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

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.

In 2018, the Centre had first brought four medical devices , i.e. nebuliser, blood pressure monitoring device, digital thermometer and glucometer, within the ambit of drug. In 2020, all medical devices were notified as drugs.

The court 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.

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 court said.