Intervention by Indian Regulator CDSCO sought with Smoking Gun Import Proof
New Delhi: The controversy currently raging in Indian media around a surgical robot sounds like a Chinese sneaking into Indian electoral roll to violate Indian democracy. The case of Mizzo Endo 4000, allegedly ‘Made in China’ but being passed off as Made in India has, it seems, stirred a hornet’s nest in Indian domestic medical device domain upbeat about becoming global hub any time soon. As pressure on the regulator CDSCO piles up, it may have to do a Bihar fame SIR like exercise to establish the veracity of the claims of Meril, the company in question. Import record certainly seems like a chink in the armor of claims put forth by Meril about said controversial surgical robot.
CDSCO (Central Drugs Standard Control Organization), in receipt of the complaint by ‘Made in India’ surgical robot SSIMantra, is expected to soon revisit documents to establish whether manufacturing claims of the company under Indian license are genuine or otherwise. Making it clear at the outset that it is all for fair competition, SS Innovations, maker of Mantra, has claimed it has smoking gun proof that ‘MIZZO Endo 4000 is a Chinese surgical robot KangDuo SR 2000 in Make in India clothing’. As it stands until CDSCO comes clean on it, this issue is all poised to blaze as cause célèbre involving the whole community of ‘Make in India’ enthusiasts in medical device sector.
Despite Indian company Meril, so called original maker of Mizzo Endo 4000, calling these allegations bullshit claiming that its surgical robot is an Indian manufactured product, SS Innovations has taken this issue to the regulator CDSCO to call its bluff without mincing any words. SS Innovations, Gurugram based surgical robot maker, in its letter to health authorities including CDSCO has alleged in clear terms that Meril, a firm based in Vapi (Gujrat) has imported a fully manufactured Chinese made surgical robot KangDuo SR2000 and is flaunting it as its made in India product, though Meril has manufacturing license issued by CDSCO.
SS Innovation’s letter to CDSCO has debunked the claims made by Meril in the media that its Mizzo Endo 4000 system has been assembled and validated under Indian government license. Meril claims in the media that ‘core assembly, software integration and quality checks were performed entirely in India and only select components were sourced from abroad’. On the other hand, citing import record of Meril, SS Innovations has asserted that Meril has brought in fully manufactured surgical robots named KangDuo 2000 from China and relabeled and repackaged them as Mizzo Endo 4000 without any local assembly or local addition.
Talking to Medicare News, the iconic Dr Sudhir Srivastava, one of the few top notch cardiac robotic surgeons in the world and maker of surgical robot SSIMantra inspired by Make in India slogan of PM Modi , seemed rattled by such alleged shenanigans . Dr Srivastava, who embellished USA by his over 1500 cardiac robotic surgery and is famed as father of robotic surgery in India expressed his angst saying, ‘Under the spell of nationalistic ‘Make in India’ call of PM Modi I plunged gung ho and invested my sweat, blood and tears to fulfill my visionary leader’s dream. We spent nearly five years to develop Mantra, talented engineers went through the rigorous drill day in and day out, went through full process of pre clinical studies and human clinical trials ahead of CDSCO approval. We are all for fair competition but such machinations will certainly dampen our Make in India spirit.”
In the mean time, “Made in India for World’ surgical robot with a mission to make surgery by robot affordable and accessible for one and all is holding the ‘Make in India’ flag aloft with 35 flawless Tele Surgeries so far, including one between 10, 000 kilometer apart France and India and over 5000 surgeries.’ SSI Mantra, sounding like Sanatan and divinity, is undoubtedly the greatest trophy of Make in India in Medical device domain.
