TWN Info Service on Health Issues (Aug26/01)
22 August 2026
Third World Network

Expert Committee recommends local clinical trial waivers for generic lenacapavir

New Delhi, 22 August (Chetali Rao) - India has moved closer to the availability of generic lenacapavir for HIV prevention after a Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) recommended the waiver  of  local clinical trial for Dr. Reddy’s Laboratories Limited and Emcure Pharmaceuticals Limited.

This recommendation could accelerate access in India, subject to final marketing authorisation and mandatory post-marketing Phase IV efficacy studies.

The recommendations concern lenacapavir injection 463.5 mg/1.5 mL for use as pre-exposure prophylaxis, or PrEP, to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at increased risk of acquiring HIV.

The recommendations were made by the Subject Expert Committee on Antimicrobial and Antiparasitic Drugs at its 08th/26 meeting, held on 11 August 2026 at the CDSCO headquarters in New Delhi.

The committee’s recommendations represent an important regulatory step. The companies must still obtain the necessary permissions from the competent regulatory and licensing authorities and comply with the conditions stipulated by CDSCO.

Committee recommends waivers for the PrEP indication

Dr. Reddy’s Laboratories and Emcure Pharmaceuticals sought waivers of local Phase III clinical trials and bioequivalence studies for their respective applications. The applications relied, among other material, on clinical evidence generated for the innovator product and regulatory approvals granted in the United States, European Union, United Kingdom, Australia and other jurisdictions.

The committee considered the data presented by the innovator and recognised that long-acting lenacapavir for HIV prevention addresses an unmet medical need in India.

On this basis, the committee recommended waiver of the proposed local Phase III clinical trial and bioequivalence study requirements for the PrEP indication, subject to specified regulatory conditions. The individual must be HIV-1 negative before lenacapavir is initiated.

Mandatory Phase IV efficacy study recommended as a condition of authorisation

The committee recommended that the grant of marketing authorisation to both applicants be subject to a requirement to conduct post-marketing Phase IV studies in India, with efficacy as the primary endpoint, among individuals receiving lenacapavir for PrEP.

Accordingly, upon grant of marketing authorisation, each company would be required to submit its Phase IV study protocol to CDSCO within three months. The protocols would then be placed before the committee for further evaluation.

Requested waiver not recommended for the HIV-treatment indication

On Emcure Pharmaceuticals’ application for waiver, the committee did not recommend the same regulatory flexibility for the use of lenacapavir in heavily treatment-experienced people with multidrug-resistant HIV-1 whose existing treatment regimen is failing. The committee noted that lack of adequate evidence related to pharmacokinetic and ethnicity did not support the requested waiver for the treatment indication.

The applicants would therefore need to address the evidentiary deficiencies identified by the committee and comply with any additional data or study requirements specified by CDSCO before the treatment indication could be authorised in India.

The committee’s recommendations therefore distinguish between two separate uses of lenacapavir: PrEP to prevent HIV-1 acquisition in people without HIV, and treatment, in combination with other antiretrovirals, of heavily treatment-experienced people living with multidrug-resistant HIV-1.

A major advance in HIV prevention

Lenacapavir is a first-in-class, long-acting HIV-1 capsid inhibitor. Under the internationally approved PrEP regimen, initiation requires both oral lenacapavir tablets and subcutaneous injections. The subsequent maintenance dose is 927 mg every six months, administered as two subcutaneous injections of 463.5 mg/1.5 mL each. Availability of both the injectable and oral initiation components will therefore be necessary for implementation of the complete regimen.

In the international PURPOSE 1 trial, no HIV infections occurred among participants receiving lenacapavir at the primary analysis. In PURPOSE 2, lenacapavir reduced HIV incidence by 96% compared with estimated background incidence. These results established twice-yearly injectable lenacapavir as a highly effective new option for HIV prevention.

Long-acting PrEP could be particularly valuable for people who face difficulties taking a tablet every day because of adherence challenges, stigma, lack of privacy, mobility or limited access to healthcare services.

Potential to accelerate affordable access in India

The committee’s recommendations could substantially shorten the regulatory pathway for Indian manufacturers by avoiding duplicative local Phase III trials where substantial international efficacy and safety evidence already exists.

Upon accepting the recommendations and grant of the necessary permissions, Dr. Reddy’s Laboratories and Emcure Pharmaceuticals could become among the first Indian manufacturers authorised to supply generic lenacapavir for PrEP in India, subject to compliance with the stipulated conditions. This is essential to bring lenacapavir within the reach of individuals and public health programmes. Indian manufacturers are already central to international efforts to make affordable generic lenacapavir available in low- and middle-income developing countries.

The committee’s recommendations therefore represent a significant step towards expanding access to long-acting HIV prevention in India. Nevertheless, timely final regulatory decisions, affordable pricing, adequate manufacturing capacity, inclusion in national HIV-prevention programmes, provider training and reliable HIV-testing systems will all be necessary to translate the regulatory pathway into meaningful access.

Third World Network (TWN) along with patient groups and organizations working on HIV and AIDS from the Asia-Pacific region and other Civil Society Organizations had previously written to CDSCO and the Ministry of Health and Family Welfare urging waiver of duplicative local Phase III trial requirements for generic lenacapavir for PrEP. TWN highlighted the extensive international Phase III evidence already available and cautioned that requiring additional local efficacy trials would unnecessarily delay access to an important HIV-prevention option in India. The committee’s latest recommendations address these concerns by allowing reliance on existing evidence while requiring India-specific efficacy data to be generated through post-marketing Phase IV studies.+