A war of words has broken out in the medical devices industry following a recent Health Ministry clarification that effectively ended the import of pre-owned or refurbished products.
The import of refurbished products has been a raw nerve for domestic medical device-makers for several years now. Their complaint was that it ran counter to government efforts encouraging local manufacturers to make medical devices locally.
The industry is clearly a divided house, with domestic medical device makers lauding the Central Drugs Standard Control Organization (CDSCO)’s recent communication to the Office of the Principal Commissioner of Customs, stating that refurbished products cannot be imported into India, as there were no specific regulatory provisions governing them.
Representatives speaking off-record for multinational medical device makers say, the practice is prevalent even in developed markets, governed by a regulatory framework to ensure patient safety. Allowing OEMs or their authorised third party to bring in refurbished products in adherence to quality and safety standards would give the local population access to pre-owned medical devices that could be 25- 50 per cent cheaper, an industry representative had told in a recent conversation on the issue.
With imports of refurbished products stopped, Rishi Agrawal, Chief Executive and Co-founder of TeamLease RegTech called for a regulatory framework governing such devices in terms of their traceability, transparency on maintenance details, component replacement records etc – in the interest of patient safety. A calibrated approach is required, he said, so that companies are accountable and India does not become a dumping ground for low-quality products. Meanwhile, local manufacturers should use the opportunity to invest and produce globally-competitive products, he added.
The Association of Indian Medical Device Industry’s (Aimed) Rajiv Nath welcomed “healthy competition” and called on multinationals to invest in India and make high-technology equipment, at an affordable cost to Indian patients. There is a policy review underway on whether refurbished imports are needed, he said. Already India’s import bill for medical devices is going up annually, with a 13 per cent jump in 2023-24 alone, Aimed said. India currently imports ₹69,000-crore worth of devices, it added.
Cost-effective solutions
Medical Technology Association of India (MTAI), however, pointed out that pre-owned medical equipment market constituting about 10 per cent of the total medical equipment industry in India, played “a critical role in meeting the growing demand in tier 2, 3, and 4 cities, as well as rural and underserved areas”.
These regions – where 70 per cent of healthcare facilities are privately-run small clinics, nursing homes, diagnostic centers etc – rely on cost-effective solutions, it said. “Globally, even developed regions like the US and EU have a 7 per cent – 9 per cent dependency on pre-owned medical equipment, underscoring its importance in ensuring affordable healthcare solutions. Countries like the US, several European nations, Japan, the UK, Canada, South Korea, New Zealand, and Australia permit the import and sale of pre-owned medical equipment in accordance with their regulations,” Mtai said, pegging the pre-owned equipment industry in India at ₹1,500 crore.
“If a swiftly implementable policy is not introduced soon, it could lead to irreversible damage to both healthcare providers and the workforce. … Currently, the import of refurbished devices remains at a standstill, posing a threat to both the healthcare system and the industry itself,” it added.
E-waste destination
Pointing out that “used medical equipment import was an error” in the first place, Vishwaprasad Alva, Founder and Managing Director, Skanray Technologies said, “We don’t allow second hand and refurbished cars, textile, printing, metal working machinery, into the country. 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.”
Sudhir Srivastava, Past Chair of the Medical Device Committee at PHDCCI added, the CDSCO’s decision reinforced India’s self-reliance in medical technology. “Allowing refurbished medical devices into the country would have jeopardised the quality of healthcare, disincentivised local innovation, and undermined the spirit of the ‘Make in India’ initiative,” he said in a statement.