Al Wakeelo
Your Digital Lawyer, Always on Duty
Initializing Secure Chambers
Your Digital Lawyer, Always on Duty
Initializing Secure Chambers
Petitioner: Pakistan Tibbi Pharmaceuticals Manufacturers VS Respondent: Fed. of Pakistan and Ors
Court Name: Sindh High Court Judge(s): Omar Sial, Munib Akhtar Title: Pakistan Tibbi Pharmaceuticals Manufacturers vs Fed. of Pakistan and Ors Case No.: CP D-4387 of 2014 Date of Judgment:2018-02-26 Reported As: 2018 SHC 471, 2018 SHC 482 Result: petition disposed of
Judgment Munib Akhtar , J.: By this common judgment, we intend disposing off the petitions mentioned in para 51 below . The petitions arise under and in relation to the Drug Regulatory Authority of Pakistan Act, 2012 ("DRAP Act"). The core issue is whether , as the petitioners contend, the DRAP Act cannot, does not and should not apply to various products as manufactured, sold, used or imported by them, including Unani medicines, prescriptions and preparations, food supplements, animal feeds etc. The questions that the petitioners raise to press the core issue fall into two sets. One set sounds on the constitutional plane, primarily with reference to Article 144 of the Constitution, under which the DRAP Act has been enacted by Parliament. The other set comprises essentially of questions regarding the interpretation of various provisions of the DRAP Act. One important plank on which the petitioners rest their case is the relationship of the DRAP Act with earlier legislation, the Drugs Act 1976 ("1976 Act"). This law therefore also needs to be examined. In addition, certain rules framed under the DRAP Act, being the Alternative Medicines and Health Products (Enlistment) Rules, 2014 ("2014 Rules") need to be considered. 2. Learned counsel for the petitioner in CP D-4387 of 2014 submitted that the DRAP Act was challenged in relation to the legislative competence of the Federation to enact the same in its applicability to the Province of Sindh. Learned counsel submitted that even if the statute were found to be competently enacted certain provisions thereof violated Articles 18 and 25. In addition the 2014 Rules were also challenged as being ultra-vires the DRAP Act. By way of background, learned counsel submitted that the initial legislation in respect of drugs was the Drugs Act 1940 ("1940 Act") enacted under the Government of India Act, 1935 ("GOIA"). Referring to various legislative entries in the lists contained in Schedule VII of the GOIA, learned counsel submitted that the aforesaid Act was passed under s. 103 of the GOIA. (We may note here that this section is in all material respects the same as Article 144 of the present Constitution.) Referring to post-Independence developments as well as the Indian Constitution, learned counsel submitted that there was no entry as such in relation to "drugs and medicines" in the earlier constitutional dispensations, and it was for the first time that such an entry came to be found as entry No.20 of the Concurrent
---
## Page 2
Legislative List of the present Constitution . It was with reference to this entry that the Drugs Act 1976 ("1976 Act") was enacted by the Federation, which statue also repealed the 1940 Act. Learned counsel submitted that after the 18 Amendment whereby the Concurrent List, including entry No.20, was omitted the 1976 Act passed to the exclusive Provincial domain. With reference to the DRAP Act, learned counsel submitted that three Provinces, being Sindh, KPK and the Punjab Assemblies passed resolutions under Article 144 whereupon first an Ordinance was promulgated and, ultimately , the DRAP Act enacted, the latter receiving the President' s assent on 12.1 1.2012. 3. Learned counsel referred to the date on which the Provincial Assemblies passed the resolutions aforesaid (being 15.02.2012 in all three cases) and to the definition in s. 3(g) of "drug" as contained on that date in the 1976 Act. Learned counsel submitted that the petitioners whom he represented dealt with Unani medicines and preparations, as practitioners of Tibb, i.e., the Unani system of medicine. Referring to the resolution passed by the Sindh Assembly , it was submitted that it only allowed Parliament to make a law constituting a drug regulatory authority and nothing more or further . It was submitted that such authority could only regulate what was a "drug" as on the date of the resolution, which necessarily meant that it could only regulate drugs that came within the definition contained in the 1976 Act. As regards the DRAP Act, learned counsel accepted that the petitioners' medicines and preparations did come within the definition of "drug" therein contained. However , it was contended that the petitioners' products did not come within the meaning of "drug" as contained in the 1976 Act. On such basis it was contended that, at least insofar as this Province was concerned, Parliament while acting under Article 144 could only enact a law establishing a drug regul atory authority but could not alter the meaning of "drug", whereas this was exactly what the DRAP Act purported to do. Therefore, the definition contained in the latest statute was ultra vires the powers that had been conferred by the resolution of the Sindh Assembly on Parliament. What learned counsel contended, more generally , was that those portions of the DRAP Act that did not come within the scope of the resolution of the Sindh Assembly could not be enforced in this Province. The net result, as we understood the case, was that the petitioners' Unani medicines and preparations could not be regulated by and under DRAP Act. 4. Referring to various provisions of the DRAP Act, learned counsel submitted that allopathic medicines and drugs on the one hand and Unani medicines and preparations on the other constituted two separate and distinct categories or classes. They represented two distinctly different systems of medicine. It was submitted that to impose one and the same regulatory regime in terms of the DRAP Act on these two classes, that ought to be regarded as distinct and separate, was in violation of the rights of the petitioners under both Articles 18 and 25 of the Constitution. Insofar as the 2014 Rules were concerned, learned counsel referred to various rules thereof to submit that the regulatory regime set up for "alternative medicines" (as defined in s. 2(ii) of the DRAP Act and which included the Unani system of treatment) was ultra vires the parent statute. It was submitted that the various bodies, committees, inspectorates etc constituted under the 2014 Rules failed to recognize that allopathic medicines and Unani medicines represented the output of two distinct and separate systems, which could not be handled in one unified manner . More precisely , the methodology and practices of the allopathic system could not be imposed on the Unani system, as had purportedly been done under the 2014 Rules. Thus, according to learned counsel the petitioners were entitled to suitable relief and he prayed accordingly . 5. Learned counsel appearing in CP D-1684 of 2014 submitted that the petitioner therein was a manufacturer and user of Unani medicines and a practitioner of that system. Learned counsel reiterated the submissions already made as to how the Unani system was entirely different and distinct from the allopathic system. Learned counsel submitted that Unani medicines did not come within the scope of the 1976 Act and in this regard referr ed also to the Unani, Ayurvedic and Homeopathic Practitioners' Act 1965, which regulates the practitioners of the Unani system. It was submitted that the DRAP Act had been enacted with ulterior motives to defeat and frustrate the rights of the practitioners of the Unani system. In addition, learned counsel made submissions with regard to the 2014 Rules that were substantially the same as noted above. As regards the resolutions passed by the three Provincial Assemblies, learned counsel drew attention to, and placed reliance on, the difference between the language of the resolutions passed by the Punjab Assembly and the Sindh Assembly . It was emphasized that insofar as this Province was concerned, only a drug regulatory authority could be set up by the law to be enacted by Parliament under Article 144 and reference in this context was made to s. 32 of the DRAP Act.th
---
## Page 3
6. Learned counsel who appeared for the petitioners in CP D-6262 of 2016 and others referred to the definition of "alternative medicines" as given in the DRAP Act on the one hand and the definition of "drug" contained in the 1976 Act on the other. Learned counsel submitted that the products which were imported and/or otherwise dealt with by the petitioners were food, dietary or health supplements and they could not and did not come within the definition of "drug" as contained in the 1976 Act. It was submitted that in fact those supplements were simply "food" and this came within the scope of the Pure Food Ordinance 1961. Learned counsel referred to the definition of "food" as therein contained and also the description and characteristics of the food supplements etc. which were the subject matter of the petitions by referring to material placed on record. It was submitted that in fact earlier many food supplements were registered as drugs under the 1976 Act but they were de-notified by the Federal Government in 1985. Learned counsel submitted that after the 18th Amendment when, as noted above, "drugs and medicines" became an exclusive Provincial subject and the DRAP Act came to be enacted, the petitioner's products did not come within the meaning of "drug" as set out in Schedule-I to the DRAP Act. Nonetheless, the 2014 Rules were sought to be enforced in respect of food supplements etc. and the petitioners' products were included therein. Learned counsel emphasized, referring to Article 144 and the resolutions passed by the Assemblies, that the 1976 Act was the controlling statute and there could be nothing in either the DRAP Act or the 2014 Rules that could go beyond what was contained in the former statute. Insofar as that food supplements etc. were sought to be brought within the ambit of the DRAP Act by including the same under the aforementioned Schedule-I, learned counsel submitted that the provisions thereof were ultra vires the legislative competence granted to Parliament under Article 144. 7. Learned counsel in CP D-5892/2017 submitted that the petitioner 's products were meant for animals. Though they were included in Schedule-I to the DRAP Act and thus also stood included in the 2014 Rules, learned counsel submitted for substantially the same reasons as already noted that this could not be so and these provisions traveled beyond the legislative competence of Parliament, as conferred in terms of Article 144. In support of his case learned counsel also relied upon a Punjab law , the Punjab Animals Feed Stuf f and Compound Feed Act 2016. 8. Learned counsel appearing in CP D-4421 of 2017 submitted that the products imported by the petitioner were food supplements and in support of this contention referred to various documents and material on the record to show the nature and characteristics of the said products. For substantially the reasons already advanced it was submitted that the petitioner 's food supplements did not and could not come within the scope of the DRAP Act. 9. Learned counsel who appeared in CP D-1921/2017 submitted that the subject matter of this petition was various types of animal feed products. Learned counsel adopted the submissions earlier made and emphasized that the DRAP Act could not be made applicable to animal feed products. It was submitted that the petitioner 's products did not need to be enlisted in terms of the 2014 Rules. The products were imported by the petitioner and the Customs Department was insisting on such enlist ment. Learned counsel submitted that the petitioner 's products did not come within the scope of Schedule-I to the DRAP Act. It was submitted that feed for animals was different from food for humans especially as regards the administration of it. Explaining his point learned counsel submitted that the product had to be used according to certain measures. It was submitted that different standards were used for drugs for animals on the one hand and drugs for humans on the other . Learned counsel submitted that the animal feed as was the subject matter of the petition had no therapeutic effect. It was contended that there had to be a differentiation between animal feed which had therapeutic effect, which could be regulated, and that which had no such effect, and could not be so regulated. In failing to draw this distinction the 2014 Rules were in excess of the DRAP Act insofar as an attempt was being made to apply the same to the petitione r's products. Referring to certain definitions in the 2014 Rules learned counsel submitted that the products of the Petitioner did not come within the definitions of "therapeutic claim" and "health related purpose" but that in any case these definitions were broader than the scope of the DRAP Act and hence ultra vires accordingly . 10. Learned counsel in CP D-4421/2017 submitted that the subject matter of this petition were food and dietary supplements etc., which were not sold as drugs but rather simply and only as food. It was submitted that these products did not come within the definition of drugs and, therefore, could not be regulated by the DRAP Act.
---
## Page 4
11. The learned Additional Attorney General, relying on entries Nos. 3, 27, 39 and 59 of the Federal List submitted that the regulation of drugs as well as the manufacture thereof was a federal subject. The learned AAG submitted as regards Article 144 that although there was some variation in the language used in the three resolutions, the effect and substance was nonetheless the same namely to grant legislative competence to Parliament to make a law in respect of "drugs and medicines". It was submitted that before the enactment of the DRAP Act, an Ordinance in substantially the same terms had been promulgated on 16.02.2012, i.e., one day after the resolutions were passed. This Ordinance was ultimately replaced by the DRAP Act. Referring to the material placed on record the learned AAG contended that the Sindh Assembly was well aware of the draft of the Ordinance and what was requested by Parliament as regards the enactment of a federal law on the subject. It was submitted that all the Provinces were fully on board at all material times in this regard and well appreciated and accepted the need for country-wide legislation. Thus the extent and scope of the proposed federal legislation was well within the knowledge of the Sindh Assembly. This was also the case for the other Assemblies. All the resolutions were passed on the same day. Thus, the learned AAG contended, the resolution of the Sindh Assembly had to be read in the same manner and to the same effect, and had the same scope, as the resolutions of the Punjab and KPK Assemblies. The DRAP Act was therefore very much applicable and enforceable as it stood in this Province. 12. The learned AAG submitted that traditional medicines, which included medicines prepared under the Unani system, had always been within the meaning of the drugs as contained in the 1976 Act. In support of this submission the learned AAG submitted that on its true and proper reading, s. 3(g)(i) of the 1976 Act fully established that Unani medicines etc were well within the meaning of "drug" as therein contained. Insofar as food supplements and the other products involved in the various petitions were concer ned, with the passage of time it was recognized that they also had to be regarded as drugs. Thus, it was contended, the definitions of traditional/alternative medicines and food supplements as contained in the DRAP Act only reflected the changes in approach and thinking that had come about between 1976 and 2012. The learned AAG submitted that these were developments that had taken place internationally . Referring to material placed on record the learned AAG submitted that the definitions and scope of the DRAP Act built on what was already within the scope of 1976 Act. Reliance was also placed on certain case law in this regard. 13. Insofar as the grievance of the petitio ners who practiced in the Unani system, that they were not appropriately represented on the bodies and committee s established in terms of the 2014 Rules, the learned AAG submitted that this was incorrect. There was no discrimination or violation of any right that inhered in these petitioners nor had any damage been caused to any of their interests. As regards food supplements, learned counsel submitted that they in fact also came within the scope of s. 3(g)(i) of the 1976 Act and sought to establish this from the material placed on record by the relevant petitioners in their petitions. The learned AAG further submitted that in its essence what the DRAP Act sought was enforcement of certain WHO guidelines that had been issued by that UN Organization in respect of traditional medicines and placed on record various documents and material in this regard. Reference was made to various provisions of the DRAP Act where specific reference is made to the WHO. Relying in particular on s. 7 of the DRAP Act the learned AAG submitted that it gave statutory recognition in municipal law to the convergence between international guidelines on the one hand and national and local regulations on the other in order to ensure that there was harmony and uniformity in this regard. Reference in this context was also made to the statement of reasons and objects when the Bill that eventually became the DRAP Act was introduced in Parliament. The learned AAG, with reference to animal feeds and to the specific facts of the petitions where such substances were the subject matter , submitted that the substances were artificial and not natural and therefore came within the drugs both under the 1976 Act and the DRAP Act. By way of illustration, the learned AAG referred to one type of animal feed which was meant for cattle and which comprised of seaweed. It was submitted that seaweed would not normally be regarded as food for cattle in this country and that here it had to be regarded as a drug within the meaning of the aforesaid statutes. 14. Insofar as Article 144 was concerned, the learned AAG also compared the same with Article 147 of the Constitution. It was contended that in terms of Article 144 once a Province resolved to entrust a legislative
---
## Page 5
competence in its exclusive domain to Parliament that meant that the whole of the legislative field become open to the latter . In other words, the learned AAG contended that Article 144 operated on an "all or nothing" basis. This was precisely what had happened in the present case. The entire legislative field of the erstwhile entry No. 20 being open to it, Parliament had properly and competently enacted the DRAP Act, which was applicable as such in all the Provinces. For all of these reasons it was submitted that the petitions were without substance and ought to be dismissed. 15. The learned Additional Advocate General Sindh submitted that the primary question was whether Parliament could now legislate in respect of traditional medicines and food supplements. It was submitted that the DRAP Act was properly enacted in exercise of the powers conferred under Article 144. However , the learned AAG emphasized that this statute could only have been enacted if the Provincial Assemblies had passed resolutions under the aforementioned Article since, if Parliament could itself have enacted the law as submitted by the learned Additional Attorney General, there would have been no need to invoke this Article. With reference to the reliance placed by the learned Additional Attorney General on entry No.3 of the Federal List, the learned AAG submitted that Parliament did have the power to give force in municipal law to international treaties, etc., but if the subject matter of the same related to a legislative compe tence exclusive to the Provinces, as soon as a Provincial Assembly made a law then to the extent of any inconsistency the federal law had to give way. The learned AAG submitted that in its pith and substance the DRAP Act related to the legislative competence of "drugs and medicines" and none other and it had been enacted only by reason of Article 144. Thus, according to the learned AAG, entry No. 3 had no application to the case at hand. 16. Referring to the resolutions passed by the Provincial Assemblies and in particular to that of the Sindh Assembly, the learned AAG submitted that it too covered the whole of the legislative competence and was not circumscribed in the manner as contended by learned counsel for the petitioners. The learned AAG further submitted that although the resolution referred only to "drugs" it was sufficiently brought to include within its competence "medicines" as well. Without prejudice to this submission and in order to properly present the case of the Province, the learned AAG submitted, in opposition to what had been submitted by the learned Additional Attorney General, that a resolution under Article 144 could even grant power over part of a legislative competence. In other words, his case was that it was not an "all or nothing" matter as submitted on behalf of the Federation. Furthermore, the learned AAG submitted, if the resolution related only to a part of a legislative field and Parliament enacted a law beyond the grant, the said law would be incompetently made to the extent of the overreach. However, the learned AAG emphasized that such was not the position at hand and the DRAP Act, as enacted, was fully applicable in this Province as well. The learned AAG submitted that the nature of the subject was such that it required a unified approach which justified the resolution of the Sindh Assembly being given a broad meaning and scope. It was submitted that the context in which the resolution came to be passed, and the intent of the Assembly in passing the same, were relevant for purposes of interpreting it and determining its scope and extent. On such basis the learned AAG submitted that the narrow and restricted meaning urged on behalf of the petitioners and the resultant limitations placed on the scope of the DRAP Act were incorrect and did not apply . 17. With regard to food supplements the learned AAG submitted that while the DRAP Act in its pith and substance related to "drugs" and not "food", the food supplements which were the subject matter of the various petitions came in the former and not the latter category . According to the learned AAG, "food" was something else and different from drugs. Reference was made to various provisions of the Sindh Food Authority Act, 2016. In this context the learned AAG submitted that it was immaterial whether the food supplements would be regarded as drugs or not under the 1976 Act. It was the DRAP Act that controlled and it applied in terms as just stated. It was prayed that the petitions be dismissed. 18. The right of reply was exercised. Learned counsel for the petitioner inCP D-4387/2014 submitted that the resolutions of the Provincial Assemblies operated on the constitutional plane and had to be read and applied as such. Referring to the non-enumerated competences which were exclusive to the Provinces and which, according to learned counsel, constituted a residuum of legislative power , it was submitted that they were not legislative fields at all. In fact, they were only the residuum once the enumerated powers had been properly identified. They could
---
## Page 6
thus be regarded as a "topic" or an "item" and Article 144 applied accordingly . Learn ed counsel referred to the 1940 Act and its position in India, where it still applied though in much amended form. Some of the provisions of the 1940 Act, as amended, were referred to and compared with certain provisions in the 1976 Act and the DRAP Act with regard to the definition of drugs. Learned counsel submitted that "drugs" was not a separate or independent legislative competence but rather a part of the legislative competence of "public health". It was emphasized that the 1976 Act continued to remain in the field in un-amended form and that, therefore, when the Sindh Assembly passed its resolution it could only have been to allow Parliament to set up a regulatory authority that regulated and gave effect to this law and not to any provisions of enlarged scope, independently of the 1976 Act. 19. Continuing with his submissions learn ed counsel submitted that after the 1976 Act became a provincial law on account of the omission of the Concurrent List, the executive authority in relation thereto also devolved on the Provinces. However , the Provinces were unable to properly exercise this authority and that was the context in which the resolutions were passed. It was submitted that when so understood the scope of the Sindh Assembly became obviously limited only to allowing Parliament to set up a regulatory authority and not beyond…
Read the unabridged text and precedent citation network on Al Wakeelo Legal Research Platform.