Medical Devices: Regulations and Control


    In News

    • A recent Parliamentary panel Report stated that the Central Drugs Standard Control Organisation (CDSCO) was falling short in effectively regulating the medical devices industry.


    • 138th Report: This was the 138th Report on the subject “Medical Devices: Regulations and Control” submitted to Rajya Sabha.
    • Reason for ineffectiveness of CDSCO: The organisation in its existing structure and expertise is more pharma centric.

    Major Issues with Medical Devices

    • Few Medical Device Testing Laboratories: The country has only 18 certified Medical Device Testing Laboratories that have been approved by CDSCO and that is grossly insufficient keeping in view the size of the country. 
    • Underuse of Labs: The institutes which have high-tech labs are not being used and are not allowed to be used to test medical devices for their electronic, electromagnetic, biochemical-run aspects.
    • Absence of Research Ecosystem: Indian Medical Devices Industry presently lacks research ecosystem and infrastructure for manufacturing of high tech, advanced medical devices (Class C&D)
    • Low Standards: The Indian Medical Devices Industry doesn’t have facilities to produce such medical devices comparable to global standards. 
    • Over-Regulations: The multiplicity of regulations are creating chaos.

    Significance of Better Laboratories

    • Encourages Local Manufacturers: Having adequate common infrastructure including accredited laboratories in various regions of the country for standard testing would significantly encourage local manufacturers to get their products tested for standards.
    • Lower Cost of Production: The measures undertaken would also help in reducing the cost of production which ultimately will improve the availability and affordability of medical devices in the domestic market.

    Recommendations of Committee

    • Feedback Based Surveillance System: There is a dire need for developing a robust IT enabled feedback driven post market surveillance system for Medical Devices to evaluate the efficiency of specific Medical Devices.
    • Medical Device Registry: A medical device registry, particularly for implants, should also be made to ensure traceability of patients who have received the implant in order to assess the performance of the implant and to seek feedback on the functional capacity of medical devices. 
    • Imparting Skills: The Ministry should work in synergy with State governments and impart the necessary skills to the local medical device officers and also devise a mechanism to regularly designate State Medical personnel as Medical Device/Medical Device Testing Officers so that the mandate of the legislation can be implemented effectively. 
    • Easing Medical Device Regulations: The government should not afford regulation of medical devices by pharma experts and it’s time that at ground level the medical device regulations are dispensed with by qualified and well-trained Medical Device Officers to give a fillip to the Medical Device industry in the country.
    • New Network for Testing: The Ministry should allow the new regulator to involve institutions such as IISC, CSIR, DRDO and network of IITs to test medical devices for safety and efficacy. These institutes have high-tech labs and thus can be used to test medical devices for their electronic, electromagnetic, biochemical-run aspects. 
    • Single Window Clearing/Approval System: A single window clearance for all the Department/Ministries would significantly boost investment in R&D in the field of medical devices and would also reduce the time required for obtaining approvals from different Departments/Ministries. 
    • More Investments: Additional investments should be made to raise the standards of these labs as per the requirements.
    • Research Linked Incentive (RLI) Scheme: The Department should start a Research Linked Incentive (RLI) Scheme in Line with the PLI scheme. The Department should facilitate academia-industry partnership for undertaking research projects on industry challenges and incentivise successful outcomes.
    • Inculcating Culture of R&D: It advocated for invigorating a culture of research and development in medical devices in institutions such as IITs, NITs and other academic institutions.

    Central Drugs Standard Control Organization (CDSCO)

    • It is headed by the Drugs Controller General of India, under the Ministry of Health & Family Welfare. 
    • It is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
    • CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
    • Major functions of CDSCO:
      • Regulatory control over the import of drugs, 
      • Approval of new drugs and clinical trials, 
      • Meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), 
      • Approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters.

    Source: TH