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Medical devices industry annoyed over Centre’s failure to delink Schedule M III from Schedule M
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Suja Nair Shirodkar
March 28 , 2015
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Annoyed with the lack of pro-activeness in genuinely addressing the
issues of the sector, the medical devices industry has expressed severe
angst over incompetency of the CDSCO over regulating the medical devices
sector. This outburst comes in the wake of the failure of the Centre
in delinking Schedule M of pharmaceuticals from Schedule M III for
medical devices in Rule 76, in spite of repeated representations.
In
a recent draft notification with reference No. GSR 11(E) that was
released by the health ministry in January, there seems to be an error
in drafting the amendment of Rule 76. Instead of deleting only the word
'and' from Schedule M (and Schedule M III in respect of medical devices)
erroneously, the government has deleted 'Schedule M and'. Further
complicating the matter for the industry is the fact that the
notification retains sub clause (2) and sub clause (3) of Rule 76 which
is still applicable to all the drugs specified in rule 76 including
medical devices.
“What we wanted is deletion of reference of
Schedule M-III from sub clause (2) & (3) of Rule 76 and addition of
sub clause (3)a for medical devices. But the government has resorted to
tactics to prolong their control over the medical device sector even
though they do not have the expertise nor the manpower to do so. This
attitude is having a huge impact on the industry and we want the
government to take cognizance of this fact at least now,” stressed,
Rajiv Nath, forum coordinator of Association of Indian Medical Device
Industry (AIMED).
He further pointed out that though the
government did take some measures in the micro level, their main demand
for amending rules and schedule different from drugs have still not been
considered. The industry has been demanding the Centre to define GMP
compliance as per IS:15579/ISO 13485 and delink Schedule M of
Pharmaceuticals from Schedule M III for medical devices in Rule 76.
However,
AIMED pointed out that the government has again failed to address their
demand and in fact have tried to misrepresent and masquerade the whole
process further, to confuse the industry. Nath said that this attitude
of the government stands testament to their intention to continue to
regulate medical devices like pharmaceuticals, which should not be the
case.
Schedule M specified for pharmaceuticals has four elements
namely, good manufacturing practices (GMP), requirement of premises,
equipment and plant. While, Schedule M III for medical devices defines
only one element i.e. requirement of premises. Nath pointed out that
what is critical and missing is GMP and the quality management system
(QMS) which the industry wants to be restricted to only IS: 15579.
Nath
informed that to comply with this 20 page BIS document which includes
eight clauses and then additionally expect manufacturers to comply with a
57 pages draft Schedule M III detailed document with 29 Schedule as for
Schedule M for devices and additionally 33 clauses in diagnostics, is
an excessive burden for a manufacturer with engineering and no
pharmaceutical background.
“If this gets implemented we fear that
the excessive overkill will scare of investment in this import
dependent sector. We are going in circles and a simple task to encourage
make in India is needlessly getting complex and delayed. All we want
from the government is to refer entire copy of BIS: 15579 w.r.t. GMP
only, rather than to relate clause by clause Schedule M III to BIS
15579/ ISO 13485 for specific requirements,” informed Nath.
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