The Govt. yesterday held its first meeting to discuss the “road map” for regulating the sale and use of medical devices in India. The meeting was held by the Central Drugs Standard Control Organization, the National Medical Device Regulator, with major stakeholders of the medical device industry association representing overseas and Indian manufacturers. It discussed regulatory measures, including safety of patients and pricing.
The meeting was “in pursuance of the order by Ministry of Health and Family Welfare and in order to prepare road for regulations of all medical devices”.
Mr. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) who was a part of the meeting said “We complement CDSCO & MoH&FW for listening to our requests to bring in a separate regulatory framework for medical devices independent of Drugs and carry forward the initial rolling out of regulations from the launch of Medical Devices Rules earlier in Jan 2018, to a logical conclusion. A re-start of the process that had stalled has been made.” Sharing the outcome of meeting, Mr. Rajiv Nath highlighted the recommendations made by general consensus to MoH in rolling out Medical Devices regulations in a phased manner:
- All Medical Devices need to be regulated.
- No Compromise on Quality & Safety wrt medical devices.
- Competency Building measures over a defined Transition Period measures to be taken for Regulators, Industry & Infrastructure, including periodic Training.
- Separate and clear regulations from Drugs required.
- Registration of all Manufacturers & Importers of all non-notified Medical Devices at earliest. Devices labels to carry registration number and address to enable traceability.
- Importers & Mfrs need to list their ISO13485 certification from NABCB / IAF accredited Certification Body (Indian/ International) Transition period to be provided. Traceability criteria for verification of manufacturing site & commercial office to be defined.
- Quality Complaints Handling system to be made robust. Serious Adverse Event Reporting mechanism needs to be strengthened
- Representation on DTAB by a Medical Devices Industry nominee as a special invitee till we have MTAB
- Constitution of MD – EAG (Medical Devices – Expert Advisory Group ) to aid MoH in Rolling out medical devices regulations in a phased manner.
- Separate Medical Devices Law & Authority (or revamping of CDSCO ) in due course .
“We are glad that the committee has made some very impactful recommendations that will create a new regulatory marketing approval system for medical devices and Govt. will come to know who imports, who is manufacturing what. Right now its all unknown and without data and facts, it’s impossible to take correct policy decisions.” Added Mr. Nath
“Let’s hope MoH&FW will act on these suggestions and stop procrastinating in the need to ensure patient safety and encourage domestic manufacturing that had been negatively impacted in absence of a predictable regulatory environment.”
“If its implemented in its true spirit this will bring a lot of transparency and reduce huge import dependency in this sector which is still at 70-90%, make India a global robust hub for medical devices manufacturing and fulfill Govt’s ambitious mission of making quality healthcare affordable for common masses” concluded Mr. Rajiv Nath.