Source: The post is based on the article “CDSCO falling short in effectively regulating the medical devices industry: Parliamentary panel” published in The Hindu on 15th September 2022.
What is the News?
The Parliamentary Standing Committee on Health has submitted a report titled “Medical Devices: Regulations and Control”.
What are the key highlights from the report?
Regulating Medical Devices Sector: Central Drugs Standard Control Organization(CDSCO) was set up to regulate pharma, related segments and medical devices. However, it is falling short in effectively regulating the medical devices industry.
Hence, new legislation should be enacted for setting up a new set of regulators at different levels for regulating the medical devices’ industry.
Medical Device Testing Laboratories: India has only 18 certified Medical Device Testing Laboratories that have been approved by CDSCO. This is grossly insufficient keeping in view the size of the country.
Feedback 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.
Training of officers: The Central Government 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.
Involve institutions for testing: Government should allow the new regulator to involve institutions such as IISC, CSIR, DRDO and a 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
Fast Track approval: A single window clearance for all the departments/Ministries should be set up. This 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.