India’s patent policies: Lifeline for HIV/AIDS treatment worldwide
This article is authored by Professor TC James, president, NIPO and visiting fellow, Research and Information System for Developing Countries (RIS).
A major concern during the negotiations on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, finalised in 1994, was how it would affect access to affordable medicines for diseases like HIV/AIDS since it contained provisions for a stronger and longer patent protection regime. On the 36th World AIDS Day which falls on December 1, we reflect on how the new laws have affected the global fight against HIV/AIDS.
India has since 2000 emerged as the pharmacy of the developing world due to its robust pharmaceutical industry, which produces a significant share of the world’s generic medicines. Approximately 80% of the antiretroviral drugs (ARVs) used in low- and middle-income countries, including for HIV treatment, are sourced from Indian manufacturers. Over 10 million people living with HIV/AIDS worldwide receive treatment with Indian generics.
This contribution has been instrumental in ensuring that millions of people living with HIV can manage the virus effectively and live longer and healthier lives. Over the past two decades, Indian pharmaceutical companies have provided these lifesaving drugs at a fraction of the cost of patented medications from transnational pharmaceutical companies. This has been particularly critical in the context of ARVs, which are required for lifelong treatment.
The Indian Patents Act plays a key role in enabling the production of low-cost generics. While the Act complies with the TRIPS Agreement, it also includes provisions prioritising public health over patent rights. One of the most important features of the Indian Patents Act is its provision to prevent "patent evergreening," a practice where patent holders make minor changes to existing products to extend their patent term. In India, the law allows for strict scrutiny of patent applications, ensuring that only genuinely novel drugs are granted patents. This enables generics manufacturers to produce affordable versions of life-saving HIV drugs as soon as the original patent expires, thus lowering costs and increasing accessibility. In many cases, the price difference is staggering. For example, while the cost of patented ARVs can be upwards of Rs. one million per year per patient, generic ARVs from Indian manufacturers are often available for less than ₹10,000 per year. ARV prices have decreased by up to 90% since 2000, making treatment more accessible.
India's role in increasing access to HIV treatment has been bolstered by its partnerships with global health organisations such as the Medicines Patent Pool (MPP). The MPP is a global initiative designed to increase access to HIV treatments by negotiating voluntary licensing agreements with patent holders and facilitating the production of generic versions of patented medicines. Indian pharmaceutical companies have been instrumental in these efforts. These collaborations have expanded access to HIV medications significantly and have been pivotal in achieving global health goals, particularly in sub-Saharan Africa, which bears the heaviest burden of the HIV epidemic.
In addition to increasing the availability of ARVs, Indian companies have also been at the forefront of developing patient-friendly formulations. Innovations such as tenofovir-based fixed-dose combinations (FDCs) of ARVs, where multiple medications are combined into a single pill, have made it easier for people living with HIV to adhere to treatment regimens. These formulations not only simplify treatment but also reduce the burden on patients, leading to better health outcomes and improved quality of life.
Indian pharmaceutical companies have also pioneered the development of formulations for paediatric patients, including syrup forms of ARVs and chewable tablets that are easier for children to take. This has been especially important in regions where children with HIV are disproportionately affected by the virus and face additional challenges in accessing care.
India’s commitment to public health and access to medicines is underscored by its leadership in creating health-focused IPR policies. By balancing the protection of patents with the overriding need for affordable treatment, India has set an example for other nations on how to protect both innovation and public health. India now ranks 6th globally in terms of patent applications, underscoring that the laws have encouraged innovation. The Indian model of patent law, particularly its rigorous examination process and provisions for compulsory licensing, has been widely recognised as a model for other countries looking to prioritise access to essential medicines and has earned India praise from the global health community.
As we observe World AIDS Day, it is essential to recognise the extraordinary contribution of the Indian pharmaceutical industry to the global fight against HIV/AIDS. Through its production of affordable generic drugs, strategic partnerships, and innovations in drug formulations, India has played a central role in making HIV treatment accessible to millions worldwide. By prioritising public health over the patent owner’s interests, India has demonstrated that access to essential medicines should be a fundamental right, not a privilege. As the world continues its battle against HIV, India’s pharmaceutical sector will remain a key player in ensuring that access to treatment is a reality for all those who need it.
This article is authored by Professor TC James, president, NIPO and visiting fellow, Research and Information System for Developing Countries (RIS).
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