The
Delhi High Court has upheld the Centre's decision to include all medical
devices within the ambit of "drug" under the law regulating drugs and
cosmetics.
A
bench headed by Justice Rajiv Shakdher rejected petitions by the Surgical
Manufacturers and Traders Association challenging the central government's 2018
and 2020 notifications first declaring four medical devices as drugs under the
Drugs and Cosmetics Act, and then spreading the net to cover all medical
devices.
The
court said the decision to include all medical devices as drugs was a policy
matter and no case for interference was made out as there was no arbitrariness
or unreasonableness.
MHFW
(Ministry of Health and Family Welfare), in its wisdom, thought it fit to bring
all medical devices within the ambit of the expression 'drug '. This is clearly
a policy matter, the bench, also comprising Justice Tara Vitasta Ganju, said in
a recent order dated September 1.
To
our minds, there is no manifest arbitrariness or unreasonableness in the shift
in policy of bringing all medical devices within the ambit of a regulatory
regime. Our postscript is, if we were to allow the writ petitions, figuratively
speaking, we would be throwing away the baby with the bathwater, the court
opined.
The
authorities should, however, take measures to quickly iron out the kinks found
while progressing the regulatory regime, the court said.