The availability of Lenacapavir, a groundbreaking HIV treatment developed by Gilead Sciences, remains uncertain in India, according to treatment activists. Despite Gilead issuing voluntary licenses to several generic manufacturers, including three in India—Dr Reddy’s Laboratories, Emcure, and Hetero—the drug is not expected to be accessible soon. Lenacapavir is a long-acting injectable medication considered a major advancement in HIV prevention that could redefine AIDS treatment approaches globally.
Last October, Gilead Sciences issued these licenses to facilitate the manufacturing and distribution of Lenacapavir by various companies, which also included international firms such as Eva Pharma from Egypt and Ferozsons Laboratories from Pakistan. Even though Indian manufacturers can provide Lenacapavir at a significantly reduced cost, activists warn that regulatory hurdles and ongoing patent applications by Gilead jeopardize timely access to the drug.
As World AIDS Day approaches on December 1, advocacy groups are urging Indian regulatory bodies, specifically the Drugs Controller General of India, to review their stance on clinical trial waivers for Lenacapavir. They claim that the existing data from foreign trials sufficiently supports the drug's approval without requiring redundant local trials. Leena Menghaney, a public health lawyer, noted that Lenacapavir meets all criteria for a clinical trial waiver under India's New Drugs and Clinical Trials Rules, which allows for expedited approval based on data from recognized foreign regulatory bodies. In a significant endorsement, the World Health Organization recently recommended Lenacapavir for HIV prevention.
Neither Dr Reddy’s Laboratories, Emcure, nor Hetero responded to inquiries regarding the status of the voluntary licenses granted. Eldred Tellis, director of Sankalp Rehabilitation Trust, emphasized the necessity of a collaborative effort among regulatory bodies, patent offices, and global partners to ensure that long-acting HIV prevention measures are rapidly accessible. He remarked on the potential benefits of Indian generic manufacturers producing Lenacapavir at significantly lower costs, a change that could have a profound effect on nations like South Africa, which has the world’s highest number of new HIV infections.
Fatima Hassan from South Africa's Health Justice Initiative highlighted that delays in regulatory processes could hinder India's ability to supply affordable generic Lenacapavir in time for critical needs. She pointed out that such delays could adversely impact low- and middle-income countries reliant on Indian generics, particularly those threatened by exclusion from essential global health programs launched under the Trump administration.
In conclusion, the current landscape surrounding Lenacapavir showcases the urgent need for regulatory reform to facilitate quicker drug access, especially for vulnerable populations that stand to benefit most from this innovative treatment. Keeping in mind its life-saving potential, the global health community must pivot together to eliminate unnecessary barriers that prevent timely access to this important HIV prevention tool.