Bangkok, Thailand 23 January 2026: The Thai Network of People Living with HIV/AIDS (TNP+), which coordinated and joined civil-society organizations in Thailand and across South and Southeast Asia, has contributed to a growing regional movement calling on India’s drug regulator to waive local Phase III clinical trial requirements for lenacapavir (LEN), a breakthrough long-acting HIV prevention medicine.
On 21 January, an open letter was submitted to the Central Drugs Standard Control Organization (CDSCO), addressed to the Drugs Controller General of India (DCGI). The letter was jointly endorsed by a total of 65 civil-society organizations from across Asia and the Asia-Pacific region — including 37 organizations from Thailand — urging Indian authorities to grant a waiver for local trials and allow the timely approval of generic lenacapavir for HIV pre-exposure prophylaxis (PrEP).
Lenacapavir, the first-in-class long-acting HIV capsid inhibitor, has already been approved by several stringent regulatory authorities, including the U.S. Food and Drug Administration and the European Commission, following strong evidence from large, multi-country Phase III clinical trials demonstrating superior effectiveness in preventing HIV infection. Civil-society groups stress that requiring additional local trials in India would unnecessarily delay access to this life-saving innovation — particularly in low- and middle-income countries that rely on Indian generic medicines.
The open letter emphasizes that timely approval of Indian generic versions of lenacapavir is essential for enabling global access, supporting public health programmes, and reducing new HIV infections, especially in countries with high HIV burdens.
“For people living with and at risk of HIV in Thailand and across our region, the availability of affordable generic lenacapavir as an additional option for HIV prevention could be truly transformative,” said Ms. Yupa Sukhroeng, Chairperson of the Thai Network of People Living with HIV/AIDS (TNP+).
“Long-acting HIV prevention options expand choices and help reduce barriers related to daily pill-taking, stigma, and access to services. India’s leadership in generic production has always been critical for our public health response. Approving generic lenacapavir without unnecessary delays would give real meaning to the promise of ending AIDS — not only for Thailand, but for millions of people across Southeast Asia and beyond.”
Civil-society organizations noted that India’s decision will have far-reaching global implications, as regulatory approval in India enables generic manufacturers to supply affordable medicines to many countries through national treatment and prevention programmes.
The coalition urged Indian authorities to recognize both the robust scientific evidence supporting lenacapavir and the urgent public-health need for rapid access, underscoring that accelerating the availability of generic medicines is critical to achieving equitable and effective HIV prevention worldwide.
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The open letter is available in English.
The open letter is available in Thai.
