CDSCO’s notification on medtech regulations not as per industry’s aspirations: AIMED

Baffled to see the notification same evening in conflict with our discussion at the first meeting held by the Central Drugs Standard Control Organization regarding the “road map” for regulating the sale and manufacture of all medical devices, said Rajiv Nath of The Association of Indian Medical Devices Industry


New Delhi: Recently on 8th February, the Central Drugs Standard Control Organization (CDSCO) had called a meeting with the medical technology industry for consultations regarding planning a phased regulatory road map. The stakeholders had expressed their satisfaction at the discussions. However, now the Indian association representing domestic medical devices companies has lamented that the same evening, a notification which is in conflict of what was discussed to regulate all devices gradually with adequate transition period, was issued by the CDSCO.

In his reaction, Mr Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) stated, “We are baffled to see above notification same evening in conflict with our discussion at the first meeting held by the Central Drugs Standard Control Organization regarding the “road map” for regulating the sale and manufacture of all medical devices in India in a phased step by step approach. We wonder what’s the logic and rationale behind this random pick and choose approach? ”

Voicing Industry’s concern Mr Nath said – Until 2020  is too short, at least 5 years Transition period is needed to build infrastructure and capability and capacity of Regulators, Auditors , Testing facilities and also of Manufactures or you will have a case of non enforced/ non enforceable regulations and inadvertently building market access barriers to home grown manufacturers who will be struggling to get licensed and competing with USFDA qualified importers.

Similar opinion was given by Mr Anil Jauhri, CEO of QCI – NABCB who had given a presentation to regulate all medical devices at the Department of Commerce Conclave on Standards at Mumbai last week. “Device by Device regulations will not work. “He has suggested following a hierarchy of standards to regulate categories of devices – e.g., initially using horizontal Risk Management & Quality Management Standards common to all products followed by semi horizontal standards that are applicable on specific categories of devices eg Sterility for sterile products, electrical safety for electronic devices and biocompatibility for implants etc.”

Another expert , Dr Jitendar Sharma, Managing Director of Andhra Medtech Zone opined, “Better than item by item regulations it’s prudent to regulate devices by category in a phased manner. It’s better to regulate by category eg: non ionising diagnostic equipment, ionising diagnostic equipment, all medical electronics with power extrusion , all medical electronic equipment with or without motors, all IVD consumables & all IVD Disposables, all medical disposables , all medical consumables etc.with listed examples with common validation and testing needs”.

                                                   Notification by the CDSCO.

“It’s better to initially regulate categories by risk classification eg high risk devices first or where devices are being manufactured already in India to support manufacturers with Regulatory certification for enabling their credibility or Indian manufacturers need to seek 3rd country regulatory approval to sell and are challenged to access our own home market and items where we have less manufacturing capabilities could be considered last of all as expertise to test, audit, qualify may not be there immediately as acknowledged by DCGi in meeting and country needs time to develop regulatory capacity and capability, said Nath.

Urging for CDSCO’s immediate support to amend the Ministry of Health’s notification, Dr Jitender Sharma said “The notification issued is a faulty notification made without a draft notification having been discussed or consulted with all impacted stakeholders and this needs amending ASAP or it will kill impetus being created of make in India of high end equipment being initiated in AMTZ. You can’t regulate a few 100 Dialysis equipment and not regulate lacs of dialyzers at all”

*This news is based on a press release.