Staff Reporter

Says Centre must first set up required infrastructure

CHENNAI: The new guidelines for import and manufacture of medical devices notified by the Ministry of Health and Family Welfare would affect the medical devices manufacturing sector in Indian, the Confederation of Indian Industry (CII) said.

Chairman of its Medical Equipment Division, Alok Mishra said though there is a need for regulation as all medical devices undergo stringent quality norms globally, the Centre must first establish the required infrastructure to undertake product testing, certification and quality evaluation to ensure quality of imports.

"The industry too needs time and funds to recruit and train competent personnel for collating data and creating files for submission," he said in a press release.

According to the notification, sterile devices, including cardiac stents, catheters, intra-ocular lenses, heart valves and orthopaedic implants, are to be considered as drugs, requiring Central clearance prior to import, manufacture or marketing in India from March 1.

For importing medical devices, the guidelines make it mandatory for importers to apply for import and registration. In case of devices that have not been imported before, no import would be permitted without approval of a competent authority.

"Restrictive rules"

Vis-à-vis stents or drug eluting stents, the guidelines said import would not be permitted if the applicant had not sold less than 1,000 stents of the particular specification prior to the notification.

Such stipulations restrict the entry of new players into the devices sector, Mr. Misra said.

Stating that the domestic medical equipment industry and the multinational players mainly import devices, he said the proposed registration fees of $ 1,000 per device was high and would become a burden for small manufacturers. It could also affect the available range of products in India as the sales per device were usually small. The Centre must discuss the guidelines with the industry, as it was essential to support the rapidly growing healthcare industry and medical tourism sector.