Medical device makers fear closure as new norms kick in

The central government announced the final medical devices regulations on Thursday. The rules state the shelf life of medical devices should be five years. The notification classifies medical devices into four categories — low risk, low-moderate risk, moderate-high risk and high risk devices. While the entire medical devices industry welcomes separate rules for medical devices, they are not quite happy with the fine points mentioned in the notification. 

Rajiv Nath from the Association of Indian Medical Device Industry (AiMeD) says, “The proposed regulations may result in closure of domestic manufacturing and drive jobs out of India as more manufacturing of high-risk high technology devices will switch to imports.” India already imports 70 per cent of devices. 

The notification mandates inspection of all Indian manufacturing units by drug controlling authorities. The domestic manufacturers’ lobby states this defeats the purpose of self-regulation. Nath feels the government has practically done nothing to make it easy for manufacturers to do business in India. He says, “The regulator doesn’t have the expertise to conduct checks. We asked them to consider a third-party certification which they have not incorporated in the final notification.” 

As for the shelf life, the central drug controller, CDSCO, had been arguing that in Indian conditions, five years would be a reasonable shelf life. The notification has mentioned shelf-life extension shall be given on a case-to-case basis. It states, “The shelf life of the medical devices shall be determined, keeping in view the technical parameters and shall ordinarily not exceed sixty months from the date of manufacture to be reckoned from month to month except in cases where satisfactory evidence is produced by the manufacturer to justify a shelf life of more than sixty months of a device to the satisfaction of the Central Licensing Authority.”

Multi-national device manufacturers feel that limiting the shelf-life to five years is an impediment for the industry. In a statement, Medical Technology Association of India (MTAI) says, “Since the implementation of these rules is yet a year away, and because the health ministry and CDSCO has kept all stakeholders closely engaged, we are hopeful that any adjustments which may be in overall patient interest and assured availability of these devices can still be made.” 

While the regulations have been finalised, they will be effective from January 1, 2018.