26 COVERStory
BioSpectrum | November 2017 | www . biospectrumindia . com
Devices Rules 2017 , AIMED , an umbrella Association of Indian Manufacturers of Medical Devices covering all types of Medical Devices including consumables , disposables , equipment of diagnostics representing the interest of over 700 manufacturers pointed out that a golden opportunity to accelerate manufacturing of Medical Device Industry is being lost . The association requested the authorities to kindly review and incorporate its suggestions by issuing an Amendment at the earliest which will be addressed in proposed Medical Device Bill .
Rajiv Nath , Forum Coordinator Association of Indian Medical Device Industry ( AIMED ) in a representation to the Joint Secretary ( Health ) Ministry of Health and Family Welfare said that majority of the recommendations from Indian Medical Device Manufacturer that were collated and submitted remained unaddressed in the subject document . “ We would strongly recommend review of the document and suitable amendment , and for permitting a transition period of minimum two years for Medical Devices other than IVD , for IVD it may be three years ,” he observed .
Needs Attention Although the government has come up with the Rules for medical devices industry , the industry says that still it needs more to be done to support this niche and growing industry . Sharing his views on issues Dr Shama Bhat , Managing Director , Bhat Biotech India ( P ) Ltd said that unfortunately the current regulatory authorities need to be educated as the pharma regulators have very little knowledge about the diagnostics industry that is
SEGMENT WISE MARKET SHARE OF MEDICAL DEVICES
• Diagnostic Imaging
• Consumables
• IV Diagnostics
• Patient Aids
• Orthos and Prosthetics
• Dental Products
• Others ( Patinent Monitor , ECG , Oxygenators etc .)
0.12 0.35
3.8
2015
0.94
0.27 0.39 0.63 1.18
8.16
2020
1.98
0.26 0.57
0.75 0.82
1.31
2.47
8
6
4
2
0
USD BN the licensing authority as of now . This leads delayed approvals . However , the new implementation of the IVD regulatory Authority ( Medical Devices Rules 2017 ) who need to approve on a time bound schedule . With this we are hoping that the system will be industry friendly for the ‘ Make in India ’ vision of our Prime Minister Modi .
Another problem faced by the Diagnostic Industry , is the unregulated Diagnostic Services Industry . One can find a Diagnostic Lab in each and every nook and corner of any city by an unqualified person with just 3 months of Diploma in Medical Laboratory Technology ( DMLT ) certificate .
Dr Bhat further said that importing raw materials is another problem area due to customs clearance procedure . Now we need to get NOCs from three departments- Drug controller , Environment and Agriculture ( Animal Husbandry ). This will delay by about 5 to 7 additional days . “ We are also facing a major problem with the availability of proper standards for the manufacturing Industry , which are a must for the in-house validation of diagnostic products . Today , NIB provides standards for some of the critical care products . Hope the new Regulatory Authority will work on this ,” he added .