BIO LEADS (PVT.) LIMITED vs FEDERATION OF PAKISTAN through Secretary, Ministry of Law and Justice Ss

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BIO LEADS (PVT.) LIMITED VS FEDERATION OF PAKISTAN through Secretary, Ministry of Law and Justice Ss. 2(xxxvi), 2(xviii) & 23---Medical Devices Rules, 2017, Rr.2(xlii), 3(a) & (b), 12(1), 21---Enlisting and registration of medical devices including the ones for in-vitro use (the "IVD medical devices"), requirement of---Regulatory domain of Drug Regulatory Authority of Pakistan (the "DRAP")---Authority of DRAP to regulate the import of IVD medical devices---Promulgation of Medical Devices Rules 2017, under Drug Regulatory Authority of Pakistan Act 2012, vires of---Petitioners were engaged in the business of importing and selling of "in-vitro diagnostic" (IVD) medical devices and challenged the inclusion of such devices within the regulatory domain of the Drug Regulatory Authority of Pakistan (DRAP) under the Medical Devices Rules, 2017, framed pursuant to S. 23 of the DRAP Act, 2012---Petitioners mainly contended that the regulatory control of DRAP over IVDs was unconstitutional, ultra vires the DRAP Act, and imposed arbitrary and financially burdensome requirements---In short, petitioners were aggrieved by the requirement for the Medical Devices Board to enlist and register medical devices including the ones for in-vitro use, and the devices which provide information by means of in-vitro examination of specimens derived from a human body---Held: As per the preamble of the DRAP Act, one of the objective of the said Act was to regulate the manufacture, import, export, storage, distribution and sale of therapeutic goods---The said Act defined "therapeutic goods" to include drugs or alternative medicine or medical devices, whereas, "medical devices" has been defined to mean medical devices as specified in Schedule-I which included instruments, medical equipment, implants, disposables and software, used mainly for the purpose of diagnosis, monitoring and treatment of diseases, whereas, IVD medical devices meant a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human or animal body solely or principally to provide information for diagnostic, monitoring or compatibility purpose---Chapter-IV of the Medical Devices Rules, 2017 (Rules 2017) dealt with the subject of "enlistment and registration of medical devices"---Rules 12(1) of Rules 2017 provided that Medical Devices Board should enlist and register medical devices which included any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material or other similar or related article, intended by manufacturer to be used, alone or in combination, for human beings or animals for one or more of the specified purposes listed in the said Rule---Meaning given to the medical devices in paragraph 3 of Schedule-I of the DRAP Act included an IVD medical device as defined in the Medical Devices Rules, 2017---As long as a medical device was intended to be used for diagnostic monitoring or treatment of disease whether through in-vitro examination or otherwise it was subjected to regulatory oversight of the DRAP---The mere fact that any equipment or machine was intended to be used as an aid in diagnosis through in-vitro examination did not take such equipment of machine out of the meaning of a medical device or beyond the regulatory domain of DRAP---With respect to the vires of Medical Devices Rules, 2017 being promulgated under the DRAP Act, Art. 144 of the Constitution permitted the Provincial Assemblies to amend the law enacted by the Parliament pursuant to the said Article and since none of the Provincial Assemblies repealed the provision in the DRAP Act empowering to make rules, therefore, Medical Devices Rules, 2017 made under S. 23 of the DRAP Act were not ultra vires---This silence by the Provinces endorsed the view that the Medical Devices Rules, 2017 were in conformity with the Drug Regulatory Authority of Pakistan Act, 2012 which was enacted to the authority given by the Provinces to the Parliament under Art. 144 of the Constitution---Since no provision in the Medical Devices Rules, 2017 was pointed out which was in derogation of the DRAP Act, present Constitutional petitions being without merit were dismissed, in circumstances.

BIO LEADS (PVT.) LIMITED vs FEDERATION OF PAKISTAN through Secretary, Ministry of Law and Justice Ss — 2025 CLC 1715 ISLAMABAD

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