New Delhi : The Central Drugs Standard Control Organisation (CDSCO) is reviewing a task force report submitted to the Drugs Controller General of India (DCGI) on laboratories for testing medical devices.
The need for appropriate infrastructure to test medical devices is one of the government’s top priorities as mentioned in the National Medical Devices Policy, 2023.
The department of pharmaceuticals (DoP) had formed the task force to survey the testing infrastructure for medical devices on the request of the department for promotion of industry and internal trade (DPIIT).
“DPIIT requested for a comprehensive review of all laboratories operating under concerned medical devices sector to ensure that necessary infrastructure & qualified human resource are available and applicable processes are followed diligently. Besides this, a review meeting was held in DoP on the measures to be taken towards strengthening testing infrastructure to enable smoother transition to licensing for medical devices,” said an official aware of the matter, requesting anonymity.
A task force on mapping the testing infrastructure for medical devices in India was constituted last year with a mandate to address the need for quality testing infrastructure for medical devices.
The task force studied the classification of medical devices by CDSCO via-a-vis the available BIS product standards and arrived at the list/category of MDs with different types of standards available and the kinds of tests and testing equipment required for different types of medical devices.
It also mapped the existing infrastructure available in public/private/institutional to test medical devices.
“The task force has submitted its interim report and examined by DoP. It has now been forwarded to the CDSCO for further action,” the official mentioned above said.
According to the DoP, the medical devices sector is a sunrise sector and growing at a fast clip. The market size of the medical devices sector in India was estimated at about ₹90,000 crore in 2020 and its share in the global medical devices market is estimated at 1.5%.
Queries sent to the DoP and the ministry of commerce for DPIIT’s comments remained unanswered.