Lords Mark Industries’ Renalyx Secures CDSCO Licence and CE Marking for AI-Based Hemodialysis Machines

Lords Mark Industries Ltd. (LMIL) said its med-tech arm, Renalyx, has received a licence from the Central Drugs Standard Control Organisation (CDSCO) to manufacture Class C hemodialysis machines in India. Class C devices fall under the high-risk, life-sustaining medical equipment category and require extensive regulatory compliance.

The company also said the hemodialysis machines have received CE marking, which allows the product to be marketed across the European Economic Area. With this certification, LMIL–Renalyx becomes one of six companies globally to hold CE certification for dialysis systems, according to the company.

Under India’s medical device regulations, Class C manufacturing licences are issued after assessment across quality management systems, biocompatibility, electromechanical safety, sterility, component traceability, documentation, and plant audits. The licence permits domestic manufacturing of the dialysis equipment.

India’s dialysis market was valued at around USD 5 billion in 2024 and serves an estimated 18–20 lakh patients with chronic kidney disease (CKD). Industry data indicates that approximately 2.2–2.5 lakh new end-stage renal disease (ESRD) cases are reported annually. The country currently has fewer than 6,000 dialysis centres, while demand is estimated to be growing at 10–12% annually. A significant portion of dialysis equipment used in India is imported.

According to the company, the AI-enabled hemodialysis machines developed with Renalyx integrate automation, safety alerts, treatment monitoring, and real-time data analytics to support dialysis procedures. The manufacturing licence enables commercial-scale production of these machines in India.

LMIL–Renalyx said it has expanded its research and development efforts in areas including kidney-care technologies, liver-care devices, sensing systems, and renal data analytics.

Commenting on the development, Sachidanand Upadhyay, Managing Director, Lords Mark Industries Ltd., said:

“This licence is not just a regulatory approval, it’s a recognition of India’s ability to build and lead in the world’s most advanced med-tech categories. With our AI-Driven smart Hemodialysis Machine and continuous R&D team efforts, we aim to redefine renal care globally. Our mission is to create intelligent, safe, and accessible healthcare technologies from India that can serve the world.”

The company said the combination of the CDSCO manufacturing licence and CE certification allows LMIL–Renalyx to manufacture and supply the dialysis machines for domestic use as well as export markets.