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2021 LHC 7445

M/s 3N-LIFEMED PHARMACEUTICALS vs Government of Punjab through

Citation2021 LHC 7445
CourtLahore High Court
Case No.W.P. No. 65575/2021
Date2021-11-01
Judge(s)Asim Hafeez
ResultPetition dismissed

ORDER

Petitioner entity seeks relief in following terms;

(i) Set aside the Impugned Condition/requirement of providing a valid CE/UNFP A/JMHL W/US FDA approval certification or pre-qualification by WHO/Impugned conditions prescribed in Knockdown Clause No.7 and Knockdown Clause No. 10 financial annual turnover of Rs. 330 million of local manufacturers for being manifestly , arbitrary , unnecessary and violative of Rules 4, 10, 26(2) and 34 of the Punjab Procurement Rules, 2014.

(ii) Direct respondents to exclude the impugned conditions from the pre-qualifi cation and issued revised pre- qualifications;

(iii) Suspend / stay the further procurement process, till the decision of instant petition.

(iv) Direct the respondents to allow the petitioner to participate in the procurement process by exempting the clause No.7 and 10, in the interest of justice ."

Introductory paragraph

2. Facts ascertained, from the record, are that applications for pre-qualification were sought through advertisement in the press dated 28.08.2021, arranged by the purchase cell of the respondent department, in terms whereof applications were solicited for procurement of medical devices for the Financial-Y ear 2021-2022. Estimated cost of procurement was worth PKR 3 billion (approx.). Last date for submission of applications online was 14.09.2021 - hard copies to be provided till 16.09.2021 - and bids would be opened on same day - 16.09.2021.

Grievance of the petitioner :

3. Petitioner entity claims to be a manufacturer of Bicarbonate hemodialysis solution, which, for the purposes of present petition, claimed eligibility to bid for the process of procurement of medical devices for Financial Year 2021- 2022, initiated by the respondent No.1. Evidently , petitioner has not submitted bid / application invited for the pre- qualification of interested applicants, apparently being aggrieved of certain condit ions referred in pre-qualification documents. And now petitioner has challenged few conditions / requirements prescribed on the premise that inclusion of such conditions / requirements besides being unnecessary and irrelevant are prejudicial and detrimental to the interests of local manufacturers of medical devices / drugs. It is claimed that said conditions were introduced specifically to exclude / oust local manufacturer from the procurement process.

Disputed conditions: Text of the conditions / clauses under challenge - condition No.7 and condition No.10 of the Knock Down Criteria, [section II - prequalification criteria] prescribed for local manufacturers / sole agents of the Foreign Principal - reads as; "7. The firm has provided / attached the product' s valid CE/UNFP A/MHL W/US FDA approval certification or prequalification by WHO.

Certificates provided by the firm on its own letter head are not acceptable, CE marked by conformity assessment bodies (CABs) notified in NANDO database under the relevant European directive for medical devices of European Union will be accepted only .

10. Minimum Annual financial turnover for any of single financial year (i.e. 2018-19/2019-20/2020-21)/calendar year (i.e. 2018/2019/2020) must be 330 Million Rupees or above for medical devices local manufacturer/sole agent of foreign manufacturer . Firm will provide FBR income tax return / sales Tax return for the year 2018-19, 2019-20, and 2020-21 or in case of calendar year 2018/2019/2020.

Note : Income Tax/Sales Tax return for the FY 2020-21 will be considered supported with bank statement (FY-2020- 21) of the title account of the applicant firm only. Both Tax return and Bank statement must be above 330 Million Rupees. (Firm will attach bank statement signed and stamped from concerned bank along with FBR income tax / sales tax return) and same for calendar year-2020. (Joint venture, consortium and subsidiary shall not be accepted).

Submissions:

4. Learned counsel questioned relevancy, arbitrariness, unreasonableness and redundancy of above-referred conditions. Adds that an exercise of seeking prescribed approvals is unnecessary in the wake of the approvals already extended by the regulatory authorities, ensuring Good Manufacturing Practices (GMP). Emphasized that requirement of showing prescribed minimum financial turnover of Rs.330.000/- million is solely designed and introduced to deny opportunities to the local manufacturers. Submits that various applications were filed with the grievance committee of the department to agitate incorporation of arbitrary and adverse conditions, raising objections qua their relevancy and in-applicability with respect to the products manufactured by the petitioner, but same were unattended, which inaction led to invoking of judicial review jurisdiction.

Determination .

5. This is not the case of first impression - both on facts and law. It is pertinent to highlight and refer to an earlier decision in the case of 'Silver Surgical Complex Pvt. Ltd v. Province of Punjab and others , issued in constitutional petition, bearing W.P. No.58412/2019 - along connected petitions - dated 20.01.2021, wherein inter alia relevance and validity of the requirement of obtaining certain certifications / approvals, as a condition for claiming eligibility to bid was challenged. In said case principled argument was against clause 8 of the Knock Down Criteria, identical to condition 7 of Knock down criteria. And said petition(s) were dismissed.

6. When confronted with the decision in W.P. No.58412/2019, learned coun sel submits that said case is distinguishable, wherein the petitioner had participated in the bidding process but failed to meet the requirements of certification / approvals, however , in the instant case petitioner has not participated in the process but challenged the vires of clauses, otherwise.

7. Order dated 20.01.2021 is examined, wherein, while deciding the petitions, this court has deliberated upon the specific objection raised qua the requirement of certification / approvals - as per knock-down conditions in procurement for the years 2019-2020 and 2020-2021 - and repelled the misconceived objection, that such requirements were designed and enforced, simplicitor , to oust from local manufacturer from the competitive bidding. It is misconceived to submit that element of commonness was missing in both cases. In fact, petitioner , a bye-stander , is at disadvantageous position, which had not participated in the process, let the process rolled and now invoked jurisdiction of this court, well after passing of the date of opening of bids on 16.09.2021. The intention is obvious, i.e., to thwart process of procurement. Now coming back to the decision dated 20.01.2021, wherein relevance and legality of clause 8, in said petition, was also examined in the context of provisions Punjab Procurement Rules 2014 and nothing contrary to the statutory mandate was found. In addition to the decision made in W.P.No.58412/2019 on 20.01.2021, ratio whereof is fully attracted and applied, with respect to couple of common questions agitated through instant petition, this court deems it appropriate to elucidate further the scope and extent of judicial review jurisdiction, in the context of certain checks / constraints, which have had to be honored while exercising such jurisdiction. There is no cavil that deliberation upon and inclusion of certain conditions / requirements, for the purposes of procurement, is a policy matter , falling within the domain of the executive.

In the aforesaid context, an obvious question is regarding the breadth of judicial review jurisdiction while dealing with policy matters.

The issue is well-settled, and guidelines are well-defined through numerous judicia l pronouncements, setting limits for exercise of constitutional jurisdiction under Article 199 of the Constitution of Pakistan 1973. Guidance is solicited from the principle / dicta laid down in the cases of "Dossani Travels Pvt. Ltd and others Vs. Messrs Travels Shop (Pvt) Ltd and others" (PLD 2014 SC 1) and "Cutting of Trees for Canal Widening Project, Lahore: in the matter of Suo Motu Case No. 25 of 2009 decided on 15th September 2011 (2011 SCMR 1743 ). Now the question is that whether the policy decisions, whereby certain conditions / requirements were incorporated to pre- qualify the bidders / applicants attracts exceptional situation, requiring indulgence by courts. Courts normally proceed to adjudged review policy decision / directives, if same violates constitutional limits or legal limits, or found to be patently mala-fide or discriminatory . Unless such exceptions are available, this court is not inclined to exercise judicial review jurisdiction and delve to adjudge relevancy , rationality , and sufficiency of the requirements, which probe is otherwise unwarranted when the condition of seeking approvals / certifications was incorporated to ensure that medical devices / drugs procured, meet desired standards of public health and human safety .

8. Incorporation of the conditions of pre-qualification, prescribing fiscal limits for prospective firms / bidders, to ascertain their financial capability to honour potential commitments undertaken, are not unreasonable. Placement of condition of showing strong financial position - meeting desired business / financial turnover benchmarks - is otherwise not violative of Article 18 of the Constitution of Islamic Republic of Pakistan 1973 - which too permits lawful qualifications upon conduct of trade or business. The condition imposed is a policy decision, relevance, rationality and effectiveness thereof cannot be reviewed or adjudged by invoking judicial review jurisdiction - unless it is shown that policy decision or conditions prescribed do infringe any of the constitutionally provided fundamental rights, found deficient in meeting legislative competence test or manifest erroneous assumption and exercise of powers / jurisdiction. The case at hand, incidentally , attracts none of the requisite conditions, essentially required to be present before assumption and exercise of judicial review jurisdiction. There is no legal objection that why cannot the conditions be introduced in lawful exercise of authority by the executive, for ensuring high quality and efficiency standards qua manufacturing and procurement of required medical devices / drugs. This court, while exercising judicial review jurisdiction, cannot assume the role of healthcare expert to probe into the efficacy and relevance of certification / approval, with reference to the drug / devic e - let the responsibility befalls on the relevant persons, having expertise, experience, and requisite knowledge / know-how . This court otherwise lacked finesse and expertise. Judicial Review jurisdiction cannot be stretched to delve into and adjudge policy decision / administrative policies to ascertain their validity , relevancy , and rationality - in this case conditions prescribed requiring approvals / certifications and ascertaining requisite financial capacity - and unwarranted assumption and exercise of jurisdiction has social, political and fiscal costs. There lies the rational and wisdom for non-interference in policy matters while exercising constitutional jurisdiction. Honourable Supreme Court of Pakistan in its decision in the case of "Chief Executive Officer, Multan Electric Power Company Ltd, Khanewal Road, Multan Vs. Muhammad Ilyas and others" (2021 SCMR 775), explained the pitfalls of judicial overreac h, when unnecessary and unwarranted interference potentially threaten constitutionally placed / structured system of trichotomy of powers, imparts distrust and disincentives effort / initiative. Reference is made to the case of "Watan Party and another Vs. Federation of Pakistan and others" (PLD 2013 Supreme Court 167). The allegation of ill will and mal-intent to oust local manufacturer(s) is convenient to attribute but difficult to substantiate - no such evidence / material was referred nor enclosed. Conditions impugned otherwise satisfy the test of reasonability , examined in the context of "Wednesbury Principle " - settled in the case of "Associated Provincial Picture Houses, Limited Vs. Wednesbury Corporation" [(1947) 2 All ER 680]. And, in absence of any illegality , legislative incompetence and jurisdictiona l deficiency , this court is not inclined to proceed to determine and adjudge questions touching relevancy , rationality , objectivity and efficacy of the pre-qualification conditions, assuming role of a procuring agency .

9. In view of the above, this petition is incompetent and same is, hereby , dismissed in limine . No order as to the costs.

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