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Domestic MedTech Industry
Upbeat About New Procurement Policy That Feverous
Manufacturers With Domestic Content
The Department of
Pharmaceuticals (DoP) move gives priority to bidders of
government contracts that use more local content. Around
1500 manufacturers who make medical devices in India and
sell to public healthcare agencies are beneficiaries of
the new procurement policy.
Domestic medical device
manufacturers have hailed the new healthcare procurement
policy introduced on October 29, 2021 by the Department of
Pharmaceuticals (DoP) that gives preference to
manufacturers with over 50% domestic content in the
product.
DoP move gives priority to
bidders of government contracts that use more local
content. The revised order has introduced a concept of
Class-I, II and non-local suppliers, based on which they
will get preference in government purchases of goods and
services.
“Around 1500 manufacturers
who make medical devices in India and sell to public
healthcare agencies are beneficiaries of the new
procurement policy. The total public healthcare market for
medical devices is estimated to be over Rs 30000 Crore. Rs
110,000 Crore (15 Billion $) is the market size estimated
for India. The Indian industry’s market share of public
healthcare is estimated at 20 % to 25%,” according to the
Association of Indian Medical Device Industry (AiMeD).
Rajiv Nath, Forum
Coordinator, AiMed further explains, “The new policy
changes of giving preference to Quality over L1 (lowest
bid prices) is especially of strategic impact for
healthcare products where quality is very critical to
users. The market was 80% to 90% import dependent but with
the stated preference to make in India
products, the market share of domestic
manufacturers in public healthcare can now go up from 20%
to 30% to around 40% to 50%. This will encourage more
foreign investment by overseas manufacturers who will seek
to protect their existing market share in India.”
This had been a long standing
request to the Government of India to move from L1 (lowest
price) procurement to Q1 (quality preferred) or R1 (rating
preferred- rating based on service, quality and price
performance).
He further added that the
market share can improve if public healthcare procurement
preference is also considered for Design India
certification to encourage homegrown innovation and R&D in
India.
Class-I local suppliers will
get the most preference in all government purchases
because their domestic value local content addition is 50%
or more. They will be followed by Class-II suppliers,
whose local content value addition range is more than 20%
but less than 50%.
For verification of local
content, the Class I and II suppliers shall be required to
indicate percentage of local content and provide
self-certification that the item offered meets the local
content requirement norms.
The Concept of Class-I
supplier has been introduced so that in cases where local
suppliers are to be given the order, even within that
group one should give first preference to the ones whose
domestic value addition is significantly high.
Under the revised public
procurement guidelines, it is envisaged that all Central
Government departments, their attached or subordinate
offices and autonomous bodies controlled by the Government
of India should ensure that purchase preference will be
given to domestic suppliers.
https://www.financialexpress.com/healthcare/medicaldevices/domestic-medtech-industry-upbeat-about-new-procurementpolicy-that-favours-manufacturers-with-domesticcontent/2371701/
DoP Releases
Draft Policy To Catalyse R&D And Innovation In
Pharma-MedTech Sector
The Department of
Pharmaceuticals (DoP) has come out with a draft policy to
catalyse research and development (R&D) and innovation in
pharmaceutical and medical devices sectors in India.
The draft policy aims to
encourage R&D in Pharma-MedTech sector, and promoting
innovation for India to become a leader in drug discovery
and innovative medical devices through incubating an
entrepreneurial environment. The department has invited
comments from the stakeholders by November 6, 2021.
The policy has a ten-year
perspective, and will be implemented through an Action
Plan defining roles, responsibilities, activities, targets
and timelines. The Action Plan will be broken down to five
year and annual activities for ease of implementation. A
Highlevel Task Force will be set up in the DoP to guide
and review the implementation of the policy.
The policy focuses on simplifying regulatory processes to
enable rapid drug discovery and development and innovation
in medical devices; exploring mechanisms to incentivise
private sector investment in research and evaluate various
funding mechanisms including budgetary support, venture
capital, CSR funding etc., and fiscal incentives to
support innovation; and strengthening the R&D ecosystem
through increased collaboration between industry and
academia in order to develop mechanisms to dovetail
research as per requirement of the industry.
On the regulatory front,
which is currently geared towards assuring safety and
efficacy and not differentiate in favour of innovation,
the policy contemplates to create a regulatory bias in
favour of innovation and original research by mandating
all regulators (as there are several regulators and
agencies involved in the approval processes) to work
together to reduce process overlapping and establish
timelines for requisite approvals.
A Common Specific Procedure
Pathway (CSPP) will be provided for each class of product,
including checklists, prescribed timelines, parallel
processing, joint inspections, automatic and deemed
approvals and sharing of data across regulators. The aim
is to bring down the time taken for regulator approvals
for innovative products by at least 50 per cent within the
next two years.
It also proposes to create a
single end-to-end digital portal as a single window to be
hosted by Central Drugs Standard Control Organisation (CDSCO)
as an interface between innovator and regulator.
Artificial Intelligence and natural language processing
will be used to automate dossier review and document
management workflows.
The capacity of CDSCO will be
strengthened by setting up project management roles to
provide dedicated support to the industry innovators,
including building in-house expertise in bio
pharmaceuticals and high end medical devices,
specialisation to be created or in-sources to handle
oversight of regulatory functions in respect of new
biological entities and new chemical entities, biological,
imaging medical technologies, new materials, tele-diagnostics,
AI, machine learning based innovations, sensors etc.
National Pharmaceutical Pricing Authority (NPPA) will be
supported to develop greater expertise in pricing of new
innovative products, while pursuing affordability as an
overall objective.
The government would
undertake a review of the multiple legislation’s impacting
R&D in pharma and medical devices sectors with a view to
remove inconsistencies and redundancies. This could
include measures such as exemption of products that are
cultured and cultivated artificially under controlled
conditions and not impacting natural resources from the
Biological Diversity Act, review Drug Price Control Order
2013 to enable differential pricing for innovation with
therapeutic benefits, among others. Institutional bodies
need to be empowered for approving preclinical protocols,
making Institutional Animal Ethics Committee (IAEC) to be
on par with Institutional Biosafety Committee (IBSC) to
permit regulatory approvals for pre-clinical activities.
It also proposes to enable joint inspection by CDSCO and
State drug authority, to be conducted only once, in
parallel, in case of vaccines and biological for a
particular class of product, for marketing
authorisation.It also proposes to review the legislation
enabling regulation of all medical devices in a phased
manner with a lead time of 12 months to manufacture each
category of medical devices. It also advises measures to
create dedicated licensing provisions for Ayurveda, Siddha
and Unani drugs and explore providing Ayurveda WHO
licensing authority to have the power to issue WHO GMP
certificate.
The second focus area of the
policy, on funding of innovation and incentivising
investment, the DoP kept the provisions open for
stakeholder’s consultations before adding to the draft.
Regarding the third focus area in the policy, which is
enabling an ecosystem for innovation, the policy proposes
to strengthen industry-academia linkages by strengthening
academic infrastructure and integrating it into a coherent
framework for building skilled manpower for the industry.
Modernisation and strengthening of curriculum with future
ready technology like AI, Biologics, continuous flow
technology and others, institutionalising industry
representation in NIPERs and providing varying degree of
financial and managerial involvement, integrating pharma
education at graduate, post graduate and doctoral levels
under NIPERS and enhancing expertise in biopharma
education, attract Global educational Institutions of
eminence to create centres in India, purposeful
investments n few priority institutes to build Centres of
Excellence on med-tech innovation and R&D.
The draft policy also
proposes collaboration across research and educational
institutions and sectors, setting up of an Inter-
Departmental Research Council on Pharma, creation of a
dedicated innovation hub etc.
The Action Plan will list
activities in four categories namely Policy decisions,
Program execution, Collaboration and Communications. The
Policy Action Plan will cover a five-year period with
annual plans with attendant financing framework. A
monitoring and evaluation framework will also be designed
with rational target setting, resource optimisation and
portal based reporting mechanism. An Industry led Advisory
Committee will also be set up for continuous feedback on
the implementation and monitoring. Independent evaluation
would be carried out at prescribed periodicity against the
defined outcomes, it added.
http://pharmabiz.com/ArticleDetails.aspx?aid=143514&sid=1
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