Indian Medical Device Industry and Related Regulations Rajiv Nath , President , AISNMA
.. INDIA TO BE AMONG THE TOP 5 PREFFERED SOURCES IN EACH PRODUCT FAMILY OF MEDICAL DEVICES .. INDIAN MEDICAL DEVICE REGULATORY AUTHORITY , A CENTRE FOR EXCELLENCE ASSISTING THE MEDICAL DEVICE INDUSTRY TO PRODUCE PRODUCTS WITH ADEQUATE AND APPROPRIATE CONTROLS AND SYSTEMS FOR ENSURING PATIENT SAFETY AHWP 2008 2
.. Accountable to the Public through a Regulator .. Well run & managed .. Meet the legal obligations .. Delivery of Affordable low cost products AHWP 2008 3
.. Work with Industry in transparent manner .. Supervise Directly / Through Accredited agencies .. Aim to promote public trust in Indian Industry .. Provide Guidance & Advice .. to meet legal obligations .. safety of consumers .. Facilitate the Growth of Industry .. Facilitate Introduction of Innovative & Emerging Technologies AHWP 2008 4
.. 18-20 Medical Devices under Drugs & Cosmetics Act 1940 .. Treatment similar to Drugs/Medicines .. Controlled & Inspected by .. Drug Controller General India/CDSCO .. State Drug Controller .. Central/ State Laboratories .. License Raj ,undergoing review .. Limited Knowledge/Competencies .. Inspections, not standardized audits .. Lack of acceptance of Risk based Assessment .. New products/Technologies Non existent product Standards AHWP 2008 5
.. Majority Exporting units comply with ISO13485 and Certificate/Registration with GHTF countries .. Moving up the Value Chain .. Moving up the Quality & Technology Ladder .. Top 5 Preferred Source Status achieved in: 1) Syringes 2) Needles 3) I.V. Cannulas /Catheters 4) Contraceptives 5) Surgical Blades 6) Gloves AHWP 2008 6
Strengths Cost Competitiveness, Mass production , Economies of scale , Trainable large Labor Pool ,Technology Access no conflicting national interest . Strong in Mechanical ,Software ,Biotechnology Engineering Respect for System & Document compliance . Weakness Low R&D base, Reliance on High Cost imported inputs . High Cost Multiple Taxes . Limited products regulated .Quality perception low- middle end. Opportunity Value for money competitiveness, high growth sales in global markets. Threat Regulations limiting market access if used as Protectionist Non Tariff Barrier AHWP 2008 7
Strengths Reliance on Factory Inspections for domestic producers Access to pool of inspectors well versed with GMP w.r.t Pharmaceutical Industry, Strong legal framework Weakness Limited/no knowledge of diverse nature of manufacturing technologies Limited knowledge of regulating non sterile medical devices Regulatory framework not developed , structured for medical devices Lack of accredited Testing facilities for product conformity verification No inspections for overseas manufacturers , lacks transparency & guidance Opportunities Up gradation of Regulatory framework on GHTF guidelines Facilitate Respect & Growth Of Indian industry Threats Devices from Non Regulated manufacturer may harm patients Non Recognition by overseas regulators AHWP 2008 8
.. Upgrade: .. manufacturing & testing facilities .. management competencies .. quality management systems .. Get ISO 13485 certification from internationally accredited organizations .. Get registration and certification from a GHTF member country .. Self regulation/Dialog with MOH to assist in building regulatory framework AHWP 2008 9
.. Improve transparency & dialog .. Involve Industry in creating a mutually acceptable Regulatory Framework & Infrastructure. .. Ensure timely response to guidance/ advice sought on clarifications of compliances .. Constitute expert committees on various aspects .. Define milestones for phased creation of a regulatory infrastructure & implementation .. Recognize risk based classification of devices and need for variation in regulatory controls , premarket registration & approvals proportionate to these risks. .. Delegate supervision of conformity assessment to internationally accredited organizations with proven competencies AHWP 2008 10
.. Regulations to provide non ambiguous legal requirements & guidance on best practices .. Reliance on preventing problems .. Evaluation of Risk & Hazard by MDR for suitable corrective & preventive action (CAPA) .. Reasonable time for addressing issues and implementing CAPA .. Regulator to have powers for putting things right .. Minimal/No reliance of judiciary and legal criminal action on registered units .. Reliance of Judiciary/ Police and criminal action only on non registered units. AHWP 2008 11
.. Lack of trust and dialog .. Lack of time bound response to queries .. Reliance on Tests , inspections, arbitrary controls .. Draconian punitive action .. Unreasonable expectations .. Lack of clarity of superseded rules/requirements and standards .. Conformity assessment organizations acting as consultants / trainers to same assesses AHWP 2008 12
Thank You! Lets Work in Partnership to achieve The Millennium Development Goals 13AHWP 2008 Thank You! Lets Work in Partnership to achieveLets Work in Partnership to achieve The Millennium Development GoalsThe Millennium Development Goals 13AHWP 2008
Copyrights 2009. Association of Indian Medical Device Industry.
