New Delhi, October 8, 2025: The rivalry in India’s fast-growing robotic surgery market has intensified after Gurugram-based SS Innovations (SSI), founded by cardiac surgeon Dr. Sudhir Srivastava, filed a complaint with the Central Drugs Standard Control Organisation (CDSCO). The complaint alleges that Meril Newage’s surgical robot, the Mizzo Endo 4000, is a rebranded import of the Chinese KangDuo SR2000 rather than an indigenous “Made in India” innovation.
SSI claims import data show Meril brought in fully assembled KangDuo SR2000 units from Suzhou Kangduo Robot Co. Ltd. and relabeled them as the Mizzo Endo 4000 under the “Make in India” initiative. The company argues that such actions mislead hospitals and patients, undermine local manufacturers, and distort the government’s goal of self-reliant medical technology. SSI has requested that CDSCO verify Meril’s import and manufacturing records for regulatory compliance.
Meril Newage, a division of Gujarat-based Meril Life Sciences, has firmly denied the allegations. It asserts that the Mizzo Endo 4000 was assembled, integrated, validated, and quality-tested in India at its Vapi facility under a valid CDSCO manufacturing license.
According to CEO Vivek Shah, only selected components were sourced globally, while core assembly, integration, and software calibration were performed domestically. “Meril complies with all applicable regulatory and quality standards,” Shah said, adding that the robot “is not Made in China.”
Meril unveiled the Mizzo Endo 4000 in September 2025, describing it as a next-generation surgical robot with AI-driven 3D anatomical mapping, modular open-console design, and 5G-enabled telesurgery capability for remote operations. The system supports a wide range of soft-tissue procedures, including gastrointestinal, colorectal, gynecological, ENT, oncology, urology, and thoracic surgeries.
Meanwhile, SSI’s own platform, the SSI Mantra, remains a key competitor. Since its approval in 2022, SSI reports over 125 installations across six countries and 6,000+ successful surgeries, including telesurgeries and cardiac procedures. It recently completed a human-factors validation study at Johns Hopkins University and plans a U.S. FDA 510(k) submission by late 2025.
Industry experts say the heart of this robotic surgery controversy lies in India’s regulatory ambiguity over what qualifies as manufacturing versus repackaging.
Under the Drugs and Cosmetics Act, certain assembly or labeling activities can legally be classified as manufacturing — a loophole that may allow imported systems to be presented as “Made in India.” SSI argues this ambiguity risks misleading buyers and weakening India’s MedTech credibility.
A senior regulatory analyst noted that “if the allegations are proven, it could have far-reaching implications for the government’s Make in India initiative and the global perception of India’s medical device manufacturing sector.”
India’s surgical robotics market is projected to grow from USD 851 million in 2023 to nearly USD 4 billion by 2031, but foreign robotic systems still control around 70 percent of the market share.
Analysts warn that controversies like this could slow down investor confidence and public trust in indigenous MedTech products. Transparent labeling, stronger regulation, and clear manufacturing definitions are now being seen as critical for sustaining growth and credibility.
The CDSCO is reviewing SSI’s complaint and may seek further clarification from both companies. Whatever the outcome, the case has already sparked a national conversation about innovation, integrity, and accountability in India’s high-tech healthcare sector.
Key Takeaway:
The outcome of this dispute could shape how India defines indigenous innovation and regulatory transparency in its medical device sector — setting a precedent for the future of the country’s fast-evolving robotic surgery industry.
(Rh/Eth/TL/MSM)