Ayesha A. Malik J. A challenge has been made against the legislative competence of Parliament to promulgate the Drug Regulatory Authority of Pakista n Act, 2012 ("DRAP Act") as well as a challenge to the vires of the Alternative Medicines and Health Products (Enlistment) Rules, 2014 ("Rules") . Consequently the Petitioners challenge letter dated 03.10.2016 issued by Deputy Drug Controller (Health and OTC), Notification dated 30.10.2019 issued by Ministry of National Health Services Regulations and Coordination, Government of Pakistan, Islamabad and letter dated 21.01.2019 issued by the Chief Drugs Controller Punjab, Lahore. The Petitioners as detailed in Schedule "A, B and C" have raised common constitutional issues by challenging the regulatory authority of Drug Regulatory Authority of Pakistan ("DRAP") over their business and products and have challenged the actions of DRAP requiring the Petitioners to enlist their products or entity under the Rules.
The Petitioners Arguments:
2. The Petitioners before the Court are involved in the manufacture, import and sale of diverse products which include alternative medicines, nutraceuticals and food supplements, health and over the counter ("OTC") products, disinfectants, cosmetics, veterinary supplements and baby milk. Their common grievance is that Parliament is not competent to legislate the DRAP Act; that their products do not fall in the definition of 'drug' under the DRAP Act; that the Rules go beyond the mandate of the DRAP Act seeking to regulate that which it is not authorized to regulate under the DRAP Act. Consequently , they do not fall within the regulatory regime of DRAP which includes the requirement of enlistment under the Rules.
3. The Petitioner in the instant Petition is Dawakhana Hakim Ajmal Khan (Private) Limited who manufactures and markets herbal remedies. It is their case that herbal remedies are made out of natural products and undergo animal testing; that their remedies are in accordance with established scientific and medical standards related to the science of unani, ayurvedic or tibb and that they have never been regulated as drugs and medicine. It is their case that historically under the Drug Act, 1976 ("Drug Act") , ayurvedic, unani, homeopathic and biochemical system of alternative medicine was not regulated as a 'drug'. It is the Petitioner 's case that it is regulated under the Ayurvedic, Unani and Homeopathic Practitioners Act, 1965 ("1965 Act") and that the processes adopted by DRAP does not cater for the distinct sciences of ayurvedic, unani and homeopathy , which in itself are separate traditional forms of medicine. Hence without relying on secto r experts to understand the science of traditional medicine, the Petitioner is subjected to a regulatory regime which does not recognize their subject specialty .
4. The Petitioner in WP No.36555/2016 is Nestle Pakistan Limited who manufactures and sells food items, in this case, baby milk and milk based baby food which they contend does not fall within the regulatory regime of DRAP . It is their case that food and food based products are legislated under the Punjab Food Authority Act, 2011 ("Food Act") through the Punjab Food Authority ("Food Authority") . Furthermore nutrition relating to children is regulated by the Punjab Infant Feeding Board ("Board") which has been established under the Protection of Breast-Feeding and Child Nutrition Ordinance, 2002 ("2002 Ordinance") read with the Punjab Protection of Brea st-Feeding and Child Nutrition (Amendment) Act, 2012. Under the Board' s regulatory regime, the products of the Petitioner are regulated to ensure safety and adequacy of nutrition for infants and young children. It is also their case that baby milk and milk based food products are not used for the diagnosis, cure, mitiga tion, treatment or prevention of disease, hence cannot fall within the regulatory jurisdiction of DRAP . It was argued that they have been classified as a Health and OTC Product under the DRAP Act and placed under the definition of baby milk and foods and compensatory foods for infants and young children under the Rules which is without lawful authority and beyond the mandate of DRAP . It is also argued that Notification dated 3.10.2016 issued by Ministry of National Health Services, Regulations and Coordination, Islamabad has directed the Federal Board of Revenue that no commercial importer is authorized to import categories of ingredients or products as listed in the Notification which includes baby milk and food without their authorization as required under the Rules. It is stated that the Notification dated 3.10.2016 is illegal and beyond the mandate of the DRAP Act.
5. The Petitioner in WP No.258002/2018 is Engro Foods Limited which manufactures, markets and sells olpers full cream milk powder , for the preparation of which the Petitioner imports milk powder into Pakistan. The imported milk powder falls under the category of complementary foods for infants and youn g children as defined in Section 2(xiv) of the Rules, consequent to which DRAP requires the Petitioner to enlist its product so as to have its imports cleared from DRAP . The Petitioner is engaged in the dairy business and manufactures and sells various different dairy products in compliance with the federal quality standards prescribed by the Pakistan Standards and Quality Control Authority ("PSQCA") under the Pakistan Standards and Quality Control Act, 1996 ("PSQCA Act") and as per the arguments made its products do not fall within the definition of 'drugs and medicine'. It was argued that their products are regulated by the Food Authority and by the PSQCA and is wrongfully treated as a drug by DRAP and the Petitioner cannot be compelled to get itself enlisted with DRAP or submit to its jurisdiction.
6. The Petitioner in WP No.14712/2016 is Prospect Group (Private) Limited which imports and distributes food and dietary supplements under the brand name General Nutrition Corporation Centres ("GNC") throughout Pakistan.
The product includes vitamins, minerals and herbal products, sports nutrition products and diet products. It is their case that their products are non-therapeu tic goods not intended to diagnose, treat, decease or prevent decease; that the ingredients are dietary ingredients and is treated as food and not drugs under the United States, Food and Drug Administration ("FDA") . Hence their grievance is that GNC products do not fall within the regulatory jurisdiction of DRAP; that it is regulated under the Food Act and Food Authority and in any event the import of health products falls outside the scope of the DRAP Act. The Petitioner is also aggrieved by the processes undertaken by DRAP for enlistment purposes under the Rules as they cause delay and lack clarity on how to classify products on account of which the business of the Petitioner suffers. It is their case that world over GNC products are treated as 'food' and not as 'drug' as they make no health or therapeutic claim.
7. Similarly the Petitioner in WP No.72010/2019 is Shoaib Sports, who imports food supplements to improve muscle growth and also imports weight loss products. The Petitioners in WP No.1774/2016 imports veterinary supplements and nutraceutical product s for the use and consumption by animals. The Petitioner in WP No.6881 1/2019 is CCL Pharmaceuticals (Private) Limited which is engaged in the business of production, marketing, distribution and sale of nutraceuticals and health and OTC products, such as 'Once A Day Calstrong Tablet', 'Once A Day Fish Oil Omega 3', 'Once A Day Men Tablet', 'Once A Day Women Tablet'. Their grievance is common to the grievances raised by the Petitioner who imports GNC products. They are also aggrieved by the Notification of 3.10.2016 requiring authorization DRAP for their imports.
8. The Petitioner in WP No.18865/2020 is Archroma Pakistan Limited which deals in the business of chemicals which are used for packaging food items as well as making hand sanitizers. The Petitioner 's grievance is that it does not deal in the business of drugs and medicine; that its products fall under the category of disinfectant which is not used for the treatment, mitigation, prevention or prevention of disease; that it produces a general sale item being hand sanitizers which cannot be regulated by DRAP as the product is not used for medical purposes. They are also aggrieved as pursuant to a decision of the Cabinet dated 5.5.2020, that hand sanitizer is not to be regulated by DRAP yet they continue to do so.
9. The Petitioner in WP No.75250/2017 is Medinostic Health Care (Private) Limited, which produces various different disinfectant products ranging from hand foam sanitizers, hard surface cleaners, instruments disinfectant, water purification tablets, effervescent tables, liquid soaps, skin care wipes, alcoh ol wipes, disinfectant wipes etc. which are not drugs as they are not used in any form of treatment or diagnosis for human or animals. The main consumers of the Petitioner 's product are households and hospitals. These products do not confer any authority on DRAP to regulate them as 'drugs' as they are ordinary household products which have been wrongfully classified as health and OTC products under the DRAP Act.
10. The Petitioner in WP No.21476/2018 is Inventive Cosmetics which is the manufacturer of different cosmetics under the name of Dr. Darma Divine, Pure Skin, Genesis, Neutrafresh, Silk Skin and Caviar . These products are used for external use, hence they do not fall under the definition of drugs and medicine as they are not used in the diagnosis or treatment of any medical condition. Hence their products cannot be regulated as drugs. Furthermore there are no guidelines to set out the evaluation criteria for these products. The other Petitioners claim almost similar relief.
11. All Petitioners before this Court are aggrieved as they are required to enlist their products with DRAP under the Rules. It is their contention that this is not lawful requirement as they do not fall within the regulatory jurisdiction of DRAP since they do not deal with 'drugs and medicine' per se. Consequently the Petitioners challenge the vires and legality of the Rules, which were notified vide SRO 412 (I)/2014 dated 27.05.2014 by Respondent No.2, DRAP .
It is argued that the Rules go beyond the mandate of the DRAP Act, hence is excessive delegation as the Rules seek to regulate more than 'drugs and medicine'. The Petitioners argue that previously the Drug Act regulated drugs and medicine and did not include the products of the Petitioners; that drugs and medicine is a Provincial subject after the 18th Amendment to the Constitution of Islamic Republic of Pakistan, 1973 ("Constitution") ; that the Province of Punjab along with other Provincial Assemblies delegated the autho rity to legislate on the subject of drugs and medicine to Parliament under Article 144 of the Constitution. The resolutions passed by the respective Provincial Assemblies authorize Parliame nt to make law and regulate all matters relating to drugs and medicine and does not include the products and the businesses of the Petitioners. It is the case of the Petitioners that through the Rules a new regulatory regime has been introduced, whereby all importers and manufacturers of alternative medicines, health and OTC products, food and dietary supplements for humans and animals, baby milk, disinfectants, hand sanitizers and cosmetics are mandated to enlist with DRAP . The Petitioners argue that this is beyond the scope of the delegated authority by the Provincial Assembly to Parliament and beyond the mandate of the DRAP Act.
12. It has also been argued that the impugned Rules are unjust and unreasonable; that they are against good governance and in violation of the Petitioners' fundamental rights. Learned counsel argued that there are no subject specialists to advise DRAP with reference to the different and diverse nature of the products and traditional medicine; that DRAP seeks to regulate all products and alternate medicine in the same manner as drugs and medicine which at times is neither practical nor possible. They argued that there are no guidelines and delays in the enlistment process yet a National Task Force was established vide Notification dated 30.10.2019 issued by the Ministry of National Health Services Regulations and Coordination, Government of Pakistan Islamabad to take coercive action against the Petitioners for not complying with the enlistment process under the Rules. Learned counsel argued that the actions of the National Task Force is harsh and unnecess ary especially as DRAP has not issued any guidelines as to how the various different products and alternative medicines are to be enlisted and regulated.
The Respondents arguments:
13. Notices were issued under Order XXVII-A CPC to the Attorney General for Pakistan to respond to the constitutional issues arising out of these Petitions. In response to these notices, report and parawise comments have been filed by the Federation of Pakistan. Learned Additional Attorney General for Pakistan ("AAG") argued that the Parliament legislated the DRAP Act on the passing of resolutions by four Provinces that is Punjab, Sindh, Khyber Pakhtunkhwan and subsequently Baluchistan that Parliament may, by law, regulate matters relating to drugs and medicine as per Article 144 of the Constitution. Learned AAG argued that the Provincial Assemblies have not challenged the DRAP Act nor the Rules framed thereunder nor is there a dispute pertaining to the regulatory framework of DRAP to include therapeutic goods, medicated cosmetics, health and OTC products, food and dietary supplements and alternative medicines. Learned AAG further argued that the Parliament is competent to legislate consequent to the resolutions passed under Article 144 of the Constitution and with reference to Punjab as per the Resolution of the Provincial Assembly dated 15.2.2012. Learned DAG argued that the regulation of drugs and medicine includes the products of the Petitioners and it is for DRAP to determine whether their products fall under the definition of 'drugs' under the DRAP Act; that DRAP was established vide Notification dated 28.11.2012 by the Ministry of National Regulations and Services, Government of Pakistan, Islamabad and has been ef fectively working since then.
14. Learned AAG further argued that there is a presumption in favour of the constitutionality of law which cannot be declared unconstitutional unless it is established that such law has violated the fundamental rights of the Petitioners or that Parliament lacked the legislative competence to enact the law. Learned AAG also argued that no fundamental right of the Petitioners has been infringed upon nor have they discussed any fundamental right which has been adversely affected. Further states that DRAP ensures that products are safe for the public to use, hence it is for the health and safety of the public as well as to create uniform standards against which drugs can be regulated nationwide. He explained that the Rules are not excessive delegation as they fall within the mandate of the DRAP Act and were approved by the Federal Government. He explained that during the hearing of Suo Motu Case No.1/2012 before the august Supreme Court of Pakistan, the Federal Government was directed to ensure the process of framing of rules under the DRAP Act vide order dated 28.3.2013, where after the Rules were notified on 27.5.2014. In support of his contentions, he has placed reliance on "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") wherein all issues raised before this Court have been decided and neither party filed any appeal against the decision. Hence it is binding on all the Petitioners and on DRAP . He also relied upon Government of Sindh through Secretary Health Department and others v. Dr. Nadeem Rizvi and others (2020 SCMR 1) and Messrs Sui Southern Gas Company Ltd. and others v . Federation of Pakistan and others ( 2018 SCMR 802 ) in support of his contentions.
15. Learned counsel for the Respondent DRAP argued that DRAP in exercise of powers conferred by Section 23 of the DRAP Act, with the approval of the Federal Government, promulgated the Rules through which DRAP has the power to enlist alternative medicines, therapeutic medicines, health and OTC products of manufacturers and importers, after scrutinizing the products against the evaluation criteria laid down under Rule 5 of the Rules. He further explained that the Rules call for enlistment of the entity , which is either an importer or a manufacturer and for the enlistment of the product. He explained that a large number of applications were filed for enlistment under the Rules and as of June 2020 all pending applications for enlistment of entities have been decided by the concerned Division. He also stated that several leading multi-national companies such as Abbott Laboratories, Glaxo SmithKline, ICI Pakistan Limited, Muller & Phipps Pakistan (Private) Limited, the Searle Company , Ferozsons Laboratories and Bayer Pakistan (Private) Limited have applied to the Division of Health and OTC Products and have been issued Provisional Certificates for Enlistment as manufacturers or importers. Some of these Petitioners, notwithstanding the fact that they have been issued Provisiona l Certificates for Enlistment, are before this Court. He also clarified that some of the Petitioners such as Hamdard Laboratories (Waqf) Pakistan, N.B. Sons, Shoaib Sports Company , Dabur Pakistan (Private) Limited, Heal the World, Goldshef f International Nutraceutical, Himont Laboratories (Private) Limited, Wilshire Laboratory (Private) Limited and Bless Laboratories who deal in ayurvedic, unani, homeopathic, herbal products have also applied to the Division of Health and OTC Products and have been issued Provision al Certificates for Enlistment as manufact urers or importers. Therefore he stated that the Petitioners have no grievance before this Court because they have submitted to the regulatory jurisdiction of DRAP and have obtained Provisional Certificate for Enlistment of Products and if at all they are aggrieved by the processes or the delay , those issues cannot become grounds for challenging the vires of the Rules or the competence of Parliament. Learned counsel further explained that at present DRAP is seeking to enlist the entity or the product under the Rules so as to develop its database with respect to therapeutic goods which includes alternative medicines, health and OTC products and medicated cosmetics available in the market so as to ensure that the products meet the regulatory requirements of DRAP which is essentially for the safety and protection of the public.
16. Learned counsel further argued that most countries in the region like India, Bangladesh, Sri Lanka and Iran have similar laws and regulatory regimes which call for registration of similar products in order to promote public health and safety . Furthermore DRAP acts in compliance with the guidelines issued by the WHO and follows international practices and protocols for such purposes. Learned counsel also relied upon the Azfar Laboratories Case to argue that similar challenge was made to the DRAP Act and the Rules before a learned Division Bench of the Sindh High Court which upheld the DRAP Act as well as the Rules for being in accordance with the Constitution. He stated that some of the Petitioners before this Court representing multi-nationals were also before the Division Bench of the Sindh High Court, hence they have no grievance before this Court as the matter has already been decided in the Azfar Laboratories Case, which has not been appealed by any of the Petitioners nor any of the Provinces. He explained that pursuant to the Azfar Laboratories Case, DRAP issued Guidelines for Manufacturers/Importers of Food Supplem ents or Dietary Supplements or Health Supplements or Nutraceuticals as to what is meant by Alternative Medicine and Health Products Dosage Forms ("Guidelines") , on the directions contained in para 50 of the Azfar Laboratories Case. Even otherwise DRAP regularly holds meetings with the stakeholders to discuss better management, good practices and international standards so as to ensure that its processes are efficient, effective and as per the international practices. He specified that an effort has been made to improve upon the processes, particularly after the guidance given in the Azfar Laboratories Case. Therefore it is the case of DRAP that the Petitioners have no grievance before this Court nor is there any legal basis to challenge the vires of the Rules or the competence of Parliament to promulgate the DRAP Act. Furthermore he argued that the Petitioners' contention that they are regulated under different laws other than the DRAP Act is without basis as each regulatory regime is set up to achieve its purpose, in this case the purpose being to ensure that any product which lays claim to having health benefits must be regulated for its efficacy and to ensure proper disclosure through its packaging and labelling.
17. The Government of Punjab also filed report and parawise comments wherein it is stated that Provincial Assembly of the Punjab passed a Resolution on 15.02.2012 wherein they spec ifically delegated the subject of drugs and medicine to Parliament. A copy of the Resolution has been placed on file which reads that the Provincial Assembly of the Punjab in its sitting held on 15.2.2012 has passed Resolution in terms of Article 144 of the Constitution, such that 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 terms of Article 144 of the Constitution of Islamic Republic of Pakistan, 1973 . Learned Law Officer stated that a Task Force was notified on 14.7.2016 to ensure compliance under the Rules. He also stated that so far as unani, ayurvedic and homeopathic remedies are concerned, the contention of the Petitioners that they fall within the regulatory framework of Ayurvedic, Unani and Homeopathic Practitioners Act, 1965 is incorrect as the law does not regulate the sale or registration of traditional medicines nor does it check the pharmaceutical form or presentation of the products sold by such practitioners. In the same way the National Councils for Tib and Homeopathy does not regulate drugs or medicines and does not ensure that the remedies prescribed and the products sold are safe and efficacious for public consumption. He clarified that there is no legal bar that the Petitioners cannot be regulated by more than one regulator . He stated that same argument applies for the Petitioners claiming that they fall under the regulatory regime of Food Act, as the objective and mandate of the Food Act is distinct from that of DRAP Act; that the violation of the constitutional provisions are so glaring that the legislative provisions under challenge could not survive.
Reliance was placed on State of M.P. v. Rakesh Kohli and another (2013 SCMR 34) (Supreme Court of India).
He has also placed reliance on the Azfar Laboratories Case.
Opinion of the Court: Legislative Competence
18. The challenge to the legislative competence of Parliament with reference to the DRAP Act is essentially on the ground that drugs and medicine falls within the competence of the Provin ce under the Constitution, after the 18th Amendment. Prior to the 18th Amendmen t to the Constitution, the subject of drugs and medicine fell under Item 20 of the Concurrent Legislative List of the Constitution. Consequently , the Drug Act was the law on drugs and medicine as enacted by Parliament. Post 18th Amendment Parliament can legislate on a subject which falls within the Provincial domain in terms of Article 144 of the Constitution. Article 144 of the Constitution reads as follow:
(1) If one or more Provincial Assemblies pass resolutions to the effect that Majlis-e- Shoora (Parliament) may by law regulate any matter not enumerated in the Federal Legislative List in the Fourth Schedule, it shall be lawful for Majlis-e-Shoora (Parliament) to pass an Act for regulating that matter accordingly , but any Act so passed may, as respects any Province to which it applies, be amended or repealed by Act of the Assembly of that Province.
As per Article 144 of the Constitution, the Provinces can delegate their power to legislate in favour of Parliament, if one or more of the Provincial Assemblies pass a resolution to such effect. As per the record, Parliament relied upon the resolutions passed by the Provincial Assemblies of Punjab dated 15.02.2012, Sindh dated 15.02.2012, Khyber Pakhtunkhwan dated 16.02.2012 and Balochistan dated 18.03.2015 on the basis of which legislating on the subject of drugs and medicine has been delegated to Parliament. The Respondents also relied upon the judgment passed by a learned Division Bench of the Sindh High Court in the Azfar Laboratories Case to urge the point that this matter has been duly considered by the Division Bench of the Sindh High Court wherein the Court concluded that as per Article 144 of the Constitution, the Provincial Assemblies can grant the power to make law on a matter which falls exclusively within the legislative domain of the Provinces. The Court held that the law made by Parliament can repeal expressly or impliedly or override any existing provincial law in respect of the matter for which the power has been granted to Parliament and if there is conflict between the Provincial law and Federal law then the subsequent law may prevail, depending on the circumstances of the case. While interpreting the different resolutions, passed by the Provincial Assemblies, the Court, in the Azfar Laboratories Case concluded that the purpose of delegating authority to enact law on the subject of drugs and medicine was to create a unified approach throughout the country on this subject. As the Provincial Assemblies 'invited' Parliament to make law on drugs and medicine no exception can be taken that the DRAP Act exceeds the terms of the resolutions passed under Article 144 of the Constitution. The Division Bench of the Sindh High Court held that the DRAP Act is the controlling statue, operating seamlessly as one unified law that applies trans-provincially across all Provincial boundaries and not the Drug Act, operating in each Province. Hence the challenge to the extent of legislative competence was rejected.
19. The Petitioners before this Court argue that the subject of drugs and medicine does not include their products or alternate medicine. In this regard, the Petitioners specializing in unani, ayurvedic, herbal and chinese remedies state that these are special and distinct sciences, which have to be dealt with separately and cannot be clubbed together as one in the definition of Alterna tive Medicine under the DRAP Act. The Petitioners who manufacture and import nutraceuticals, food and dietary supplements, infant milk and OTC Produ cts state that their products are regulated under other regulatory regimes and cannot be termed as 'drugs or medicines'. The Petitioners, who manufacture, import and distribute cosmetics, disinfectants and sanitizers argue that their products are not drugs or medicines as they are not consumed rather applied and not used in the treatment, mitigation, prevention or diagnosis of diseases.
20. Interestingly the Petitioners, who manufacture, sell, distribute and import alternate medicine including unani, ayurvedic, tibb, herbal and chinese remedies as well as OTC products, cosmetics, food and dietary supplements for humans and animals were before the Sindh High Court in the Azfar Laboratories Case. The Court duly considered their various different products and concluded that the challenge mounted against the DRAP Act and the Rules must fail with respect to their products. The Court came to the conclusio n that these products could fall within the meaning of 'drug' under the DRAP Act, however , this requires a conclusive determination, through a factual inquiry by DRAP . Accordingly the Court directed DRAP to issue proper guidelines so as to give meaning to pharmaceutical dosage form, separately for humans and animals as per the different sub-categories DRAP seeks to regulate. As to the various Petitioners before the Court, they were required to be given a hearing by DRAP so as to determine whether their product comes within the scope of the DRAP Act and the Rules.
21. The Petitioners before this Court do not challenge the findings in the Azfar Laboratories Case yet they argue that to the extent of the Province of Punjab the matter is somewhat different. The Provincial Assembly of Punjab passed the Amendment Act of 2017 and of 2018 respectively , whereby the provisions of the Drug Act to the extent of Punjab stood amended. They argue that the effect of the amendments is that the Provincial Assembly of the Punjab revoked its delegation to legislate on drugs and medicine . The argument is that the amendments should be read as deeming to revoke the effect of the Resolution dated 15.02.2012 passed by the Provincial Assembly of Punjab. In this regard, Article 144 of the Constitution provides that if one or more Provincial Assemblies pass resolutions to the effect that Parliament may by law regulate any matter not enumerated in the Federal Legislative List in the Fourth Schedule, then it shall be lawful for Parliament to pass a law on the subject matter and at the same time any Province can amend or repeal the law on the subject as it requires. As per the Azfar Laboratories Case, Article 144 of the Constitution does not give Parliament concurrent power to legislate on matters which fall within the Provincial legislative domain rather the Provinces 'invite' the Federal Government to regulate by law the given subject. This invitation can be amended, repealed by law, curtailed or withdrawn by the Provinces as per requirement. Now the question is whether by way of amending the Drug Act, the Provincial Assembly of the Punjab has revoked the Resolution dated 15.2.2012.
22. The Provincial Assembly of the Punjab passed the Punjab Drugs (Amendment) Act 2016 whereby Section 31 of the Drug Act was amended to establish Drug Courts in the Punjab as notified by the Provincial Government. The second amendment to the Drug Act was through the Punjab Drugs (Amendment) Act, 2017 amending certain provisions of the Drug Act in its application to the Province of Punjab for control and eradication of spurious, adulterated and substandard drugs. As per the intent given in the preamble to the 2017 Amendment Act, the amendm ents were made to enable the Province of Punjab to cope with the increasing menace of spurious, adulterated and substandard drugs and for updati ng the enforcement mechanism as well as providing a regular monitoring system with stricter penalties. The 2017 Amendment Act seeks to give the Provincial Government power to devise an enforcement and monitoring system such that it enables the Provincial Government to establish and notify drug laboratories for testing purposes and to establish a Provincial Monitoring System. It also allows the Provincial Quality Control Board ("PQCB") to specify testing by the notified drug laboratory and requires PQCB to send reports to the Provincial Government as well as the Federal Government.
By way of the 2017 Amendment Act, some amendments were made to Section 23A, 23B and 23C as well as Section 27, 27-A and 28 of the Drug Act which called for stricter penalties. However , these amendments were omitted and deleted by way of the Punja b Drugs (Amendment) Act, 2018. The Amendment Act of 2018 did not make any other significant amendment. So far as the Amendment Act of 2016, it merely gave the Provincial Government the authority to establish Drug Courts and exercise similar powers as that of the Federal Government within the Province. The argument that the Provincial Government retains some power pertaining to the subject matter on which it delegates its authority to legislate under Article 144 of the Constitution, goes against the constitutional mandate. Therefore, to answer the issue raised by the Petitioners, as to whether the amendments made by the Provincial Assembly of the Punjab to the Drug Act amounts to revocation of the Resolution dated 15.2.2012, the answer is no, it does not revoke the 'invitation' given to Parliament by the Provincial Assembly of the Punjab. The Resolution passed by the Provincial Assembly of the Punjab allows Parliament to make law to regulate the subject of drugs and medicine . The DRAP Act provides under Section 32 that the Act is in addition to and not in derogation of the provisions made in the Drug Act and any other law enforced. Therefore, by amending the Drug Act the Provincial Assembly of the Punjab has not revoked its Resolution in favou r of Parliament to make law on drugs and medicine . These amendments and the continued existence of the Drug Act cannot be taken to mean that the DRAP Act cannot be enforced or be given effect to in all the Provinces as was resolved by the Provincial Assemblies. It is important to note that the DRAP Act calls for a unified law that applies trans-provincially across all Provincial boundaries, whereas the Drug Act is applied in each Province. Hence the impact of the amendments made to the Drug Act are for the benefit of the Province of Punjab in its efforts to enforce and monitor spurious drugs. Furthermore, the 2017 Amendment Act itself provides the intent of the Provincial Assembly of the Punjab so as to make the Province more effective in its enforcement and monitoring of spurious, adulterated and substandard drugs. As to the fact that the Amendment Act in 2017 changed some of the penalties under the Drug Act, it is noted that with the Amendment Act of 2018 these amendments were omitted or deleted. Therefore the change in penalties is not an issue. For this reason the amendments to the Drug Act did not revoke or cancel the invitation to legislate on drug and medicine given to Parliament by the Provincial Assembly of the Punjab vide its Resolution dated 15.2.2012.
23. In the event that a Provincial Assembly decided to revoke the delegation given under Article 144 of the Constitution, the same should be done through a resolution passed by the Assembly in the same way as the delegation is granted and cannot be inferred through amendments in the law, because the Constitution calls for a specific resolution to be passed by the Provincial Assemblies delegating power to Parliament to legislate. Hence, in the same way, if the delegation was to be revoked, the Provincial Assemblies should pass a resolution stating its clear intent to revoke its invitation to legislate on the subject matter . If the delegation of authority to legislate under Article 144 of the Constitution were left to inferences and interpretation it would defeat the mandate of Article 144 of the Constitution. Moreover , the intent of the Provincial Assembly under Article 144 of the Constitution is made clear by way of resolution meaning that the power to legislate which is vested in the Province, has to be specifically delegated to Parliament. In the same way the revocation of that delegation has to be specifically resolved by the Provincial Assembly . Legislative competence when granted under Article 144 of the Constitution by the Provincial Assembly to Parliament through a resolut ion, requires the same for the purposes of revocation, as the matter falls within the domain of the Provincial Assembly to decide whether its resolution needs to be revoked.
24. The other question with reference to legislative competence is whether the Provincial Assembly of Punjab intended to allow Parliament to regulate more than drugs and medicine, meanin g whether the Resolution dated 15.02.2012 passed by the Provincial Assembly of the Punjab authorizes Parliament to make law which includes the different products of the Petitioners. The entire thrust of the Petitioners arguments on this issue is that Parliament can only make law on 'drugs and medicine' which means only products used in the treatment, mitigation, prevention or diagnosis of diseases. It is argued that the nutraceuticals, food supplements, baby milk are all food products registered with the Food Authority; that disinfectants, sanitizers and cosmetics are regulated under different laws including by the PSQCA; that the traditional systems of medicine have never been regulated as drugs and medicine, hence DRAP has extended its jurisdiction beyond the intended scope of the Resolution by the Provincial Assembly of Punjab. While this argument will be dealt with in greater detail in the context of the nature of the products and the applicable regulatory law, for the purposes of legislative competence 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 determ ination 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 Provincial 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.
Vires of the Rules
25. The Petitioners have challenged the vires of the Rules on the ground that the Rules are ultra vires the DRAP Act as the definition of 'drug' under the DRAP Act does not include alternative medicine, medicated cosmetic, food supplements, health and OTC products, baby milk and disinfectant. Consequently , the DRAP Act does not regulate their products; that the DRAP Act does not authorize the process of enlistment as given under the Rules; that the power to license is restricted under the DRAP Act and does not empower DRAP to license all the products of the Petitioners. Hence the Rules are inconsistent with the DRAP Act and have gone beyond the authority delegated under the DRAP Act. It was also argued that the Rules are vague, arbitrary , discriminatory and unreasonable, hence liable to be declared unconstitutio nal and illegal as they have brought within the ambit of DRAP a diverse variety of products which in no way qualify as 'drugs and medicine' as they are not used in the diagnosis, treatment or prevention of any medical condition. Furthermore, there is no regulatory infrastructure, no expertise or guidelines with reference to the enlistment process. The enlistment applications do not cater to the specific science and specifications of the products of the Petitioners nor have the evidentiary standar ds been settled on the basis of which the enlistment criteria has to be satisfied. As a result it causes confusion and delay and compels the enforcement of unreasonable requirements on the part of DRAP .
26. The DRAP Act was promulgated in November , 2012 and as per its preambl e it is an Act to provide for the establishment of DRAP in order to provide for effective coordination and enforcem ent of the Drug Act and to bring harmony in interprovincial trade and commerce of therapeutic goods. The basic objective of DRAP , as per the preamble, is to regulate, manufacture, import, export, storage, distribution and sale of therapeutic goods.
Therapeutic goods is defined in Section 2 (xxxvi) of the DRAP Act to include drugs or alternative medicine or medical devises or biologicals or other related products as may be notified by DRAP . Alternative Medicine is defined in Section 2 (ii) of the DRAP Act to mean a product used exclusively in homeopathic, unani, ayurvedic, biochemic, Chinese or other traditional system of treatment. Health and OTC Products (non drugs) is defined in Section 2 (xv) of the DRAP Act to include probiotics and disinfectant, nutritional products, food supplements, baby milk and foods, medicated cosmetics, medicated soaps and medicated shampoos. Medicated Cosmetics is defined in Section 2 (xix) of the DRAP Act to mean cosmetics containing 'drugs' as specified in Schedule-I and includes products for cleansing, beautifying, promoting attractiveness, or altering appearance but does not include soap.
The word 'drug' is defined in Schedule-I of the DRAP Act in the following terms:
2. DRUG includes:-
(a) 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, in abnormal physical state, or the symptoms therefore in human beings or animals or the restoration, correction, or modification of organic functions in human beings or animals' including substance used or prepared for use in accordance with the Ayurvedic, Union, Homoeopathic, Chinese or biochemic system of treatment except those substances and in accordance with such conditions as may be prescribed:
(b) abortive and contraceptive substances, agents and devices, surgical itigatures, sutures, bandages, absorbent cotton, disinfectants, bacteriophages, adhesive plasters, gelatin capsules and antiseptic solution;
(c) such substances intended to be used for the destruction or repulsion of such vermin, insects, rodents and other organism 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;
(d) such pesticides as many cause health hazard to the public'
(e) any substances mentioned as monograph or as a preparation in the Pakistan Pharmacopeia or the Pakistan National Formulary or the International Pharmacopoeia or the British Pharmacopoe ia or the British Pharmaceutical Codex or the United States Pharmacopo eia or the National Formulary of the United States, whether alone or in combination any substance exclusively used in the Unani Anyirvedoc, Homoeopathic, Chines or Biochemic system of treatment any and intended to be used for any use of the purposes mentioned in sub-clauses (a), (b) and (c) and
(f) any other substance which the federal Government ,may be notification in the official Gazette declare to be a drug for the purpose of this Act.
The DRAP Act also provides in Schedule-VI that the provisions of the Drug Act and the Rules made thereunder are applicable.
27. Collectively , by way of the various different definitions of the products and the definition of 'drug' in the DRAP Act read with the definition of 'drug' in the Drug Act, DRAP sets out to regulate Therapeutic Goods, Alternative Medicine, Health and OTC Products and Medicated Cosmetics. There are the broad classifications of products which are regulated by DRAP . The Rules which have been challenged are the enlistment rules wherein through the process of enlistment, products are evaluated as per the given criteria. The Rules further define products, within the classification given by the DRAP Act for enlistment purposes. If the product falls within the broad classifications under the DRAP Act, they can then be enlisted as per the criteria given under the Rules. Accordingly the definitions contained in the Rules are in furtherance of the definitions given in the DRAP Act and not ultra vires to it.
28. The definition of 'drug' under the DRAP Act is broad based and includes any substance or mixture of substances, which is offered for sale or represented for use in treatment, mitigation, prevention or diagnosis of diseases including substances used or prepared for use in accordance with the ayurvedic, unani, homoeopathic, chinese or biochemic system or any substance which the Federal Government notifies and declares is a 'drug' under the DRAP Act. Effectively the DRAP Act classifies products under different heads so as to enable DRAP to regulate similar products by setting the required regulatory standards based on the nature of the product and its intended use. In this way the definitions under the DRAP Act and the Rules are not exhaustive, such that a product can fall under any of the classifications, for a determination as to whether the product meets the required definition under the DRAP Act and Rules.
29. The Petitioners have also argued that the definition of 'drug' did not historically include their products, especially with reference to unani, ayurvedic, homoepathic and herbal remedies. The definition of 'drug' under the DRAP Act as contained in Schedule-I read with Schedule-IV and Section 32 of the DRAP Act makes it clear that the definition of 'drug' under the DRAP Act is in addition to the definition of 'drug' under the Drug Act and the Rules framed thereunder . Therefore, the definition of 'drug' under the DRAP Act is not limited or restrictive and by its very nature provides for a diverse and wide range of Therapeutic Goods which can fall within the ambit of DRAP' s jurisdiction.
This definition of 'drug' was considered at length in the Afzar Laboratories Case in the context of the historical perspective where the learned Division Bench of the Sindh High Court after comparing the definition of 'drug' under the Drug Act, 1940 ("1940 Act") , Drug Act and the DRAP Act conclude d that on a combined reading of the definitions of 'drug' traditional medicine such as unani, ayurvedic and homoeopathic were always included in the definition of 'drug' but on account of the policy of the law, they were treated separately and distinctly and not brought within the ambit of the regulatory framework of the Drug Act. The DRAP Act shows a shift in policy where unani, ayurvedic, homoepathic, herbal and biochemic system of treatments were brought within the ambit of DRAP as Alternative Medicine and Therapeutic Goods. The Court in the Afzar Laboratories Case concluded that:- Thus, from 1940 to 2012 the practical position was that the policy was to keep Unani medicines and substances out of the definition even though it must be reiterated, they would have been very much a part of it but for the exclusion. In 2012 the policy underwent a substantive change and was reversed. There is nothing inherent in Unani Medicines and substances that they did not or could not fall within the definition of drugs. We are, therefore, with respect, unable to accept the submissions that the DRAP Act has impermissibly brought about a situation that never existed before and could not exist. Since we have already held that the entire legislative competence of "drugs and medicines" has been granted to Parliament in terms of Article 144, the change brought about by the DRAP Act is constitutionally unexceptionable. It is not for the Courts to gainsay or defeat the policy that now finds statutory expression in the DRAP Act.
30. So far as food and dietary supplements, baby milk and animal feed were concerned, the Court concluded that it first has to be seen whether these goods fall within the definition of 'drug' under the DRAP Act. The test laid down for this purpose is to see whethe r they are presented in such pharmaceutical dosage form, which is intended for health related purpose. Hence in the Azfar Laboratories Case Court directed that guidelines be issued to set out the pharmaceutical dosage form for these products. Consequent thereof, DRAP in compliance with Paragraph No.50 of the judgment dated 26.02.2018 issued the Guidelines for Manufacturers/Importers of Food Supplem ents or Dietary Supplements or Health Supplements or Nutraceuticals as to what is meant by Alternative Medicine and Health Products Dosage Form. As per the Guidelines No.2 human and animal food products are not covered under the DRAP Act and the Rules provided that:-
(i) Any substance or mixture of substance or products do not attract the definition of Drug or Food Supplement or Therapeutic Goods as defined under DRAP Act 2012 and the Alternative Medicines and Health Products (Enlistment) Rules 2014.
(ii) It is not formulated into Alternative Medicine and Heath Products Dosage Form or their subcategories as defined in these guideless.
(iii) It is not presented into the form or manner into believe the general public to be a drug therapeutics good or food supplement.
(iv) It is not presented with any label claim with health related benefits under Alternative Medicine and Heath (Enlistment) Rules 2014.
(v) It does not fall under the definition of adulterated Alternative Medicines and Health Products as defined in the Alternative Medicine and Health (Enlistment) Rules 2014
(vi) It does not contain ingredients falling under the definition of prohibited substances as defined under the Alternative Medicine and Health Products (Enlistment) Rules 212.
These Guidelines give clarity to the manner in which the product will be evaluated on the basis of its pharmaceutical dosage form and presentation in the context of health related purpose under the Rules. I draw no exception to the reasoning given in the Azfar Laboratories Case as the products of the Petitioners including Alternative Medicine has always been a part of the definition of drug under the Drug Act. In this regard it is noted that the definition of 'drug' under the Drug Act and the DRAP Act are very similar covering a broad base.
31. The Drug Act defines 'drug" as follows:-
(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 diseases, 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 a substance exclusively used or prepared for use in accordance with the ayurvedic, unani, homoeopathic or biochemic 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 organism 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 monograph or as a 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 Pharmacopo eia or the National Formulary of the United States, whether alone or in combination with any substance exclusively used in the unani, ayurvedic, homoeopathic or biochemic 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 sets for infusion or blood, disposable syringes or any other substance or device which the Federal Government may , by notification, in the of ficial 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 cleansing 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 Itexture and facial glow and improvement, shower creams, skin lotions and oils, sun-burn lotions and oils, shaving cream and leathers, after-shave lotions and any other preparation or material connected therewith; The contention of the Petitioners that historically their products were never regulated as 'drug' under the Drug Act is only correct to the extent that as of policy ayurvedic, unani, homeopathic or biochemic systems were not brought within the regulatory ambit of the Drug Act. Under the Drug Act homeopathic, unani, ayurvedic, biochemic, chinese or other traditional systems of treatment were always part of the definition of 'drug', as per Section 3 (g)(i) of the Drug Act. In this regard, Azfar Laboratories Case dissected the different definitio ns to show that there are three parts to the definition in the Drug Act wherein the first part defined what drugs are, the second part excluded from the definition unani medicines and substances but the third part allows such unani substances to be brought back into the definition with such conditions as may be prescribed. In the same way under the DRAP Act, the first part of the definition of 'drug' in Schedule-I includes ayurvedic, unani, homeopathic, chinese and biochemic system of treatment hence the policy of law is to include all substances used in the preparation of the same. Therefore, the contention that homeopathic, unani, ayurvedic, biochemic, chinese or other traditional system of treatment was never part of the definition of 'drug' is incorrect. So far as the other products such as disinfectant, nutraceuticals and food supplements, baby milk and cosmetics, they have been included in the definition of 'drug' under the DRAP Act which is reflective of the legislative intent. 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. In this context the reference to previous definitions of 'drug' or the historical context of how Alternative Medicine and Therapeutic Goods, Health and OTC Products were treated is of no significance.
32. The question to be determined is why products classified as Therapeutic Goods, Health and OTC Products, Medicated Cosmetics and Alternative Medicine are brought within the ambit of DRAP . DRAP was established vide Notification dated 28.11.2012 issued by the Ministry of National Regulations and Services, Government of Pakistan, Islamabad. The composition of DRAP is that it is headed by Chief Executive Officer ("CEO") and amongst others there are Director Pharm aceutical Evaluation and Registration, Director Drug Licensing, Director Quality Assurance and Laboratory Testing, Director Medical Devices and Medicated Cosmetics, Director Biological Drugs, Director Controlled Drugs, Director Pharmacy Service, Director Health and OTC Product. As per Section 3 of the DRAP Act, the Federal Government can increase or decrease the number of directors depending on the requirement and functions. Section 7 of the DRAP Act specifically provides the powers and functions to administer the law specified in Schedule-VI meaning the Drug Act read with rules framed thereunder . Amongst other functions is the power to issue guidelines and monitor the enforcement of licensing of the manufacture and registration of Therapeutic Goods. This includes the import and export of such products. 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. As per Section 23 of the Drug Act, no person shall export, import or manufacture for sale or sell drugs which are not registered under the Drug Act as per the conditions stipulated in the registration. Hence the Drug Act also contemplated the registrat ion, 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.
33. The regulatory objective of the DRAP Act is to establish a regulatory framew ork which will ensure the safety and effectiveness of drugs and medicine sold in Pakistan, through a unified system, operating systematically across Provincial borders. The process of manufacturing, marketing and the sale of drugs, which includes the import and export of drugs has to be regulated to protect the interest and health of the public. The products before the Court statedly raise health claims which means that they are intended for or recommended for a health related purpose, which characterizes the relationship of any substance to a disease or health related condition. When seen in the context of public interest or public welfare, it is important to note that regulating health claims is about risk management, about safety and disclosure for the benefit of the public. 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. The products of the Petitioners are classified under the DRAP Act as they may be connected with some health related purpose, hence they are not ordinary consumer products since they claim to have some health benefit. Consequently DRAP has to ensure the products safety , efficacy and quality for the benefit of the public.
34. The Petitioners have argued at great length that their products do not fall within the regulatory jurisdiction of DRAP and that their products are duly regulated by different authorities created under the law, such as PSQCA, the Food Authority , Punjab Infant Feeding Board. As per the contentions made, various different regulatory regimes have been established which are compre hensive and ensure public safety with respect to the products concerned.
Specifically the Petitioners who manufacture, import or sell nutraceuticals, food supplements (for animal or human consumption) and baby milk have argue d that their products are food and are regulated by the Food Authority under the Food Act and the Punjab Pure Food Rules, 2011 ("Food Rules") , hence they cannot be regulated by DRAP . They argued that under the Rules, food supplements and dietary supplements are defined under Rule 2(xxxi) of the Rules to mean products containing vitamins, pro-vitamins , multivitamins, minerals including a mine ral salt, a naturally occurring mineral, metals and their salts, a lipid, including an essential fatty acid or phospholipids liproteins, amino-acids, proteins, fatty acids, carbohydrates, a mucopolysaccharid e, plant or herbal material (or a synthetic duplicate of that kind), including plant fibers, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll, herbal preparation, resins, balsams, volatile oils, non-human animal material (or a synthetic duplicate of that kind) including dried material, bone and cartilage, fats and oils and other extracts or concentrates, a microorganism, whole or extracted, except a vaccine expressed juices, exudates etc. alone or their combinations and are presented in pharmaceutical dosage forms intended for health related purpose. However , at the same time the Food Rules makes special provision for dietary supplements and food supplements which contain vitamins, minerals and require proper labelling and packaging in accordance with Codex Guidelines. It was also argued that the DRAP Act and the Rules define these products as 'non-drugs' yet regulates them as 'drug and medicine' which reflects inconsistency in the law. Learned counsel relied upon different jurisdictions from around the world to urge the point that these products are regulated as 'food' and not as 'drug and medicine' world over .
35. In order to appreciate the arguments of the Counsel, it is necessary to understa nd the objective and purpose of the different regulators because the regulatory objective defines the process which the regulator will follow to identify products and to ensure that the regulations and the regulatory framework serves the public interest. The entire regulatory framework is designed to effectively achieve and retain the policy objectives. Hence a regulator is identified by its objective and usually its policy objectives are evident from the law .
36. The Food Act provides for the safety and standards of food which includes regulating adulterated food, misbranded food, food additives. As per the Food Act, the power and function of the Food Authority is to regulate and monitor the food business in order to ensure safe provision of food. For this purpose they are required to formulate standards, procedures, proces ses and guidelines in relation to any aspect of food including the food business, food labelling, food additives and providing appropriate enforcement system. As per the definition of food under the Food Act, a thing shall not cease to be a food by reason that it is also capable of being used as drugs and the word drug shall have the same meaning as is assigned to it under the Drug Act. Hence the definition of food itself excludes food that may be capable of being used as a drug. The reason being that the objective of the Food Authority is to regulate the safety and quality of food so as to ensure that it is as per the prescribed standards, hygienic and contains substances which are intended for use in the preparation of food, but are not considered to be a 'drug' as defined under the Drug Act. Hence the Food Act clarifies that it does not regulate 'food' in the context of it being a 'drug'.
37. The 2002 Ordinance establishes the Punjab Infant Feeding Board to ensure the safe and adequate nutrition for infants and young children by promoting and protecting breast-feeding and by regulating products which are substances for breast milk. As per the 2002 Ordinance the complementary food is any food suitable for infant and young children in addition to breast milk or a substitute for breast milk and the Board is required to ensure compliance of the 2002 Ordinance and the rules made thereunder . Section 11 of the 2002 Ordinance assures quality as per the standards prescribed by the Codex Alimentarius Commission and the Codex Code of Hygienic Practice for Foods for Infants and Children, which are international standards. Hence the mandate of the 2002 Ordinance is to protect and promote breast feeding as well as to ensure that infant formula or complementary formula food as necessary nutritionally value as required for infants and young children. Food for infants and children is also regulated by PSQCA which provides for the Pakistan Standard specifications for foods and infants and children. The purpose of maintaining quality and standard is to ensure safe and nutritionally adequate formula products which meet the normal nutritional requirements of infants and young children. The DRAP Act and the Rules regulate Health and OTC Products which includes baby milk, milk based food. In the context of the definition of 'drug', where there is a health related purpose and the product is presented in pharmaceutical dosage form, intended for health related purpose , it falls out of the ambit of 'food' and needs to be evaluated as a 'drug'. Hence by design the very purpose and objective of DRAP is very different from the Food Authority , from the Board and from the PSQCA.
38. The 1965 Act regulates qualifications and requires the registration of practitioners of the unani, ayurvedic and homeopathic system of medicine. A bare reading of the 1965 Act itself shows that it does not consider the quality , safety or health related concerns of unani, ayurvedic and homeopathic system of medicine or its products. The rules framed thereunder called the Unan i, Ayurvedic, Homeopathic System of Medicine Rules, 1980 provides for, amongst others, to register as practitione r, as teacher and as teaching institutions under the 1965 Act. Again its regulatory objective is dif ferent from the DRAP Act.
39. The DRAP Act and the Rules regula te Therapeutic Goods, Alternative Medicines, Health and OTC Products and Medicated Cosmetics. The Rules require that products which fall within the given classifications are evaluated as per the evaluation criteria for the purposes of enlistment. The enlistment of products or the entity is a temporary process until the procedure for licensing is finalized. It is through the enlistment process that the regulatory objective of DRAP is achieved because at the time of enlistment manufacturers and importers provide, all relevant information through their application to DRAP' s Director of Division of Health related OTC Products (non-drugs).
The application for enlistment has to set out the general health claim or traditional use claim or nutritional claim or structure-function claim or therapeutic claim for disease reduction which forms the basis on which the application will be evaluated. DRAP requires that the applicant submit, as per the standards of evidence, proof regarding the quality , safety , efficacy or effectiveness of the product and recommend the conditions for use of the product.
Through the evaluation process, DRAP will ensure that the regulatory criteria set out in Rule 5 is satisfied with reference to the product under evaluation. Hence when it comes to Therapeutic Goods, Alternative Medicine and Health and OTC Products and Medicated Cosmetics, DRAP' s regulatory objective is to scrutinize the health related purpose for which the product is presented and for which the product is market ed. Health related purpose is a defined term under the Rules which basically means a health based claim which can be curative, preventive, palliative or cosmetic which is intended or recommend for the well being of humans and animals. As per the Guidelines pharmaceutical dosage form is the physical form in which the product should be produced and dispensed with for human or animal use. The dosage form essentially sets out the acceptable standard on which the product can be presented and if it is not presented in the pharmaceutical dosage form, it is not regulated by DRAP . Therefore to fall under the DRAP' s regulatory regime the product must have a health related purpose and must be presented in a pharmaceutical dosage form. When evaluating the health related purpose and the pharmaceutical dosage form, DRAP will ensure that the product is safe, qualitative, efficacious and effective in terms of its intended and recommended use. Therefore the regulatory objective of DRAP sets it apart from all the other regulators, as discussed aforesaid, in that its functions and purposes are distinct from other regulators. In this process, since a determination has to be made while evaluating the product, the applicant before DRAP can always raise its objections that its product does not fall under DRAP' s enlistment criteria as it does not have a health related purpose and its usage and consumption is neither therapeutic nor one that promotes the general health of its user. Under the DRAP Act decisions of the Authority are appealable before the Appellate Board. Hence such factual disputes can be decided by the Authority which is DRAP . Consequently the contention that the products of the Petitioners should be accepted as food or cosmetics or disinfectant per se, is not against the mandate of the DRAP Act and require a determination by DRAP . Furthermore no injury is caused to the Petitioners through the enlistment process.
There is no violation of any fundamental right including the right to be treated as per law .
40. Different regulatory regimes work for different regulatory objectives. The regulatory objective impacts the purpose of the regulator and its policy , therefore, each regulatory regime will work within its regulatory field and achieve its regulatory objective. The significant factor in this case is that each regulator works in furtherance of its own objective and in doing so there may be a situation when two or more regula tory regimes call for compliance over the same product. This suggests that there can be overlaps and even in some cases conflict between the regulatory regimes. However , neither the overlap nor the conflict can be interpreted to mean that different regulatory regimes cannot co-exist, or that a product or entity cannot be subjected to more than one regulatory regime. Regulatory overlap is possible because the legislature gives regulating authorities broad based delegation of authority to give them flexibility to respond to the changing regulatory environment. This does not make regulatory regimes incompatible or mutually exclusive. Any overlap or conflict will have to be seen on case to case basis, in the context of the facts and circumstances of the case and possibly call for better coordination and harmonization. With reference to the dispute at hand, DRAP regulates health claims, pharmaceutical dosages forms when evaluating the products of the Petitioners. 'Health Claims' go to the intent of the usage of the product, which means the purpose for which the product is recommended, marketed and sold. DRAP looks at the health motive and quality and safety of the product to ensure that the health claim is safe, effective and based on settled standards. In the context of health related purpose and intended or recommended use of product this can be easily illustrated through common examples. Food and dietary supplements or nutritional products often promote wellness and health benefits and may emphasize the prevention and treatment of disease such as alleviate risk of cancer and heart diseases or prevent or treat hypertension, high cholesterol and excessive weight etc. Such claims fall within the regulatory domain of DRAP and not the Food Authority or PSQCA or the Board or under the 1965 Act because these claims have to be assessed and evaluated in the context of the health related claims. The same will be applicable for cosmetics, disinfectant, sanitizers and other OTC Products as they have to be evaluated in the context of its impact on health or any health related condition, which is what, brings it within the ambit of DRAP' s jurisdiction.
41. In the same way, food and dietary supplements are regulated by DRAP to determine if they contain ingredients that have biological effect which may conflict with medical or medical conditions or contain hidden drugs falsely marketed which put consumers at risk. The product may contain substances which are associated with potential serious health risks or other health risks such as hair loss, altered mode, irritable, aggression and depression which need to be checked and highlighted for public safety . Non-prescription products whether there are herbal or natural need to be checked to establish whether in fact they are free from hidden drugs as they may contain harmful substances which have not been listed or labelled. Hence when seen in the context of regulatory objective, the Petitioners before the Court may be subjected to more than one regulatory regime, which means that they may be subjected to DRAPs regulatory regime along with other regulatory regimes. Althoug h the products do not fall in the medical sense of 'drug and medicine', with the increase in demand for products (non-drugs) having health or therapeutic claims it is vital that health claims and health purposes are regulated. Firstly it ensures that the claims are not unsubstantiated and secondly it requires the manufacturer or importer to bring reliable and scientific information with reference to its claim and product. Finally it ensures that proper information is disseminated for the benefit of the public such that if such products are used or consumed necessary and important health risks are made known.
42. In the same context, the Petitioners who manufacture, import and sell cosmetics and Health and OTC Products which include sunscreen, skin care products, personal care products, anti-aging products, also argue that their products are not drugs and cannot be regulated as drugs. However , Cosmetics, Health and OTC Products are evaluated in the context of their intended use whether for cleansing or beautifying or altering appearance. Where a therapeutic or health claim is made the product will fall within DRAP' s jurisdiction for evualuation. The cosmetic or drug distinction is based on how the manufacturer has marketed/promoted the product and the promises made to that effect as these claim may affect the body in a way that a drug can. It was also argued that Health and OTC Products includes disinfectants and hand sanitizers which are neither therapeutic nor related to the diagnosis or treatment of any disease. It was also argued that these are general sale items which are neither drugs nor therapeutic goods nor consumed in any manner for any health purpose. They are used to remove contaminants and germs and for cleaning surfaces, household or other . It was further argued that these products are regulated by the PSQCA which ensures quality and standard which does not fall within the regulatory objective of DRAP .
However , these arguments run counter to the regulatory objective. If a product is used or recommended for a health related purpose, DRAP can evaluate it for enlistment purposes. In the USA disinfectant are regulated by the Environmental Protection Agency and some by FDA as they may contain active ingredients like biocide. In India they are regulated under the Drugs and Cosmetics Act. In Australia under the Therapeutic Goods Act, 1989 based on the intended use which may be for skin, medical devices, household use or hospital use. Therefore, there is no justification to the argument that the Petitioners cannot be regulated by DRAP because even globally there is a practice to regulate such products to ensure they are safe for human healths.
The Enlistment Process:
43. The Petitioners have argued that process of enlistment is beyond the scope of the DRAP Act as it is not provided for under Section 7 of the DRA P Act and they have placed reliance on Section 4 (h) of the DRAP Act which provides for a Director Health and OTC Products (non-drugs), who is Incharge of the Division of Health and OTC Products (non-drugs) and is responsible for the assessment, licensing and registration of alternative medicines such as ayurvedic, chinese, unani and homeopathy , enlistment or regist ration of nutritional products and food supplements for human beings, animals and to perform other functions connected therewith. The Rules provide that enlistment means provisional allocation or entry of proper number to the firm or the produc t in the enlistment register for the purpose of temporary manufacturing and marketing authorization until the procedure for issuance of license and product registration is finalized . This means that enlistment is a provisional allocation of number given to a product or entity (manufacture or import) to authorize the manu facture, import and marketing of the product. This provisional certification has become necessary because DRAP has not initiated the process of issuing licenses, hence in order to ensure that a product or entity can continue dealing with its business, the process of enlistment has been devised through the Rules. The entity or the product has to be enlisted until the licensing function becomes operative. Therefore the argument that enlistment is not prescribed for under the DRAP Act or is beyond the scope of DRAP Act is totally misconceived. To the contrary , DRAP has facilitated the process of regulating by ensuring that before the function of licensing commences a process of enlistment is undertaken by way of which the product or entity is evaluated and enlisted and given a provisional authorization to continue with the manufacture, import or marketing as per the Rules. The process started in 2014 when the Rules were made after which time was given to ensure that manufactures and importers could switch towards DRAP' s regulatory regime. In this regard the record shows that meetings were held with stakeholders to discuss the regulatory objective and process.
44. When seen in the context of the process of enlistment, the Rules provide for the procedure under Rule 3 of the Rules that an application for enlistment shall be made to the Authority , addressed to the Director of Division of Health and OTC Products (non-drugs) in the prescribed manner . The application of enlistment of local manufactured products which contain a general health claim or traditional use claim or nutritional claims or structure function claims will be evaluated as per the criteria in Rule 5 of the Rules. In the same way any product which makes a disease reduction by therapeutic claim will also be evaluated as per the criteria given in Rule 5 of the Rules. An enlistment process has also been prescribed for imported products to ensure that all imported products, that may make a general health claim or traditional use claim or nutritio nal claims or structure function claims is enlisted. The term health related purpose has been defined under Rule 2 (xxxv) of the Rules and is fairly broad based. This further the objective of the DRAP Act and the Rules, to enlist all products which make any kind of health claim or well being claim. In this regard, the applicants are required to provide evidence with reference to the quality , safety , efficacy , effectiveness and recommended conditions for use as per standards of evidence in terms of Rule 4 (ii) of the Rules. To facilitate this process as per the direction given in the Azfar Laboratories Case the Guidelines were introduced which prescribes the pharmaceutical dosage form on the basis of which the product will be assessed and evaluated. Therefore the Petitioners' contention that the Rules are ultra vires the DRAP Act is without basis as DRAP is duly authorized to license the entity or the product or enlist them and the Rules are in furtherance of the purpose of the DRAP Act.
45. So far as the contentions with respect to the enlistment process being ambiguous, unreasonable and impractical as it lacks product specifics, counsel for DRAP explained in great detail that DRAP conducted meetings with stakeholders to understand mark dynamics, best practices and international standards. Minutes of various meetings have been placed on file to demonstrate the issues discussed, which includes enlistment issues product related ambiguities, evidentiary standards and settlement and of Recommended Dietary Allowances ("RDA") to keep products safe. In the context of alternative medicine, meetings look place to settle the authoritative books on unani, ayurvedic, homeopathic remedies. Therefore clearly the differences in the traditional systems of treatment were considered and endorsed through the authoritative books. These documents show that DRAP made a participatory effort to finalize its regulatory requirements where product specifics diverse sciences and established practices were considered. In this regards it can be said that this is an evolving process and market dynamics and concerns should be raised directly with DRAP to ensure ef fectiveness of the process under the Rules.
46. Globally drug regulations are considered to be more extensive and devoted to safety aspects. The definition of 'drug' is expansive and not confined to the strict medical definition of the word 'drug' due to the blurring of divides between what is a drug and what is not. Products may be on the borderline and may fall within the regulatory ambit of 'drug' due to their intended use. However , the balance between commercial interest and regulatory objective has to be for the greater public good. The objective is to protect the consumer before harm occurs, as products professing a health related purpose will be seen in the context of public health and safety . Hence, no illegality is made out with reference to the enlistment requirements.
47. The Petitioners have also emphasized on the lack of regulatory infrastructure under the DRAP Act and the rules not only by way of capacity issues and expertise but also due to lack of clarity of what DRAP seeks to regulate and what is required to be established before DRAP for determination on whether the product can be classified as Therapeutic Goods, Alternative Medicine, Health and OTC Products and Medicat ed Cosmetics. It has also been argued that when the required regulatory infrastructure and the regulatory guidelines are not available, DRAP should not use coercive actions against the Petitioners by seizing their products or sealing the premises as has been ordered by the National Task Force in fact for which the National Task Force was set up. The Petitioners contend that DRAP needs to set out its guidelines such as the acceptable standards of evidence which will be used, as per the product classification, during the enlistment process so that the Applicant is aware of the basis of the evaluation of the application for enlistment. It has also been argued that DRAP is required to furnish guidelines on what are the standards to determine quality and safety as well as efficacy and effectiveness, as it is not necessary that every product has to be efficacious or effective. As per the arguments made, these guidelines are readily available with similar regulators around the world which makes the process of regulating easier and efficient. In some cases DRAP is required to declare active ingredients and expedient ingredients in order to establish therapeutic claims. The Counsel argues that until these guidelines are not made, in the very least DRAP should resort to standard international practices so that the industry and the business of the Petitioners do not suffer. Further that they should not use coercive measures to enforce enlistmen t where it is not possible. The arguments raised before the Court with respect to the methods adopted by DRAP to ensure compliance of the Rules have merit especially since the Counsel for DRAP admits that matters are still under process and will take time to evolve. Notwithstanding the same, if DRAP sets out to regulate the products of the Petitioners and it does not have the required guidelines or standards against which the products can be regulated then at least they should rely on acceptable international guidelines and adopt the same on the basis of which the enlistment processes can continue and the Petition ers are facilitated. As per the Rules standards of evidence is a defined term, which in itself requires clearly defined criteria used by regulators to evaluate safety , quality and effectiveness as per the product. These standards of evidence need to clearly define the required criteria for enlistment process.
As per the record the 'standards of eviden ce' are not clearly defined as yet. DRAP can also simplify its procedures and streamline its processes to reduce administrative burden and ambiguities. The issue of delay where imports are concerned should also be dealt with not only to facilitate the importers but also the public for whose consumption the products are imported.
48. Therefore in view of the aforesaid:
(i) with respect to the issues on lack of guidelines on acceptable standards of evidence, DRAP is directed to devise guidelines setting out the acceptable standards of evidence required to support health related claims to prove quality , safety , efficacy and effectiveness of the product. Until guidelines are not available, DRAP should rely on international standards and make known the standards of evidence that the applicant is required to satisfy under the Rules. The acceptable standards of evidence should be publicized within 30 days either as per international practices or in terms of DRAP' s Guidelines;
(ii) with respect to the Petitioners who claim that the products or entities do not fall under the DRAP' s regulatory regime, a proper hearing should be given by DRAP , who should pass a speaking order as to whether the product or entity falls under the DRAP Act or Rules. Any person aggrieved of the order of the Authority order may file an appeal or seek remedy as required under the law;
(iv) with reference to the Petitioners who deal in hand sanitizers, in view of the Cabinet Decision dated 5.5.2020 and Notification dated 21.05.2020, during the period of declared emergency on account of the pandemic Covid-19, DRAP should act accordingly;
49. To the extent of the challenge to legislative competence of Parliament and the vires of the Rules, the claims of the Petitioners are without merit, hence dismissed.