A potential breakthrough in HIV prevention now hinges on regulatory decisions in India. Gilead Sciences has granted royalty-free licenses to four Indian pharmaceutical companies—Dr. Reddy’s, Hetero, Emcure, and Mylan—to manufacture lenacapavir, a long-acting injectable drug that prevents HIV transmission with nearly 100% efficacy. Each injection offers six months of protection and is expected to cost around $40 per person annually, a fraction of its original price.
If approved on time, rollout could begin as early as 2027, benefiting India as well as 115 low- and middle-income countries dependent on Indian exports. The timeline, however, is uncertain. Indian regulatory approval and the issuance of a Certificate of Pharmaceutical Product are prerequisites for both local use and international supply. Authorities may also require local clinical trials despite robust global phase 3 data,…
