The Central Drugs Standard Control Organization (CDSCO) is currently in the process of reviewing a comprehensive report submitted by a task force to the Drugs Controller General of India (DCGI). This report holds significant implications for the enhancement of laboratories engaged in the testing of medical devices.
Government's Emphasis on Quality Infrastructure for Medical Device Testing
As outlined in the National Medical Devices Policy of 2023, ensuring robust infrastructure for the testing of medical devices stands as a top priority for the government. Recognizing the critical need for accurate testing processes, CDSCO’s engagement with this task force report is a crucial step.
Task Force Formation and Objective
The Department of Pharmaceuticals (DoP) established a task force in response to a request from the Department for Promotion of Industry and Internal Trade (DPIIT). This task force was mandated to conduct a comprehensive survey of laboratories involved in medical device testing, focusing on infrastructure availability and human resource qualifications
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Strengthening Testing Infrastructure: A Dual Agenda
To align with the National Medical Devices Policy’s objectives, the DoP convened discussions on strategies to reinforce testing infrastructure. This initiative seeks to ensure a seamless transition towards medical device licensing by promoting the availability of appropriate infrastructure and skilled personnel.
Mapping India's Medical Device Testing Infrastructure
In the past year, a task force was set up to map the landscape of medical device testing infrastructure across India. This proactive approach was designed to address the pressing need for standardized and high-quality testing facilities.
Aligning Standards and Requirements
One of the task force’s key actions was to evaluate CDSCO’s classification of medical devices alongside the Bureau of Indian Standards (BIS) product standards. This alignment allowed the identification of specific standards and testing procedures required for diverse categories of medical devices.
Surveying Existing Infrastructure
The task force undertook a comprehensive survey to identify testing facilities available in public, private, and institutional sectors. This survey aimed to evaluate the adequacy of existing infrastructure in meeting the demands of medical device testing.
Task Force's Progress: Interim Report Submission
Having compiled their findings, the task force submitted an interim report, which was subsequently examined by the DoP. The report is now under the purview of CDSCO for further action.
Medical Device Sector: A Growing Opportunity
According to the DoP’s assessment, the medical devices sector is rapidly expanding and holds substantial potential. With an estimated market size of ₹90,000 crore in 2020, the Indian medical devices market contributes around 1.5% to the global medical devices market.
Awaiting Official Comments
Inquiries directed to the DoP and the Ministry of Commerce, seeking comments from DPIIT, are currently pending responses.
In conclusion, CDSCO’s engagement with the task force report underscores the government’s dedication to establishing a robust and standardized medical device testing infrastructure. This proactive approach aligns with the dynamic growth of the medical devices sector in India and its global significance.
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