4 September 2026 

“India’s Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee (SEC)’s recommendation to waive local Phase III clinical trial and bioequivalence study requirements for generic injectable lenacapavir is a significant step towards faster access to one of the most promising HIV prevention tools available today. 

Pre-exposure prophylaxis (PrEP), such as lenacapavir, could help protect people in India vulnerable to HIV acquisition, such as the 60 000 estimated to have been infected with HIV last year. India has the manufacturing capacity to help transform global access to lenacapavir through generic production. However, it would be a missed opportunity if affordable, Indian-made lenacapavir were exported internationally while people in India continued to have very limited access to PrEP of any kind. 

It is concerning that the committee did not recommend the Phase III clinical trial waiver for the use of generic lenacapavir for treatment-experienced people. For people living with multi-drug-resistant HIV, when other treatments have failed, a lenacapavir-containing regimen can be a life-saving option.” 

-Carlota Baptista, Médecins Sans Frontières/Doctors Without Borders (MSF), Global HIV HCV Access Advocacy Lead

About lenacapavir: 

  • Lenacapavir is a long-acting HIV medicine that is highly effective (100% effective – PURPOSE 1 study, 96% effective – PURPOSE 2 study) at preventing HIV. It is administered by injection only twice a year.  
  • In October 2024, Gilead Sciences signed voluntary licensing agreements with six generic manufacturers to manufacture and supply generic lenacapavir, subject to regulatory approvals, in 120 countries, with India itself included.  

About regulatory approval for generic lenacapavir: 

  • On 11 August 2026, the Subject Expert Committee (SEC) of India’s Central Drugs Standard Control Organisation (CDSCO) recommended waiving local Phase III clinical trial and bioequivalence requirements for generic injectable lenacapavir for HIV prevention (PrEP), recognising it as an unmet medical need.  
  • The recommendation applies to applications submitted by Dr Reddy’s Laboratories and Emcure Pharmaceuticals and is expected to accelerate the availability of affordable generic lenacapavir, subject to final regulatory authorisation.  
  • The SEC also recommended that manufacturers conduct post-marketing Phase IV studies in India to monitor efficacy. 
  • The committee did not recommend a waiver for lenacapavir for the treatment indication in heavily treatment-experienced people living with multidrug-resistant HIV submitted by Emcure Pharmaceuticals, despite this approved use of lenacapavir in other settings. 

About HIV in India: 

  • India has one of the world’s largest populations of people living with HIV. UNAIDS estimates indicate that approximately 2.6 million people were living with HIV in 2025, and about 60 000 people were newly infected with HIV that year.