Medical devices manufacturers have welcomed the drug regulatory authority’s decision not to allow refurbished medical devices enter the country, in a move to curtail the influx of such unregulated products.
In a letter to the principal commissioner of Customs, the the Central Drugs Standard Control Organisation (CDSCO) said there are no specific provisions for regulation of refurbished medical devices under the existing rules. No licence is issued for import of such devices, which cannot be imported in India under the Medical Devices Rules, 2017, for sale and distribution, it said in the letter dated January 10.
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.
Vishwaprasad Alva, founder of Skanray Technologies said the ban on imports of used medical equipment is a very welcome move . India doesn’t allow imports of second hand and refurbished cars, textile, printing, metal working machinery, into the country. “Used medical equipment import was an error that the government has now corrected,” he said.
Apart from becoming a dumping ground for old unsafe medical equipment , India 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 home grown manufacturing and R&D infrastructure, Alva added.
The ministry of health meanwhile is working to constitute a high-level expert committee to discuss regulatory aspects with stakeholders regarding the import of refurbished medical devices. Industry experts say the imports may remain suspended until a regulation is passed by the expert committee.
The pre-owned medical equipment market, valued at Rs 1.500 crore, constitutes around 10% of the total medical equipment industry in India, playing a critical role in meeting the growing demand in Tier-II, -III, and -IV cities, as well as rural and underserved areas.
The medical devices industry representatives said permitting such imports, despite the availability of similar products manufactured in India, threatened the efforts of Indian manufacturers to meet the vision of Aatmanirbhar Bharat. Patient safety was also at risk, as patients could be treated with non-calibrated, non-regulated medical equipment, compromising safety.
