Al Wakeelo
Your Digital Lawyer, Always on Duty
Initializing Secure Chambers
Your Digital Lawyer, Always on Duty
Initializing Secure Chambers
Petitioner: Dawakhana Hakim Ajmal Khan (Pvt.) Limited VS Respondent: Federation of Pakistan, etc
Court Name: Lahore High Court Judge(s): Ayesha A. Malik Title: Dawakhana Hakim Ajmal Khan (Pvt.) Limited vs Federation of Pakistan, etc Case No.: WP No.3973 of 2017 Date of Judgment:2020-08-05 Reported As: PLD 2020 Lahore 899, 2020 LHC 1590 Result: Petition dismissed
JUDGMENT
JUDGMENT 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
---
## Page 2
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,
---
## Page 3
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
---
## Page 4
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
---
## Page 5
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
---
## Page 6
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…
Read the unabridged text and precedent citation network on Al Wakeelo Legal Research Platform.