This World AIDS Day, India faces a critical moment in its effort to end AIDS nationally and globally. According to advocacy groups, the potential of lenacapavir, a long-acting HIV prevention medicine that confers virtually 100 per cent protection against HIV infection, is at risk due to regulatory delays and patent-related barriers. Concerns raised indicate that access for marginalised communities, including sex workers, transgender persons, gay men and other men who have sex with men, people who use drugs, and young women and girls, could be obstructed if challenges are not addressed.
Key populations are disproportionately represented among the 1.3 million people who acquire HIV every year. Outside of sub-Saharan Africa, two out of three new infections are among key populations and their sex partners. Global numbers of new HIV infections have remained virtually unchanged for 3 years, signalling the need for more effective HIV prevention tools deployed at scale.
Advocacy groups state that Indian generic manufacturers are positioned to supply lenacapavir at affordable prices, but regulatory delays and Gilead’s patent filings threaten to affect access globally. Under India’s New Drugs and Clinical Trials Rules (NDCTR) 2019, companies may seek a waiver of India’s requirement for local clinical trials if a medicine is approved by USFDA, EMA, or other specified authorities and offers a significant therapeutic advance. Lenacapavir for HIV prevention has been recognised by UNAIDS, WHO, and other global agencies as a significant advance. Without such a waiver, advocates argue that timely global introduction of Indian generics may be affected.
“Indian manufacturers can reduce the price of generic lenacapavir to US$25–40 (₹2,225–3,560) per person per year, which would be a game changer for countries such as South Africa, which has the highest number of new HIV infections in the world. Unnecessary regulatory delays will mean India cannot supply generic lenacapavir in 2026, weakening its role in supplying affordable HIV medicines for the world,” said Fatima Hassan of South Africa’s Health Justice Initiative. “This will have a devastating effect across low- and middle-income countries that depend on Indian generics, and especially countries like ours that are being targeted by the Trump administration by arbitrary exclusion from the Gilead / PEPFAR global rollout programme. We need generics urgently to save lives.”
“Few medical interventions demonstrate such remarkable efficacy. In clinical trials, lenacapavir has shown 100 per cent effectiveness in preventing HIV among cisgender women and girls, and a 96 per cent reduction in HIV risk within a gender-diverse group that includes cisgender men, transgender men, and non-binary individuals. Now we need the policies that will allow us to deliver this superior protection tool to all who need it, including a waiver of India’s requirement for national clinical trials,” said Dr Antonio Flores, Senior HIV/TB Advisor, MSF.
Community networks state that delays have real-world consequences.
“Access to more effective HIV prevention tools like lenacapavir from the HIV programme free of cost is vital because our exposure to HIV through sex work is a daily worry for us,” said Dr Protim Ray, representative of Kolkata-based, sex worker-led collective Durbar Mahila Samanwaya Committee. “When revolutionary prevention tools like lenacapavir are delayed or locked behind red tape, it’s not just policy — it’s our lives at stake.”
In addition to regulatory matters, health groups including the Third World Network have raised concerns about Gilead’s patent filings in India. They state that the claims may lack sufficient novelty and, if granted, could restrict competition in manufacturing active pharmaceutical ingredients and finished formulations.
Gilead has granted royalty-free, non-exclusive licences to six generic manufacturers, including four Indian companies, to supply lenacapavir to 120 low- and lower-middle-income countries. However, key regions with high HIV incidence among key populations, including parts of Latin America, are excluded. Granted patents in India would block non-licensees from supplying locally or to countries excluded from the list of 120 eligible nations. Groups have called for expedited rejection of pending patent claims.
“A decisive action is urgently needed. Regulatory authorities, patent offices, and global partners must work together to ensure that long-acting HIV prevention becomes accessible without delay, and that communities most at risk are not once again left behind,” said Eldred Tellis of the global LEN-LA for All Coalition. The coalition includes Health GAP (Global), the Health Justice Initiative (South Africa), Sankalp Rehabilitation Trust (India), Just Treatment (UK), and ABIA (Brazil).