NEW DELHI: A central government directive to states to prefer indigenously manufactured medical devices for public procurement is meeting stiff resistance from even Indian device manufacturers. The manufacturers have written to the Union Ministry of Health and Family Welfare saying that such a direction may end up restricting competition rather than creating a level-playing field.
In a statement, the Medical Technology Association of India said that the timing of the directive, issued this month, is surprising as the industry is actively discussing the means to streamline public procurement of medical devices without disturbing the demand-supply equation. "It is noteworthy that more than 70 per cent of the demand for medical devices is being met by global companies with a large footprint of investment in manufacturing, R&D and training of healthcare workers in India," said the statement.
These companies operate in multiple countries and therefore adhere to international standards such as USFDA or CE that are recognised in India as well as all other nations — MTaI also said that recent directive seems to have ignored these facts in asking states to prefer Indian drug regulatory certification for public procurement.
"The definition of local content in public procurement tenders needs to be reworked," said MTaI chairman and director-general Pavan Choudary. Choudary said that the directive limits the export potential of Indian companies by allowing them to conform to Indian certification alone because USFDA and CE are considered as the standard for procurement globally.
In 2018, the Central government had issued draft guidelines for public procurement, stipulating that medical devices should have a minimum local content of 25-50 per cent to qualify for public procurement.
At that time, MTaI had uniform requirement of 25-50 per cent local content without considering the missing ecosystem for manufacturing sophisticated medical devices and equipment will create a risk of ‘garage manufacturing’ with low cost low-quality Chinese knocked-down kits based assembly.
Still behind on some grounds
At present, India has adequate manufacturing capabilities for products like syringes, cannulae, stop cocks etc, but lacks the capability to produce devices like heart lung machines and pacemakers.