Prequalification

2017 PLD 124 LAHORE-HIGH-COURT-LAHORE Judicial Precedent

Ss. 32, 4 , 2(v) & Sched. 1Drugs (Licensing, Registering and Advertising) Rules 1976, R. 29Public ProcurementPrequalificationProcurement of medicines/ drugsBio-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 conformed 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.