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Medical Devices Industry Wants Govt To
Create Investor - Friendly Environment
Annoyed by the continual lackluster attitude adopted by the
central government in addressing the long pending issues of the medical devices
industry in the country, experts in the sector want immediate intervention from
the government to bolster the lagging confidence of the industry. Industry feels
that too many policy decisions awaiting announcement amidst differences between
the ministers to get consensus amongst cross lobbyists is hurting the interest
of the industry.
Experts stressed that rather than creating an investor
friendly environment by easing and simplifying the process, the Centre has
further complicated the matter by creating fear and confusion among
stakeholders. Rajiv Nath, forum coordinator of AIMED, stressed that just
marketing and sloganeering about ‘Make in India’ will not do any good for the
industry unless it is backed by clearly defined policy framework, strategies and
listed reforms that are tangible.
Instead of taking any pro-active measures in sprucing up the
domestic manufacturing arena, the government is further creating a complicated
market condition for the industry. Though the government has started taking baby
steps towards reviving the sector, their initiatives are not sufficient, and
they need to walk the talk by making sure that the ministers are involved in the
reform process, Nath stressed.
“In spite of all these promises, the industry is still
reeling under pressure due to the government creating unfavorable conditions for
the investors. Even after announcing setting up of medical devices park across
the country, there are lot of uncertainties on the regulatory front. We strongly
fear that it will be huge challenge to attract investors to these parks with so
mach confusion which will undoubtedly derail the ease of doing business
assurance given by the Centre,” Nath informed.
He stressed that bureaucrats have to see the ground realities
and work with the industry to ensure that the sector gets its due. Reiterating
AIMED’s call for action on its suggestions, Nath pointed out that since medical
devices being a critical sector, it is only expected of it to have a centralized
regulation for all medium and high risk devices categories, leaving the
re-sellers whether wholesalers, retailers or healthcare providers to be
regulated by state regulatory bodies. Thus in this context considering the
present limitations of the regulatory bodies in terms of competency, capacity
and resource capabilities, our suggestions to the regulatory body to encourage
voluntary compliance backed by third party certification to ensure patient
safety stands valid, Nath added.
(Ref:
http://pharmabiz.com/PrintArticle.aspx?aid=98402&sid=1)
Medical Device Industry Rues
Recommendations Not Incorporated In The Draft For New Medical Device Rules
Government must consider industry recommendations for Medical
Device Rules to circumvent severe jeopardy to critical healthcare in India and
it falls short of the expectations of the medical devices sector, feels the
industry.
In a statement, the industry experts say that the Medical
Device Rules were initially prepared with industry consultation, however the
comments of the industry as well as certain elements where agreement was
obtained between industry and Health Ministry officials were not incorporated in
the draft that was published on October 17th, 2016 for stakeholder’s comments
(within 30 days).
“In their current form the Medical Device Rules could
severely jeopardize the continued supply of critical care medical devices to
India. They will also endanger the huge investments made in Manufacturing in the
country by global companies & will dent the FDI which has been growing multifold
since it was sagaciously brought on the automatic route by the current
government. Having said that, we are engaged with the Health Ministry as well as
the CDSCO on the Rules, and if the past is anything to go by, their inclusive
approach and nuanced understanding of the issues will help us once again reach
solutions so that the supply of critical care devices will continue
uninterrupted to the Indian patient,” commented Pavan Choudary, director
general, Medical Technology Association of India (MTaI) in a statement.
Also, the Advanced Medical Technology Association (AdvaMed) –
a trade association expressed that the rules in its current form lack
harmonization with international norms of medical device regulation, which is
necessary to provide the necessary fillip to the sector that provides
extraordinary growth opportunity for the country through creation of high paying
jobs, economic value and better patient outcomes. In addition to the device
rules, the Association also, strongly, recommends inclusion of the globally
harmonized definition of medical devices into the current Act, which is not part
of the drug definition, it says in a statement.
Varun Khanna, chairman, AdvaMed India Working Group, and
Executive Committee Managing Director, BD India & South Asia said, “All policy
decisions need to be based on scientific due diligence. The Medical device draft
rules 2016, at this stage, need more clarity and alignment with global best
practices to fully meet the sector specific requirements in order to ensure
predictability in the Indian market, which is a critical factor when it comes to
investment decisions. The current rules address some but not all of the issues
that were deliberated upon during several industry consultations while working
on this draft. AdvaMed and its members appreciate the efforts made by the Indian
government to improve the overall landscape for medical devices. We request the
Government to continue consultations with the innovative industry and build on
their experience to come up with a methodology that will address reasonable
concerns around access and affordability while promoting research and med-tech
innovation.”
He also said, “The government needs to be mindful of the fact
that without sufficient capacity it will be challenging for them to implement
these rules. Therefore, a critical step for the successful implementation of the
medical device rules would be to take measures for building capacity of the
relevant ministries and ensure greater understanding of the sector dynamics and
criticalities among the regulators.”
The association members have urged the regulators to make
necessary revision in provisions that hinder operational ease of doing business
for the device companies. For instance, the additional requirement for clinical
investigation of medical devices already approved in GHTF countries shall cause
unnecessary delay in the availability and access of innovative medical devices
to the HCPs and the patient population. Moreover, the provisions with respect to
labeling of medical devices should be aligned with the Draft rules published in
July 2016, and the clause with respect to the shelf life of medical devices
should be amended to be in line with global requirements.
The members said that while the implementation of UDI is a
positive step, it is imperative for the government to have realistic timelines.
For example, as per the US and EU implementation timeline, the complete
implementation including direct part labeling will be over only by 2022. Hence,
it is premature to incorporate this in the current rules, as manufacturers are
not ready for implementation of UDI.
The association said that encouraging measures for medical
device regulation would enhance penetration of essential medical devices, and it
is hopeful that its perspective would be reflected in the final version.
(Ref:
http://pharmabiz.com/NewsDetails.aspx?aid=98982&sid
=2&fromNewsdog=1)
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