Ayesha A. Malik J. The instant Petition along with connected Petitions as detailed in Schedule "A" have challenged the legality and authority of the Drug Regulatory Authority of Pakistan ("DRAP") to regulate medical devices. The Petitioners also challenge the Medical Devices Rules, 2017 ("2017 Rules") for being excessive delegation essentially on the ground that the Medical Devices Board constituted thereunder is without the required authority under the DRAP Act. Consequently the Petitioners seek a declaration that the Respondent DRAP be permanently restrained from interfering in the manufacture, import and sale of medical devices.
2. There are three categories of Petitioners before the Court, namely importers, exporters and manufacturers of medical devices. The medical devices range from devices related to Covid-19, such as masks, oximeters, shields and gloves, to devices related to cosmetic surgery , in-vitro diagnostic device s, ultrasound, sutures, stents, legatures, disposable syringes, stapler guns to life saving medical devices. The exporters of medical devices essentially specialize in surgical instruments. Some of the Petitioners import medical devices for their own use whilst others act as importers/distributors for onward supply .
The case of the Petitioners
3. The basic contentions of the Petitioners is that Parliament does not have legislative competence on the subject of medical devices as medical devices do not fall within the ambit of 'drugs and medicine'. It is argued that since medical devices do not fall within the ambit of 'drugs and medicine', the resolution passed by the Punjab Provincial Assembly under Article 144 of the Constitution of Islamic Republic of Pakistan, 1973 ("Constitution") on 15.2.2012 with reference to 'drug and medicine' is not applicable to 'medical devices'. Hence Parliament is not competent to make law with reference to medical devices. It is also argued that 'drugs and medicine' are substances, which are ingested or applie d whereas medical devices are instrume nts, apparatus or machines and related articles used for diagnosis or non-medical procedures, hence are neithe r drugs nor medicine and were never intended to be treated as 'drugs and medicine'. Counsel for the Petitioner argued that historically medical devices were not included in the definition of 'drug' under the Drugs Act, 1976 ("Drugs Act") whereas under the Drug Regulatory Authority of Pakistan Act, 2012 ("DRAP Act") it has been included under 'therapeutic goods' which in itself suggests that medical devices are not drugs and medicine. It is also argued that for all intents and purposes 'drugs and medicine' are distinct from medical devices and they cannot be treated as drugs and medicine as their functions and usage is different. Consequently the resolution dated 15.2.2012 passed by the Punjab Provincial Assembly does not authorize Parliament to legislate on medical devices. With reference to the 2017 Rules, it is argued that they are beyond the mandate and power provided unde r the DRAP Act as there is no concept of a Medical Devices Board under the DRAP Act, hence the Medical Devic es Board established under the 2017 Rules is illegal, based on excessive delegation of power . It is also argued that the medical devices imported by the Petitioners are all high quality , certified by prestigious international bodies, hence requiring further certification and permission from DRAP for the purposes of import and clearance is totally against the mandate of the law; that the Respondents have failed to establish standards against which the Petitioners' import and export or production and sale can be regulated; that the timelines followed by DRAP are long and are not in the best commercial interest of the Petitioners. It is further argued that the 2017 Rules are arbitrary and impracticable. The exporters of medical devices claim that the export of surgical instruments cannot be regulated by DRAP . It is their case that they manufacture high quality surgical instruments through various artisa ns and technicians working at a small scale from their homes or small workshops and specialize in one of the many steps involved in the process of manufacturing surgical instruments. Hence regulating the export of surgical instruments is impracticable and does not fall under DRAP' s mandate.
4. The Petitioners who import in-vitro diagnostic devices and cosmetic devices argue that these devices do not interact with the subject used upon and are only used for diagnostic and monit oring purposes or for cosmetic purposes, hence they cannot be classified as a drug or medicine, as they do not treat any disease. Similar is the argument for those importing devices used during the pandemic Covid-19 as they also agitate that they should not be required to obtain an NOC for import and release of their consignments as this is not DRAPs mandate. Learned counsel for the Petitioners have placed reliance on Constitution Petition No.127 of 2012 (PLD 2013 SC 829), Johnson and Johnson Pak (Pvt.) Ltd. v. Pakistan and others (2008 PTD 345), Dr. Shahnaz Wajid v.
Federation of Pakistan through Secretary Establishment Division, Government of Pakistan, Islamabad (2011 SCMR 1737 ), Nadeem Ahmad Advocate v. Federation of Pakistan (2013 SCMR 1062 ), Khawaja Ahmad Hassaan v. Government of Punjab and others (2005 SCMR 186) and Pakistan through Secretary Finance, Islamabad and 5 others v. Aryan Petro Chemical Industries (Pvt.) Ltd. Peshawar and others (2003 SCMR 370) in support of their arguments.
The case of the Respondents
5. On behalf of the Respondent DRAP , learned counsel argued that medical devices have historically always been treated as 'drugs' under the Drugs Act as it is specifically included in the definition of 'drug' in Section 3(g)(ii)(vi) and (viii). He stated that even otherwise the nature of the definition of 'drug' under the Drugs Act covers medical devices as these devices are used in the treatment, monitoring, prevention or diagnosis of diseases which include substances or devices which the Federal Government may by notification declare as a drug for the purposes of the Drugs Act. He argued that under the DRAP Act medical devices are included in the definition of therapeutic goods in Section 2(xxxvi) and defined in Section 2 (xii) of the DRAP Act. As Medical devices are used for treatment, diagnosis, facilitation and prevention of disease they must be regulated to ensure safety , effectiveness and efficacy .
At the heart of the regulatory objective is the health and well being of the person for whose benefit the medical device is to be used. He stated that the 2017 Rules are in accordance with law as a summary for the approval of the 2017 Rules was moved before the Federal Cabinet which approved the same on 15.1.2018. The 2017 Rules were published on 17.1.2018 consequent to which DRAP is authorized to regulate importers and exporters of medical devices to ensure the registration of their products and also to ensure that the medical devices are compliant of the required standards. He stated that this is as per international practice where medical devices are subject to strict review and scrutiny at the time of import or export not only to ensure that they have been manufactured in accordance with the applicable laws but also to ensure the safety , efficacy and effectiveness. He also argued that this matter was considered by the august Supreme Court of Pakis tan in 2017 in a Suo Motu Case with reference to the substandard cardiac stents and it was on the clear directions of the august Supreme Court of Pakistan that the 2017 Rules were promulgated. He stated that the Medical Devices Board has been constituted in accordance with the law and the direction of the august Supreme Court and that most of the Petitioners before the Court are duly registered with DRAP and have applied for registration with the Medical Devices Board.
6. Learned counsel for DRAP further stated that the resolution by the Punjab Provincial Assembly on 15.2.2012 which is with reference to 'drugs and medicine', for all intents and purposes it includes medical devices because at the time medical devices were regulated under the Drugs Act. He explained that prior to the Eighteenth Amendment to the Constitution, matters related to drugs and medicine were listed under Entry No.20 of the Concurrent Legislative List in the Fourth Schedule to the Constitution and were administered under the Drugs Act.
The definition of 'drug' under the Drugs Act was not exhaustive and included the medical devices specifically and those included by way of the notifications issued by the Federal Government from time to time. He further argued that medical devices are considered to be part and parcel of the definition of drugs throughout the world and are subject to regulatory compliance. Therefore he argued that DRAP is duly authorized to regulate medical devices under the Drugs Act and the DRAP Act.
7. Report and parawise comments have also been filed on behalf of the Respondent Federation. Learned Additional Attorney General for Pakistan argued that the statute cannot be declared unconstitutional unless its invalidity is beyond reasonable doubt; that all matters relating to drugs and medicine have been allocated to the National Health Service, Regulation and Coordination, Division, Islamabad and that Parliament is empowered to regulate the subject matter of medical devices. Report and parwise comments have also been filed on behalf of Federal Board of Revenue and Collectorate of Customs. Learned counsel argued that the matter does not fall within the domain of the stated Respondents.
8. On the basis of the arguments made before the Court, the issues before the Court are firstly; whether Parliament is competent to legislate on medical devices and whether medical devices fall within the ambit of the resolution passed by the Punjab Provincial Assembly on 15.2.2012 and Secondly; whether the Medical Devices Board as constituted under the 2017 Rules has been constituted in accordance with law and finally whether the processes before the Medical Devices Board is laborious and time consuming so as to prejudice the businesses of the Petitioners.
On Legislative Competence
9. The basic case of the Petitioners is that medical devices do not fall within the ambit of 'drugs and medicine', hence Parliament cannot legislate on the same. Learned counsel for the Petitioners argued that the resolution passed by the Punjab Provincial Assemb ly dated 15.2.2012 is specifically with reference to 'drugs and medicine' and does not mention medical devices. Hence they argued that Parliament cannot legislate on medical devices as the Provincial Legislature is competent to legislate on the subject of medical devices. They have relied on various definitions of drugs and medicine to establish the point that medical devices are not drugs and medicines as they are not substances, nor injected and in some cases not used for medical purposes.
10. On behalf of Respondent DRAP , it is argued that historically medical devices have been regulated under the Drugs Act; that the Drugs Act specifically mentions medical devices within the definition of 'drug' under Section 3(g)
(ii) (vi) and (viii). Learned counsel further argued that the courts have interpreted the definition of drugs to mean and include medical devices. Reliance is placed on Chimanlal Jagjivandis Sheth v. State of Maharashtra (AIR 1963 SC 665 (V 50 C 102) in which the court has held that the definition of 'drugs' is comprehensive enoug h to include drugs and medicines as well as medical devices that is substances which are not strictly used as medicine but undertake similar functions for treatment and diagnosis. Learned counsel further argued that the Federal Government can notify any substance to be treated as a drug, hence SRO 957(1)/2009 dated 5.11.2009, SRO 916(1)/2010 dated 30.9.2010, SRO 917(1)/ 2010 dated 1.10.2020, SRO 918(1)/2010, SRO 919(1)/2010, SRO 824(1)/2018 dated 28.6.2018 have been issued which includes medical devices in the definition of drug under the Drugs Act.
11. So far as the DRAP Act is concerned, medical devices have been specifically included in the definition of 'therapeutic goods' and are defined unde r Section 2(xxxvi) of the DRAP Act read with Schedule-I of the DRAP Act so as to include all instruments, medical equipments, implants, disposables and software which are used in the diagnosis, monitoring and treatment of disease or any other item which the Federal Government may declare by way of notification to be a medical device. Therefore he argued that for all intents and purposes medical devices have always been construed as a drug and have always been regulated so as to ensure its safety , effectiveness and efficacy . Consequently at the time when the Punjab Provincial Assembl y passed the resolution dated 15.2.2012, the definition of 'drugs and medicine' included medical devices.
12. The scope of the resolution passed by the Punjab Provincial Assembly has already been discussed by this Court vide judgment dated 5.8.2020 passed in WP No.3973/2017 titled Dawakhana Hakim Ajmal Khan (Pvt.)
Limited v. Federation of Pakistan, etc. ("Dawakhana Case"), so as to include a large variety of produc ts which as per the petitioners before the Court in that case did not fall within the meaning of 'drugs and medicine' which reads as under:- For the purposes of legislative competenc e there is no legal basis to urge the point that certain products were not intended to be regulated by and under the DRAP Act. Whether or not a product falls under DRAP' s regulatory jurisdiction, will be seen in the context of DRAP' s regulatory objective and the processes laid out to evaluate the products. It is not the Resolution passed by the Provincial Assembly of Punjab which will determine this issue rather the criterias set out by DRAP to determine whether a product falls under its regulatory jurisdiction. This has to be done in the context of the DRAP Act, the Rules and the regulatory objective of DRAP . Furthermore, classification of products requires a formal determination by DRAP and cannot be broadly categorized as per the dictionary meaning of food or drug or cosmetic for that matter . Similarly alternative medicine encompasses a wide array of traditional remedies, products and therapies which have to be seen in the context of the statutory definition under the DRAP Act. Hence there is no merit in the argument that the Provin cial Assembly of Punjab never intended to grant legislative authority for these products, as this issue can only be answered in the context of the DRAP Act and the Rules. In this regard, it is also important to note that the Province of Punjab has not challenged or questioned the competence of Parliament to regulate drugs and medicine under the DRAP Act nor have they stated in their report and parawise comments filed before this Court, there is a dispute. To the contrary the Province of Punjab has taken the position that the DRAP Act is in addition to and not in derogation of the Drug Act and that the objective of the amendments to the Drug Act was to enable the Provincial Government to deal more efficiently with spurious, adulterated and substandard drugs. Therefore based on the aforesaid, Parliament is competent to enact the Drug Act and the amendments to the Drug Act have not revoked or cancelled the Resolution dated 15.02.2012 given by the Provincial Assembly of the Punjab to Parliament to regulate the subject of drugs and medicine.
In this regard, it is important to note that the entire case of the instant Petitioners with reference to medical devices is also based on the strict interpretation of the words 'drugs and medicine' used in the resolution passed by the Punjab Provincial Assembly . The said resolution allows Parliament to make laws to regulate the subject of 'drugs and medicine' in the following terms: The Provincial Assembly of the Punjab resolves that the Majlis-e-Shoora (Parliame nt) may, by law, regulate matters relating to drugs and medicines in term of Article 144 of the Constitution of Islamic Republic of Pakistan.
Hence the issue before the Court is whether medical devices are 'drugs and medicine'.
13. The DRAP Act under Section 32 provides that the Act is in addition to and not in derogation of the provision s made in the Drugs Act and any other law enforced. The Drugs Act defines 'drug' in Section 3(g) in the following terms:- Drug Act, 1976 Section 3(g) (i) to (viii)
(g) "drugs" includes,--
(i) any substance or mixture of substances that is manufactured, sold, stored, offered for sale or represented for internal or external use in the treatment, mitigation, prevention or diagnosis of disease, an abnormal physical state, or the symptoms thereof in human beings or animals, or the restoration, correction, or modification of organic functions in human beings or animals, not being substance exclusively used or prepared for use in accordance with the ayurvedic, unani, homeopathic or biochemical system of treatment except those substances and in accordance with such conditions as may be prescribed;
(ii) abortive and contraceptive, substances, agents and devices , surgical ligatures, sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, gelatin capsules and antiseptic solutions;
(iii) such substances intended to be used for the destruction or repulsion of such vermin, insects, rodents and other organisms as cause, carry or transmit disease in human beings or animals or for disinfection in residential areas or in premises in which food is manufactured, prepared or kept or stored;
(iv) such pesticides as may cause health hazard to the public;
(v) any substance mentioned as monog raph or as preparation in the Pakistan Pharmacopoeia or the Pakistan National Formulary or the International Pharmacopoeia or the British Pharmacopoe ia or the British Pharmaceutical Codex or the United States Pharmacopoeia or the national Formulary of the United States, whether alone or in combination with any substance exclusively used in the unani, ayurvedic, homeo pathic or biochemical system of treatment, and intended to be used for any of the purposes mentioned in sub-clauses (i), (ii) and (iii); and
(vi) immediate packing containers for sterile preparations which are in direct contact with the drug, blood bags, disposable giving set for infusion or blood, disposable syringes or any other substance or device which the Federal Government may, by notification in the Official Gazette, declare to be a "drug" for the purposes of this Act;
(vii) Infant formulas, follow up milks, milk substitutes, baby foods, baby gruels, baby teas and juices, bottles and treats and any other product used as infant formula as such;
(viii) Cosmetics including hair Sprays, perfumes, facial and talcum powders, hair treatment shampoos, hair conditioning aids and devices and all formulas and lotions connected therewith for conditioning and cleaning of hair, hair colours, facial make-up foundations, vanishing and cold creams, creamy make-up sticks, bath lotions and oils, blushers and blush-ons, texture improvement devices, moisturizers of all kinds, mascaras, vaselines, sunnas, wrinkle-care creams, hair oils/herbal preparations for texture and facial glow and improvement, shower creams, skin lotions and oils, sun-burn lotions and oils, shaving cream and lathers, after-shave lotions and any other preparation or material connected therewith; (emphasis added)
Devices find mention specifically in Section 3(g) (ii) and (vi) of the Drugs Act. Section 3(g)(ii) specifically lists out certain devices including surgical ligatures, sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, gelatin capsules and antiseptic solutions which have been included in the definition of drug. It also provides that substances, agents and devices are included in the definition of drug, meaning thereby that the definition of 'drug' was not limited to medicine or substances which are ingested, applied or administered but include devices. Furthermore Section 3(g)(vi) of the Drugs Act allows the Federal Government to notify any substance or device as a drug. Consequently the Federal Government notified certain substance to be a drug vide SRO 957(1)/2009 dated 5.11.2009 declaring canula, catheter and stent, being medical devices, to be drugs under the Drugs Act and vide SRO 916(1)/2010 dated 30.9.2010 amended the Drugs (Licensing Registering and Advertising) Rules, 1976 to include medi cal devices. It prescribed the requiremen ts for manufacturing of medical devices. SRO 917(I)/2010 amended the Drugs (Specification) Rules, 1978 to includ e medical devices and required medical devices to meet the requirements set out in British Pharmacopoeia and where specifications are not given in the British Pharmacopoeia, to follow specifications given by International Stand ards Organization, World Health Organization "WHO" ), United States Pharmacopoeia and International Pharmacopoeia. SRO 918(I)2010 amended the Drugs (Labelling and Packing) Rules, 1986 to include medical devices and regulated labelling and packing of medical devices. SRO 919(I)/2010 amended the Drugs (Import and Export) Rules, 1976 to include medical devices for regulating its import and export. Hence the contention of the Petitioners that medical devices have never been regulated under the Drugs Act is without basis. Medical devices were regulated under the Drugs Act, and were included in the definition of 'drug' either specifically or through the authority given to the Federal Government under the Drugs Act. Not only does the definiti on include devices but the Drugs Act allows the Federal Government to declare substances or devices to be drugs. This means that the legislature was conscious of the fact that the list provided in the definition of 'drug' under the Drugs Act is 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 .
14. There is no specific definition of the term medical devices. They are used in diverse settings, at home, by paramedical staff, in clinics, in hospitals by doctors or dentists. They can be used for diagnoses, for monitoring for assistance and for life support purposes. As per the WHO there are an estimat ed two million different kinds of medical devices on the world market in more than 22000 generic groups. Consequently the term medical devices cover a wide range of products that are used in processes or procedures where the health and safety of the user is relevant. Globally 'medical devices' are regulated due to their use in the diagnosis, prevention, mitigation and treatment of disease. They include health care equipment as well as devices used in cosmetic surgery and processes as well as in-vitro diagnosis medical devices. The WHO defines medical devices and IVD in the WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices as: 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, for one or more of the specific medical purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury; investigation, replacement, modification or support of the anatomy or of a physiological process; supporting or sustaining life; control of conception; disinfection of medical devices; providing information by means of in vitro examination of specimens derived from the human body , and which does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body , but which may be assisted in its intended function by such means.
IVD 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 body solely or principally to provide information for diagnostic, monitoring or compatibility purposes (1). For a glossary of other relevant terms, see Appendix 1.
There may also be products on the market that are similar to medical devices in function and risk that do not fit within these definitions. For reasons of protecting public health they are regulated as if they were medical devices.
Examples include: impregnated bed nets to protect against malaria-bearing mosquitoes; personal protective devices to avoid cross-infection; lead aprons to protect against radiation; some medical gases; and implantable or other invasive products for a cosmetic rather than a, medical purpose.
15. As per the definition given by the WHO it is the purpose of the medical device which is relevant and which renders medical devices to regulations similar to drugs and medicine. This is fundamental to the health and safety of the user of the medical devices. Hence 'drugs and medicine' cannot be restrictively construed particularly when the record shows that drugs included medical devices. Therefore the term 'drugs and medicine' unsed in the resolution passed by the Punjab Provincial Assembly cannot be given limited application as the term drug has always included medical devices and it is for DRAP to decide whether a medical device is to be regulated. This Court has already held in the Dawakhana case that; A bare reading of both definitions show that the intent of the legislature has always been to cover a broad category of products. For the purposes of the dispute at hand the products of the Petitioners are classified under the definition of Alternative Medicine, Therapeutic Goods, Health and OTC Products and Medicated Cosmetics which definitions do not offend any fundamental right or interest of the Petitioners. The intent of the legislature is to provide a broad based definition so as to ensure that if a product falls within the regulatory objective of DRAP it must be compliant with its regulatory requirements. DRAP is also authorized to ensure implementation of internationally recognized standards, especially implementation of guidelines issued by World Health Organization.
To execute its powers and functions, the composition of DRAP is made of specialist directors in every field and if required the Federal Government can always increase the number of divisions or directors as required. The Drug Act also provided for regulating the import and export of drugs, the manufacture of drugs and the sale of drugs.
Hence the Drug Act also contemplated the registration, licensing and regulation of the manufacture of drugs as well as the import and export of drugs. The DRAP Act being in addition to the Drug Act maintains these functions in addition to those stipulated in the DRAP Act. Accordingly the legislative intent is clearly to build upon the regulatory framework under the Drug Act to include Therapeutic Goods, Alternative Medicine , Health and OTC Products and Medicated Cosmetics. The objective of the regulatory framework is to ensure that the consumer or user of the product is protected from harm, and that the consumer knows what they are buying or consuming.
16. So far as the DRAP Act is concerned, it includes medical devices in the definition of therapeutic goods bringing it within DRAP' s regulatory domain. Section 2(xviii) of the DRAP Act provides that medical devices means the devices stipulated in Schedule-I and Schedule-I provides that medical devices are (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. The DRAP Act as per its preamble states its purpose as being to regulate the manufacture, import, export, storage and distribution and sale of therapeutic goods. The reason being that therapeutic goods which have a health related purpose have to be regulated for safety , efficiency and efficacy .
Hence medical devices have been specifically and purposefully included in the range of therapeutic goods for the purposes of regulation. In this regard, it is for DRAP to decide whether a medical device falls within their regulatory domain as the underlying principle will be the purpose for which the device is used. This is because medical devices play a significant role in health care delivery and also carry some element of risk associated with the purpose and usage. Medical devices are regulated by DRAP to ensure safety , effectiveness and quality and are assessed on the basis of their classification. Medical devices are classified in four categories based on intended use with class A being lowest in risk and class D being highest in risk. Even in "Messrs Azfar Laboratories Private Limited through Directors and others v. Federation of Pakistan through Secretary Ministry of National Health Services and 4 others" (PLD 2018 Sindh 448) ("Azfar Laboratories Case") while discussing the resolution passed by the Punjab Provincial Assembly the Court concluded that it appears to be stated in the broadest of terms. The Court also concluded that the silence and lack of action by the Provincial Assembly is significant, as it suggest that the Provincial Government has no objection to the regulatory ambit of DRAP as per the DRAP Act. Hence for all intents and purpose medical devices fall within the authority granted by the Punjab Provincial Assembly to Parliament vide resolution dated 15.02.2012 as the sole object of the resolution was to authorize Parliament to regulate the subject of medicine which includes medical devices.
17. The next question is whether the Medical Devices Board has been established lawfully under the DRAP Act read with the 2017 Rules or whether it is a case of excessive delegation. Learned counsel argued that the DRAP Act in Section 7(u) has not constituted a registration board or a licensing board as defined in Section 2(xvii) and (xxxii) of the DRAP Act. It is further argued that only board established under the DRAP Act is the policy board in terms of Section 9 of the DRAP Act and there is no provision under the DRAP Act which establishes a Medical Devices Board. Learned counsel further argued that the Medical Devices Board has not been catered for even in the definitions or in any provisions of the DRAP Act, hence its establishment under the 2017 Rules is illegal and amounts to excessive delegation.
18. On behalf of the Respondents it is argued that the Registration Board is constituted under the Drugs Act which provides for a registration board as well as licensing board in terms of Section 5 and 7 of the Drugs Act. Learned counsel further argued that Section 7(u) of the DRAP Act includes the power to establish a board for the purposes of the licensing, registration, pricing and appellate function. He stated that on the directions of the august Supreme Court of Pakistan in Human Rights Case No.623-P/2017 (in the matter of imbedding substandard cardiac stents)
("HRC") regarding sale of substandard stents, several directions were given to DRAP which included the direction to establish a separate board for medical devices to improve its regulatory regime over medical devices.
Consequent thereof in the 241st meeting of the Registration Board held on 23.12.2013, the matter was taken up by the Registration Board and it was decided that a separate board be established for medical devices. Finally in the 268th meeting of the Registration Board, a decision for the establishment of Medical Devices Board was approved, such that the experts with reference to medical devices on the Registration Board were shifted to the Medical Devices Board. Learned counsel further argued that essentially the registration board established and constituted under the Drugs Act was bifurcated so as to become a separate registration board for medical devices. Learned counsel argued that the Registration Board and the Licensing Board under the Drugs Act was originally registering and licensing drugs which included medical devices but with the constitution of the Medical Devices Board the task of registering and licensing medical devices was shifted to the Medical Devices Board. He further argued that majority of the Petitioners before this Court have been registering their medical devices originally with the Registration Board and now with the Medical Devices Board, hence they cannot aprobate and reprobate at the same time. In this regard he has relied on the registration certificates of various different medical devices by the Petitioners including the instant Petitioner before the Court, Johnson & Johnson Pakistan (Private) Limited. He has placed a list of all importers and local manufacturers registered with the Medical Devices Board on record.
19. As per the record, a summary for the Federal Cabinet was prepared on 15.12.2 017 for approval of the Medical Devices Rules, 2017. The Medical Device Rules, 2017 were submitted for approval of the Cabinet on 15.12.2017.
On 26.12.2017 the Cabinet considered the summary dated 15.12.2017 submitted by National Health Services, Regulations and Coordination Division for approval of Medical Devices Rules, 2017 and approved the same. In terms of letter dated 15.1.2018 issued by the Ministry of National Health Services, Regulations and Coordination, Islamabad, Chief Executive Officer, DRAP was requested to notify the approved Medical Devices Rules, 2017 and to submit a copy of the notified rules for onward submission to Cabinet Division. On 17.1.2018 SRO 32(1)/2018 was issued by the Ministry of National Health Services, Regulations and Coordination Drug Regulatory Authority of Pakistan, Islamabad whereby the Medical Devices Rules, 2017 were notified in the official gazette. Thereafter through SRO 143(1)/2018 dated 7.2.2018, in terms of Rule 59 of the Medical Devices Rules, 2017, Medical Device Board was constituted comprising of ten members. Furthermore the record shows that as per order dated 2.3.2017 in the HRC Case the august Supreme Court of Pakistan directed that a committee be constituted comprising of all stakeholders to resolve the issue of registration of medical devices and to make the process efficient. The Association of Medical Devices, some importers and some local manufacturers of medical devices were all before the august Supreme Court of Pakistan on that date. Subsequently consultative meetings were held on 6.3.2017 and 10.3.2017 with representation of all stakeholders. In fact notification dated 21.3.2017 issued by Ministry of National Health Services, Regulations and Coordination, Islamabad shows that several of the Petitioners were part of the Committee established to revise the Medical Devices Rules 2015 for improving the working of DRAP towards medical devices. The meetings resulted in the 2017 Rules which is now under challenge.
20. Section 5 of the Drugs Act calls for the grant of licenses to manufacture drugs on the terms and conditions provided by the Central Licensing Board . Section 7 povides for the registration of drugs in accordance with the conditions prescribed by a Registration Board comprising of such persons as may be prescribed. Consequent thereof a Registration Board was establis hed which was performing the functions of registration of drugs including medical devices. Under the Drugs (Lice nsing, Registering and Advertising) Rules, 1976. The requirements of registration of drugs by the Registration Board are provided in Chapter III Rule 24 and 25 read with Rule 29 which prescribes the procedure for registration. As the DRAP Act provides under Section 32 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 establishment of the Registration Board as per Section 7 of the Drugs Act is in accordance with law. The DRAP Act established DRAP under Section 3 of the DRAP Act and the composition of DRAP is in Section 4 which has created different directors which includes the Director Medical Devices and Medicated Cosmetics. He is incharage of the Division of Medical Devices and is responsible for all functions related to regulation and enlistment. In terms of Section 7 of the DRAP Act, DRAP has the power and function to issue guidelines and monitor the enforcement of licensing registration and regulations for therapeutic goods and under Section 7(u) DRAP is to perform the functions of licensing, registration, pricing and appellate functions. Consequently the DRAP Act does not need to constitute a registration board that has already been constituted under the Drugs Act. DRAP has the authority to issue guidelines and also to undertake the functions of licensing and registration. On the basis of the statutory powers, DRAP can take decision related to the functions of registration and licensing. In the 46th session of the National Assembly held on 14.9.2017 the Minister for National Health Services, Regulations and Coordination apprised the Assembly that medical devices were regulated as 'drugs' under the Drugs Act and that the august Supreme Court of Pakistan has directed in a case related to the sale of substandard stents that DRAP formulate a more efficient process with respect to medical devices. Subsequently , a report was tendered by the Secretary to the Prime Minister in which it was recommended that there should be a Medical Devices Board which will specialize in the function of registration and licensing of medical devices so as to ensure efficiency in the process and also to simplify procedures for the benefit of its users. Consequently the matter was taken up at the 241st meeting of the Registration Board of DRAP wherein it was decided that a Medical Devices Board shall be set up which will deal specifically with registration and licensing of medical devices. Hence as per the record, the Medical Devises Board is a subset of the Registration Board duly constituted under the Drugs Act and in line with its functions and authority .
21. Under the DRAP Act, Section 7 provides for the powers and functions of the authority which specifically requires that the authority issue guidelines and monitor the enforcement of licensing, registration, advertisement, drug specifications, pricing among other functions. Sub-section (u) provides specifically for the functions of licensing, registration, pricing and appellate function thereof and Section 8 gives the authority the power to delegate its functions to any of those officers as it may deem appropriate. The 2017 Rules defines Medical Devices Board to be the body responsible for the enlistment and registration of medical devices, licensing of establishment and issuance of permits for export and import of medical devices and for matters related there to. All these functions are provided for under the DRAP Act and were previously administered by the Registration Board under the Drugs Act. The Registration Board and the Licensing Board are contemplated under the Drugs Act and were constituted accordingly . The Medical Devices Board as a subset of the Regist ration Board specializes in the enlistment, licensing of medical devices and is duly constituted. Hence there is no illegality in sub-dividing the functions of the registration board so as to create a separate board for the purposes of registering and licensing medical devices. The Medical Devices Board is in fact the registration and licensing board contemplated under the Drugs Act but has been given a separate name so as to distinguish it from drugs and other therapeutic products registered under the DRAP Act.
22. As per the record provided by the DRAP , the minutes of meeting of the Medical Devices Board show that the Petitioners have applied for registration and licensing before the Registration Board and the Medical Devices Board since its inception. In fact the Respondent DRAP has relied upon WP No.3134/2017 filed by Ferozsons Laboratories Limited in which the petitioner admitted and accepted the registration process before the Medical Devices Board wherein it was specifically stated that the Medical Devices Board is responsible for registration and licensing of medical devices and in fact it was their case that the 2017 Rules will regulate all medical devices and that all medical devices registered unde r the Drugs Act should be deemed to be registered under the Medical Devices Rules, 2017. In this regard, it is noted that the petitioner Ferozsons Laboratories Limited is also before the Court in WP No.16171/2020 now challenging the establishment of the Medical Devices Board in total negation of their earlier contention in WP No.3134/2017. Hence there appears to be no justifiable ground for challenging the constitution of the Medical Devices Board.
23. The Petitioners have argued that the process and procedure adopted by DRAP with reference to medical devices are laborious and not conducive to good practices, hence have an adverse impact on the commercial interests of the Petitioners. The Petitioners have agitated on the enforcement of timeline by DRAP on the fees structure followed by DRAP , on the application methodology for enlistment or for licensing and for NOCs as being tedious and encumbring and un-practical, hence the 2017 Rules are liable to be struck down. Learned counsel for DRAP along with Dr. Ghazanfar Ali Khan, Secretary/Director Medical Devices Board has explained that the consultative process is underway in which several of the issues highlighted by the Petitioners are before a committee seeking to revise the rules. It is stated that previously before the establishment of the Medical Devices Board a consultative process was adopted to revise the 2015 Rules which resulted in the 2017 Rules. In the same way a consultative process is again underway and most of the issues highlighted by the Petitioners can be placed before DRAP , however it does not necessitate striking down the rules. Learned counsel has placed reliance on the facilitative processes adopted by DRAP for the purposes of medical devices, such as Standard Operating Procedures ("SOPs") for enlistment purposes, for renewal purposes, for obtaining NOCs for clearance of imported products and for inspection of good distribution practices for medical devices.
24. Regulating medical devices is an evolving field which may face various different complications on account of the variety of issues that are related to the development of medical devices, their usage and performance. The primary regulatory objective of DRAP is to ascertain the performance and usage of the medical devices and thereafter to ensure safety and effective ness in the performance of medical devices. This is essentially done through the process of risk assessment which involves analysis and evaluation of the risks involved with respect to the medical device, which is why the devices are categorized and classified as per the risk involved in their usage.
It is noted that even under the Drugs Act, the import, export and manufacturing of medical devices including packing, advertisement, sale and distribution was regulated so as to ensure that the medical device is as per the required standards to ensure safety , efficacy and effectiveness. In this regard, it is noted that one of the arguments put forward was that where medical devices are registered with regulatory authorities of foreign jurisdiction they should not be re-evaluated by DRAP for the purposes of enlistment, licensing or clearance. However , this argument is totally misplaced as the mere fact that a product is registered with a regulatory authority of foreign jurisdiction does not mean that the medical device should not be scrutinized at the time of manufacture, import or export by DRAP to ensure compliance with its regulatory requirements. For the purposes of medical devices manufactured, imported or exported into Pakistan or from Pakistan it must be ensured that the standards set out by DRAP are complied with. As the issues raised are with respect to processes and delay , the Petitioners can raise it with DRAP to duly consider the same and make changes in the rules or SOPs where required and if required. So far as the regulatory regime of medical devices is concerned, as provided for under the Drugs Act, DRAP Act and the 2017 Rules, 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 to ensure the safety and ef fectiveness of the medical devices.
25. Under the circumstances, no case for interference is made out. All these Petitions are dismissed.