Summary PPRA orders independent review of Punjab health department's cardiac consumables procurement criteria after bidder challenges US FDA-only tender requirements.
LAHORE (Web Desk) – The Punjab Procurement Regulatory Authority (PPRA) has raised concerns over the Specialized Healthcare and Medical Education Department's (SHC&MED) procurement process for cardiac consumables after allegations that revised tender specifications unfairly restricted competition and increased costs for the 2026–27 financial year.
The issue was brought before the PPRA after M/s 4S International, through its legal counsel Zeeshan Akhtar, challenged the department's decision to make United States Food and Drug Administration (US FDA) approval mandatory for several high-volume cardiac consumables. The company argued that excluding products certified under the European CE Mark, which had previously been accepted, created discriminatory tender conditions and led to higher procurement prices.
According to an order issued by PPRA Managing Director Sahibzadi Wasimah Umer, the complainant said balloon catheters (Item C3) carrying European CE certification were procured during the 2025–26 fiscal year at Rs6,985 per unit. Under the revised tender conditions requiring US FDA approval, the estimated price for the same item increased to Rs9,800 per unit.
The company further alleged that the US FDA requirement had been selectively applied to high-volume items, including C3, C4, C7, C19 and C20, while European CE Mark-certified products continued to be accepted for comparable items such as C5, C6 and C8.
M/s 4S International also claimed that concerns over the revised procurement criteria were raised during a pre-bid meeting on June 30, 2026, but were not reflected in the official meeting minutes. It maintained that its CE Mark-certified products are registered with the Drug Regulatory Authority of Pakistan (DRAP) and are widely used in leading cardiology centres across Punjab.
During a PPRA hearing on July 8, 2026, SHC&MED Contract Manager Shafique Hussain said the US FDA requirement had been introduced on the recommendation of medical experts to ensure higher quality standards. However, the department later requested that the matter be referred back for reconsideration.
In its ruling, the PPRA noted that public procurement laws require fairness, transparency and value for money. It said the distinction between accepted certification standards should be carefully examined to determine whether it was based on clinical necessity, patient safety or other objective criteria, or whether it unnecessarily restricted competition.
The authority directed the health department to establish an independent technical committee comprising impartial experts and departmental officials to conduct an evidence-based review of whether limiting procurement to US FDA-approved products is clinically essential. The committee has also been tasked with assessing whether DRAP-registered products carrying European CE certification meet the required safety and performance standards.
The PPRA further instructed the department to give M/s 4S International an opportunity to present its case before a final decision is made and ordered the immediate refund of the company's Rs50,000 security deposit.
