the consent of the patent holder to meet the needs of the public interest. India's patent law provides that if a patented product or process is underutilized within India, or if it is beyond the reach of the majority of the public, or if it is insufficient to meet the needs of the public, or if it has an adverse effect on public health or the environment, then India** or the Indian court may grant a patent compulsory license to allow generic drug manufacturers in India to produce and sell the patented drug at a low cost and only need to pay a certain license fee to the patent holder.
Restrictions on the granting of patents for some compounds refer to the fact that India's patent law has strict standards for the patenting of drugs, and does not allow minor changes to known compounds to apply for new patent protection, which is known as "patent perpetuation". India's patent law requires that a patent application for a drug must demonstrate a significant improvement in efficacy over existing drugs, otherwise it will be denied. This provision allows India to refuse to grant patents to some innovator companies, thus providing space for generic drug manufacturers in India to produce and sell.
India's legal system for generic drugs has been recognized and supported by countries such as Europe and the United States, mainly based on the provisions of the WTO's Agreement on Intellectual Property Rights Related to Trips (TRIPS) and the Doha Declaration on TRIPS and Public Health, as well as humanitarian and global drug accessibility considerations.
The TRIPS Agreement is an international agreement signed by WTO member states in 1994 to protect and enforce intellectual property rights, including patents, trademarks, copyrights, etc. The TRIPS Agreement sets out minimum standards for the protection of intellectual property rights and requires all Member States to bring their national laws into line with the TRIPS Agreement within a certain transition period. However, the TRIPS Agreement also allows Member States to make limitations or exceptions to intellectual property rights in exceptional circumstances to protect the public interest, including a system of compulsory patent licensing.
The Doha Declaration is a political statement adopted by WTO member states at the Ministerial Conference held in Doha in 2001 to address the relationship and balance between the TRIPS Agreement and public health, particularly in some developing countries facing the threat of major diseases. The Doha Declaration clarified the flexibility and interpretive space of the TRIPS Agreement, emphasizing the right of Member States to take the necessary measures to protect public health and promote access to medicines, in accordance with their national circumstances, including the implementation of compulsory patent licenses and the import of low-cost generic medicines.
In addition to the provisions and support of the WTO, India's legal system of generic drugs has also been recognized and praised by some international organizations and non-** organizations, such as the World Health Organization (WHO), the United Nations Programme on HIV/AIDS (UNAIDS), Doctors Without Borders (MSF), etc., who believe that Indian generic drugs have an important contribution to global public health and access to medicines, especially for some poor and developing countries.
The advantages and contributions of generic drugs in India are mainly reflected in their size, quality and quality, as well as their role and impact in some major diseases.
India is the world's third-largest pharmaceutical producer and the world's largest exporter of generic drugs, accounting for more than 20% of the global generic drug market, mainly exported to developing countries such as Africa, Asia and Latin America. India's generic drug industry has strong production capacity and technology to produce drugs in various types and dosage forms to meet different market needs and consumer preferences. India's generic drug industry is also highly competitive and innovative, able to quickly adapt to international legal and first-class changes, and develop new generic drugs and production processes.
Indian generics are often only a fraction or even a tenth of the original drug, making Indian generics a life-saver option for many patients who cannot afford the expensive original drug. The low cost of generic drugs in India** is also conducive to reducing global drug spending and improving the accessibility and affordability of medicines. The advantages of Indian generic drugs are mainly due to India's low-cost production factors, such as cheap labor, raw materials and equipment, as well as India's legal system, such as compulsory patent licensing and restrictions on the granting of patents for some compounds.
The quality of generic drugs in India has also been approved and regulated by agencies such as the Drug Authority of India and the World Health Organization, guaranteeing their safety and efficacy. Generic drug manufacturers in India must comply with Indian drug standards and practices, as well as international drug quality management systems such as GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), GCP (Good Clinical Practice), etc., to ensure the quality and consistency of their generic drugs. Generic drug factories in India must also be inspected and certified by agencies such as the Drug Authority of India and the World Health Organization to obtain the registration and marketing license of their generic drugs. In addition, generic drug manufacturers in India have established partnerships with some international drug procurement and distribution agencies, such as the United Nations Children's Association (UNICEF), Global** (GF), and the United States** Emergency Plan to Fight AIDS (PEPFAR), to provide generic drugs that meet international standards.
The role and impact of generic drugs in India in some major diseases is immeasurable, especially for patients in some poor and developing countries. Indian generics have provided life-saving hope and options to millions of patients around the world with chronic and infectious diseases such as AIDS, cancer, tuberculosis, malaria, etc., greatly improving their quality of life and survival expectations. Indian generic drugs have also made important contributions to global public health and disease control, promoting human health and well-being and social progress. 
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Although Indian generic drugs have many advantages and contributions, they also face many difficulties and pressures, mainly from both domestic and international aspects.
Domestically, the development of generic drugs in India has been constrained and affected by India's medical system and drug regulation. India's medical system is imperfect, the distribution of medical resources is uneven, the quality and accessibility of medical services are not high, and the coverage and level of medical security are insufficient, resulting in a huge gap and imbalance in the demand and consumption of drugs by the public in India. India's drug supervision is also not strict, the registration and approval process of drugs lacks transparency and efficiency, the production and circulation process of drugs lacks supervision and inspection, and there are hidden dangers and risks in the quality and safety of drugs. There are also some problems and drawbacks in India's generic drug industry, such as the uneven quality of generic drugs, insufficient R&D investment in generic drugs, weak innovation ability of generic drugs, and poor brand image of generic drugs. These problems and drawbacks have not only affected the domestic market and consumer trust of Indian generic drugs, but also affected the international reputation and competitiveness of Indian generic drugs.
Internationally, the development of generic drugs in India has encountered challenges such as patent rights protection of original drug companies, market access and barriers in Europe and the United States, as well as the rise of the generic drug industry in other developing countries. Innovator drug companies have conducted frequent lawsuits and** on patent infringement of generic drugs in India, trying to prevent or delay the production and sale of generic drugs in India in order to maintain their patent rights and market share. Europe and the United States and other countries have set up various obstacles and restrictions on the market access and quality of Indian generic drugs, such as putting forward higher standards and requirements for the quality and safety of Indian generic drugs, such as implementing stricter supervision and inspection on the import and sales of Indian generic drugs, such as implementing more intervention and sanctions on the ** and subsidies of Indian generic drugs. The generic drug industry in other developing countries is also developing and growing rapidly, such as China, Brazil, South Africa, etc., they have not only made significant progress and innovation in the production and technology of generic drugs, but also have more expansion and opportunities in the market and cooperation of generic drugs, and the competition and challenges for generic drugs in India are intensifying.
In summary, Indian generic drugs have been developed on the basis of their special historical and legal background, as well as public interest and international support, and they have made important contributions to global access to medicines and public health, but they also face many difficulties and risks. The experience and lessons of Indian generic drugs are worthy of reference by other countries and regions, and at the same time, they need to be continuously improved and innovated to adapt to changes and needs at home and abroad, and make greater contributions to the health and well-being of all mankind.