February 2019 saw the release of two major policy documents, Budget 2019 and the CDSCO notification.
Budget 2019, was presented by Piyush Goyal, Union Finance Minister on February 1, 2019. The budgetary allocation for the health sector for the 2019-2020 was increased by 16 percent over last year, from Rs 52,800 crore to Rs 61,398 crore. The MedTech industry will be impacted by the Rs 250 crore allocated for setting up Ayushman Bharat Health and Wellness Centers under the National Urban Health Mission, and the Rs 1350.01 crore under the National Rural Health Mission; and the Rs 3599.65 crore for setting up various AIIMS in the country.
On February 8, 2019 after detailed discussions with industry bodies, on a phased, step-by-step roadmap, CDSCO, MoH&FW issued a notification announcing some additional devices for regulating sale and manufacture. The list included CT scan equipment, MRI equipment, defibrillators, dialysis machines, X-ray machines, and bone marrow cell separators. This turned out to be a random device list, defying all logic and rationale.
It had not taken into consideration whether import substitution by 2020 for this equipment is possible, if yes, would the segment be able to attract requisite capital, is 5 years enough time to build infrastructure and capability for test facilities for this equipment, and so many other relevant aspects.
Should there not be a hierarchy of standards to regulate categories of devices? Industry experts had recommended to either regulate in phases, by categories as non-ionizing diagnostic equipment, ionizing diagnostic equipment, medical electronics with power extrusion, medical electronic equipment with or without motors, consumables and disposables, with listed examples with common validation and testing needs. Alternatively, it could be by risk classification or devices being manufactured already in India, followed by items with less manufacturing capabilities, and then as where time to develop regulatory capacity and capability is required. To complicate further, multiple ministries for CDSCO, NPPA, BIS, and QCI need to be approached, for some regulatory clearance or the other.
Is it any wonder that the Rs 30,300 crore MedTech industry is feeling completely baffled?