Mumbai, India: Lord’s Mark Industries Ltd. today announced that it has received approval from the Central Licensing Authority (Licence No. MFG/IVD/2023/000058) for its LordsMed HIV 1&2 Self Test. With this, the company becomes the second in India among only three approved players nationally, and one of nine companies globally to achieve this milestone. The approval enables the manufacture and export of a Class D in-vitro diagnostic self-test, designed for private use and compliant with India’s Medical Devices Rules, 2017. This approval is specifically for export markets, with the product currently not intended for domestic commercial distribution in India. With exports set to commence from June 2026, Lord’s Mark will enter key international markets across Africa, Europe, and Latin America regions that are witnessing a structural shift toward decentralized, self-administered diagnostics. The global HIV self-testing market is entering a high-growth phase, projected to reach approximately USD 600–650 million by 2033, expanding at a CAGR of over 13%, driven by increasing awareness, policy support, and the need for accessible testing solutions. Africa remains the epicentre of demand, accounting for the highest HIV burden globally, where large-scale donor-funded programs and public health initiatives continue to accelerate adoption of self-testing kits. In parallel, Europe is seeing a steady rise in consumer-led testing, with privacy-driven healthcare behavior and expanding pharmacy and online distribution channels contributing to double-digit market growth. Latin America is emerging as a strong growth market, supported by government-backed testing programs and increased availability of self-test kits through retail and digital platforms, with countries such as Brazil leading regional adoption. Commenting on the development, Sachidanand Upadhyay, Managing Director, Lord’s Mark Industries Ltd., said, “This approval marks a defining moment not just for Lord’s Mark, but for India’s role in global healthcare. Being among the only nine companies worldwide to receive this clearance reflects our commitment to quality, innovation, and accessibility. With the LordsMed HIV Self Test, we aim to expand access to reliable and private diagnostics across regions where early detection can significantly improve health outcomes.” The LordsMed HIV 1&2 Self Test is a single-use, rapid diagnostic solution that enables individuals to detect HIV-1 and HIV-2 antibodies using a simple finger-prick blood sample, without requiring laboratory infrastructure. Built on globally accepted lateral flow immunoassay technology, the product aligns with current market demand, where blood-based rapid tests account for a significant majority of HIV self-testing usage worldwide. This milestone is underpinned by LordsMed, the healthcare division of Lord’s Mark Industries, which has been steadily expanding its footprint in diagnostics and medical technology. With WHO-GMP compliant manufacturing facilities and globally recognized certifications, LordsMed offers a broad portfolio of diagnostic solutions across rapid testing, reagents, and medical devices. The division’s focus on innovation and scale has enabled it to cater to both domestic and international healthcare ecosystems, positioning it as a credible player in the global diagnostics landscape. As Lord’s Mark prepares to operationalize exports, the approval not only strengthens its international market entry but also reinforces India’s growing credibility as a hub for high-quality, regulation-compliant medical diagnostics. To know more, visit - www.lordsmark.com (Disclaimer: The above press release comes to you under an arrangement with NRDPL and PTI takes no editorial responsibility for the same.). PTI PWR

Export approval for Class D HIV self-test highlights regulated private diagnostics and expansion into global healthcare markets. Approval has been granted for the manufacture and export of a Class D in-vitro diagnostic HIV 1&2 self-test under the Medical Devices Rules, 2017. The product is designed for private use and uses rapid lateral flow immunoassay technology with a finger-prick blood sample to detect HIV-1 and HIV-2 antibodies without laboratory infrastructure. The approval is for export markets only and is not intended for domestic commercial distribution in India.