Chinmaya IAS Academy – Current Affairs Chinmaya IAS Academy – Current Affairs
- Recently, important issues of Medical Technology (MedTech) Industry were taken-up at the first meeting of the reconstituted National Medical Device Promotion Council (NMDPC).
- Central Drugs Standards and Control Organisation (CDSCO) and the State Licensing Authorities (SLAs) provided updates for the smooth transition to licensing of Class A and B Medical Devices w.e.f 1st October 2022.
Medical devices under Medical Devices Rules, 2017are classified as:
- Class A (low risk): E.g., absorbent cotton balls, alcohol swabs.
- Class B (low moderate risk): E.g., thermometer, BP monitoring device.
- Class C (moderate high risk): E.g., implants.
- Class D (high risk): E.g., heart valves.
Concerns Highlighted:
- There is a regulatory burden of labelling requirements of Medical Devices.
- There are 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.
- Indian Medical Devices Industry presently lacks research ecosystem and infrastructure for manufacturing of high tech, advanced medical devices (Class C&D).
Key Recommendations made by the NMDPC
- There is a need to move forward to harmonize the provisions of labeling of Medical Devices under the Legal Metrology (Packaged Commodity) Rules, 2011 into Medical Device Rules, 2017, for licensed medical devices.
- The Medical Devices Industry Associations representatives were encouraged to actively engage with states, which were sanctioned Medical Devices Parks by the Department for creating common infrastructure facilities and come forward to invest in the proposed parks to boost domestic manufacturing.
- The industry’s support was also asked for the proposed National MedTech Expo, 2022 to showcase the strengths and capabilities of Indian Medical Devices Industry.
- An adequate common infrastructure including accredited laboratories in various regions of the country for standard testing should be in place.
- There must be a robust IT enabled feedback driven post-market surveillance system and medical device registry, particularly for implants to ensure traceability of patient who has received the implant in order to assess the performance of the implant.
- The Committee has recommended that the new legislation should set up a new set of regulators at different levels for regulating the medical devices industry.
- The Ministry of Chemicals and Fertilizers should allow the new regulator to involve institutions such as Indian Institute of Science (IISc), Council of Scientific and Industrial Research (CSIR), Defence Research and Development Organisation (DRDO) and network of Indian Institute of Technology (IITs) to test medical devices for safety and efficacy.
- Medical device regulations must be dispensed with by qualified and well-trained Medical Device Officers to give a boost to the Medical Device industry in the country.
NMDPC
- National Medical Device Promotion Council (NMDPC) is chaired by the Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers.
- It has members from stakeholder departments/ organizations, functions of which have a bearing on the growth of the sector.
- Also, it has representation from several medical device industry associations, representing the sector in India.
- NMDPC, going forward, is expected to become a vibrant forum for all issues relating to the medical devices sector, which is a sunrise sector with huge potential for social obligations and the economic aspirations of India.
SOURCE: THE HINDU,THE ECONOMIC TIMES,MINT
