These devices are widely used in the home treatment of Covid-19 patients and are facing high demand amid the second wave of the pandemic sweeping across the country. 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.
Clampdown by Authorities
These medical devices were previously not covered under any specific regulations.
The industry is not opposed to regulation, but wants that to be specific to medical devices and not under the Drug Act which is for medicines.
“Companies need to take approval and undergo inspection even if they want to expand production capacities, set up a new line or a warehouse for any medical electronics regulated as a drug now,” said Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry. These are measures that can be adopted during peacetime and not when it is a war-like situation, said Nath, who is also managing director of Hindustan Syringes & Medical Devices. “The government needs to allow relaxations on regulatory compliance for medical electronics for a few months till the second wave is controlled.”
States such as Maharashtra that have imposed restrictions on the sale of non-essentials have not made oxygen concentrators an essential, which has further impacted availability, manufacturers said.
A few sellers and retailers have some stock but are unable to sell, they said.
A senior executive at a leading medical device manufacturer said drug authorities in Maharashtra had clamped down on online sellers and retailers of oxygen concentrators in the last two-three days, saying that they needed to supply to state governments instead of directly selling them since the product came under the Drugs Act.
“Drug inspectors say we have to comply with them. While the intention may be good as they want to prevent hoarding, but it reduces retail availability,” he said.
A drug license is required to even stock these medical devices and sell them. Hence, the number of sellers on ecommerce platforms has reduced drastically so has individual stores selling them, since now only pharmacies in brick-and-mortar retail can sell such products.
“The entire process of licensing to sell them has increased the shortage as compared to last year,” a senior ecommerce industry executive said.
Despite facing these regulatory issues, companies such as BPL Medical Technologies and Philips are working on increasing the supplies of oxygen concentrators and other devices.
“Oxygen concentrators should be considered as an essential product to ensure wider availability through retail stores and ecommerce even as we are sourcing units and trying to ramp up local production,” a BPL Medical spokesperson said.
Nath of the medical device industry association said currently there was demand for almost 2,000 units of oxygen concentrators daily since hospital beds were not available.
“The whole process of taking approval, undergoing inspection to scale up supplies will take days, which will delay availability of these products if covered under compulsory manufacturing license as required under Drugs Act. Also, it is not the best time to bring in these devices under the enforcement of the Act,” he said.
Last week, the union health ministry extended the timeline by six months to classify eight critical medical equipment including CT scans, MRI machines, defibrillators, dialysis units and X-ray machines as drugs for existing manufacturers and importers. It also allowed voluntary drug licensing for manufacturers and importers of pulse oximeter till August 2022. But there was no relaxation of the rules for nebulisers, BP machines, digital thermometers, glucometers and oxygen concentrators, despite requests from the industry.