Lord’s Mark Industries has secured regulatory approval from the Central Licensing Authority to manufacture its LordsMed HIV 1&2 Self Test, marking a significant step in India’s emergence as a global diagnostics hub. The licence  permits the company to produce a Class D in-vitro diagnostic self-test for export markets, in compliance with the Medical Devices Rules, 2017.

With this clearance, Lord’s Mark becomes the second Indian company among only three nationally approved players, and one of just nine firms worldwide authorised to manufacture such HIV self-testing kits. The product, however, is currently approved solely for exports and is not intended for domestic commercial distribution.

The company plans to commence exports from June 2026, targeting high-demand regions including Africa, Europe and Latin America. These markets are witnessing a shift towards decentralised and self-administered diagnostic solutions, driven by growing awareness, policy backing and the need for accessible healthcare tools.

The global HIV self-testing market is projected to reach $600–650 million by 2033, expanding at over 13% annually. Demand remains strongest in Africa, which carries the highest HIV burden globally and benefits from large-scale donor-funded health programmes. Meanwhile, Europe is seeing increased uptake due to privacy-driven healthcare preferences and wider availability through pharmacies and online platforms. Latin America is also emerging as a key growth region, supported by government initiatives and expanding retail access, particularly in countries such as Brazil.

Commenting on the development, Managing Director Sachidanand Upadhyay said the approval reflects the company’s focus on quality, innovation and accessibility, and positions India as a credible contributor to global healthcare solutions.

The LordsMed HIV 1&2 Self Test is a rapid, single-use kit that detects HIV-1 and HIV-2 antibodies using a finger-prick blood sample, eliminating the need for laboratory infrastructure. Based on lateral flow immunoassay technology, it aligns with global trends favouring blood-based rapid testing.

The milestone strengthens the global footprint of LordsMed, the diagnostics arm of Lord’s Mark, and underscores India’s growing capability in producing high-quality, regulation-compliant medical technologies.