Bengaluru (Karnataka) [India], January 23: In a landmark decision, the Central Drugs Standard Control Organisation (CDSCO) has prohibited the import of used and refurbished medical devices in India. This progressive step is a significant milestone in enhancing patient safety, promoting quality healthcare, and fostering the growth of India’s indigenous MedTech manufacturing sector.

Dr. Jitendra Sharma, MD & Founder CEO of AMTZ, emphasized, “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. This will also help patients receive appropriate medical care, thereby bringing the best value for the medical equipment cost being spent by them and by the payers, including insurance agencies. This is a welcomed and much-awaited, long-due intervention.”

At Innvolution, we wholeheartedly commend CDSCO for its vision and decisive action. By halting the influx of second-hand medical devices, India is sending a clear message about its commitment to delivering uncompromised healthcare standards to its citizens. This move also aligns with the “Make in India” initiative, encouraging local manufacturers to innovate and deliver cutting-edge technologies tailored for Indian healthcare needs.

No country allows even new medical equipment to be sold within its borders without thorough inspections, including mandatory visits to the manufacturing facilities in the country of origin. It is imperative that India enforces similar standards for pre-owned equipment to mitigate potential risks to patients.

“India now has the manufacturing capacity and technological capabilities to cater to domestic demand for high-end, High Value medical equipment. This suspension offers an opportunity to further strengthen local manufacturing and innovation while ensuring a level playing field. We look forward to collaborating with all stakeholders in framing a policy that promotes safety, quality, and self-reliance in the medical technology sector.” said by Mr. Gaurav Agarwal, Managing Director, Innvolution Healthcare Pvt. Ltd.

Highlighting the capacity and capabilities of domestic manufacturers to meet both domestic and international demand, Mr. Atul Sharma, Cofounder & Director, Innvolution healthcare mentioned that the manufacturing sector contributes more to the value chain, driving innovation, advancing technology, and creating a significantly larger number of jobs than the refurbishing industry. By focusing on building and enhancing our local manufacturing capabilities, we are positioning India for long-term self-reliance and economic growth. In the broader perspective, this approach will lead to sustainable growth and a healthier healthcare ecosystem, aligning with the nation’s goals of self-sufficiency and job creation. The upcoming regulatory frameworks must ensure that this restriction remains intact, encouraging domestic manufacturing and long-term employment opportunities over short-term solutions like refurbishing.

Industry leaders like, Ms. Chandra Ganjoo, Group CEO, Trivitron Healthcare appreciated the initiative by the CDSCO and said that It is a visionary step which endorses the Government of India’s commitment to self-reliant India. It is not only going to protect and boost the domestic medical device industry, but it will also be the springboard to project India as a major world manufacturer in the medical devices sector. Further to this, I hope that with the review of the policy by the Ministry of Health, it would be formulated more in direct alignment with the goals of the National Medical Devices Policy 2023. The policy envisages India as a leading hub for the design, development, and production of best in technology medical devices to serve both domestic and international markets.  This decision is very significant and has an intention to ensure safe and quality treatments for patients and promote innovation within the country. Clearly, with a good roadmap and enabling policy, the country is seen to redefine its role in the global healthcare model.

“This is a Very welcome clarification and a huge Make in India investment enabler. Recently at a seminar on Medical Devices Regulations it was clarified that while one ministry and its regulations may permit imports of preowned medical devices w.r.t. e-waste management concerns other regulators like AERB or CDSCO have to play their own role and until there is an unequivocal policy decision by MoH&FW permitting imports of pre-owned equipment and amendments to MDR to suitably address the high risk patient safety concerns it’s not permissible to import preowned medical equipment and if any such pre-owned equipment is under import clearance without an import license it will not be permitted by Port Officer and will need to be exported back to country of origin. We welcome this from AiMeD.

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. We welcome MNCs to invest in India and make these high technology equipment in India and make these affordable to Indian Patients as being done in mobile phones and automobiles sector. A healthy competition is welcome “ said an elated Rajiv Nath , Forum Coordinator, AiMeD.

Industry also recommend that scrutiny must begin at the country of origin for these used devices. This step will help ensure that outdated or unsafe equipment does not enter the Indian market under the guise of refurbishment being invoiced as New. Collaborating with international regulatory bodies and establishing a robust inspection framework can bolster the effectiveness of this ban.

Innvolution remains committed to advancing India’s healthcare landscape through innovative, affordable, and high-quality solutions. Together with regulatory bodies like CDSCO, we can work towards building a safer and more self-reliant MedTech ecosystem, ensuring the highest standards of care for patients across the country.

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