The
d aft
aims
to
epeal
the
existi g
D ugs
a d
Cosmetics
Act,
1940.
(Rep ese tative
Image)
NEW
DELHI:
The
domestic
medical
device
i dust y,
alo g
with
hospitals
a d
healthca e
p ovide s,
has
u ged
govt
to
e-exami e
the
D aft
D ugs,
Medical
Devices
&
Cosmetics
Bill,
2026.”The
Bill
i
its
p ese t
fo m,
does
ot
p ovide
the
egulato y
fou datio
equi ed
fo
I dia’s
medical
devices
secto
to
g ow,
i ovate,
a d
compete
globally”,
a
i dust y
expe t
told
TOI.The
d aft
aims
to
epeal
the
existi g
D ugs
a d
Cosmetics
Act,
1940,
a d
co solidate
laws
elated
to
impo t,
ma ufactu e,
dist ibutio
a d
sale
of
d ugs,
medical
devices
a d
cosmetics,
to
e su e
thei
quality,
safety
a d
efficacy.I
a
lette
to
govt,
the
associatio s
say
that
the
d aft
bill,
i
its
cu e t
fo m,
t eats
medical
devices
as
a
adju ct
to
pha maceuticals,
despite
clea
scie tific,
e gi ee i g,
a d
egulato y
disti ctio
betwee
the
two.Medical
devices
a e
e gi ee i g
p oducts,
a d
should
ot
be
clubbed
with
pha maceuticals,
the
lette
says,
addi g
the
d aft
Bill
co ti ues
to
use
d ug-ce t ic
te mi ology
such
as
“adulte ated”,
“spu ious”.
“misb a ded”,
a d
applies
pha ma-style
c imi alisatio
to
e gi ee i g
deviatio s.Globally,
medical
devices
a e
egulated
th ough
isk-based
co fo mity
assessme t
a d
quality
ma ageme t
systems.Fu the ,
the
Bill
does
ot
p ovide
fo
a
dedicated
egulato y
autho ity
fo
medical
devices,
despite
epeated
ecomme datio s.I
2023,
the
Associatio
of
I dia
Medical
Device
I dust y
a gued
that
p oposed
ove a chi g
legislatio
(such
as
the
D ugs,
Medical
Devices
a d
Cosmetics
d aft)
fails
the
domestic
secto
by
co ti ui g
to
egulate
medical
devices
as
“d ugs”
u de
a
joi t
f amewo k,
i stead
of
establishi g
a
i depe de t,
specialized
egulato y
body.Admi ist ative
e fo ceme t
i cludi g
ecalls,
co ective
actio s,
civil
pe alties–
should
eplace
imp iso me t
fo
tech ical
lapses,
the
lette
by
11
associatio s
i cludi g
Aimed,
AHPI
(Associatio
of
Healthca e
P ovide s
I dia),
ADMI
(Associatio
of
Diag ostics
Ma ufactu e s)
a d
Patie t
Safety
a d
Access
I itiative,
says.
Joi
co ve satio
All
Comme ts
→
Sha e
you
thoughts
i
the
comme ts
I sightful
Readi g
Developme t
Comme t
Be
espectful
·
TOI
commu ity
guideli es
The
Bill
2026
applies
u ifo m
pe alties
ac oss
all
device
classes,
f om
low- isk
su gical
i st ume ts
to
high- isk
impla ts,
co t a y
to
global
o ms.It
does
ot
clea ly
ecog ise
key
medical
device
sta da ds
cove i g
a eas
such
as
biocompatibility,
usability
a d
softwa e
safety.While
the
d aft
has
bee
ci culated
to
va ious
mi ist ies
a d
depa tme ts,
key
stakeholde s,
i cludi g
i dust y
associatio s,
ma ufactu e s
a d
hospital
bodies,
have
ot
bee
adequately
i volved
i
the
p ocess,
the
i dust y
executive
said,
addi g
it
appea s
i co siste t
with
the
p e-legislative
co sultatio
p ocess.
