The Struggle for Access to HIV/AIDS Medications in India

In 2001, something remarkable happened in the global fight against HIV/AIDS. Indian pharmaceutical company Cipla offered a triple-drug antiretroviral combination to Médecins Sans Frontières for less than one US dollar a day – a 97% reduction from what multinational companies were charging at the time. That single offer changed the trajectory of HIV treatment for millions of people across low- and middle-income countries. India’s pharmaceutical sector had, for decades, served as the world’s pharmacy. But that role has been under sustained pressure ever since India reformed its patent laws in 2005. For people living with HIV/AIDS (PLWHAs) in India and across the developing world, the stakes in this legal and policy battle could not be higher – it is, quite literally, a matter of life and death.

Why antiretroviral drugs were once unaffordable 🔗

Before the early 2000s, antiretroviral (ARV) drugs – the medicines that suppress the HIV virus and allow patients to live normal lives – were controlled almost entirely by large multinational pharmaceutical corporations. The price tag was US$10,000 to $15,000 per patient per year, a sum completely out of reach for the vast majority of people in developing nations like India. This was not because the drugs were inherently expensive to manufacture. It was because patent monopolies gave originator companies exclusive rights to produce and sell them, with no competition to drive prices down.

India’s older patent framework, in place since the Patents Act of 1970, did not permit product patents on medicines. Indian manufacturers could study a patented drug and produce a generic version using a different manufacturing process. This legal environment allowed companies like Cipla and Aurobindo to produce ARVs at a fraction of the branded price. By 2008, Indian-manufactured generic ARVs accounted for over 87% of donor-funded ARV purchases in developing countries, making India the undisputed global supplier of affordable HIV treatment.

The 2005 patent law amendment and its impact on HIV treatment 🔗

The landscape shifted significantly when India joined the World Trade Organization (WTO) and became obligated to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS required all member nations to grant 20-year product patents on new medicines. India amended its Patents Act in 2005 to comply, meaning that any ARV drug introduced after January 1, 1995 – and not yet patented in India – could now be claimed by its originator company. Indian generic manufacturers were effectively locked out of producing these newer drugs without a licence from the patent holder.

The consequences were direct and serious. Patents were granted to multinational companies including Pfizer, Tibotec, and Merck for newer ARVs such as maraviroc, etravirine, and raltegravir. Indian pharmaceutical companies could no longer produce generics for drugs introduced after 2005 due to the new product patent regime. The older first-line ARVs continued to be available cheaply, but patients who needed to switch to second-line regimens – often due to drug resistance or toxicity – found themselves facing dramatically higher costs. In some countries, switching from first-line to second-line treatment increased the cost of treatment between nine and seventeen times over.

Section 3(d): India’s built-in safeguard against evergreening 🔗

India did not accept TRIPS obligations without building in legal protections. The most significant of these is Section 3(d) of the Patents Act, 1970, which prohibits the practice known as evergreening. Evergreening refers to the strategy by which pharmaceutical companies make minor, often trivial modifications to an existing drug – changing its salt form, coating, or dosage – and then apply for a fresh patent. This effectively extends their monopoly beyond the standard 20-year window and keeps cheaper generic alternatives off the market.

Section 3(d) blocks patents on new forms of a known substance unless the applicant can demonstrate that the new form results in significantly enhanced efficacy. This provision became globally significant in 2013 when the Supreme Court of India upheld the rejection of Novartis’s patent application for a modified form of its cancer drug Glivec (imatinib), ruling that the changes did not meet the enhanced efficacy threshold required under Indian law. The Indian Parliament had incorporated strict patentability criteria and the right for anyone to oppose a patent grant – protections that proved vital in keeping essential medicines accessible.

The relevance of Section 3(d) to HIV treatment is ongoing. As recently as 2024, civil society groups in India filed patent oppositions against Gilead’s applications for lenacapavir (LEN), a promising new HIV prevention drug administered via twice-yearly injections. Advocacy organisations argued that Gilead’s applications sought patents on salt forms of the drug that did not constitute genuine innovations, and therefore fell foul of Section 3(d)’s anti-evergreening provisions.

Compulsory licensing: another tool in the access toolkit 🔗

Beyond Section 3(d), Indian law also permits compulsory licensing (CL) – a mechanism by which the government can authorise a third party to manufacture a patented drug without the patent holder’s consent, typically in situations involving public health need, unaffordable pricing, or inadequate supply. This is permitted under both the Indian Patents Act and under TRIPS flexibilities affirmed by the WTO Doha Declaration on TRIPS and Public Health in 2001, which explicitly stated that patent rules must be interpreted to protect public health and promote access to medicines.

However, compulsory licensing has rarely been used in India for HIV drugs. Indian law requires generic manufacturers to wait three years after a patent is granted before applying for a compulsory licence, except in national emergencies. Countries like Brazil and Thailand have made broader use of compulsory licensing for ARVs, with demonstrable success in reducing treatment costs. India’s experience remains limited, and advocacy groups continue to push for more proactive use of this mechanism, especially for newer, more expensive second-line and third-line ARV regimens.

India’s free ART programme and its limitations 🔗

On the government’s side, the National AIDS Control Organisation (NACO) launched India’s free antiretroviral treatment programme in April 2004, initially across eight government hospitals in six high-prevalence states. The programme has since been scaled up substantially, with ART centres operational across 31 states and union territories. Today, millions of eligible PLWHAs receive free first-line and second-line ARVs through this network.

Yet the programme has significant gaps. Access to newer, less toxic ARV regimens recommended by the World Health Organization remains uneven. Indian pharmaceutical companies cannot produce generic versions of post-2005 drugs due to the product patent regime, which means newer formulations – including better-tolerated second-line drugs and paediatric formulations – are either unavailable through public channels or available only at high cost. Adherence is also a persistent challenge, complicated by stigma, geographic distance from ART centres, poverty, and inadequate counselling support.

The role of civil society and PLWHA advocacy 🔗

One of the most powerful forces shaping India’s access-to-medicines landscape has been organised advocacy by people living with HIV/AIDS. Networks of PLWHAs, supported by legal organisations like the Lawyers Collective, have filed patent oppositions, engaged in policy consultations, and pressured governments on trade negotiations. It was persistent advocacy by PLHIV networks that led the Indian government to announce its free antiretroviral treatment programme in December 2003.

These networks have also been active on the global stage. When the European Union and India engaged in Free Trade Agreement negotiations, leaked texts revealed that the EU was pushing for TRIPS-plus measures – patent term extensions, data exclusivity, and border enforcement rules – that would have made generic production even harder. PLWHA networks collaborated with legal experts and submitted detailed analyses to the Indian government, helping to resist provisions that would have undermined India’s role as a supplier of affordable medicines to the developing world.

At the level of patent law, civil society groups have successfully opposed evergreening attempts on ARVs. People living with HIV, supported by the Lawyers Collective, used India’s patentability safeguards to oppose patents on HIV medicines that did not fulfil the patentability criteria. In 2008, the Delhi Patent Office rejected Boehringer Ingelheim’s application for a patent on a modified form of nevirapine – a commonly used ARV – after a successful opposition arguing the modification offered no enhanced efficacy.

The road ahead: newer drugs and persistent barriers 🔗

The HIV treatment landscape continues to evolve. Newer ARVs offer fewer side effects, simpler dosing regimens, and better long-term outcomes. Lenacapavir, which demonstrated 100% efficacy in preventing HIV infection among cisgender adult and adolescent women in the PURPOSE 1 clinical trial, represents a potential turning point in prevention – but only if it can be made affordable. According to UNAIDS, long-acting prevention technologies like LEN could play a major role in reversing the epidemic if access is ensured globally.

The challenge, as always, is pricing. Originator companies retain pricing power over patented newer drugs, and without generic competition, costs remain prohibitive for public health programmes in low- and middle-income countries. Strategies being explored include voluntary licensing agreements – where originators licence production to generic manufacturers at reduced royalties – as well as patent pools, a mechanism that allows collective management of patent rights to enable generic production across multiple manufacturers simultaneously. India’s pharmaceutical manufacturers remain central to any realistic path toward affordability.

Access to HIV/AIDS medicines in India is not simply a public health question – it is a human rights issue, a legal battleground, and a test of whether international trade rules can coexist with the needs of vulnerable populations. The Indian Patents Act’s safeguards under Section 3(d), the mechanism of compulsory licensing, and the sustained advocacy of PLWHA communities have together kept the pipeline of affordable ARVs alive. But with newer, more expensive drugs entering the market and patent protections tightening, the pressure on each of these mechanisms is only growing.

What do you think? Should governments in countries like India be more willing to use compulsory licensing to ensure access to newer HIV drugs, even at the cost of potential diplomatic friction with patent-holding nations? And as newer drugs like lenacapavir show remarkable efficacy in prevention, what legal and policy frameworks should India strengthen to ensure that life-saving innovations do not remain out of reach for those who need them most?

References

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