Lord’s Mark Industries secures UK MHRA registration for IVD portfolio, advances launch to December

Lord’s Mark Industries Limited has received registration from the UK Medicines and Healthcare Products Regulatory Agency for its in-vitro diagnostics portfolio, clearing a key regulatory requirement for commercial sales in Great Britain from December 2026.

The planned launch is about two months ahead of the company’s earlier schedule and broadens its UK healthcare push beyond renal-care equipment. The registration, dated September 24, 2026, lists Lord’s Mark Industries as a registered manufacturer and covers haematological cell analysers, clinical chemistry analysers, buffered sample diluents, and cleaning agents for instruments and analysers.

The approval matters because medical devices, including IVD products, must be registered with the MHRA before being placed on the Great Britain market. It provides a route for Lord’s Mark to begin commercialisation in the UK, although any expansion into UK-allied markets will remain subject to the regulations applicable in those jurisdictions.

The latest registration follows the company’s MHRA registration for its AI-enabled Renalyx haemodialysis system, announced in September. Together, the two developments indicate that Lord’s Mark is building a wider overseas healthcare portfolio that spans dialysis equipment, diagnostics and laboratory services rather than relying on a single medical technology product.

Managing Director and Chief Executive Officer Dr Sachidanand Upadhyay said the Renalyx registration had opened an important door in the UK and allied markets, while the IVD registration demonstrated that the company’s healthcare ambitions extended beyond one product. He said commercialisation was now planned two months ahead of schedule, followed by the pathology laboratory launch in January 2027.

The company intends to commence operations at its pathology laboratory in January 2027. The laboratory is expected to add a services layer to its diagnostics business, alongside the sale of analysers, reagents and related products. In its recent investor communication, management had outlined an analyser-led model in which placements can generate recurring demand for proprietary reagents and consumables. The UK entry could therefore be relevant not only for equipment sales but also for the development of repeat consumables revenue, depending on customer adoption and the pace of installations.

The international expansion comes as Lord’s Mark seeks to shift its business mix towards healthcare and medical technology. In the June 2026 quarter, the company reported net sales of Rs 307.68 crore and profit after Tax of Rs 33.18 crore. While sales and profit were lower sequentially than in the March quarter, operating profitability improved, with PBIDT margin excluding other income rising to 15.98 per cent from 12.13 per cent.

The UK initiative remains execution dependent. MHRA registration is a necessary step towards market access, but commercial traction will depend on distribution arrangements, pricing, service support, competition and regulatory compliance in each market where the company seeks to sell. The pathology laboratory plan will also require successful operational rollout after its scheduled January 2027 start.

As of 10:10 am on October 5, 2026, Lord’s Mark Industries shares were trading at Rs 81.50, up 2.61 per cent from the previous close of Rs 79.43. The stock was about 87.8 per cent below its 52-week high of Rs 669.70, while remaining around 29.4 per cent above its 52-week low of Rs 63.00. The company’s market capitalisation stood at Rs 3,394.24 crore.

Disclaimer: The article is for informational purposes only and not investment advice.