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Health Ministry To Rope In
State Governments To Establish Medical Devices Testing
Laboratories
The ministry of health and
family welfare (MoHFW) is planning to rope in state
governments also to establish or designate their existing
laboratories as state medical devices testing laboratories
and bring in enabling rules to support setting up of more
testing laboratories for medical devices across the
country as the sector is experiencing major regulatory
paradigm shift including the introduction of a licensing
regime.
The Union health ministry is
looking at bringing in the support of state governments to
actively participate in the testing activities, in order
to ensure the quality of medical devices. It is amending
the Medical Devices Rules, 2017, with introduction of
sub-rules and changes in the existing ones relevant to
bring in the desired
regulatory framework.
A draft rule has been
notified by the Ministry, under which it has proposed to
insert a new sub-rule to the Rule 19, that the state
government may, by notification, establish state medical
devices testing laboratory for the purpose of testing and
evaluation of medical devices or to carry out any other
functions as may be specifically assigned to it.
State government may also
designate any laboratory having facility for carrying out
and evaluation of medical devices as state medical devices
testing laboratory for purpose, with a condition that the
laboratory should be accredited by the National
Accreditation Body for Testing and Calibration
Laboratories (NABL).
It has also added a
definition to the state medical devices testing
laboratory, stating that it means a laboratory established
or designated by the state government under the Rule
19(3), which is the freshly proposed sub-rule. While the
Rule 19 was specifically for Central medical devices
testing laboratory, it has been proposed for amendment by
omitting the word ‘Centre’, this emphasising that the
laboratories could be established either by the Central or
the state government.
Draft amendment is expected
to be taken into consideration in seven days from t date
of making the draft available to the public.
Industry experts have been
raising concerns about availability of proper medical
devices testing laboratories for faster testing
operations, considering that the licensing regime for a
majority of the medical devices is expected to be in place
soon.
As on November, 2022, around
28 laboratories were registered with the office for
testing purposes. The Drugs Controller General (India) [DCGI's]
office is receiving the applications for registration
under Medical Devices Rules (MDR), 2017 from various
laboratories for testing of different medical devices,
said the regulator in December, last year.
http://www.pharmabiz.com/NewsDetails.aspx?aid=156725&sid=1
Parliamentary Panel Expresses Concern Over
Under-Utilisation Of Funds For Medical Devices Parks
A Parliamentary panel analysing the performance of the
Department of Pharmaceuticals (DoP) and the budgetary
requirements and allocations it has received in the year
2023-24 has raised concerns over the severe under
utilisation of allocated funds for the sub scheme of
promotion of medical devices parks, in the previous fiscal
year and advised the department to take up the matter with
the State governments for speedy implementation.
The Department Related Parliamentary Standing Committee
for Chemicals and Fertilisers, in its latest report on
Demands for Grants for the DoP for the year 2023-24, said,
“The Committee, however, are greatly concerned to note the
severe shortfall in utilisation of allocated funds during
FY 2022-23, where out of the allocated amount of Rs.120
crore at RE stage, the Department could utilise Rs. 89
lakhs only up to February, 2023.”
The reason for the shortfall is stated to be that funds
were not utilised as the States could not spend the 60 per
cent of first installment of Rs. 30 crore and equivalent
amount of the state funds, in order to become eligible for
receiving second installment as per the scheme guidelines
as Utilization Certificates (UCs) could not be submitted
to receive second installment of Rs. 30 crore.
“The Committee are of the strong view that the scheme for
promotion of Medical Parks for creation of Common
Infrastructural Facilities should not be allowed to suffer
for procedural delays. Hence, the Department should take
up the matter with the respective State Governments at the
highest level without further loss of time for early issue
of Utilisation Certificates from respective States,” said
the report.
Though this project entails substantial investment
initially, the benefits accruing out of it over a period
of time would also be far greater. The Committee hoped
that the Department would take immediate steps in this
direction and would be able to optimally utilize Budget
Estimate 2023-24 of Rs. 200 crore under the scheme.
The panel was looking at various schemes including the
umbrella scheme ‘Development of Pharmaceuticals Industry’,
which includes the sub-scheme Promotion of Medical Devices
Parks and Promotion of Bulk Drug Parks.
The promotion of medical devices parks scheme, has an
objective to promote four Medical Device Parks by
providing Grants-in- Aid for creation of common
infrastructure facilities (CIF). Total financial outlay
for the Scheme is Rs. 400 crore for the period 2020-21 to
2024-25 and Rs.100 crore per park or 70% of the cost of
the CIF, whichever is less. The assistance would be 90%
for the North Eastern Region and Hill States.
http://www.pharmabiz.com/NewsDetails.aspx?aid=157423&sid=1
Dop Revises
Guidelines For PLI Scheme For Medical Devices To Include
Investment Into Clinical Trials In Eligibility Criteria
The Department of
Pharmaceuticals (DoP) has revised the guidelines of
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