medical devices: Many high-risk medical device manufacturers stop production

Many high-risk medical device makers have stopped manufacturing products as they await a manufacturing licence from the drug regulator.

Earlier this year, the Central Drugs Standard Organisation (CDSCO) had set the October 1 deadline for bringing ‘class C’ and ‘class D’ medical devices under regulation to control quality.

According to the new regulation, medical devices belonging to these categories, such as ventilators, imagining equipment, oxygen therapy equipment, nebulisers, x-ray equipment, surgical robots and oncology treatment linear accelerator, can’t be sold from October 1 without a manufacturing licence.

Several of these manufacturers said they had filed for a licence in July but were still awaiting audits on the basis of which they will be given licences.

“There is no information or communication from the health ministry or drug regulator on the issuance of licence and consequently we have stopped manufacturing. Legally, we can’t manufacture from October 1,” said a manufacturer that deals in equipment for newborns.

The supply chain may see a disruption in the coming days, said Rajiv Nath, forum coordinator, Association of Indian Medical Devices Industry. “Medical devices supply chain disrupted for moderately high-risk and high-risk (class C and D) devices in absence of manufacturing licences, which have not been issued to even those manufacturers who had registered and sought a licence.”