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With the FDA approving the world’s first twice-yearly HIV prevention injection, India’s role as a key manufacturer raises urgent questions about the country’s preparedness to adopt next-generation public health tools.
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In June 2025, the United States Food and Drug Administration (US FDA) approved Gilead’s lenacapavir as a first-of-its-kind Human Immunodeficiency Virus (HIV) prevention tool – a long-acting injectable administered only twice a year. Marketed as Yeztugo, this capsid inhibitor is now the first and only PrEP (pre-exposure prophylaxis) option offering 6 months of continuous protection per dose. The FDA’s green light is a landmark moment hailed by experts and agencies worldwide. Early trial results were so compelling that they were stopped ahead of schedule: no new HIV infections occurred among women receiving lenacapavir in one Phase 3 trial, and only 2 infections occurred in a parallel trial of men and transgender participants. In total, the injectable provided protection in nearly 100 percent of recipients compared to daily oral PrEP (tenofovir/emtricitabine). According to the director of The Joint United Nations Programme on HIV/AIDS (UNAIDS), the approval is a milestone on the heels of decades of scientific advancement, and its success will rest on making the drug available and affordable to all.
Lenacapavir is an innovative antiretroviral and the first HIV capsid inhibitor with a new mechanism of action that disrupts several stages in the virus's lifecycle. For prevention, its novelty lies less in terms of its molecules and more in its ultra-long-acting formulation. Compared to once-daily standard PrEP pills, lenacapavir is administered as a single injection every six months, which maintains sustained drug levels, preventing HIV acquisition. In reality, biannual injections can reliably prevent HIV, a convenience and dosing benefit that can surpass most obstacles to HIV prevention.
The World Health Organization (WHO) points out that a discreet, twice-yearly shot can help address issues like the daily pill fatigue, the need for frequent clinic visits, and the stigma that some face when taking HIV medication regularly. In essence, lenacapavir could attract new populations to PrEP who were unable or reluctant to use existing methods. Given that current PrEP uptake has remained far below eligible levels in many countries (only 36 percent of at-risk individuals in the US, for example, have been prescribed PrEP), a long-acting option like lenacapavir is seen as a crucial innovation to boost uptake and persistence in using prophylaxis.
Given the strength of its generic pharmaceutical industry, India can play an important role in making lenacapavir a widely available product. In October 2024, Gilead Sciences announced voluntary licensing agreements with six generic manufacturers to provide affordable lenacapavir to countries with high HIV burdens, in anticipation of the need for affordable access. Notably, at least four of them have India-based headquarters: Dr. Reddy's Laboratories, Hetero Labs, Emcure Pharmaceuticals, and Mylan (Viatris), a testament to India’s status as the "pharmacy of the developing world". Under these royalty-free licenses, the Indian companies will receive technology transfers (completed by the end of 2024) and are tasked with manufacturing generic lenacapavir as quickly as possible once regulatory approvals are in place. However, it is unclear whether India is included in the list of countries covered for domestic access, as Gilead has not publicly disclosed all 120 countries under license. India is not in the list of 18 priority registration countries that account for 70 percent of the global HIV burden.
The inclusion of multiple Indian manufacturers is pivotal: India has a track record of producing quality-assured generics for HIV at a massive scale — as seen with antiretroviral therapy in the 2000s — and can enable lenacapavir to reach millions in the Global South at a fraction of its branded cost.
This early licensing move is unprecedented in its scope for an HIV prevention drug — it aims to cover 120 primarily low- and lower-middle-income countries. This comes after pressure from global health advocates and is informed by lessons from past HIV interventions – particularly that timely generic production is essential to avoid years-long delays in access. The inclusion of multiple Indian manufacturers is pivotal: India has a track record of producing quality-assured generics for HIV at a massive scale — as seen with antiretroviral therapy in the 2000s — and can enable lenacapavir to reach millions in the Global South at a fraction of its branded cost. Indian generics could help bring the annual cost of lenacapavir down below US$100 per patient — a dramatic reduction from prices in the West — and quicken rollout, given India’s capabilities.
The real test for lenacapavir will be in its real-world implementation, especially in countries with the highest HIV rates. While the science is a breakthrough, the affordability gap between current pricing and potential generic costs raises serious concerns. Gilead revealed a US list price of around US$28,000 per person per year (approximately INR ₹24 lakh) for lenacapavir’s two injections. This puts it far out of reach for individuals or public health systems in low and middle-income countries if no subsidies or generic alternatives are available. By contrast, independent researchers estimate that generic lenacapavir could be mass-produced for only US$35–46 per person per year at scale, potentially dropping to about US$25 as larger volumes (5–10 million doses annually) are manufactured. In other words, the drug could be manufactured and sold for well under US$100 per year in an efficient generic market – a price point comparable to or lower than existing oral PrEP pills.
Gilead’s response has been a two-pronged global access plan. First, as noted, is the push to rapidly enable generics in 120 countries via Indian and other manufacturers. Second, the company has pledged to supply its own branded lenacapavir at no profit in those license-covered countries until the generics can meet demand. In practice, Gilead has committed to providing up to 2 million people access to lenacapavir in those nations during the interim period. While this commitment is important, it still may not fully bridge the accessibility gap. For one, even 2 million courses cover only a fraction of the global need – the WHO estimates that around 10 million people should be on PrEP to meet the 2030 HIV prevention targets. Moreover, the timeline for generic rollout remains a factor: while regulatory approvals outside the US are being fast-tracked (through mechanisms like the EU Medicines for All procedure and WHO prequalification), it is expected that generic shots will not be widely available until 2025–2026.
By contrast, independent researchers estimate that generic lenacapavir could be mass-produced for only US$35–46 per person per year at scale, potentially dropping to about US$25 as larger volumes (5–10 million doses annually) are manufactured.
On paper, India should qualify for Gilead’s license (as a lower-middle-income country) and thus should eventually obtain generic lenacapavir at a low cost for domestic use, although this remains uncertain. In practice, however, the Indian population should be cautious about relying on rapid local access. For one, until generics are approved and produced at scale, the only available lenacapavir will be the high-priced branded version – effectively unfeasible to roll out in India’s public health system due to its high cost. Indian health officials have thus far been slow to embrace PrEP in any form. The drafted guidelines for oral PrEP were released a few years ago, following the Drug Controller General of India’s earlier approval of an HIV fixed drug combination in 2016. However, public sector rollout of existing PrEP medications has remained limited because of funding constraints, low overall awareness, and slow programme-level adoption, and PrEP is still largely restricted to private providers and NGO-led demonstration projects.
India has often been a paradox in health innovation: a producer for the world but slow to adopt innovations at home. This pattern must change with lenacapavir. With approximately 2.54 million people living with HIV in India as of 2023, and with an annual incidence of around 66,400 new HIV infections, the country cannot afford complacency. Prevention must be a cornerstone, and PrEP, which has long been neglected, should be scaled up alongside traditional preventive methods like condoms and treatment-as-prevention (TasP).
To operationalise PrEP effectively in India, one key strategy would be to integrate PrEP delivery into established HIV services, such as ART centres, targeted intervention sites, and Integrated Counselling and Testing Centres (ICTCs), where key populations like sex workers, men who have sex with men (MSM), and transgender individuals are already being reached. Early pilot initiatives, such as PrEP demonstration projects with female sex workers in Kolkata, illustrated that community-based rollouts integrated within trusted prevention programmes significantly facilitated linkage and adherence.
However, public sector rollout of existing PrEP medications has remained limited because of funding constraints, low overall awareness, and slow programme-level adoption, and PrEP is still largely restricted to private providers and NGO-led demonstration projects.
Furthermore, in India’s emerging digital health ecosystem, tele-counselling, risk assessment, appointment booking, and adherence follow-up can be efficiently delivered through telephonic and digital channels in remote and underserved regions. This could be facilitated through the Ayushman Bharat Digital Mission and its related platforms. For long-term sustainability, community health workers and trained primary care providers could be empowered to manage the PrEP services.
Indian policymakers and public health authorities should also view the FDA approval as a catalyst to accelerate domestic regulatory and policy preparations. This involves engaging with the published WHO guidelines, expediting any required approval processes for lenacapavir (potentially leveraging WHO prequalification or EMA’s reliance mechanisms once they’re in place), and importantly, allocating a budget and crafting delivery strategies for PrEP. The National Aids Control Organization’s (NACO) PrEP guidelines need to move from paper to practice, for instance, by launching pilot programmes in high-incidence cities or states, training healthcare workers to provide counselling and injections, and working to destigmatise PrEP usage. With adequate resources and community involvement, this medical breakthrough can help save lives around the world.
K. S. Uplabdh Gopal is an Associate Fellow with the Health Initiative at the Observer Research Foundation.
The views expressed above belong to the author(s). ORF research and analyses now available on Telegram! Click here to access our curated content — blogs, longforms and interviews.
Dr. K. S. Uplabdh Gopal is an Associate Fellow within the Health Initiative at ORF. His focus lies in researching and advocating for policies that ...
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