Is Lenacapavir Approved in India?
Lenacapavir is a long-acting HIV drug developed by Gilead Sciences, designed to address treatment challenges for individuals with multi-drug-resistant HIV. While this innovative treatment has been approved in some countries, its regulatory status and accessibility in India require closer examination. Below is a detailed overview of Lenacapavir’s current situation in India, including licensing agreements and ongoing approval processes.
Current Approval of Lenacapavir Status in India
As of January 18, 2025, lenacapavir has not yet been approved for use in India. Although the drug has demonstrated efficacy in addressing HIV treatment challenges globally, its availability in India depends on ongoing regulatory processes.
Licensing Agreements with Indian Manufacturers
To facilitate access in low- and middle-income countries, Gilead Sciences has signed royalty-free licensing agreements with several Indian pharmaceutical companies, including Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, and Hetero Labs. These agreements allow these companies to manufacture and commercialize generic versions of lenacapavir in 120 countries, including India (1).
Role of Indian Manufacturers
Indian manufacturers such as Dr. Reddy’s Laboratories are working on establishing production capabilities, conducting necessary studies, and obtaining regulatory approvals. This step is crucial for ensuring that lenacapavir becomes accessible and affordable in India and other eligible markets (2).
Global Approvals and Investigations
Lenacapavir has already been approved in countries like the United States for the treatment of multi-drug-resistant HIV when used in combination with other antiretrovirals. However, its application for HIV prevention (Pre-Exposure Prophylaxis or PrEP) remains under investigation and has not yet been globally approved for this indication (3).
Patent and Legal Challenges in India
In India, lenacapavir’s approval is also influenced by ongoing patent challenges. Public health groups have raised concerns about potential patents, as they could limit the production of affordable generic versions. The Indian Patent Office is reviewing applications and pre-grant oppositions related to lenacapavir under the country’s patent laws.
In summary, while lenacapavir is not currently approved in India, steps are being taken to facilitate its future availability, pending regulatory approvals and resolution of patent considerations.