Summary: (a) Competition Act, 2010 ----S. 10(1) & S. 10(2)(a), (b)—Deceptive marketing practices—Misleading advertising—Non-disclosure of material change in product composition—Allegation that respondent continued marketing "Strepsils" as a medicinal remedy for sore throat despite de-registration as a drug—Failure to explicitly inform consumers about removal of pharmaceutical ingredient—Use of claims such as "Soothes in less than 10 seconds" and "Instant Relief" considered misleading—Competition Commission of Pakistan (CCP) determined that continued branding and marketing of product created a false impression of therapeutic efficacy—Deceptive omission established—Prima facie violation of S. 10 of the Act found. (b) Consumer Protection & Marketing Regulations ----Obligation of undertakings to provide truthful and non-misleading information—Deceptive practices include omission of material facts likely to mislead consumers—Absence of clear disclaimers on product packaging and marketing material regarding de-registration as a drug—Standard for deceptive marketing based on "ordinary consumer" perception rather than "reasonable consumer"—CCP ruled that deceptive claims capable of harming business interests of competitors—Non-disclosure of third-party manufacturing arrangement with confectionary brand "Candyland" also considered misleading. (c) Regulatory Compliance & Market Conduct ----Duty of businesses to ensure accurate representation of product nature—Failure to distinguish product from medicinal alternatives may cause consumer confusion—CCP relied on precedent set in Procter & Gamble Pakistan Ltd., 2010 CLD 1695 and China Mobile Pakistan (Zong) Order, 2010 DLC 1478—Held, advertisements must be assessed based on overall net impression—Omissions and implied claims collectively determined as misleading under S. 10(2)(b) of the Act—CCP directed respondent to modify marketing practices in compliance with fair competition laws. Disposition: Respondent found in violation of S. 10 of the Competition Act, 2010 for engaging in deceptive marketing practices—Directed to rectify misleading claims and ensure transparency in product representation—Case disposed of accordingly.

Summary: Background:The Supreme Court convened a Suo Moto Case regarding combating the COVID-19 pandemic in Pakistan.Various representatives from federal and provincial governments, regulatory authorities, and concerned organizations attended the hearing.Reports were submitted by the National Disaster Management Authority (NDMA), Plant Protection Department, Governments of Punjab, Sindh, KPK, and Gilgit Baltistan.---Issues:Lack of transparency in NDMA's procurement of machinery for N95 masks production.Approval sought by NDMA for import of unregistered drugs.Operational status of aircraft for locust control.Verification of pilots' licenses and degrees.Allocation of funds for luxury vehicles by the Sindh Government.Inadequate measures for dealing with COVID-19 and related issues.---Holding/Reasoning/Outcome:NDMA directed to provide details of purchases, payments, and taxes related to N95 masks production.NDMA asked to explain special favor given to a company for machinery import.NDMA's request for importing unregistered drugs subject to conditions from DRAP.DG Civil Aviation Authority ordered to appear and explain the issue of fake pilot licenses.CEOs of airlines to provide reports on pilot verification.Sindh Government restrained from allocating funds for luxury vehicles until further notice.Concerns raised about Sindh Government's budget allocation and lack of funds for essential services.Government departments directed to take strict action against hoarders of COVID-19 related supplies.DRAP and relevant authorities instructed to ensure availability and reasonable pricing of essential medical supplies.Adjourned to a date after three weeks.

Summary: The court discusses various petitions filed by the pharmaceutical companies against the Impugned Notice and Impugned SRO (Statutory Regulatory Order) issued by DRAP. The pharmaceutical companies challenge the validity of the notice and order, claiming that they are in violation of the orders of the honorable Supreme Court. The companies argue that the pricing of drugs should be based on the 2018 Drug Pricing Policy rather than the 2015 Policy, which the Impugned SRO relies on. The court's judgment emphasized the role of the statutory appellate board in resolving disputes related to drug pricing and the importance of adhering to the directions provided by the honorable Supreme Court. It stated that the parties should pursue their grievances through the established statutory appeals process rather than approaching the High Court directly. The court directed the pharmaceutical companies to file appeals before the appellate board and to seek interim relief within that process. The judgment also highlights the power of the appellate forum to grant interim relief during the pendency of appeals, even if the governing statutes do not explicitly provide for such relief. The court urged the appellate board to expeditiously hear and determine the appeals and applications for interim relief in accordance with the law. Overall, the judgment underscored the importance of following the established legal procedures for dispute resolution and appeals, as well as the significance of adhering to the directives of the higher courts.

Summary: The petitions arise under and in relation to the Drug Regulatory Authority of Pakistan Act, 2012 (DRAP Act). petitioners contend, the DRAP Act cannot, does not and should not apply to various products as manufactured, sold, used or imported by them, including Unani medicines, prescriptions and preparations, We start with the first set of questions, which relate to the constitutionality of the DRAP Act as enacted under Article 144. This Article originally had two clauses, of which the second was omitted by the 8th Amendment in 1985. two changes made by the 18th Amendment, one was necessitated by the omission of the Concurrent List, and need not detain us. The other, which will require some comment, was that originally Article 144 applied only if two or more Provincial Assemblies passed the necessary resolutions. The present Constitution of course had two Legislative Lists on its commencement. The competences listed in the Federal List were exclusive to the Federation, those on the Concurrent List were common, and those which were not enumerated were exclusive to the Provinces. VThat ability of course is one of the defining characteristics of federal legislative power, since in respect of matters that lie in the Federal domain by right Parliament can make laws for the whole of Pakistan or any part thereof. It would be unduly restrictive of the purpose and intent behind Article 144 if Parliament, while making the law for which it has been given power cannot include therein provisions that relate to matters in the Federal domain as of right. Secondly, a provincial law made subsequent to the law made by the Federation under Article 144 may override or impliedly repeal the latter. This follows directly from the express provision that the Provincial Assemblies may amend or repeal the law made by Parliament. The 1976 Act, in like manner, fractured and receded. It became provincial legislation and hence territorially bound. It now so operates in this and all other Provinces. It must be kept in mind that this position has remained unaltered, and is unaffected by the enactment of the DRAP Act under Article 144. Whatever may be the relationship of, and interaction between, the two laws, the 1976 Act does not now transcend or cross provincial boundaries in the manner of the DRAP Act. It is therefore our conclusion that in the present case, the scope of the legislative competence entrusted to Parliament in terms of Article 144 is governed by the terms of the resolution passed by the Punjab Assembly. Within 30 days of announcement of judgment the Authority under the DRAP Act shall issue proper guidelines, Simultaneously with posting the guidelines on its website, the Authority shall issue notice to each petitioner in the petitions to which this para applies. Interim orders made in any petition to which this para applies shall continue but will lapse 30 days from the date on which the guidelines are posted as above or the date on which the determination is made, whichever is later. following petitions are dismissed: CP D-4387/2014 and CP D-1684/2017. e following petitions are disposed off in terms of para 50herein above: CP Nos. D- 6532/2014, 2623/2016, 6262/2016, 6263/2016, 6264/2016, 6265/2016, 6310/2016, 6820/2016, 7134/2016, 7135/2016, 1135/2017, 1921/2017, 2329/2017, 424/2017,4421/2017, 5237/2017 and 5892/2017.

Summary: Background: Multiple writ petitions were filed by petitioners who were former officials of the Drug Regulatory Authority of Pakistan (DRAP). They sought post-arrest bail in connection with a National Accountability Bureau (NAB) reference alleging corruption and misuse of authority. The petitioners were accused of granting illegal price increases for certain pharmaceutical drugs during the 5th and 6th Drug Pricing Committee (DPC) meetings, resulting in substantial financial loss to the public and undue benefit to pharmaceutical companies. -----Issues: 1- Whether the petitioners, in their official capacities, misused their authority by granting illegal price increases for drugs in violation of the Drugs Act, 1976, and the Drug Regulatory Authority Act, 2012. -----2- Whether the actions of the petitioners constituted corruption and corrupt practices under Section 9(a)(vi) of the National Accountability Ordinance, 1999 (NAO). -----3- Whether the petitioners were entitled to bail based on the circumstances of the case. -----Holding / Reasoning / Outcome The Islamabad High Court dismissed the petitions for post-arrest bail. The petitioners misused their authority during the 5th and 6th DPC meetings by allowing price increases for drugs without verifying costing data, import invoices, or compliance with required procedures, leading to undue benefits for pharmaceutical companies. The petitioners failed to act in accordance with the Drugs Act, 1976, and the Drug Regulatory Authority Act, 2012. Their actions were deemed a misuse of authority involving mens rea (guilty intent) and actus reus (unlawful acts). The court rejected claims of indemnity under Section 38 of the Drugs Act, 1976, noting that the indemnity applies only to acts performed in good faith, which was absent in this case. Substantial financial losses to the public and undue benefits to companies, amounting to over PKR 1 billion, established prima facie evidence of corruption and corrupt practices under Section 9(a)(vi) NAO. Granting bail would interfere with the ongoing trial and investigative process. The court emphasized that public servants involved in corruption and causing loss to the public exchequer are not entitled to leniency. The petitions for bail were dismissed, and the petitioners were advised to seek their defense in the ongoing NAB trial. -----Citations / Precedents: Drugs Act, 1976 and Drug Regulatory Authority Act, 2012: Governed the petitioners’ duties and obligations, highlighting their legal violations. National Accountability Ordinance, 1999: Section 9(a)(vi) defines corruption and misuse of authority. The State vs. Anwar Saif Ullah Khan (PLD 2016 SC 276): Explained misuse of authority and the burden of proof in corruption cases. Imran Mohsin vs. NAB (2016 SCMR 1965): Established that bail should not be granted in cases of gross misuse of authority resulting in significant financial loss to the public. Kamran Saeed vs. NAB (W.P. No.1632/2016): Discussed the duties and obligations of public servants to protect the public exchequer and avoid corruption.

Summary: The dispute arose when the government of Punjab invited bids for the procurement of drugs, including "Injection Pegylated Interferon 180 mcg Alpha2a/120mcg Alpha 2b," a medication used for Hepatitis C treatment. Getz's Unipeg had not been certified by these laboratories and did not meet the bidding criteria. Alfalah, an authorized distributor of Getz, filed a lawsuit challenging the bidding documents' clause. The trial court temporarily suspended the clause. However, when the government reissued the tender with prequalification requirements, Getz applied for prequalification but was later rejected. They filed a grievance application, which was dismissed. The current writ petition challenges this decision. The case primarily revolved around whether the bidding document requirements violated the Federal standards set out in the Drug Regulatory Authority of Pakistan Act, 2012 (DRAP Act). The court analyzed the DRAP Act and found that it closely followed the World Health Organization (WHO) Guidelines for the licensing of biosimilar drugs. Getz's Unipeg had received conditional registration but was yet to meet the bio-similarity standards. Therefore, the court determined that the bidding document requirements aligning with the DRAP Act did not violate the law. Additionally, the court found that Alfalah was not a proper party in this case, as it did not participate in the second tender process. Getz's attempt to involve Alfalah in the proceedings due to previous stay orders granted by a civil court was not sufficient. Overall, the court upheld the legality of the bidding document requirements and dismissed the petition. The case highlighted the importance of adhering to international standards for biosimilar drugs and the authority of government bodies to set procurement criteria for public health reasons.

Summary: (a) Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012)—Enlistment Rules for Alternative Medicine and Health Products. ----The Alternative Medicine and Health Products (Enlistment) Rules, 2014, issued under Section 23 of the Act, aim to regulate the previously unregulated field of herbal and Ayurvedic products, safeguarding public health and addressing malpractices. (b) Public Interest Litigation—Prematurity of Petition. ----A petition seeking enforcement of recently notified rules (less than a month old) may be considered premature. However, concerns about public health and regulation of alternative medicines are valid and merit the attention of the relevant regulatory authorities. (c) Administrative Guidance—Implementation of Public Interest Rules. ----Regulatory authorities are expected to enforce the Alternative Medicine and Health Products (Enlistment) Rules, 2014, in letter and spirit, given the significant public health implications. Petitioners should be afforded an opportunity to present their concerns. ----Result: Petition disposed of with directions to the respondents to take appropriate measures for implementing the rules and ensuring no grievances arise due to non-enforcement. Respondents are encouraged to hear the petitioner's concerns to aid effective implementation.

Summary: (a) Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012) —- Ss. 4(1), 4(2), 7(m), 14(1), 15(5)(a)&(b), 23 & 24 Prescribing of rules—Scope—Authority of Federal Government and DRAP—Distinction between "rules" and "regulations" under the Act—Effect of non-framing of rules—Provisions of the DRAP Act requiring the Federal Government to prescribe, on recommendations of the Policy Board, qualifications, terms, and mode of appointment for Directors (S.4(2)) and the criteria for recruitment by the Policy Board (S.14(1)) must be discharged through statutory rules under S.23—Such powers could not be exercised through regulations under S.24 which only require approval of the Policy Board—Regulations cannot substitute or override the statutory requirement of rules approved by the Federal Government—2015 Regulations were made under S.24 and thus could not fulfill the requirement under Ss. 7(m), 14(1) and 15(5)(b)—Court held that DRAP failed to frame valid rules for service terms, promotion, or recruitment as mandated under the Act—Regulations made without rules were premature and potentially inconsistent with the statute. Held, DRAP shall frame rules under Ss. 7(m), 14(1), and 23 with the approval of the Federal Government within two months. —Mustafa Impex v. Government of Pakistan PLD 2016 SC 808 and Zia Ghafoor Piracha v. Chairman BISE, Rawalpindi 2004 SCMR 35 ref. (b) Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012) —- S. 15(5)(a)&(b) Civil servants' option to remain in service or be absorbed in DRAP—Validity of option exercised in absence of rules—Effect—Estoppel—Petitioners exercised their irrevocable option to continue serving as civil servants in 2015—No rules under S.23 had been framed at that time—Held, while ideally rules should have existed for a meaningful choice, petitioners voluntarily exercised their option with full knowledge of existing 2015 Regulations—Court held that petitioners could not, after a lapse of more than four years, seek to undo their decision—They were estopped by their conduct and delay—Exercise of option remained valid despite lack of rules. Held, options exercised under S.15(5)(a) were irrevocable and petitioners were barred from reversing them. (c) Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012) —- S. 4(1) Appointment of Directors—Requirement of recommendation by Policy Board—Legal consequence of non-compliance—Section 4(1) mandates that Directors be appointed by Federal Government on recommendation of the Policy Board—Any appointment made without such recommendation, even if by the Federal Government, would be without lawful authority—However, formation of Departmental Promotion Board chaired by Secretary of NHSR&C (also Chairman Policy Board) to consider Additional Directors for promotion did not contravene the Act—Such process was found valid and not suffering from any legal infirmity. Held, impugned office order dated 11.02.2020 was intra vires and legally sustainable. (d) Constitution of Pakistan—Art. 199 Constitutional jurisdiction—Delay and acquiescence—Effect—Laches—Petitioners approached the Court more than four years after exercising irrevocable option under DRAP Act—Held, unexplained and prolonged delay defeated the petitioners’ right to relief—Doctrine of laches applied—Petitioners' acquiescence precluded them from asserting rights previously relinquished. Held, writ petitions were not maintainable due to delay and acquiescence. (e) Delegated legislation—Rules vs. Regulations—Statutory effect—Test of validity—Regulations made under S.24 of the DRAP Act have no statutory effect unless they are consistent with validly framed rules under S.23—Regulations without statutory backing are mere internal guidelines—Court reiterated that subordinate legislation must be in harmony with parent statute—Challenge to vires of 2015 Regulations was dismissed in absence of any demonstrated inconsistency with the Act—Presumption of validity applies unless clearly rebutted. —Suo Motu Case No.13/2009 PLD 2011 SC 619 and Multiline Associates v. Ardeshir Cowasjee PLD 1995 SC 423 ref. Disposition: Writ petitions dismissed. Petitioners estopped from challenging their irrevocable option under S.15(5)(a) of the DRAP Act. Directions issued to Federal Government and DRAP to frame requisite statutory rules under Ss. 4(2), 7(m), 14(1), and 23 within two months. No order as to costs.

Summary: (a) Drugs Act, 1976 ---- Ss. 19(6), 23, 27 & 30; Constitution of Pakistan ---- Arts. 4, 10A & 199 Jurisdiction of Drug Court --- Summoning of accused --- Initiation of prosecution under special statute --- Mandatory procedural safeguards --- Petitioners were summoned by Drug Court on an application filed by Assistant District Public Prosecutor (ADPP) without a statutory complaint by a Federal or Provincial Drugs Inspector as required under S.30 of the Drugs Act, 1976 --- Held, ADPP has no independent authority under the Act to initiate prosecution or revive proceedings once the District Quality Control Board has concluded proceedings by issuing a warning letter --- Section 30 of the Act, 1976 mandates that only an Inspector duly authorized by the Board may institute prosecution, and no deviation is permissible --- Drug Court acted without lawful authority in entertaining the ADPP’s application and summoning the petitioners without a fresh complaint or notice --- Proceedings suffered from jurisdictional defect and violated Articles 4 and 10A of the Constitution guaranteeing legal protection and fair trial --- Absence of notice to the petitioners rendered the impugned summoning order void ab initio --- Concurrent administrative decision attained finality and could not be circumvented through collateral judicial action. Cited Cases: • The State v. Iqbal Ahmed Khan (1996 SCMR 767) • Jameel Qadir v. Government of Balochistan (2023 SCMR 1919)

Summary: (a) Intellectual Property Law – Trademark Infringement in Pharmaceuticals: ---- Trademark Rights – Infringement – Whether registration of a drug can override trademark rights – The petitioner’s trademark FERINJECT was registered in 2005, whereas the respondent’s drug FERIJET was registered in 2005 by the Drug Registration Board – The Intellectual Property Tribunal decreed that FERIJET was deceptively similar to FERINJECT and restrained the respondent from manufacturing, marketing, and selling the drug – Held, that registration of a drug under Drugs Act, 1976 does not override intellectual property rights under the Trade Marks Ordinance, 2001 – Executive bodies such as the Drug Regulatory Authority of Pakistan (DRAP) cannot override or disregard the findings of a court of competent jurisdiction in intellectual property matters. ----Cited Cases: • Novartis AG v. Nabiqasim Industries (Pvt.) Ltd. (2017 CLD 1136) • The Welcome Foundation Ltd. v. Messrs Karachi Chemical Industries (Pvt.) Ltd. (2000 YLR 1376) • Pfizer Ltd. v. Wilson's Pharmaceuticals (2002 CLD 1653) • Cadila Healthcare Ltd. v. Cadila Pharmaceutical Ltd. (2001(5) SCC 73) (b) Administrative Law – Regulatory Jurisdiction of DRAP: ---- Jurisdiction of DRAP – Whether DRAP can override Intellectual Property Tribunal decisions – The Drug Registration Board refused to cancel the registration of FERIJET despite the Intellectual Property Tribunal’s finding of trademark infringement – Held, that DRAP is an executive regulatory authority, not a judicial body – It has no power to sit in judgment over a decree of the Intellectual Property Tribunal – Where a trademark infringement ruling exists, DRAP must enforce it under Sections 7(11) and 23 of the Drugs Act, 1976 – Failure to do so amounts to undermining judicial authority and violates the principle of legality. ----Cited Cases: • Dawakhana Hakim Ajmal Khan (Pvt.) Ltd. v. Federation of Pakistan (PLD 2020 Lahore 899) • Soneri Travel & Tours Ltd. v. Soneri Bank Ltd. (2011 CLD 193) • Sandoz Ltd. v. Pakistan Pharmaceutical Products Ltd. (1987 CLC 1571) (c) Consumer Protection – Public Health Risks in Trademark Disputes: ---- Public Health – Likelihood of consumer confusion in drug trademarks – Confusion between pharmaceutical trademarks can lead to serious health risks – Held, that a stricter test must be applied in cases of pharmaceutical trademark infringement due to potential life-threatening consequences – Even minor phonetic or visual similarities between drug names can lead to misuse or incorrect prescriptions – Consumer protection takes precedence over regulatory convenience – DRAP failed to recognize the impact of public safety in its decision. ----Cited Cases: • Cadila Healthcare Ltd. v. Cadila Pharmaceutical Ltd. (2001(5) SCC 73) • Sanofi-Aventis v. GlaxoSmithKline Biologicals SA ((2010) 89 CPR (4th) 378 (TMOB)) • Novartis AG v. Nabiqasim Industries (Pvt.) Ltd. (2017 CLD 1136) (d) Interpretation of Laws – Harmonization of Drug & Trademark Laws: ---- Statutory Interpretation – Whether Drug Laws Override Trademark Laws – The Drugs Act, 1976 and the DRAP Act, 2012 regulate drug safety, efficacy, and registration – The Trade Marks Ordinance, 2001 protects trademark rights and prevents consumer deception – Held, that both statutes must be read harmoniously – There is no conflict between drug registration laws and trademark laws, as counterfeit drugs are explicitly prohibited under Section 23 of the Drugs Act – Regulatory authorities must give effect to final judicial determinations regarding trademark infringement. ----Cited Cases: • Bayer Corporation & ORS v. UOI & ORS (ILR (2009) SUPP. 2 Delhi 145) • Getz Pharma (Pvt.) Ltd. v. Servier Laboratories (France) (2016 CLD 2229) (e) Disposition: ---- Impugned orders set aside – Drug FERIJET declared a counterfeit drug – Registration cancelled under Section 7(11) of the Drugs Act – DRAP directed to enforce the Intellectual Property Tribunal’s judgment – Respondent No.4 ordered to change the name of its drug before applying for re-registration – Costs of Rs.50,000 imposed on Respondent No.4, payable to the Petitioner within 4 weeks.