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RE-INVIGORATING INDIAN MEDICAL DEVICES INDUSTRY
The Indian Industry has
been demanding a separate regulator. Moreover, as Industry
feels that there is confusion about some definitions and
in respect of some other issues. What is your opinion on
the subject?
The government has already
notified the Medical Device Rules, 2017 which brings
clarity about the definitions that are globally
harmonized. Some work has also been done for enactment of
the new law. However, it could not be taken to a logical
conclusion. The idea to have a separate regulator for
medical devices has been floated from time to time. It is,
however, not necessarily a smart idea. No doubt, there is
a need for setting up of the specialized verticals for
regulating different kinds of medical products such as
medical devices, biological products, stem cells and other
emerging therapeutic options. Satyananda Mishra Committee
had in its Report submitted in June 2015 suggested
creation of six such verticals. This was, however,
thwarted by bureaucrats in the MoHFW who refused to
acknowledge that structures that are not headed by them
also need to be strengthened. Having said that, both
good-quality drugs and medical devices are integral
components of healthcare management, and there are a large
number of products that do not strictly fit in the binary
of either a medical device or a drug as explained in
answer to the previous question. Having a separate
regulator would result in many problems in coordination
and also intra-structural rivalry. Keeping this in view,
it would be sufficient if separate verticals with duly
qualified manpower in sufficient numbers are created in a
statutory and autonomous Medical Products Regulatory
Authority with harmonized coordination between verticals.
The Government of India
has acknowledged that the Medical Device Industry in India
suffers from a considerable cost of manufacturing
disability. And hence with a view to offset some part of
it, the GOI has launched the Production Linked Incentive
Scheme (PIL). However, the Industry is of the opinion that
the incentive is too less to ensure
any meaningful addition to capacity. What is your opinion?
I fully agree that the
current PLI schemes have come little too late and do not
necessarily take care of many aspects. However, it goes to
the credit of the government that it has, long last,
recognized that there is a potential opportunity and it
should be availed of. The very fact that the medical
devices sector had been identified as the focus sector
over six years back brings home the point that at the
level of the political executive, the intent is very
clear. The launch of PLI scheme and the scheme for medical
devices are the steps in furtherance of this recognition.
Unfortunately, it has not been possible to translate this
into actual delivery owing to insufficient engagement with
the stakeholders and failure to think big. The Country
needs to come out of the mindset of scarcity and move on
to thinking about abundance. Incrementalism and inward
thinking will never be able to catapult the country to the
top.
What is your opinion on
the importance of a synergy/harmonization of activities of
different agencies viz CDSCO, QCI, BIS etc. to ensure
quality of medical devices?
Standards provide a handy
tool with which an independent judgment regarding the
quality of medical products can be made. Stated
conversely, the measurement of quality is not feasible
without specifying standards and standards are meaningless
without the authority to enforce them. BIS is responsible
for the harmonious development of activities related to
standardization, marking and quality certification of
goods and for matters connected therewith. QCI on the
other hand is responsible for leading the nationwide
quality movement in all spheres of activities and develop
capacities at the level of Governments, Institutions and
enterprises for institutionalizing continuous quality
improvement and to develop, establish and operate National
Accreditation programmes. It is also mandated to build
capacities relating to regulation, conformity assessment
and accreditation as also for encouraging development and
application of third party assessment model for use in
government, regulators, organizations and society. The
synergy between the CDSCO, QCI and BIS in the
circumstances is critical for structured growth of medical
devices sector.
What role can the Industry
(Manufacturers and Suppliers) play to ensure safe,
reliable and affordable availability of medical devices
and hence healthcare delivery?
Manufacturers of medical
devices have to take all steps to ensure that the quality
of medical devices is not compromised and for this, it is
essential that each one of them ensure highest degree of
conformance with the quality specifications both in
respect of in-house manufacturing as well as outsourced
activities. The industry should, in partnership with the
government, explore newer markets and take steps for
scaling up the capacity, reduce cost and enhance
affordability. The industry also
should proactively engage with the government, the
regulators and take steps for global harmonization of
standards and practices to ensure that the ease of exports
can be maximized as the domestic demand will never ever be
able to generate sufficient scale for the made in India
products to be globally competitive. Given the inertia in
the governmental structures, it will be essential for the
industry to don the leading role.
Can you please show some
light on importance of Research, Development and
Innovation as important pillars of success of
“Make-In-India” and “Atmanirbhar Bharat “missions?
Leadership in the field of
R&D has to be a longer term goal for India. That will help
in enhancing the sustainability of the medical devices
industry. Make-In-India and Atmanirbhar Bharat should not
be construed to mean living in a cocoon or inward looking
policies. These have to be the vehicles to drive the
Indian medical device industry to cater for global
requirements. In the longer run, only the leadership in
the field of technology will make it possible. In the
short run, collaboration with other developed countries,
who are willing for it, needs to be leveraged..
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