The Central Drugs Standard Control Organisation (CDSCO) is presently regulating 28 categories of notified medical devices under the provisions of the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017, said Minister of State for Health Ashwini Choubey in a written reply.
Further, in order to regulate all medical devices, the health ministry has issued a notification dated February 11, defining medical devices and specifying mechanism for regulation of all non-notified medical devices in a phased manner to ensure quality, safety and performance of these devices, he said.
Asked if the government has set up a roadmap for India’s self-reliance in medical equipment, medical devices and medical lab kit sector, the minister said various schemes have been formulated to promote domestic manufacturing of medical devices/equipments and attract large investment in the sector.
Such schemes/initiatives are the National Biopharma Mission, DBT-AMTZ COMManD (COVID-19 Medtech Manufacturing Development) Consortia launched by the Department of Biotechnology with Andhra Pradesh Med-tech Zone (AMTZ), Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices and Scheme for Promotion of Medical Devices Parks.
A scheme called ‘Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices’ has been approved by the Centre with a total financial outlay of Rs 3,420 crore.
Another scheme ‘Promotion of Medical Device Parks’ has also been approved by the government with a financial outlay of Rs 400 crore. The National Biopharma Mission, with an outlay of Rs 148.79 crore is meant for establishment of infrastructure and facilities for manufacturing and testing of medical devices. Nine such facilities have been funded and Rs 105.42 crore have been utilized, he added.