India could be moving closer to making a new, long-acting option for HIV prevention available at an affordable price, after a key regulatory panel recommended waiving local bioequivalence (BE) studies and clinical trials for generic injectable lenacapavir intended for pre-exposure prophylaxis (PrEP).
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. 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.
The recommendation by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) could pave the way for Indian manufacturers to seek marketing approval for generic lenacapavir for adults and adolescents at increased risk of sexually acquired HIV infection.
The SEC, which considered separate applications from Dr Reddy’s Laboratories and Emcure Pharmaceuticals at its August 11 meeting, agreed that conducting another set of full local BE studies and clinical trials for the PrEP indication would duplicate evidence already generated internationally.
But the recommendation is not yet an approval to market the drug. The companies will still have to obtain the necessary regulatory permissions and comply with conditions laid down by CDSCO, including post-marketing evidence generation.
So what does the SEC recommendation mean?
In simple terms, a BE and clinical-trial waiver means, if approved by the CDSCO, the companies may not have to repeat certain studies in India before seeking approval for the specific PrEP use, because the committee considered the existing evidence sufficient for this indication.
The drug is already approved in the US, Canada, the UK, the European Union, Australia and some other countries.
The SEC specifically considered the lenacapavir injection 463.5 mg/1.5 mL for PrEP in adults and adolescents weighing at least 35 kg who are at increased risk of acquiring HIV-1.
The individual must have a negative HIV test before starting the medicine, an important safeguard because PrEP is intended for people who do not already have HIV.
India has a large population living with HIV and continues to face the challenge of preventing new infections, particularly among populations that may find daily medication difficult to maintain.
A long-acting option could be particularly useful for people who struggle with daily pills because of stigma, lack of privacy, frequent travel, mobility, adherence difficulties or limited access to healthcare facilities.
The SEC has recommended that both companies conduct a Phase-IV study, with efficacy as the primary endpoint, among people requiring PrEP.
The companies have also been asked to submit their Phase-IV study protocols to CDSCO within three months of receiving market authorisation for further consideration.
This provides a post-marketing safety and effectiveness check rather than requiring the same scale of pre-approval trials to be repeated locally.
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 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.
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 government cannot afford complacency.
