In a development that affects millions of HIV-vulnerable Indians, a revolutionary preventive drug remains inaccessible despite being manufactured within the country. Approximately 25 lakh Indians living with HIV have partners who could benefit from lenacapavir, a twice-yearly injection that offers nearly 100% protection against infection.
The Regulatory Roadblock
The Central Drugs Standard Control Organisation (CDSCO) has refused to waive local clinical trials for lenacapavir, creating a significant barrier to access. This decision came when Hetero Labs Limited, one of four Indian generic manufacturers licensed to produce the drug, applied for exemption from local trials.
The CDSCO committee stated that the company failed to present clinical study data on the Indian subset to prove absence of substantial ethnic variability. According to the regulator, there was insufficient efficacy and safety data to confirm that the proposed dosage would be adequate for the Indian population.
Global Approval vs Local Requirements
This regulatory stance appears contradictory when compared with historical precedents. In 2015, the same apex committee of CDSCO granted waivers for local trials for antiviral drugs targeting Hepatitis C under similar circumstances.
The drug already possesses strong clinical trial data from reputable international regulators, including the US Food and Drug Administration (US FDA). Lenacapavir is priced at approximately $40 per person annually, making it an affordable solution for large-scale prevention programs.
Manufacturing Paradox: Export Yes, Domestic No
In September, a US-based pharmaceutical giant granted royalty-free licenses to four Indian generic manufacturers - Dr Reddy's, Hetero, Emcure, and Mylan - to produce lenacapavir. These companies have received permissions to conduct Bioavailability/Bioequivalence studies for export purposes.
These studies, currently underway, aim to prove that the generic version matches the reference drug in performance. However, this creates a paradoxical situation where the drug manufactured in India will be accessible to 120 low-and-middle-income countries but not to Indian citizens.
Eldred Tellis, Director of Sankalp Rehabilitation Trust, which has been part of a global coalition advocating for affordable access to lenacapavir, expressed concern about this irony. "Once they have the export permission, it would mean that 120 low-and-middle-income countries would have access to the medicine, but not India, even as it would be manufactured here," Tellis stated.
Ongoing HIV Challenge in India
Despite significant progress in HIV management, India continues to face substantial challenges. Chaitali Rao, a lawyer specializing in patents, access to medicines, and health issues with Third World Network, highlighted the persistent nature of the epidemic.
"The epidemic has fallen from what it was in the 90s, but each year, we have thousands of cases," Rao noted. She suggested that concerned parties could appeal to CDSCO to initiate discussions, adding, "we will explore all possible solutions."
The current situation leaves millions of vulnerable Indians waiting for a prevention tool that could significantly reduce HIV transmission rates, even as the country positions itself as a global manufacturing hub for affordable medicines.
