LAHORE: The Lahore High Court (LHC) on Friday rejected challenges to the jurisdiction of the Drug Regulatory Authority of Pakistan (Drap) to regulate the medical devices.

The Johnson & Johnson (Pvt) Limited and several other companies had filed petitions challenging the legality and authority of Drap to regulate the medical devices. They also challenged Medical Devices Rules, 2017 for being excessive essentially on the ground that the Medical Devices Board was without the required authority under the Drap Act.

The petitioners sought a declaration that Drap be permanently restrained from interfering in the manufacture, import and sale of medical devices.

The petitioners/companies included importers, exporters and manufacturers of the medical devices ranging from devices related to the Covid-19, such as masks, oximeters, shields and gloves, to devices related to cosmetic surgery, in-vitro diagnostic devices, ultrasound, sutures, stents, legatures, disposable syringes, stapler guns to life-saving medical devices.

The basic contention of the petitioners was that the parliament did not have legislative competence on the subject of medical devices as such devices did not fall within the ambit of drugs and medicine.

They argued that since medical devices did not fall within the ambit of drugs and medicine, a resolution passed by Punjab Assembly under Article 144 of the Constitution on Feb 15, 2012, with reference to drug and medicine was not applicable to medical devices.

Justice Ayesha A. Malik, in her judgment, observes that the Drap Act under Section 32 provides that the Act is in addition to and not in derogation of the provisions made in the Drugs Act and any other law enforced.

The judge notes that the legislature was conscious of the fact that the list provided in the definition of ‘drug’ under the Drugs Act was not exhaustive, hence it authorised the government to keep adding substances and devices for the purposes of the definition of ‘drug’ as it was deemed necessary.

She further observes that the public is the ultimate beneficiary of the medical devices whether used at home or in a clinic or hospital, whether for cosmetics or in-vitro diagnostic purposes, there is an obligation on the respondents (government functionaries) to ensure the safety and effectiveness of the medical devices.

The judge dismissed the petitions as no case for interference was made out.

Published in Dawn, December 12th, 2020