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Centre Readies To
Regulate Medical Device Alongside Drugs; Industry
Expresses Dismay
No committee was formed to review the different tenets of
the Bill: AIMED
Consumer Patient groups, Healthcare Providers have joined
manufacturers associations in expressing profound dismay
as the Centre reportedly prepares to table the New Drugs,
Cosmetics & Medical Device Bill, 2023 in Parliament
without adequately addressing their concerns.
The proposed legislation, aimed at regulating the medical
device sector, had earlier garnered widespread
apprehension from industry stakeholders who feel that
their input has been overlooked.
Despite recent consultations, industry leaders argue that
key issues such as regulatory complexities, the potential
impact on innovation, and the need for a conducive
business environment have yet to be adequately assured by
redressal in the bill.
The lack of alignment with industry expectations has
raised fears of stifling growth and hindering
technological advancements in the medical device sector
and continued import dependence as it is easier to import
high end medical devices than to get regulatory approval
for domestic manufacturers.
As the Bill is reported to move forward, there is a
palpable sense of frustration among industry leaders who
were hopeful for a more collaborative and responsive
approach from the government.
Association of Indian Medical Device Industry (AIMED)
Forum Coordinator Rajiv Nath, while expressing his
disappointment, said, "NITI Aayog had drafted an excellent
Medical Devices (Safety, Effectiveness and Innovation)
Bill, 2019 but in vain and we keep going in circles. Who
gains from putting Indian manufacturers at a disadvantage
over imports and by Drug pharmacists weighed biased
regulatory controls? Even the impactful recent progressive
legislations in countries like Canada, UK, EU, Brazil,
Malaysia, Singapore and Saudi Arabia were not studied. Who
blocked that progressive visionary Bill?”
Discussing the potential impact of the Bill, which appears
to favour foreign players, Dr Giridhar Gyani, Direcor
General of the Association of Healthcare Providers India (AHPI),
said, "In the national interest, it is crucial for us to
highlight that if the Bill is passed as is, the healthcare
providers sector, heavily reliant on medical devices and
advocating for increased availability of affordable,
high-quality, made-in-India medical devices, may once
again face challenges in management of supply chain,
leading to crisis and country wide lockdown similar to the
onset of Covid. Domestic manufacturers might lose their
capacity to swiftly address domestic demand, especially in
the event of a pandemic”
K L Sharma, former Joint Secretary in the Ministry of
Health & Family Welfare, GoI (2014-17), who coordinated
the creation of Medical Devices Rules, 2017 stated,
"Treating medical devices at par with drugs for regulatory
purposes is fraught with danger for various reasons
including the fact that such an arrangement puts
unnecessary burden on medical device manufacturers in
terms of compliances and leaves out more vital aspects
that are crucial for ensuring the safety and effectiveness
of medical devices."
Gaurav Agarwal, Managing Director, Innvolution Healthcare
that produces cardiac imaging equipment said “If food can
have FSSAI we need a separate regulatory framework too if
we aspire to be global leaders."
Interestingly the Parliamentarians in the Health Committee
had initially responded specifically that instead of
drafting a combined legislation for Drugs, Medical Devices
and Cosmetics, the Ministry should formulate a separate
legislation for Medical Devices.
The Committee had reiterated its earlier recommendations
that the new legislation should set up a new set of
regulators at different levels for regulating the Medical
Devices industry. Unlike the present structure, the
proposed National regulator should license the
manufacturing of medical devices like FSSAI, and the state
regulators be supervised by the National Regulatory
Authority to help harmonise the regulatory process
throughout the country.
https://www.biospectrumindia.com/news/22/23964/centrereadies-to-regulate-medical-device-alongside-drugs-industryexpresses-dismay.html
16 December 2023
DoP Adds More Devices To PLI
Scheme For Medical Devices And Invites Fifth Round Of
Applications Under Category B
The Department of Pharmaceuticals (DoP) has invited the
fifth round of applications from eligible candidates under
the Category B of the production linked incentive (PLI)
scheme for promoting domestic manufacturing of medical
devices after revising the guidelines to include more
medical devices under the two categories on which the
industry can apply for the government support.
The Department said that it has issued a corrigendum, or
addendum, to the guidelines on December 19, based on the
arising needs and subsequent to the decision taken with
the approval of the competent authority.
As per the revised guidelines, the Department has amended
the indicative eligible products on which the Category A
applicants are allowed to remove collimator and flat panel
detector and MRI monitors from the radiology and imaging
medical devices list.
A significant revision has been made for the Category B
applicants, under which several devices are added to the
eligible products. Under the list of cancer care and
radiotherapy medical devices, where there were four
products were specifically named while including other
products generally, the revised guideline has around 12
products including Cryoablation unit, cryoprobe,
cryotherapy, HDR Brachytherapy, Holmium Laser system with
MOSES technology, hyperthermic intra vesicular therapy,
vacuum assisted breast biopsy machine among others listed.
Under the list of radiology and imaging devices (both
ionising and non-ionising radiation products) and nuclear
imaging devices, instead of four to five devices
specified, the new list specifies almost 26 products
including collimator, monitor, flat panel detector, 3T
digital PET/MR, biplane DSA, cone beam computed
tomography, CR system, dedicated solid-state cardiac SPECT
camera, densitometer with computer, DEXA scan, DEXA
scanner (BMD), ECHO and USG machine, among others are
freshly added.
In the list of anesthetic and cardio respiratory medical
devices including Catheters of cardiorespiratory category
and renal care medical devices, instead of around five
products specifically listed, the new list has over 50
products specifically mentioned including kidney
transporter with 05 sets of expendables with each
equipment, laparoscopic surgery set with high-definition
camera, minimally invasive cardiac instruments,
non-invasive jugular oximetry monitor, paediatric
bronchoscope set, paediatric cystoscope and resectoscope
set/cystoscope and resectoscope, paediatric laparoscopy
set, among others.
In the list of all implants including implantable
electronic devices segment, products such as
Bi-Ventricular Pacemaker with Quadripolar LV lead,
expandable corpectomy device, MRI conditional automatic
implantable cardioverter defibrillator, MRI conditional
cardiac resynchronisation therapy - pacing and others were
added.
For products not specifically mentioned in the list, the
technical committee shall decide whether such products
shall be considered eligible under the target segment. Any
product which is listed in Category A will also not be
considered under the 'other products' mentioned in
Category B.
It added that a key component which constitutes a major
part of the finished medical device (such as rotating
anode tube, stationary anode tube, MRI magnet, Flat panel
detector and similar components), and has a distinct HS
code for itself, will be considered as included in the
corresponding target segment.
Following the release of the updated list, the DoP invited
applications from eligible Category B applicants for
medical devices for the eligible products. The
applications should be based on the guidelines revised on
February, 25, 2023.
"Investment for this round of applicants are as defined in
the scheme guidelines and shall be considered for
determining eligibility under the scheme provided such
investment is made on after April 1, 2021," said the
Department. The eligible applicants may apply through
online mode till January 18, 2024.
The Department, while inviting Category B applicants for
an earlier round in February, revised the guidelines
making the cost incurred by the applicants towards
clinical trials of eligible products in India as an
investment determining the eligibility to be selected
under the scheme, though it would be capped at a maximum
of 10 per cent of committed investment.
It has also changed the provisions related to investment
required for determining the eligibility of the applicant
for the scheme, mandating that for those who apply for
incentives in the fourth round of invitations from the
Department, eligibility would be based on the investment
made on or after April 1, 2021, in comparison to the
previous rounds where investments made on or after April
1, 2020 were considered.
The Department amended the guidelines, issued on October
29, 2020, on August 18, 2022 dividing the eligible
products into two categories and allocating incentives
separately for them. The applicant applying for products
listed in Annexure 1 of the guideline shall be referred to
as Category A applicant and those applying for products in
Annexure 1A shall be referred to as Category B. Changes
are made in other clauses and Annexures based on this
revision.
While in the initial guidelines issued on October 29,
2020, the indicative eligible products for the Cancer
Care/radiotherapy medical devices segment were listed as
Brachytherapy Systems, Rotational Cobalt Machine,
Radiotherapy Simulation Systems, Linear Accelerator (LINAC),
Workstations - Radiotherapy planning, proton therapy
system and other products, under the revised guideline,
Rotational Cobalt Machine and LINAC are in Category A and
the rest of the products are in Category B.
Similar division has been applied in the other three
segments - Radiology & imaging medical devices (both
ionising and nonionising radiation products) and nuclear
imaging devices; Anesthetics and cardio respiratory
medical devices including catheters and renal care medical
devices; and All implants including implantable electronic
devices, it said in August, 2022.
http://www.pharmabiz.com/NewsDetails.aspx?aid=165324&sid=1
December 22, 2023
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