SHAHID KARIM, J. This constitutional petition challenges the order dated 18.10.2018 passed by the Provincial Quality Control Board Punjab while dealing with the review petition filed by the petitioner under Section 11 of the Drugs Act, 1976 in its 194th meeting held on 18.10.2018. The case relates to inspection carried out by Drug Inspector on the premises of M/s UDL Distribution (Pvt.) Ltd. During inspection he took samples of certain contraceptives for the purpose of test/analysis and declared these contraceptives to contain an allopathic ingredient. The District Quality Control Board after issuing show cause notice to the petitioner and providing opportunity of hearing recommended to grant permission for prosecution. It is admitted on all hands that the petitioner's product is placed in clause 'C' of Classification under Rule 17 of the Schedule 'A' of Medical Devices Rules, 2017 and such products are regulated by Medical Devices Board. In the reply submitted on behalf of the respondents having admitted the product to be regulated by Medical Devices Board, put forth the following reason for initiating proceedings in respect of that product by the Drug Inspector under the Act, 1976: "...However, petitioner's product, although is a condom, but is declared to contain allopathic ingredient i.e., Lignocaine which is a drug in terms of Section 3(g)(i)&(v) of Drugs Act, 1976 and comes under the jurisdiction of Drug Inspector, Drugs Testing Laboratory and Provincial Quality Control Board. Moreover, the intended therapeutic use of lubricating the condom with Lignocaine is to delay ejaculation/to treat premature ejaculation instead of contraception as the use of local anesthetic (like Lignocaine also known as Lidocaine) is well documented in medical literature for the said purposes."
2. Thus, the reason which weighed with the Drug Inspector as well, as led to the passing of the impugned order is that since the product contains an allopathic ingredient which is a drug in terms of section 3(g)(i) & (v) of the Act, 1976, it falls within the jurisdiction of Drug Inspector as well as the Board. This is a fallacy to say the least and undoubtedly since the product of the petitioner falls within the ambit of Rules, 2017 the entire set of disputes relating to that product are to be adjudicated and decided by the Board set up under the rules. It is pertinent to mention that these rules have been framed in exercise of powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012. In the Rules, 2017 adulterated medical device means: "(v) "adulterated medical device" means a medical device,--
(a) which consists in whole or in part of any filthy, putrid or decomposed substance or which contains any foreign matter, vermin, worm, rodent or insect;
(b) which has been manufactured, packed or held under unsanitary conditions whereby it has been contaminated with dirt, filth or any other foreign matter or whereby, it may have been rendered injurious to health;
(c) which releases any poisonous or deleterious substance which may render it injurious to health; or
(d) which has been mixed or packed with other substance or article so as to reduce its quality or performance' or for which any substance or an article has been substituted wholly or in part:
3. These rules not only provide for the procedure of grant of establishment license but also to approve the conditions of establishment license by the Medical Device Board which is a Board responsible for enlistment or registration of medical devices and for the matter ancillary thereto. It also empowers the Board to classify and grouping of medical devices for the purposes of registration and enlistment. By Rule 21 it has been provided that a medical device may be imported subject to the condition that importer shall possess a valid medical device license. The medical board is also empowered to lay conditions for import by medical devices and prescribe conditions to import medical devices for personal use or for clinical investigation. Significantly, by rule 38 general provisions have been provided of labelling of medical devices and it clearly states that no person shall place any medical device in the market unless it has been appropriately labelled including information of establishment,' license's details, registration number etc. Further that the use or operation of any medical device on another person shall not be permitted unless the appropriate label has been provided with the medical device. Chapter VI further refers to the location of labelling of medical devices as well as the format of labeling the medical devices etc. All of these Conditions have to be complied with by any person holding a license or any importer or registration holder. In case of breach or non-compliance the medical board is empowered to fix responsibility of the offences and may refer the case to the court for determination. The power of the Board has been delineated in Rule 59 of the Rules, 2017. The allegations made against the petitioner in the impugned order is a case of misbranded medical device and squarely relate to the responsibilities and duties of the Medical Devices Board and come within the exclusive ambit of the Board and ouster the jurisdiction of the Drug Inspector in all such matters. Surely it cannot be permitted that although a separate regime has been set up for dealing with all issues relating to medical devices, certain issues may still be taken up by the Drug Inspector to the detriment of the valid license holders under the Rules, 2017 so that the persons are required to respond to the allegations made and actions initiated by different authorities whereas the clear intent of the legislature is to combine the powers and jurisdiction of these authorities under the statutory structure which has been promulgated for specific purpose to, deal with the issues arising under these separate statutory regimes. The question herein is not that the petitioner has committed an offence or otherwise but the question is regarding the respective scope of the authority of Drug Inspector and the Provincial Quality Control Board to enter upon these matters and to initiate proceedings which are within the exclusive domain of the Medical Devices Board under the Rules, 2017.
4. In view of the above, this petition is allowed. The impugned order as well as the preceding orders on which the impugned order is premised are also set aside. It is made clear that the Medical Devices Board may initiate action against the petitioner if deemed fit.