Indian Medical Device Sector - Blue Print & Regulatory Policy Roadmap

Suchita et al.International Journal of Drug Regulatory Affairs. 2020; 8(2): 25-35healthcare institutes under GoI, setting-up andoperationalization of Andhra Pradesh Medtech Zone(AMTZ) medical devices park in Andhra Pradesh andestablishment of Kalam Institute of HealthcareTechnology (KIHT) to accelerate indigenouslydeveloped technologies and Government‟s decision tohave more IITs for speeding up research in the country.(9,10)together with State / Central Health Corporations andProcurement Agencies, as such delays may not onlydampen the spirits of Make-in-India but also land thesemanufacturers into bankruptcy.Infrastructure creation3. Key Policy initiatives by the Government of IndiaThe Union cabinet on 21st March 2020 has approveda scheme on promotion of medical device parks forfinancing common infrastructure facilities in fourmedical device parks with financial implications of Rs400 crore, and approved the Production Linked Incentive(PLI) scheme for promoting domestic manufacturing ofmedical devices with financial implications of Rs 3,420crore," it said. Under the sub-scheme for promotion ofmedical device parks, common infrastructure facilitieswould be created in four medical device parks, which isexpected to reduce manufacturing cost of medicaldevices in the country. "The PLI scheme for promotingdomestic manufacturing of medical devices would boostdomestic manufacturing and attract large investments inthe medical device sector, particularly in the identifiedtarget segments. It will lead to expected incrementalproduction of Rs 68,437 crore over a period of fiveyears".Envisaged EcosystemIntellectual Property & Skill buildingTo deliberate on some of the challenges faced by theIndustry, Department of Pharmaceuticals, Ministry ofChemicals and Fertilizers, Government of India (GoI)constituted a specialized Task Force. The task forceelucidated a set of recommendations for boosting growthof MDI in India in its report on 8th of April 2015 (Figure6). (4) The Government envisaged addressing some ofthese issues to create enabling ecosystem for medicaldevice development in the country. Some of thecomponents of the envisaged ecosystem with key policyinitiatives are given below:The policy envisages the support of Indian PatentOffice for transfer/operationalization of IntellectualProperty, for facilitating voluntary technology uptakeand up-gradations through established commercialmodels creating enabling protective measures to protectoutright purchase of patents from research institutionsand start-ups based in India. For assisting productdevelopment and regulatory compliances, there is a needfor developing capabilities in testing of medical devicesin the country. The existing laboratories need to beupgraded and accredited while ensuring low cost testingfor doing research on IVD with tested blood samples.Laboratories in certain Universities with bio technologycourses can be encouraged to provide antigens andantibodies and sero-conversion panels to IVD industrywhich currently depends totally on imports. Workingwith stakeholders such as National Skill DevelopmentAgency (NSDA) for promotion of occupational andvocations standards for training of engineeringworkforce for medical devices industry will also behelpful and should be suitably pursued. (4)Some of the areas however are still unattended to, andrequire more concentrated and comprehensive approach.While many of these steps have been comprehensiveefforts from various Government of India (GoI)Ministries and Departments including from Ministry ofHealth & Family Welfare; Ministry of Science andTechnology, Department of Biotechnology, Ministry ofCommerce & Industry and Quality Council of India;Department of Pharmaceuticals, NITI Aayog andMinistry of Electronics, however, a need for centralinformation pooling and coordination mechanism hasbeen felt by the Government and the Medical deviceindustry, however, it is yet to take-off through suitablepolicies.Coordinating & Facilitating AgencyTo promote indigenous manufacturing of qualitymedical devices and attract investments in the sector, thegovernment has set up a facilitation body called the“National Medical Devices Promotion Council(NMDPC)”. Created under the aegis of Department forPromotion of Industry and Internal Trade (DPIIT),Ministry of Commerce and Industry, Government ofIndia and with its technical secretariat at the AndhraPradesh MedTech Zone (AMTZ) it has been providingnecessary facilitation and coordination to variousdepartments and ministries for promotion anddevelopment of the Indian Medical Devices Industry.Some broad activities undertaken by the council includespolicy facilitation, strategic forums (to discuss ssemination of International Norms, Industry Support(Manufacturing, Regulatory Challenges, etc.) andMarket Access. It has been playing an instrumental roleto urge Public Procurement Agencies (both from Stateand Central Govt.) to adhere to transparent procurementnorms as per the DPIIT‟s Public Procurement Order2017. Additionally, NMDPC has advised thegovernment to clear payments of manufacturers orsuppliers, especially those which are stuck for yearse-ISSN: 2321-6794A huge demand for certified & skilled manpower toserve the healthcare industry e.g., to export medicalequipment to other countries like USA or Europe and toinstall high end equipment Indian biomedical engineersneed licences or certification which is recognized inrespective country. To address this, AMTZ inpartnership with AiMeD and QCI created IBSC. It waslaunched during February 2018 in an event hosted by theDepartment of Pharmaceuticals at Bengaluru. IBSCdeveloped an institutional mechanism for having aregistry for more than the two lakh BiomedicalEngineers in the country. IBSC is deemed as aGovernment of India Sector specific Skill Council tocertify clinical & biomedical engineers across hospitals,manufacturing units, R & D etc. Reputed academicinstitutions and organizations has partnered with IBSC.[29]

Suchita et al.International Journal of Drug Regulatory Affairs. 2020; 8(2): 25-35IBSC has also signed the MoU with Association for theAdvancement of Medical Instrumentation (AAMI),USA, were certified candidates will have equalopportunities to practice biomedical profession globally.In addition to the skill certification, IBSC designed &developed five qualification packs and these skillprograms were approved by National Skill QualificationCommittee (NSQC) and listed in National SkillQualification Frame Work (NSQF) under Ministry ofSkill Development and Entrepreneurship (MSDE).manufacturing, knowledge sharing platforms, and otherevents for quality promotion of medical devicesmanufacturing sector. There is also a need for creatinggeneral awareness on medical devices safety, standardsand facilitate sharing of all such relevant informationwith general public, medical professionals, all otherstake holders and setting-up of medical device rdization. The Government may also considerselection and designation of “Centers of Excellence” ent and improving their access to medicaldevice industry and establishing technical and financialframeworks for such initiatives. The Indian Medicaldevice industry also urges the Government to promoteregulatory standards, standards of Bureau of IndianStandards (BIS), any voluntary standards as adopted bythe medical device industry in India for buildingconfidence and credibility to this industry sector. (4)Quality PromotionGiven that quality of product has implications ontheir acceptability and applicability and therefore a directbearing on their markets, policy impetus is required forfacilitation and promotion of industry specific qualitystandards and benchmarks in consonance with nationaland international best practices, creation and/or adoptionof medical device industry specific manufacturingstandards and best practices, technology upgrades inFigure 6. The envisioned ecosystem of DoP, Government of India (4)device companies showing keen interest of investors inthis sector. (10)4. Key Policy Interventions by the Government ofIndia to boost Medical Device Sector-The Journey sofar5. Key Achievements-Central Drugs StandardsControl Organisation (CDSCO)To foster foreign investments in the medical devicesector in the country, in January 2015, The Governmentmodified the FDI regulations allowing 100 per cent FDIunder automatic route in Greenfield and brownfieldprojects in this sector.With the release of the MDR17, to expediteexamination and increase transparency in evaluation ofapplications, the application process at the CDSCO hasbeen made online through the Sugam Portal. New onlinesystem for medical devices is now functional foruploading the applications for Import licensing andManufacturing license of Medical devices and IVDs forpost approval changes, registration of medical devicetesting laboratories, clinical investigation etc. The keyregulator, CDSCO in consultation with the medicaldevice expert group has finalised the classification ofMedical Devices and IVDs which can be reviewed andThe sector has received an investment of USD 505 mnfrom 27 M&A transactions and around 43 venturecapital/ private equity investments in the last five years.The sector has witnessed around 7 inbound, 8 outboundand 13 domestic mergers and acquisitions tractions in thelast five years (2011-2016). In this period only, around 9angel/ seed funding deals were also witnessed in medicale-ISSN: 2321-6794[30]

Suchita et al.International Journal of Drug Regulatory Affairs. 2020; 8(2): 25-35accessed by the medical device industry stakeholdersthrough the CDSCO website. The new online system forMedical devices is now functional for the registration ofNotified bodies also. Six notified bodies have beenregistered for assisting CDSCO for ensuring regulatorycompliance. Grouping of Medical Devices and IVDsalong with essential principle checklist has beenfinalized in consultation with the stakeholders which hasbeen made available by CDSCO for ease of adoption bythe medical device industry. (11)Figure 7. FDI Trends inMedical Device Sector in IndiaTo address the skill and testing infrastructure gap in thissector, notifications for manpower recruitment includingMedical device officers and Medical Device testinglaboratories have been published and CDSCO envisagesrecruiting a number of officers for implementing medicaldevice regulations. For addressing various questions onregulatory practices in medical devices, FrequentlyAsked Questions (FAQ) on medical devices and in vitrodiagnostics (IVDs) have been prepared and are availableonline for reference and adoption of the MDR17.Specific guidance documents on performance evaluationof in-vitro diagnostic medical devices have also beenprepared and made available for use by the industry.Guidance document for stability study and postmarketing surveillance of IVDs has also been preparedand shared with the stakeholders for their comments. Asa proactive approach, CDSCO has also set-up a PublicRelation Office which is acting as a single window toguide, assist and provide information to the innovatorsregarding regulatory requirements. CDSCO has alsolaunched support cells for WHO Performance, Qualityand Safety (PQS) process for IVDs to provide guidanceto the Indian manufacturers for achieving WHO Prequalification of In-Vitro Diagnostics programme inIndia. (11)To monitor Medical Device-associated Adverse Events(MDAE), to create awareness among healthcareprofessionals about the importance of MDAE reportingand generate independent credible evidence-based safetydata of medical devices, a Materio-vigilance programwas successfully launched by the Government on 6th July2015 at Indian Pharmacopoeia Commission, Ghaziabad.Sree Chitra Tirunal Institute for Medical Sciences &Technology (SCTIMST), Thiruvananthapuram acts asNational collaborating centre fo implementation of thisprogram. National Health System Resource Centre(NHSRC), New Delhi, acts as Technical support partnerto the CDSCO in successfully implementing thisprogramme. (11)Policy support sought by the Medical device IndustryIncentivizing quality products from India, givingpreference to locally manufactured products andimplementation of a robust and dynamic „PreferentialMarket Access Policy‟ is the key to boost indigenousmanufacturing, as per the Government of India‟s PublicProcurement Order 2017, which is quintessential toachieve Make-in-India. The public procurement orderprescribes the following percentages of minimum localcontent for various categories of medical devices and forpreference in public procurement:Table 1 Medical Device, their Current and Envisaged Local ContentCategory of Medical DevicesMedical disposables and consumablesMedical electronics, hospitalequipment, surgical instrumentsImplantsDiagnostic ReagentsMinimum Local Content50%25%40%25%Also, accordingly the Department of Pharmaceuticals(DoP) is the Nodal Agency for carrying out strategicmarket access programs with the support of NationalMedical Devices Promotion Council.e-ISSN: 2321-6794Local content to be increased in phasedmanner over next 3 yrs50% to 70%25% to 45%40% to 60%25% to 45%The Indian Medical device Industry urges the GoI toconsider introducing policies in line with ufacturing through Preferential Market Access. The[31]

Suchita et al.International Journal of Drug Regulatory Affairs. 2020; 8(2): 25-35Public Purchase Order for Preferential Market Accesswith GFR 153 and WTO / GATT Compliant PreferentialPricing (e.g. as per World Bank Terms) may bebenchmarked for suitable inclusions in Indian PublicHealthcare Tenders.are some of the interventions expected and needed by themedical device industry. (12) To ensure patient safety,there is also a need for policies imposing restriction onimport of pre-owned medical equipments until India hasa robust regulatory framework to ensure patient safetyand calibration. (12)The Indian Medical device industry envisages that thepublic healthcare system needs to move from lowestprice basis to UN system of Sustainable supply chainbasis and penalize suppliers with a poor track record ofservice and delivery and reward those with provenservices as well provide opportunity to new entrants andstartups.6. Regulations to ensure Patient Safety & ConsumerProtection:The Indian Medical Device industry seekscomprehensive regulation of medical devices and apredictable policy regime. The industry looks forward tosuitable policies to ensure patient safety and buildcompetence and competitiveness whereby Governmentshould incentivize voluntary Indian Certification forMedical Devices by QCI (Quality Council of India) andexpedite legislation for Regulation of all MedicalDevices outside the ambit of the Drugs & Cosmetics Actat one go with a defined transition period for enablingcapacity building for the manufacturers and regulators.(12)Suitable policies should also be drafted by theGovernment for promoting activities supportingtechnology transfers, increase in market access andcommercialization of innovations. There is a need forapplication of international best practices in evidencebased industry promotion strategies includingmanufacturing incentives such as interest subsidies,concessional power tariffs, provision of seed capitaland/or viability gap funding. To boost the indigenousMake in India for medical device sector, the Governmentmay consider providing tax liberalization measuresincluding but not limited to - higher weighted taxdeduction on approved expenditure on R & D to cater tohigh gestation period; extension of R&D tax benefits tolimited liability partnerships; tax and regulatory/non taxbarriers on import of pre-owned medical devices,wherever found necessary/applicable; incentivizingexport of medical devices; and formulating guidelinesfor mergers and acquisition in this sector to protect theinterest of medical devices industry. (12)The Government should consider necessity to unbundleregulations and create a regulatory framework consistingof a revamped and more competent Indian HealthcareProducts Regulatory Authority with separate divisionsfor Medical Devices or an independent NationalRegulatory Authority to regulate the registeredmanufacturing or subcontracting sites in India orglobally and the Market Access Authorization Holder(MAAH) whether it‟s a manufacturer, importer, agent ora marketing company. With the assistance of 3rd itation Board for Certification Bodies (NABCB),the medical device companies should be able to get thenecessary compliances. The State regulators may bemandated to regulate all the domestic resellers whetherwholesale, dealer, retailer or healthcare provider (Figure8). (12)Other policy interventions may include drafting aplanned and predictable tariff policy to enable businessviability to make investment in this sector attractive andprovide protection in a phased manner. (12) To providefurther impetus to this sector, the GoI may considerincreasing the basic import tariff from 0-7.5% to 15% forMedical devices and duty on components to be 7.5% as aMake in India enabler. Concessional duty on medicalgrade raw materials may be retained at 2.5% for now, fornext few years. Industry also needs a supportive clinicalenvironment for clinically validating the safety of theirproducts. Policy to encourage government hospitals &medical colleges that would partner with domesticmanufacturers in clinical evaluation as per regulatoryrequirements and HTA (Health technology assessment)studies with reasonable charges, publication of studies ofclinical outcomes as incentive to healthcare professionalsTable 2 Risk based classification of Medical Devicese-ISSN: 2321-6794Central Drugs Standard Control Organization (CDSCO)is responsible for regulating the registration and sale ofnotified medical devices in India. Indian medical devicesmarket regulators have distributed another draft list ofmedical devices which explains how they are classifiedby the Medical devices rules 2017. CDSCO headed byDrug Controller General of India (DCGI) classifiesmedical devices into four classes (A, B, C, and D) as perthe regulation.[32]

Suchita et al.International Journal of Drug Regulatory Affairs. 2020; 8(2): 25-35To bring credibility to the Indian Medical Devicesthrough regulations, the medical device industryproposes to have a system of Voluntary compliancebacked by 3rd Party ICMED Certification from QCI to beconsidered as a compliance option with reducedoversight enabling Ease of Doing business. There is aneed for policy to financially support all manufacturersto attain

Figure 2: Category-wise Import Summary of Medical devices (2018-19)7,8 Figure 2. Category-wise Import Summary of Medical devices (2018-19) (7,8) Figure 3. Year-wise status of imports in India for medical devices from top 5 countries (7,8) There are six (6) broad categories of medical devices which are imported in India including Surgical