A new rule in January classifying medical devices such as nebulisers, blood-pressure monitors, digital thermometers and glucometers as drugs is causing a short supply of these products, their manufacturers and suppliers said.
These devices are widely used in the home treatment of C-19 patients and are facing high demand amid the second wave of the pandemic sweeping across the country.
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But companies dealing in these said they are facing hurdles in scaling up production, import and retail of the products as every process now needs government approval and licenses under the Drugs Act.
Ecommerce companies said there are fewer sellers of these devices on their platforms compared with last year.
The government hasn’t put oxygen concentrators under the Drugs Act yet — these portable machines to produce oxygen can be sold under voluntary license registration till September.
But manufacturers and sellers are already facing harassment from drug inspectors, who ask them to take government approvals and follow the drug rules, two senior industry executives said.
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