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MESSRS ALFALAH MEDICOS versus GOVERNMENT OF PUNJAB

ections Section 32, 4, 2 (v) and Schedule 1 - Drugs (Licensing, Registration and Advertising) Rules 1976, R 29 - Priority of Public Purchase - Drugs / Drug Purchases - Bio-Similarity of Drugs / Bio-Equivalence - "Instructions Similar biotherapeutic products (SBPs) issued by the World Health Organization (WHO) issued by the World Health Organization (WHO) and the Nexis of the Drug Regulatory Authority of Pakistan Act, 2012 Guzar, a drug maker and distributor, urged the rejection - a tan for procurement of medicines issued by the provincial government. On the contrary, in their Eligibility Bid - applicants were not considered disqualified due to the fact that certain provisions of the pre-qualification document, in accordance with the guidelines set forth in the Bio Equivalence / Bio Compatibility Studies (W) HO), which could not provide the applicant The question before the High Court was whether the terms and conditions of these clauses prevented free competition from the bidding document and the terms of the Drug Regulatory Authority of Pakistan Act, 2012 - held Indeed, regulatory authorities around the world have a strong need for data to demonstrate the biochemical relevance of drugs. You have outlined and the geo-matched manufacturers will need to prepare data from lab testing, and non-clinical trials to show that the bio-drug they developed provides the same treatment therapeutics and risks. Because the reference bio-therapeutic product - applicants, was required to study the bio-similarity with WHO guidelines. Drug Regulatory

P L D 2017 Lahore 124

Before Shams Mehmood Mirza, J

Messrs ALFALAH MEDICOS through Sole Proprietor and another—Petitioners

versus

GOVERNMENT OF PUNJAB through Secretary,

Primary and Secondary Healthcare and 4 others—Respondents

Writ Petition No. 10045 of 2016, heard on 6th May, 2016.

(a) Drug Regulatory Authority of Pakistan Act (XXI of 2012)-

——Ss. 32, 4 , 2(v) & Sched. 1—Drugs (Licensing, Registering and Advertising) Rules 1976, R. 29—Public Procurement Prequalification—Procurement of medicines/ drugs—Bio- similarity /bio-equivalence of drugs—“Guidelines On Evaluation of Similar Bio-therapeutic Products (SBP}s) Standards” issued by the World Health Organization (WHO)—Nexus of WHO Guidelines and the Drug Regulatory Authority of Pakistan Act, 2012—Petitioners, who were drug manufacturers and distributors, impugned the rejection of their Prequalification bids, on a tender for procurement of a drug issued by the Provincial Government—Petitioners were deemed not prequalified due to the fact that certain clauses of the pre-qualification document, required bio-equivalence/bio-similarity studies according to the prescribed guidelines of the World Health Organization (WHO), which the petitioners could not provide—Question before the High Court was whether the terms and conditions of said clauses of the bidding document stifled free competition and the terms of Drug Regulatory Authority of Pakistan Act, 2012—Held, Regulatory authorities all over the world had outlined robust data requirements to demonstrate bio-similarity of drugs and bio-similar manufacturers would need to generate data from lab-testing, and non-clinical testing to show that the bio-similar drug they had developed would provide the same therapeutic benefits and risks to patients as the reference bio-therapeutic product—Petitioners, in the present case, were required to conduct bio-similarity study along the WHO Guidelines—Perusal of the Drug Regulatory Authority of Pakistan Act, 2012 revealed that the same had adopted standards/protocols prescribed by the World Health Organization (WHO) in its guidelines for licensing of bio-similar drugs and after its promulgation, all applications for seeking authorization for manufacturing and marketing of bio-similar drugs, were required to be done on basis of said WHO Guidelines , and thus said guidelines had a statutory force—Stringent regulatory framework had been provided by the Drug Regulatory Authority of Pakistan Act, 2012, by adopting the WHO Guidelines, to ensure the health and safety of the public and the petitioners had not obtained the requisite certificate from the prescribed laboratories—Provincial Government, in the present case, was within its rights to demand and lay down the conditions in the tender for bio-similarity studies which were consistent with and confÓrm;ed to the Drug Regulatory Authority of Pakistan Act, 2012 and the larger public interest outweighed the narrow commercial interest of the petitioners—Inclusion of impugned clauses in the pre-qualification document, therefore, did not offend the Drug Regulatory Authority of Pakistan Act, 2012—Constitutional petition was dismissed, in circumstances. [pp. 131, 132, 135, 138, 139, 140] A, B, C, D, E, F & G

Mian Fazal Din v. Lahore Improvement Trust Lahore and another PLD 1969 SC 223 and Messrs S. M. Ilyas and Sons Ltd. v. Monopoly Control Authority, Islamabad and others PLD 1976 Lah. 834 distinguished.

(b) Constitution of Pakistan—

—Art. 199—Constitutional jurisdiction of High Court—Public policy—Judicial review—High Court, in the exercise of its Constitutional jurisdiction, was only concerned with the process of the decision for which judicial review was sought and not the merits of the decision—Ordinarily, the High Court was reluctant to interfere in, or judicially review, decisions related to Government policy initiatives as the same was neither the duty of the High Court nor was it desirable for it to pass a decision on the fairness of a particular policy or the decision(s) taken in fulfilment of that policy, however the same did not apply to cases where the impugned decision was based on irrelevant considerations or was arbitrary, whimsical or illegal. [p. 141] H

Imran M. Sarwar for Petitioner No.l.

Faisal Naqvi for Petitioner No.2.

Haider Ali Khan for Respondents.

Mrs. Sarnia Khalid, Assistant Advocate General. Date of hearing: 6th May, 2016.

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