CDSCO recommends BE and Phase III trial waivers for generic lenacapavir PrEP from Dr Reddy’s and Emcure, with Phase IV efficacy studies required.
Written By: Rishabh Sonawane, BPharm
Reviewed By: Pharmacally Editorial Team
India’s Central Drugs Standard Control Organisation (CDSCO) Subject Expert Committee (SEC) on Antimicrobial & Antiparasitic Drugs has recommended bioequivalence (BE) and Phase III clinical trial waivers for generic lenacapavir injection intended for pre-exposure prophylaxis (PrEP) against sexually acquired HIV-1. The recommendation was made during the committee’s meeting held on 11 August 2026.
The recommendation applies to lenacapavir injection 463.5 mg/1.5 mL (309 mg/mL). For Dr Reddy’s Laboratories, the committee recommended the requested BE and Phase III clinical trial waivers after reviewing innovator-product data and noting that lenacapavir is already approved in the United States, Canada, the United Kingdom, the European Union, Australia and other countries.
Why the Lenacapavir PrEP Recommendation Matters
Lenacapavir is a long-acting HIV-1 capsid inhibitor that can be administered as injectable PrEP twice a year. The World Health Organization recommends twice-yearly injectable lenacapavir as an additional HIV prevention option, while the U.S. FDA-approved PrEP product is indicated for adults and adolescents weighing at least 35 kg who are at risk of sexually acquired HIV-1. The long-acting dosing schedule provides an alternative to daily oral PrEP and may help address some barriers associated with daily pill use.
PrEP Identified as an Unmet Medical Need in India
The committee specifically recognised prevention of sexually acquired HIV-1 infection among adults and adolescents weighing at least 35 kg who are at increased risk of HIV-1 acquisition as an unmet medical need. Individuals must have a negative HIV-1 test before initiating lenacapavir.
Based on the innovator data presented by the applicant, the committee considered the evidence sufficient to support the BE and Phase III clinical trial waivers for this PrEP indication.
The committee subsequently made a similar recommendation for Emcure Pharmaceuticals, which also sought permission to manufacture and market the same-strength lenacapavir injection. For Emcure, the committee recommended BE and Phase III clinical trial waivers specifically for the PrEP indication.
Phase IV Evidence Required After Market Authorisation
The waiver recommendation does not eliminate post-marketing clinical evidence requirements. For both applicants, the committee recommended a Phase IV study in people requiring PrEP, with efficacy as the primary endpoint.
The applicants must submit the Phase IV study protocol to CDSCO within three months of receiving market authorisation for further evaluation by the committee. This requirement would allow India-specific post-authorisation efficacy data to be generated while the pre-approval BE and Phase III trial requirements are waived for the PrEP indication.
Treatment Indication Remains Subject to Additional Evidence
The waiver recommendation did not extend to lenacapavir for the treatment of heavily treatment-experienced patients with multidrug-resistant HIV-1 infection. In Emcure’s application, the committee identified insufficient evidence concerning pharmacokinetics and ethnicity and therefore did not recommend a Phase III clinical trial waiver for this treatment indication.
The distinction indicates that the regulatory pathway is being assessed according to the available evidence and the specific clinical use rather than applying a blanket waiver across all lenacapavir indications.
What the Recommendation Means for Generic Lenacapavir in India
The recommendations could shorten the regulatory development pathway for generic lenacapavir for HIV PrEP by removing the need for the waived pre-approval BE and Phase III clinical trial requirements. This could potentially facilitate earlier market authorisation, subject to CDSCO’s standard review and market authorisation procedures and the post-marketing obligations specified by the committee.
The SEC recommendation is not itself a market authorisation. The applicants must still complete the applicable CDSCO regulatory process and obtain market authorisation before the products can be marketed in India. If authorisation is granted, the mandated Phase IV protocol must then be submitted within three months for further evaluation.
The recommendations therefore establish a regulatory pathway that combines reliance on existing innovator evidence for the waived pre-approval requirements with India-specific post-authorisation efficacy evaluation.
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About the Writer
Rishabha Sonawane, B.Pharm (LinkedIn) is healthcare writer with a strong interest in medical writing, regulatory affairs, clinical research, and AI-driven drug discovery. He has completed specialized training from the NIH and ICMR in clinical pharmacology, clinical research, and scientific writing. Passionate about evidence-based healthcare communication, he focuses on translating complex scientific research into clear, accurate, and engaging medical content.