The Delhi High Court has upheld the Central government’s decision to include all medical devices within the ambit of the term ‘drug’ under the Drugs and Cosmetics Act.
In an order on September 1, a Bench of Justice Rajiv Shakdher and Justice Tara Vitasta Ganju rejected a plea by the Surgical Manufacturers and Traders Association challenging the Centre’s 2018 and 2020 notifications.
In 2018, the Centre had first brought four medical devices, namely nebuliser, blood pressure monitoring device, digital thermometer, and glucometer, within the ambit of the word ‘drug’. In 2020, it notified all medical devices as ‘drugs’.
Calling these decisions by the Ministry of Health and Family Welfare (MHFW) a “policy matter”, the Bench said no case for interference was made out as there was “no manifest arbitrariness or unreasonableness in the shift in policy of bringing all medical devices within the ambit of a regulatory regime”.
The High Court added that the authorities should take measures to quickly iron out the kinks found while progressing the regulatory regime.
It also observed that the implementation of the policy was “calibrated” and gave ample time to the manufacturers, importers, sellers, and distributors to transition to a mandatory licensing regime.
“The MHFW’s reasons are manifold, which include the desire to align itself with the international regulatory regime and to further the interest of the patients. Mere errors, if any, in the policy, which is otherwise robust and devised bearing in mind patient safety, cannot be upturned by the court while exercising the power of judicial review under Article 226 of the Constitution, unless it is a clear case of demonstrable violation of fundamental rights,” the September 1 order read.
