In a decisive regulatory move, India’s Central Drugs Standard Control Organisation (CDSCO) has instructed the Customs office to ban the import of refurbished medical devices. Announced on January 10, 2025, this directive seeks to enhance patient safety, foster indigenous innovation, and prevent India from becoming a repository for unregulated and potentially unsafe medical equipment.
Strengthening India’s Medical Device Ecosystem
This landmark decision aligns with the government’s ‘Make in India’ and ‘Atmanirbhar Bharat’ initiatives, receiving widespread support from industry leaders. The prohibition is seen as pivotal in bolstering India’s self-reliance in medical technology while reinforcing the regulatory framework designed to maintain high-quality healthcare standards.
Dr. Sudhir Srivastava, Past Chair of the Medical Device Committee at PHDCCI, emphasized the significance of the move, stating:
“This decision by CDSCO marks a pivotal step towards reinforcing India’s self-reliance in medical technology. Allowing refurbished medical devices into the country would have jeopardized the quality of healthcare, disincentivized local innovation, and undermined the spirit of the ‘Make in India’ initiative. Indian manufacturers are making significant strides in R&D, delivering cutting-edge solutions tailored to our healthcare needs. By curbing refurbished imports, we not only protect the integrity of our medical ecosystem but also send a strong message to global investors that India is committed to building a robust, indigenous medical device industry. This move safeguards both the future of healthcare innovation in India and the well-being of our patients.”
Industry Perspectives on Indigenous Growth
Gaurav Agarwal, Managing Director of Innvolution Healthcare, praised the clarification issued under the Medical Devices Rules (MDR) 2017, adding:
“We welcome and applaud the clarity provided by CDSCO regarding the prohibition of importing refurbished medical devices. This decisive step ensures the highest standards of patient safety while creating a robust environment for indigenous manufacturing growth. By eliminating ambiguity, CDSCO has further strengthened the push towards self-reliance, innovation, and quality in India’s medical technology sector. Innvolution Healthcare remains committed to supporting these national objectives by delivering cutting-edge, locally manufactured solutions that enhance healthcare delivery and patient outcomes.”
Guarding Against Unsafe Imports
Vishwaprasad Alva, Founder and Managing Director of Skanray Technologies, highlighted the risks of allowing refurbished imports:
“We don’t allow second-hand and refurbished cars, textiles, printing, or metalworking machinery into the country. Used medical equipment import was an error that the government corrected. It’s the right move. India being a large nation and a growing market, apart from becoming a dumping ground for old unsafe medical equipment, we would have also become an e-waste destination for the world. The Government seems to be sensitive and serious about world-class healthcare and also helping homegrown manufacturing and R&D infrastructure.”
A Commitment to Innovation and Safety
This ban reinforces India’s commitment to fostering a globally competitive medical device industry. It protects domestic innovation while ensuring patient safety and maintaining a regulatory framework that positions India as a leader in healthcare technology.
By prioritizing local manufacturing and development, this decision strengthens India’s medical ecosystem and aligns with the vision of a self-reliant and innovative nation.
