The Central Drugs Standard Control Organisation (CDSCO) has recommended waiving local Phase III clinical trials and bioequivalence studies for generic lenacapavir, citing unmet medical need. According to reports from Moneycontrol, this recommendation covers applications from Dr Reddy's and Emcure, though final regulatory authorisation is still required. The panel has recommended post-marketing Phase IV studies in India, which could significantly cut development time and costs for Indian manufacturers. Carlota Baptista, MSF's Global HIV HCV Access Advocacy Lead, described the waiver as "a significant step towards faster access to one of the most promising HIV prevention tools available today."
Emcure Pharmaceuticals has already filed its injectable version with the Drugs Controller General of India (DCGI) and is hopeful of securing approval by the end of the fiscal year. As reported by Moneycontrol, whole-time director and chief operating officer Samit Mehta indicated the company is responding to regulatory queries on priority, with typical DCGI approvals for ARV drugs being fast-tracked. The company expects commercialisation around 12 months from filing, though expedited reviews could shorten this timeline. Mehta emphasized that price could be another breakthrough, noting that public indications from Dr Reddy's and Hetero point to an annual treatment cost of around $40, covering twice-yearly injections and accompanying tablets. For India, the stakes are significant with an estimated 2.6 million people living with HIV in 2025 and about 60,000 new HIV acquisitions during the year, according to UNAIDS figures.
According to Moneycontrol reports, the generic price would be just a fraction of the drug cost in developed markets where prices can exceed $28,000 to $42,000 annually. Public indications from Dr Reddy's and Hetero point to an annual treatment cost of around $40, covering twice-yearly injections and accompanying tablets. For India, the stakes are significant with an estimated 2.6 million people living with HIV in 2025 and about 60,000 new HIV acquisitions during the year, according to UNAIDS figures cited by MSF. The generic rollout across licensed low- and middle-income markets is expected from 2027, as reported by MSF.
As reported by Moneycontrol, Emcure is vertically integrated for the product, including its own active pharmaceutical ingredient, and has invested in manufacturing capacity for tablets used alongside the injection. Dr Reddy's recently expanded its Gilead partnership to include the investigational once-yearly lenacapavir formulation, with CEO Deepak Sapra noting it may offer additional long-acting HIV prevention options. Gilead signed royalty-free voluntary licensing agreements with six generic manufacturers in 2024 covering 120 countries, including India. Emcure, Dr Reddy's Laboratories and Hetero are among the Indian companies racing to develop generic lenacapavir under these voluntary licenses.
According to MSF, generic rollout across licensed low- and middle-income markets is expected from 2027. However, MSF cautioned that the CDSCO panel did not recommend a similar Phase III waiver for lenacapavir's treatment indication in heavily treatment-experienced people with multidrug-resistant HIV, potentially leaving another important access gap. Sapra from Dr Reddy's noted that if approved, investigational once-yearly lenacapavir may offer an additional long-acting HIV prevention option for people at risk of HIV acquisition, particularly in regions where access and adherence remain significant challenges. Lenacapavir's long-acting formulation could be a game changer because it sharply reduces the dosing burden, making it particularly valuable for regions where access and adherence remain significant challenges.
