Delhi HC upholds Centre’s decision to include all medical devices as drugs

Delhi HC upholds Centre’s decision to include all medical devices as drugs

Subject: Govt schemes

Section: Health

In News: Delhi High Court upholds the Central government’s decision to include all medical devices within the ambit of the term ‘drug’ under the Drugs and Cosmetics Act.

Key Points:

• 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 (MOHFW) a “policy matter”, the HC notes that no case for interference was made out as there was no arbitrariness or unreasonableness in the shift in policy.
•  It was 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.
• MOHFW’s reasons include the desire to align itself with the international regulatory regime and to further the interest of the patients.
• HC noted that a policy cannot be overturnedin view of errors, 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.