Existing infra for testing medical devices inadequate: Parliamentary panel

The report presented in the Parliament by a standing committee stated that along with more testing labs, the country needs a robust IT-enabled and feedback-driven post-sales surveillance system

The Central Drugs Standard Control Organisation (CDSCO) is falling short in regulating the medical devices industry, and more medical device testing laboratories need to be set up, a report presented in the Parliament by the Standing Committee on Health stated. The committee was headed by Ram Gopal Yadav, a member of Parliament, as reported by The Hindu.

 

The "Medical Devices: Regulations and Control" report stated that along with more testing labs, the country needs a robust IT-enabled and feedback-driven post-sales surveillance system, The Hindu report added. 

 

The surveillance of medical devices, including implants, will help regulators to keep track of their performance. Currently, India has only 18 such regulators approved by CDSCO. 

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The committee's report focused on the fact that India lacks the research ecosystem to develop medical devices as per global standards. Also, it recommended the government start a Research Linked Incentive (RLI) scheme similar to the Production Linked Incentive (PLI) scheme to facilitate the academia-industry partnership.

 

It said that the Health Ministry must allow the regulators to include IISC, CSIR, DRDO and IITs to test the medical devices to meet the growing demand. Moreover, other institutes should be developed to enable the testing of medical devices. 

 

The need to remove the multiple regulations and set up a single window clearance platform for the application of the license for manufacturing as well as trading of these devices was also discussed in the report. 

 

"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. The Ministry must incorporate such an all-encompassing 'single window clearing/approval system' in the proposed new separate Act for the regulation of Medical Devices," the report added.