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The Centre has asked traders and resellers of medical devices to register in an attempt to expand the ambit of regulating the medical devices industry in the country.
The move can have far-reaching consequences for both consumers and traders alike as products like face masks or prophylactics — now sold through grocers and other channels — may face issues of availability.
In a notification dated September 30, the union ministry of health and family welfare said anyone wanting to sell, stock, exhibit or offer for sale or distribute a medical device, including in-vitro diagnostic medical device, will need a certificate of registration.
These rules may be called the Medical Devices (Fifth Amendment) Rules, 2022, it observed.
Explaining the Centre’s rationale, Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry, said that the Medical Devices Rules of 2017 defined the regulations and responsibilities of manufacturers and importers, but not of resellers, wholesalers, traders, and retailers.
“Earlier a wholesale drug licence was required by resellers of medical devices notified as drugs.
"Considering the vast and diverse range of medical devices not sold at pharmacies like reading glasses, gloves, adult diapers, orthopaedic assistive products like walkers and wheelchairs, oximeters, masks, condoms, oxygen concentrators, etc, it was imperative to have a separate regulatory mechanism for resellers of medical devices in shopping malls, grocery stores, kiosks that were initially seeking only a simple online registration process to enable traceability and recalls if desired by manufacturers and regulators.”
In February, the government had issued a draft notification to cover the resale of medical devices by traders as part of the ongoing transition to regulate medical devices for ensuring patient safety.
The devices industry is happy with the new notification.
“We are pleased to note the notification is out as the marketplace was undergoing turmoil, with traders being asked by state regulators to seek a wholesale drug licence for which they would not qualify — in most cases they are not pharmacists.
"We are glad the qualification criteria are not cumbersome in the notification released and will address the issue of uncertainty,” added Nath.
However, for products like masks, condoms freely available at a paan shops or the neighbourhood grocer, there may be availability issues.
“These small traders/resellers will find the requirement for registration challenging, especially in rural areas.
"The government may possibly need to come out with an exemption list, so that while patient safety aspects are covered in most cases, the aspect of continuity of business is also addressed,” said an industry source.
