2025 PLP 1715 (CLC)
Messrs BIO LEADS (PVT.) LIMITED and others — Petitioners Versus FEDERATION OF PAKISTAN through Secretary, Ministry of Law and Justice and others — Respondents
| Citation | 2025 PLP 1715 (CLC) |
| Forum / Court | Islamabad |
| Bench Members | N/A |
| Parties | Messrs BIO LEADS (PVT.) LIMITED and others — Petitioners Versus FEDERATION OF PAKISTAN through Secretary, Ministry of Law and Justice and others — Respondents |
| Primary Law | (d) Constitution of Pakistan, (c) Constitution of Pakistan, (b) Constitution of Pakistan |
Q1: What are the key laws and sections cited in 2025 PLP 1715 (CLC)?
This judgment primarily cites: (d) Constitution of Pakistan, (c) Constitution of Pakistan, (b) Constitution of Pakistan, (a) Drug Regulatory Authority of Pakistan Act (XXI of 2012), (e) Interpretation of statutes as referenced in Pakistani case law index.
Q2: Which judicial bench decided the case 2025 PLP 1715 (CLC)?
The case was heard and decided by the Islamabad bench comprising: N/A.
Q3: What is the official citation format for this judgment on Pakistan Law Portal?
Cite this legal precedent as: 2025 PLP 1715 (CLC) (Messrs BIO LEADS (PVT.) LIMITED and others — Petitioners Versus FEDERATION OF PAKISTAN through Secretary, Ministry of Law and Justice and others — Respondents). Read the full summary and cross-referenced laws free on Pakistan Law Portal.
Laws Cited
Representation
- Barrister Ahmed Pervaiz, Barrister Ehsan Ali Qazi, Sifat Ullah, Advocates and Hafiz Bilal Bin Akbar, Assistant Director (Legal), DRAP.
- Sajid Mahmood Baig for Respondent No. 6 (in W.P. No. 2198 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).
- 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.
- 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.
- 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.
Headnotes / Summary
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.
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
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.
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
Parliament was competent to legislate on the subject of medical devices which came within the meaning of drugs and medicines.
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.
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.
Judgment & Decree
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 Parliament pursuant to the said Article. Since none of the Provincial Assemblies have repealed the provision in the D.R.A.P Act empowering D.R.A.P to make rules, therefore, the MD Rules made by DRAP in exercise of the powers conferred by Section 23 of the DRAP Act cannot be declared ultra vires simply on the ground that a Provincial Assembly has amended the Drugs Act, 1976. It is an admitted position that none of the Provinces have questioned the vires of either the DRAP Act or the MD Rules. If it is assumed that the MD Rules to the extent of bringing IVD medical devices within the regulatory domain of DRAP was beyond the authority given by the Provincial Assemblies to the Parliament to legislate on the subject of drugs and medicines, it is not understandable as to why the Provinces have not questioned the vires of the MD Rules to the said extent. This silence by the Provinces would endorse the view that the MD Rules are in conformity with the DRAP Act, which was enacted pursuant to the authority given by the Provinces to the Parliament under Article 144 of the Constitution.
19. The DRAP Act was enacted on 13.11.2012. As per the preamble of the said Act, one of the objectives of the said Act is to regulate the manufacture, import, export, storage, distribution and sale of therapeutic goods. The said Act defines therapeutic goods to include drugs or alternative medicine or medical devices or biological or other related products as may be notified by DRAP whereas the term medical devices has been defined to mean medical devices as specified in Schedule-I. Paragraph 3 of Schedule-I to the said Act provides that the medical devices include (a) instruments, medical equipment, implants, disposables and software, used mainly for the purpose of diagnosis, monitoring and treatment of disease; or (b) any other item which the Federal Government may, by notification in the official Gazette, declare as medical device.
20. Rule 2(xlii) defines an in-vitro diagnostic (IVD) medical device as follows:- in-vitro diagnostic (IVD) medical device means 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 purposes including reagents, calibrators, control materials, specimen receptacles, software and related instruments or apparatus or other articles and are used, for example, for the test purposes of diagnosis, aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction and determination of physiological status.
21. Rule 52 of the MD Rules exempts certain medical devices from the operation of the said Rules for the period specified in the said Rule. The said Rule also provides that all life saving and life sustaining medical devices specified in Schedule-D to the said Rules required to be registered shall be deemed to have been registered under the said Rules till the validity of their exemption period specified in the said Rule subject to the conditions specified therein.
22. Chapter-IV of the MD Rules deals with the subject of enlistment and registration of medical devices. Rule 12(1) in this Chapter provides that the MDB shall enlist and register medical devices which include any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings or animals for one or more of the specific medical purposes listed in the said Rule. The petitioners are aggrieved by the requirement for the MDB 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.
23. The Medical Devices Board has been defined in the MD Rules to mean a body responsible for enlistment or registration of medical devices, licensing of establishments and issuance of permits for export and import of medical devices and for matters ancillary thereto. Chapter-III of the said Rules, which deals with the subject of classification and grouping of medical devices, provides that for the purposes of registration and enlistment, the method of classification and grouping of medical devices shall be in accordance with Schedules-A and B to the said Rules, which the MDB may amend from time to time as per the GHTF or the IMDRF guidelines. The said Chapter also provides that in case of any dispute or uncertainty or combination product over classification of a medical device, the establishment may request the MDB to decide the dispute and the MDB shall take a decision in writing on the dispute.
24. The provision in the MD Rules which, according to the petitioners, most adversely impacts them is Rule 21 which provides that a medical device may be imported subject to the condition that the importer shall possess valid medical device establishment licence and medical device enlistment or registration and have premises under his possession for proper storage to preserve its properties. The power to issue licences is with the MDB. Rule 3 of the said Rules provides that the MDB shall issue (a) licence to manufacture medical devices, and (b) licence to import medical devices.
25. Chapter-IV of the said Rules provides for the classes of medical devices to be enlisted and registered, and the procedure for their enlistment and registration, IVD medical devices can fall in any of these categories depending on the hazard that it prevents. Section 4(d) of the DRAP Act makes the Director, Medical Devices and Medicated Cosmetics to be Incharge of the Division of medical devices and medicated cosmetics, which is responsible for the assessment, enlistment or registration of medical devices and medicated cosmetics, etc. Section 7(c) of the said Act empowers DRAP to issue guidelines and monitor the enforcement of inter alia the registration of therapeutic goods.
26. As regards the contention of the learned counsel for the petitioners that medical devices do not come within the meaning of drugs and medicines, the same has been authoritatively determined by the Hon'ble Lahore High Court vide judgment dated 22.10.2020 passed in W.P.No. 20263 of 2020. In paragraphs 13 to 16 of the said judgment, the Hon'ble Lahore High Court, after making reference to the relevant provision of the Drugs Act, 1976, and in particular to the definition of Drugs in Section 3(g)(i) to (viii) of the said Act as well as the World Health Organization Global Model Regulatory Framework for Medical Devices, held that the term drugs and medicines used in the resolution passed by the Provincial Assembly of Punjab would include medical devices, and consequently DRAP could regulate medical devices. The said judgment has till date not been suspended or set-aside. Therefore, the authority of DRAP to regulate medical devices has been judicially endorsed.
27. The question that remains to be considered is whether IVD medical devices are specie altogether different from medical devices and beyond the regulatory domain of DRAP. Now, the definition of therapeutic goods in Section 2(xxxvi) of the said Act includes medical devices. Paragraph 3 of Schedule-I to the said Act provides that the medical devices include (a) instruments, medical equipment, implants disposables and software, used mainly for the purpose of diagnosis, monitoring and treatment of disease; or (b) any other item which the Federal Government may, by notification in the official Gazette, declare as medical device. I am of the view that the meaning given to medical devices in paragraph 3 of Schedule-I of the DRAP Act would include an IVD medical device as defined in the MD Rules. The final document issued by the GHTF also describes an IVD medical device as 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. As long as a medical device is intended to be used for diagnostic monitoring or treatment of disease whether through in-vitro examination or otherwise it would be subject to regulatory oversight of DRAP. The mere fact that any equipment or machine is intended to be used as an aid in diagnosis through in-vitro examination would not take such equipment or machine out of the meaning of a medical device or beyond the regulatory domain of DRAP.
28. Rule 4(2) of the MD Rules require an application for inter alia the import of medical devices to be made to the MDB on the format set out in Form 2, which has been made a part of the said rules. The said form requires an applicant for the import of medical devices to produce a drug sale licence issued by the Provincial Government. This Court had granted interim relief to the petitioners to the effect that the requirement of furnishing a drug sale licence shall not be an obstacle for a licence to import medical devices to the petitioners. During the pendency of the petitions, the Ministry of National Health Service, Regulations and Coordination has issued notification dated 04.06.2021 whereby the requirement of furnishing a drug sale licence has been done away with by omitting serial number (viii) in column (2) of Form-2. Therefore, the petitioners' grievance to the extent of requiring them to furnish drug sale licences as part of their application for the issuance of licences to import medical devices have been rendered infructuous.
29. It is well settled that the vires of the MD Rules framed in exercise of the powers conferred by statute can be challenged on the touchstone of violation of the statute under which they are framed or the provisions of the Constitution. It is also well-settled that 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. Rules 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. In suo motu case No. 13 of 2009 (PLD 2011 SC 619), the Hon'ble Supreme Court held as follows:- [A] rule making body cannot frame rules in conflict with, or in derogation of, the substantive provisions of the law or statute, under which the rules are framed. Rules cannot go beyond the scope of the Act. Thus, we are inclined to hold that no rule can be made which is inconsistent with the parent statute, whereas, no regulation can be made inconsistent with the parent statute or the rules made thereunder and the provisions of these rules or regulations, as the case may be, to the extent of their inconsistency with the parent statute or the rules shall be inoperative.
30. The learned counsel for the petitioners have not pointed out any provision in the MD Rules which are in derogation of the DRAP Act. I have already observed herein above that the authority of DRAP to regulate the import of IVD medical devices is in conformity with the meaning given to medical devices in paragraph 3 of Schedule-I to the DRAP Act. It is not disputed that most of the petitioners have got themselves enlisted and so have the medical devices imported by them.
31. In view of the above, I do not find any merit in these petitions which are dismissed with no order as to costs. SCHEDULE-A Sr. No. Case No. Title Dates of Hearing
1. W.P. No. 1586/2020 Messrs Bio Leads (Pvt.) Ltd. and others v. Federation of Pakistan and others. 19.02.2021, 11.03.2021, 24.03.2021, 05.05.2021 and 02.06.2021
2. W.P. No. 2767/2018 Messrs Total Tech. (Pvt.) Ltd. v. Federation of Pakistan and others. -do-
3. W.P. No. 3350/2018 Naveed Felix v. Federation of Pakistan and others. -do-
4. W.P. No. 3351/2018 Messrs Euronano Diagnostics (Pvt.) Ltd. v. Federation of Pakistan and others. -do-
5. W.P. No. 3460/2018 Messrs Pakistan Microbiological Associates and others v. Federation of Pakistan and others. -do-
6. W.P. No. 3593/2018 Messrs Keyyani Medical Solutions v. Federation of Pakistan and others. -do-
7. W.P. No. 4490/2018 Messrs DWP Technologies v. Federation of Pakistan and others. -do-
8. W.P. No. 4736/2018 Messrs Gulf Marketing International and others. -do-
9. W.P. No. 1670/2020 Messrs AGBL Pakistan (Pvt.) Ltd. v. Federation of Pakistan and others. -do-
10. W.P. No. 1722/2020 Messrs Reaction Scientific (Pvt.) Ltd. v. Federation of Pakistan and others. -do-
11. W.P. No. 1764/2020 Wali Med v. Federation of Pakistan and others. -do-
12. W.P. No. 1843/2020 Messrs Cares Worth Pakistan Ltd. v. Federation of Pakistan and others. -do-
13. W.P. No. 1863/2020 Messrs Al Qazi Marketing Group and others v. Federation of Pakistan and others. -do-
14. W.P. No. 2148/2020 Irshad Sharif v. Federation of Pakistan and others. -do-
15. W.P. No. 2156/2020 Messrs Arrow Tech Medical Systems and others v. Federation of Pakistan and others. -do-
16. W.P. No. 2162/2020 Messrs Nycotech Incorporation and others v. Federation of Pakistan and others. -do-
17. W.P. No. 2198/2020 Dr. Niranjan Kumar v. Federation of Pakistan and others. -do-
18. W.P. No. 2258/2020 Hearing Care Services and others v. Federation of Pakistan and others. -do-
19. W.P. No. 2357/2020 Messrs Asia Pacific Technologies v. Federation of Pakistan and others. -do-
20. W.P. No. 2569/2020 Messrs JK Traders and others v. Federation of Pakistan and others. -do-
21. W.P. No. 2970/2020 Messrs Sky Ltd. and others v. Federation of Pakistan and others. -do-
22. W.P. No. 3047/2020 Messrs Raffay Associates v. Federation of Pakistan and others. -do-
23. W.P. No. 3582/2020 United Systems Corporation and others v. Federation of Pakistan and others. -do-
24. W.P. No. 3961/2020 Messrs Tokyo Medical Company and others v. Federation of Pakistan and others. -do-
25. W.P. No. 310/2021 Messrs Amarat Medical Tech. and others v. Federation of Pakistan and others. -do-
26. W.P. No. 580/2021 Messrs Alisco Agencies and others v. Federation of Pakistan and others. -do-
27. W.P. No. 634/2021 Messrs Abdullah Traders v. Federation of Pakistan and others. -do-
28. W.P. No. 674/2021 Messrs Doctor's Enterprises and others v. Federation of Pakistan and others. -do-
29. W.P. No. 772/2021 Messrs Science Tec v. Federation of Pakistan and others. 11.03.2021, 24.03.2021, 05.05.2021, 02.06.2021, 04.06.2021, 18.06.2021 and 01.07.2021
30. W.P. No. 836/2021 Messrs Scientific House v. Federation of Pakistan and others. 24.03.2021, 05.05.2021, 02.06.2021, 04.06.2021, 18.06.2021 and 01.07.2021
31. W.P. No. 899/2021 Messrs Medvision International and others v. Federation of Pakistan and others. -do-
32. W.P. No. 1006/2021 Messrs SAF Traders v. Federation of Pakistan and others. -do-
33. W.P. No. 1007/2021 Messrs Pro Carewell v. Federation of Pakistan and others. -do-
34. W.P. No. 1317/2021 Messrs Medical Ray X v. Federation of Pakistan and others. 05.05.2021, 02.06.2021, 04.06.2021, 18.06.2021 and 01.07.2021
35. W.P. No. 1349/2021 Messrs Medilab Services v. Federation of Pakistan and others. -do-
36. W.P. No. 1400/2021 Messrs A.Z Enterprises and others v. Federation of Pakistan and others. -do-
37. W.P. No. 1431/2021 Laiba International and others v. Pakistan and others. -do-
38. W.P. No. 1569/2021 Messrs Saim International and others v. Federation of Pakistan and others. -do-
39. W.P. No. 1650/2021 Messrs Orbit Diagnostics v. Federation of Pakistan and others. -do-
40. W.P. No. 1841/2021 Messrs FW Logistics and Trading v. Federation of Pakistan and others. -do-
41. W.P. No. 88/2021 Messrs M.J Medical Suppliers (Pvt.) Ltd. v. Arshad Jawad and others. -do-
42. W.P. No. 1951/2021 Messrs Medi Rays and others v. Federation of Pakistan and others. 04.06.2021
43. W.P. No. 1952/2021 Messrs Pakistan Medical Diagnostics Devices Association v. Federation of Pakistan and others. -do-
44. W.P. No. 1956/2021 VaryBiz v. Federation of Pakistan and others. -do-
45. W.P. No. 2134/2021 Messrs Power Zone and others v. Federation of Pakistan and others. 18.06.2021
46. W.P. No. 2337/2021 Messrs Multi Trade International Corp and others v. Federation of Pakistan and others. 01.07.2021 UN/12/Isl Petitions dismissed. * Received in 2025.