The Centre has now asked traders and resellers of medical devices to also register themselves in an attempt to expand the ambit of regulating the medical devices industry in the country. The move can have a far-reaching impact for both consumers and traders as several common items like masks or condoms which now freely sell through grocers and other channels may face availability issues.
In a notification dated September 30, the Union Ministry of Health said that any person who wants to sell, stock, exhibit or offer for sale or distribute a medical device including in-vitro diagnostic medical device would need a registration certificate. These rules may be called the Medical Devices (Fifth Amendment) Rules, 2022, it said.
Explaining the move by the Centre, Rajiv Nath, Forum Coordinator, AiMeD (Association of Indian Medical Devices Industry) said that Medical Devices Rules of 2017 were defining rules and responsibilities of manufacturers and importers but not of resellers, wholesalers, or traders or retailers.
“Earlier a wholesale drug licence was required by resellers of medical devices notified as drugs. Considering the vast and diverse range of devices that aren’t necessarily sold at pharmacies, such as spectacles, condoms, gloves, adult diapers, orthopaedic assistive products like walker and wheelchairs, oximeters, masks, oxygen concentrators etc, it was imperative to have a separate regulatory mechanism for lakhs of resellers of medical devices in malls, grocery stores, paanwala etc that was 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 patients safety.
The devices industry is happy with the new notification. “We are pleased to note the notification is out as the market place was undergoing turmoil with uncertainty and traders being asked by state regulators to seek a wholesale drug license for which they would not qualify as in most cases they were not pharmacists. We are glad that qualification criteria are thankfully not cumbersome in the notification released and this will address the uncertainty,” Nath added.
However, for very common items like masks, condoms etc which are now freely available at a paan-stall, or a neighbourhood grocer; there may be some 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 aspects of continuity of business and affordable and freely accessible is also met with in certain cases,” said an industry source.