Full Judgment Text & Judicial Ruling

2025 C L C 1715 [Islamabad] Before Miangul Hassan Aurangzeb, J Messrs BIO LEADS (PVT.) LIMITED and others ---Petitioners Versus FEDERATION OF PAKISTAN through Secretary, Ministry of Law and Justice and others ---Respondents Writ Petition No. 1586 of 2020 (and other connected Petitions), decided on 31st August, 2021.* (a) Drug Regulatory Authority of Pakistan Act (XXI of 2012)--- ----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. (b) Constitution of Pakistan--- ----Arts. 142(d) & 144---Drug Regulatory Authority of Pakistan Act (XXI of 2012), Preamble---Constitution (Eighteenth Amendment) Act (X of 2010), Preamble---Drugs, medicine and medical devices, subject of---Legislative powers exercised by the Parliament---Scope and extent---Constitutionality of Drug Regulatory Authority of Pakistan Act, 2012 challenge to---Vires of law---Scope---The legislative power exercised by the Parliament under Art. 144 of the Constitution was discussed in the case reported as 'PLD 2018 Sindh 448'---After doing so and referring to the resolutions passed by the provincial assemblies authorizing the Parliament to legislate on the subject of drugs and medicines and the establishment of a regulatory authority, Sindh High Court dismissed the challenge to the constitutionality of the Drug Regulatory Authority of Pakistan Act, 2012 (the "DRAP Act")---While referring to the reported case supra the High Court in the present matter adopted the same stance as taken by the Sindh High Court by upholding the constitutionality of the DRAP Act. Azfar Laboratories' case PLD 2018 Sindh 448; Dawakhana Hakeem's case PLD 2020 Lah. 899 and Johnson and Johnson's case W.P. No. 20263 of 2020 ref. (c) Constitution of Pakistan--- ----Arts. 142(d) & 144---Drug Regulatory Authority of Pakistan Act (XXI of 2012), Preamble---Constitution (Eighteenth Amendment) Act (X of 2010), Preamble---Medical devices, subject of---Plea that subject of medical devices could not have been legislated upon by the Parliament---Validity---Parliament was competent to legislate on the subject of medical devices which came within the meaning of drugs and medicines. Dawakhana Hakeem's case PLD 2020 Lah. 899 and Johnson and Johnson's case W.P. No. 20263 of 2020 ref. (d) Constitution of Pakistan--- ----Arts. 142(d) & 144---Drug Regulatory Authority of Pakistan (XXI of 2012), S. 40---Legislative competence of provincial legislature to amend or repeal Drug Regulatory Authority of Pakistan Act, 2012 (the "DRAP Act")---Applicability of the DRAP Act to the Islamabad Capital Territory---Scope---Indeed the provincial legislature has the legislative competence to amend or appeal the DRAP Act to the extent to which it applies to the Province---This is explicitly provided in Art. 144 of the Constitution---As regards the applicability of the DRAP Act to the Islamabad Capital Territory, Art. 142(d) of the Constitution provides that the Parliament shall have exclusive powers to make laws with respect to all matters pertaining to such areas in the Federation as are not included in any Province---The Islamabad Capital Territory is indeed an area in Federation not included in any Province and therefore the Parliament has the exclusive powers to make laws with respect to all matters, including the regulation of drugs and medicines for such area---Insofar as the applicability of the DRAP Act to the Islamabad Capital Territory is concerned, it is only the Parliament that can amend or repeal the said Act. (e) Interpretation of statutes--- ----Rules made under a statute---Scope---Rules shall always be consistent with the statute and no rule shall militate or render the provisions of a statute ineffective---The test is whether the provisions of the statute and that of rules can stand together---The main object of the Rules is to implement the provisions of the statute---Rules cannot enlarge the scope of an Act under which the same have been framed---Rules and regulations are subordinate and delegated legislation deriving authority and legal cover from the provisions of the statute---The authority of the executive to make rules and regulations in order to effectuate the policy and intention of the legislature must be exercised within the limits of mandate given to the rule-making authority and the rules framed under the enactment must be consistent with the provisions of the said enactment---In case of conflict between the statute and the rules, the rules must give way to the provisions of the statute---Rule should not be repugnant to the enactment under which they are made since they have the same force as the provisions of the statute under which they are framed---Rules being subordinate legislation can neither override nor over-reach a provision of the substantive statute but if the rules explain the latter and provide aid to facilitate its understanding, it shall, be quite legitimate to read and refer to them, especially when they, on all counts, conform to and are subordinate to the substantive statute. Suo Motu case No. 13 of 2009 PLD 2011 SC 619 rel. Petitioners by: Rana Abid Nazir Khan, Raja Bilal Mustafa, Ms. Nadia Asghar, Rana Mehboob Ahmad, Ch. Shahid Mehmood (in W.Ps. Nos. 1586, 1670, 1863, 2162, 2357, 2569, 2970 and 3961 of 2020, 310, 580, 634, 674, 772, 836, 899, 1006, 1317, 1400, 1569, 1841, 1951, 1952, 2134 and 2337 of 2021). Haroon Duggal, Subhe Nasib (in W.Ps. Nos. 2767, 3350, 3351, 3460 and 3593 of 2018). Syed Zameer Hussain Shah (in W.Ps. Nos. 1722 and 2156 of 2020). Sikandar Naeem Qazi (in W.P. No. 1764 of 2020). Khawaja Manzoor Ahmad (in W.Ps. Nos. 1843 of 2020 and 1007 of 2021). Raja Mumtaz Ali (in W.Ps. Nos. 3047 of 2020 and 1007 of 2021). Sardar Haseeb Ahmed (in W.P. No. 1956 of 2021). Syed Iftikhar Gillani and Barrister M. Saad Butter (in W.P. No. 4736 of 2018). Zia-ur-Rehman (in W.Ps. Nos. 2148 and 2198 of 2020). Muhammad Umar Khan Verdaq (in W.P.No. 2258 of 2020). Afzal Awan and Nazma Parveen (in Crl. Org. No. 88 of 2021 in W.P. No. 310 of 2021). Nasrum Minallah (in W.P. No. 1349 of 2021). Atta Ullah Hakim Kundi (in W.P. No. 1431 of 2021). Qazi Isaac Ali (in W.P. No. 1650 of 2021). Raza Ali Shah (in W.P. No. 3582 of 2020). Ch. Muhammad Tariq Ali Goheer (in W.P. No. 4490 of 2018). Respondents by: Arshid Mehmood Kiani, Deputy Attorney-General. Barrister Ahmed Pervaiz, Barrister Ehsan Ali Qazi, Sifat Ullah, Advocates and Hafiz Bilal Bin Akbar, Assistant Director (Legal), DRAP. Binyamin Abbasi MCC (in W.Ps. Nos. 1670, 1722, 1843, 1863, 2148, 2156, 2357, 2970, 3047 of 2020, 310, 580, 634, 836, 1349 and 1431 of 2021). Dr. Farhat Zafar for MCC Customs Appraisement (East), MCC Port Qasim Karachi and MCC Islamabad (in W.Ps. Nos. 2569 and 2970 of 2020, 310, 580, 634, 674, 772, 899, 1006, 1349 and 1431 of 2021). Sajid Mahmood Baig for Respondent No. 6 (in W.P. No. 2198 of 2020). Ch. Muhammad Nawaz for CC Appraisement (West) Karachi (in W.P. No. 674 of 2021). Ch. Muhammad Zafar Iqbal (in W.Ps. Nos. 2198 of 2020, 634, 772 and 899 of 2021). Arshad Mehmood (in W.P. No. 2148 of 2020). Mrs. Naziran Malik, Advocate for Customs (in W.P. No. 1764 of 2020). Irshad Ahmad Zada Mohammadzai for Respondent No. 4 (in W.P. No. 2258 of 2020). Dates of hearing: 19th February, 11th, 24th March, 5th May, 2nd, 4th, 18th June and 1st July of 2021. JUDGMENT MIANGUL HASSAN AURANGZEB, J. ---Through this judgment, I propose to decide writ petitions listed in Schedule-A hereto. 2. The petitioners have assailed the vires of the Medical Devices Rules, 2017 ("the MD Rules") made by the Drug Regulatory Authority of Pakistan ("DRAP") in exercise of the powers conferred by Section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 ("the DRAP Act"). These Rules have been made with the approval of the Federal Government. 3. The petitioners are engaged in the business of import and sale of diagnostic medical devices, and are aggrieved by the inclusion of In-Vitro Diagnostic Medical Devices ("IVD medical devices") in the regulatory domain of DRAP pursuant to the provisions of the MD Rules. 4. Rana Abid Nazir Khan, Advocate Supreme Court of Pakistan, learned counsel for the petitioners submitted that all the petitioners are importers of medical devices (as defined in paragraph 3 of Schedule-I to the DRAP Act) and IVD medical devices (as defined in Rule 2(xlii) of the MD Rules); that the definition of medical devices does not include IVD medical devices; that the Global Harmonization Task Force ("GHTF") guidelines also define medical devices separately from IVD medical devices; that the said guidelines define an IVD medical device to mean a medical device, whether used alone or in combination, intended by the manufacturer for in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes; that an IVD medical device cannot be termed as a therapeutic good, and therefore its import and sale cannot be regulated or dealt with either under the provisions of the DRAP Act or the MD Rules; that Rule 14 of the said Rules provides the procedure for enlistment and registration of medical devices but not IVD medical devices; and that IVD medical devices imported by the petitioners are not being released by the customs authorities on the grounds that neither are they enlisted and registered nor have their importers been issued drug sale licences. 5. Furthermore, it was submitted that IVD medical devices imported and sold by the petitioners have nothing to do with the cure and treatment of diseases, and are not therapeutic goods; that IVD medical devices are used for examination and diagnosis of samples outside the living organism, and therefore have nothing to do with the cure and treatment of diseases; that it was obligatory upon the Medical Devices Board ("MDB") to have classified the medical devices in accordance with the GHTF and International Medical Device Regulators Forum ("IMDRF") guidelines, which define medical devices separately from IVD medical devices; that the inclusion of an IVD medical device in medical devices by the M.D.B. is in collusion with large companies which want to weed out the petitioners from the competitive arena; that the list of medical devices given in Schedule-A to the MD Rules are all IVD medical devices since they do not come in direct contact with patients; and that none of the devices listed in Schedule-A can be termed as IVD medical devices. 6. Syed Iftikhar Gillani, Senior Advocate Supreme Court of Pakistan, learned counsel for the petitioners submitted that the DRAP Act pertains to "inter-provincial trade and commerce of therapeutic goods" and does not apply to IVD medical devices which do not fall within the ambit of therapeutics; that the MD Rules do not apply to IVD medical devices as the said Rules stem from the DRAP Act, which was enacted solely for the regulation of "therapeutic goods;" that therapeutic goods and IVD medical devices are completely distinct products; that "therapeutics" has been defined as a branch of medicine that deals with treatment and cure of diseases whereas IVD medical devices pertain to those medical devices that are intended for the in-vitro (i.e. outside of the body of a living organism) examination of the human body for the purposes of diagnostic monitoring or compatibility; that the inclusion of IVD medical devices within the ambit of therapeutic goods goes against the GHTF and the IMDRF guidelines, both of which are being relied upon for the classification and grouping of medical devices under Rule 11 of the MD Rules; that the petitioners are opposed to the inclusion of IVD medical devices among therapeutics goods; that the inclusion of IVD medical devices among therapeutic goods is the result of collusion between DRAP and big pharmaceutical companies in order to protect their monopoly and give them a free hand to charge exorbitant prices from people; and that inclusion of IVD medical devices among therapeutic goods also places an unnecessary financial burden on the petitioners since they have to hire Class-A pharmacists, and possess a 600 sq. yard refrigeration unit which can be inspected by a Drug Inspector. 7. Barrister Haroon Duggal, Advocate Supreme Court of Pakistan submitted that prior to the abolition of the Concurrent Legislative List through the Constitution (Eighteenth Amendment) Act, 2010 ("18th Amendment") the subject of Drugs and Medicines was at Entry No.20 of the said list; that due to the abolition of Concurrent Legislative List through the 18th Amendment, the said subject did not fall within the legislative domain of the Parliament; that by virtue of Section 270 AA (6) of the Constitution, the Drugs Act, 1976 continued to remain in force until altered, repealed or amended by the Competent Authority, i.e. the Provincial Legislature; that under Article 144 of the Constitution, the Provincial Assembly of Punjab passed resolution dated 15.02.2012 to the effect that the Parliament may by law regulate matters relating to drugs and medicines; that the other Provincial Assemblies have also passed similar resolutions; that thereafter the Parliament, on 13.11.2012, enacted the DRAP Act; that Article 144 also empowers the Provincial Assembly to amend or to repeal the law enacted by Parliament pursuant to Article 144 of the Constitution; that after the enactment of the DRAP Act by the Parliament, the Provincial Assembly of Punjab has amended the Drugs Act, 1976 from time to time; that after such amendments, the authority given by the Provincial Assemblies to the Parliament to make law for the regulation of matters relating to drugs and medicines stood rescinded; that after the amendments made by the Provincial Assembly of Punjab in the Drugs Act, 1976, DRAP could not make the MD Rules in exercise of the powers conferred by Section 23 of the DRAP Act; and that such rules could not be made applicable to the Province of Punjab. 8. Furthermore, it was submitted that medical devices do not come within the meaning of "drugs"; that the MD Rules are manifestly arbitrary, unworkable and provide impossible deadlines which are contrary to the international best practices; and that the procedure prescribed in the MD Rules for the registration and renewal of medical devices are cumbersome. 9. The learned counsel for the petitioners prayed for the writ petitions to be allowed. The other counsel for the petitioners adopted the aforementioned arguments. Mr. Muhammad Umar Khan Vardag, Advocate, however, submitted that the petitioner whom he represents imports hearing aids, which do not come within the meaning of medical devices. 10. On the other hand, Barrister Ahmed Pervaiz learned counsel for DRAP submitted that the questions as to whether medical devices fall within the meaning of drugs and medicines, and the competence of the Parliament to legislate on the subject of drugs and medicines (which include medical devices) pursuant to the resolutions passed by the Provincial Assemblies under Article 144 of the Constitution has been exhaustively dealt with and decided by the Hon'ble High Court of Sindh in the judgment reported as Azfar Laboratories (Pvt.) Ltd. v. Federation of Pakistan (PLD 2018 Sindh 448) ("Azfar Laboratories' case") and by the Hon'ble Lahore High Court in the judgment reported as Dawakhana Hakeem Ajmal Khan (Pvt.) Ltd. v. Federation of Pakistan (PLD 2020 Lahore 899) ("Dawakhana Hakeem's case") as well as in the judgment dated 22.10.2020 passed in Writ Petition No. 20263 of 2020 titled "Johnson and Johnson Pakistan (Pvt.) Ltd. v. Federation of Pakistan and others." 11. Furthermore, it was submitted that medial devices have always been regulated as "drugs" under the Drugs Act, 1976 and were included in the definition of drugs either specifically or through the authority given to the Federal Government under the said Act; that not only does the definition of "drugs" in the said Act include medical devices but also allows the Federal Government to declare substances or devices as drugs; that it is not the petitioners' case that previously medical devices had not been regulated as drugs; that in the case reported as PLD 1992 SC 455, the Hon'ble Supreme Court held inter alia that the definition of drug in the Drugs Act, 1976 is wide and covers any matter, material or stuff manufactured and sold for the treatment, mitigation, prevention, or diagnosis of disease in human beings or animals; that the petitioners have not challenged any specific provision of the MD Rules; that the petitioners do not want the trade in IVD medical devices to be regulated by DRAP; that paragraph 3 of Schedule-I to the DRAP Act includes a device used for diagnosis, monitoring and treatment of disease to be a medical device; that IVD medical devices are critical for diagnosis and there can be no monitoring or treatment without diagnosis; that the GHTF and IMDRF guidelines also define IVD medical devices as medical devices; and that the mere fact that the compliance with the MD Rules would be inconvenient to the petitioners is not a valid ground to strike down vires of the said rules. Learned counsel for DRAP prayed for the writ petitions to be dismissed. 12. I have heard the contentions of the learned counsel for the contesting parties and have perused the record with their able assistance. 13. I propose in the first instance to decide the question as to whether the authority to legislate on the subject of drugs and medicines could be exercised by the Parliament pursuant to the resolutions passed by the provincial assemblies under Article 144 of the Constitution. 14. The scope and extent of the legislative power exercised by the Parliament under Article 144 of the Constitution has been discussed in detail by the Hon'ble High Court of Sindh in Azfar Laboratories' case (supra). After doing so and referring to the resolutions passed by the provincial assemblies authorizing the Parliament to legislate on the subject of drugs and medicines and the establishment of a regulatory authority, the Hon'ble High Court of Sindh dismissed the challenge to the constitutionality of the DRAP Act. I have gone through the said judgment with great interest and keenness and have been given no reason to take a different view. 15. Furthermore, challenge had also been made to the legislative competence of the Parliament to enact the DRAP Act before the Hon'ble Lahore High Court. In particular, it was asserted before the Hon'ble Lahore High Court that the Parliament could not legislate on the subject of medical devices as they did not come within the meaning of drugs and medicines. The Hon'ble Lahore High Court in the Dawakhana Hakeem's case (supra) and Johnson and Johnson's case (supra) upheld the constitutionality of the DRAP Act and/or the legislative competence of the Parliament to enact the said Act, and also the Parliament's competence to legislate on the subject of medical devices which were held to come within the meaning of drugs and medicines. 16. In some of the writ petitions, the vires of the DRAP Act have been challenged. It would be tedious and verbose to detail the reasoning of the Hon'ble High Court of Sindh as well as of the Hon'ble Lahore High Court in the said judgments. Suffice it to say that I am not inclined to take a different view from the law laid down in the said judgments, the petitioners' challenge to the constitutionality of the DRAP Act as well as their assertion that the subject of medical devices could not have been legislated upon by the Parliament is decided in terms of the law laid down in the said judgments. 17. Indeed, the Provincial legislature has the legislative competence to amend or repeal the DRAP Act to the extent to which it applies to the Province. This is explicitly provided in Article 144 of the Constitution. As regards the applicability of the DRAP Act to the Islamabad Capital Territory, Article 142(d) of the Constitution provides that the Parliament shall have exclusive powers to make laws with respect to all matters pertaining to such areas in the Federation as are not included in any Province. The Islamabad Capital Territory is indeed an area in Federation not included in any Province and therefore the Parliament has the exclusive powers to make laws with respect to all matters, including the regulation of drugs and medicines for such area. Insofar as the applicability of the DRAP Act to the Islamabad Capital Territory is concerned, it is only the Parliament that can amend or repeal the said Act. 18. The Provincial Assembly of the Punjab may have amended the provisions of the Drugs Act, 1976 but this by itself would not operate as a repeal of the DRAP Act to the extent of its applicability to the Province of Punjab. Article 144 of the Constitution also permits the Provincial Assemblies to amend the law enacted by the…

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