There has been a raising concern about growing imports of refurbished medical equipment in India. Domestic medical device makers say these imports have been happening without proper certification, jeopardising patient safety.
Last year, the Patient Safety and Access Initiative of India Foundation (PSAIIF) filed a public interest litigation in the Delhi High Court, highlighting concerns about reliability of these devices and the risks to patient safety. The clarification by the regulator is a “welcome move and a huge ‘Make in India’ investment enabler”, said Rajiv Nath, the forum coordinator at the Association of Indian Medical Device Industry.
He said India does not even permit import of pre-owned cars or iPhones, hence there is a huge need for this intervention. “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 the automobile sector. A healthy competition is welcome,” Nath added.
Jitendra Sharma, managing director of the Andhra Pradesh MedTech Zone, said this move will help guard the domestic industry. “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 patients in receiving appropriate medical care,” he said.
“The government has suspended all imports of refurbished medical devices until the Ministry of Health and Family Welfare establishes a policy framework for such imports,” the Medical Technology Association of India said. To safeguard the interests of the healthcare system and the refurbished medical device sector, it is imperative that the expert committee on the matter expedites the creation of a policy and, meanwhile to avoid any disruptions, allows imports through necessary approvals, it said. “The pre-owned medical equipment market currently constitutes around 10% of the total medical equipment industry in India, playing a critical role in meeting the growing demand in tier 2, 3, and 4 cities, as well as rural and underserved areas,” the association said.
