India's HIV prevention push gets a whole lot better

India's new HIV prevention strategy received a major boost with the approval of Lenacapavir, a twice-a-year injectable medication, for local production by Indian pharmaceutical giants Dr Reddy's Laboratories and Emcure Pharmaceuticals. The Central Drugs Standard Control Organisation (CDSCO), India's drug regulator, granted permission for these companies to manufacture and market the injection following positive reviews from the subject expert committee.

This move is expected to significantly enhance access to HIV prevention medication for millions in India and other low- and middle-income nations.

During a recent meeting, the committee recommended waivers for phase III and bioequivalence-trial requirements, noting that Lenacapavir had already been approved in several countries including the US, UK, Canada, and the European Union. The drug is specifically designed for pre-exposure prophylaxis (PrEP), a preventive measure to reduce the risk of sexually acquired HIV in high-risk adults and adolescents.

Patient groups and civil society organisations had previously urged CDSCO to waive the local trial requirements, emphasizing that extensive international evidence already existed, making additional trials redundant and potentially delaying access to this crucial medication.