New Delhi: There is a sudden surge of energy in so far ‘meek’ Make in India enthusiasts in domestic medtech domain, thanks to CDSCO (Central Drugs Standard Control Organization), India’s apex regulator of drugs and medical devices. In one fell swoop, a CDSCO’s public notice on January 10 regarding import of refurbished medical devices has turned around mood in domestic medical industry turf. The notice says in no uncertain terms that import of refurbished medical devices is illegal.
But for this timely and decisive breaking in by the regulator, med tech gate would have continued unabated. It looks that matter reaching court has precipitated this hurried response by the regulator. Import of second hand medical devices illegally caught the attention of a patient safety consumer activist who has gone to court opposing it tooth and nail. This public notice has completely changed the ‘climate’ in indigenous medtech arena in spite of Ministry of Environment, Forest and Climate Change (MOEFCC). Mood is jubilant among indigenous makers who had hopped on the bandwagon of Make in India and Aatmanirbhar Bharat hoping that central government will not let vested interests throttle them.
This Environment ministry’s one OM (office memo) opened floodgates for imports of refurbished high end medical devices like CT scanners, MRI machines and surgical robots to the chagrin of Make in India makers of medical devices. Thousands of second hand surgical robots manufactured by an American company have already been illegally imported and have found their ways in operation theatres of India. The public notice unequivocally reads that central rules do not provide for granting licenses for import of such devices. No license is issued for the import of such devices and they cannot be imported into India for the sale and distribution.
“This is a very welcome clarification and a huge Make in India investment enabler. India does not permit pre owned cars or I-Phones as a make in India enabled so we hope that the policy review under way at MoH will consider alignment with National Medical Devices Policy 2023 that envisions India to emerge as the leading manufacturing hub of medical devices” says an elated Rajiv Nath , Forum Coordinator, AiMeD.
Dr Sudhir Srivastava, robotic surgery maestro and Chairman of SS+Innovations, which has made best of class surgical robot SSI Mantra in India, said, ‘This step by CDSCO has restored the faith of those who believed in the slogans of Make in India and Atmanirbhar Bharat given by Prime Minister Narendra Modi. This should be understood that allowing import of refurbished medical device is the complete negation of potential of India for becoming global hub of medical devices.”
Dr Rajiv Chhibber, Joint Coordinator Policy Government Affairs AIMED, ‘This will give Atmanirbhar Bharat dream a new fillip, as more domestic manufacturers will scale their capacity towards manufacturing such goods, which will be available, accessible and affordable too. The irony is in India more than 80% of hospitals are using second hand refurbished medical equipments yet treatment prices remain high patients are categorically told that high treatment is due to high cost of imported medical technologies.
“A stop to import of refurbished medical equipment is a true policy intervention that will guard the domestic industry against dumping of equipment with uncertain quality, and will also help the patients in receiving appropriate medical care thereby bringing the best value of cost for them and for the payers, including insurance agencies. This is a welcome and much awaited long overdue intervention” said Dr Jitendra Sharma , Mg Director, AMTZ, Visakhapatnam.
Prof Bejon Kumar Misra Founder of Patient Safety and Access Initiative of India Foundation said, ‘ The circular issued by CDSCO on 10th January regarding refurbished medical devices imported into India has shown Modi 3.0 is awake and ready to listen to a common consumer. Now our next logical step should be to recall all such illegally imported medical devices from every corner of the country and destroyed in the interest of Patient Safety.
Dr. Aakaar Kapoor, Founder and Partner of City Imaging Clinical Labs expressed strong support for CDSCO’s recent public notice to disallow the import of pre-owned, refurbished medical devices into India. Dr Kapoor said, “This decision is a monumental step forward for patient safety in India. Brand-new medical equipment offers unmatched advantages over refurbished machines. Refurbished machines have significant concerns regarding radiation emissions, which can pose harm to patients”
