One shot every six months: India could change HIV prevention forever

A long-acting HIV jab promises near-perfect protection at just $40 a year, but 115 nations must wait for India's approval of generic production

For people at risk of HIV, the daily routine of taking a preventive pill can feel unmanageable. Now imagine replacing that with a single injection just twice a year. That possibility is moving closer to reality and India is emerging at the forefront of this change. 

While the science behind lenacapavir is clear, access for more than 100 low- and middle-income nations depends on how quickly Indian regulators approve generic production. Every delay could mean thousands of preventable infections, making India’s role crucial in turning this innovation into a global lifeline.

 

The promise of lenacapavir

 

Lenacapavir is not just another HIV drug — it is a long-acting pre-exposure prophylaxis (PrEP) injection designed to last six months per dose. Compared with daily oral pills, it offers major advantages in adherence and convenience. In clinical trials, lenacapavir showed near-perfect protection, with almost no new infections among participants.

 

 

Gilead Sciences, the US-based pharmaceutical giant, has granted royalty-free licences to four Indian generics manufacturers — Dr Reddy’s, Hetero, Emcure and Mylan — to produce it for use in 115 low- and middle-income countries.

 

Regulatory challenges

 

The global rollout hinges on India navigating regulatory hurdles quickly.

 

• The Central Drugs Standard Control Organisation (CDSCO) must evaluate and approve the generic versions for domestic sale and export, which involves validating data, inspecting plants, and assessing safety and efficacy.
• Once India approves, issuing a Certificate of Pharmaceutical Product (CPP) or moving towards WHO pre-qualification will allow recipient countries to rely on Indian assessments, speeding up imports and local approvals.
• Scaling injections requires cold-chain storage, trained health workers, and monitoring systems — all of which take time to set up.
• Robust global trial data is already available, which could allow Indian regulators to waive the need for local trials.

 

How long could approval take?

 

Experts say the path from licence to rollout can stretch several years unless regulators fast-track the process.

 

• Data submission and review (6–12 months): Indian firms must file manufacturing and stability data for CDSCO review.
• Plant inspections (6–12 months): Inspectors verify Good Manufacturing Practices (GMP).
• Domestic approval and CPP issue (up to 1 year): CPPs are needed before export.
• WHO pre-qualification (12–24 months): This enables automatic reliance by 115 countries.
• Commercial launch (2027 target): On standard timelines, rollout is expected around 2027 — but acceleration by CDSCO or WHO could cut years.

 

Delays could cost lives

 

According to the World Health Organization, an estimated 40.8 million people were living with HIV at the end of 2024. In India alone, the 2023 HIV Estimates report shows more than 2.5 million people living with the virus and about 66,400 new infections each year. These figures underline why time is critical: every delay in India’s regulatory process could mean thousands of preventable infections both at home and across the 115 nations relying on its generics.

 

Keeping costs low

 

One of the most remarkable aspects of the licensing and access plan is the target price: just $40 per person per year. In the US, HIV treatments can cost tens of thousands of dollars.

 

• Gilead Sciences has waived royalty payments for licensed generics in 115 countries, removing a major cost barrier.
• With potentially millions of users worldwide, manufacturers can spread fixed costs like factory setup, quality checks and regulatory filings over large volumes, driving down per-dose costs.
• Organisations such as Unitaid, the Gates Foundation and the Clinton Health Access Initiative (CHAI) are providing funding and technical assistance for technology transfer, approvals and scale-up.
• India’s strong generics industry, lower labour costs and established manufacturing base make large-scale affordable production feasible.

 

National programme inclusion

 

Even if local production is fast-tracked, access to lenacapavir in India could face hurdles. At present, the National AIDS Control Organisation (NACO) recognises only condoms as pre-exposure prophylaxis (PrEP) in its HIV prevention strategy. Officials often highlight condoms’ role in protecting against other sexually transmitted infections, but experts argue it is time to add more advanced options like lenacapavir.

 

Dr Ishwar Gilada, a leading HIV specialist, points out that behaviour change is never easy, which is why NACO’s role in sex education and awareness remains critical. “For the first time in over 40 years, we have a way to control HIV’s transmission by almost 100 per cent,” he told the Times of India, adding that this breakthrough could sharply reduce the number of people needing lifelong treatment.

 

Community voices echo this urgency. Ganesh Acharya, an HIV-TB survivor, notes that earlier long-acting drugs were expensive and less effective. Lenacapavir, he stresses, offers stronger protection, with the potential to drive down new infections.   

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This report is for informational purposes only and is not a substitute for professional medical advice.