LAHORE: The Lahore High Court has dismissed the petitions challenging the jurisdiction of the Drug Regulatory Authority (Drap) to regulate the medical devices. Johnson and Johnson (pvt) Limited and several other companies sought a declaration that the Drap be permanently restrained from interfering in the manufacture, import and sale of medical devices.

The court noted that the legislatures were conscious of the fact that the list provided in the definition of 'drug' under the Drugs Act was not exhaustive, hence it authorized the government to keep adding substances and devices for the purposes of the definition of 'drug' as it was deemed necessary.

The court thus dismissed the petitions as no case for interference was made out. The petitioners contented that the parliament not have legislative competence on the subject of medical devices as medical 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 authorized 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.

Copyright Business Recorder, 2020