The Punjab Procurement Regulatory Authority (PPRA) has questioned the procurement process adopted by the Specialised Healthcare and Medical Education Department (SHC&MED), following allegations of revised tender conditions for cardiac consumables and increased procurement costs.
The matter came before the PPRA after M/s 4S International, through its counsel Advocate 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 the move excluded products carrying the European CE Mark, which had previously been accepted, creating discriminatory bidding conditions and driving up prices.
According to an order issued by PPRA Managing Director Sahibzadi Wasimah Umer, the complainant stated that balloon catheters (Item C3) with European CE certification had been purchased during FY2025–26 at Rs6,985 per unit. Under the revised tender criteria requiring US FDA approval, the estimated price for the same product rose to Rs9,800 per unit.
The company further claimed that the US FDA requirement had been selectively imposed on high-volume items, including C3, C4, C7, C19 and C20. At the same time, comparable products such as C5, C6 and C8 continued to be procured with European CE certification.
The complaint also stated that concerns over the amended tender conditions were formally raised during a pre-bid meeting on June 30, 2026. Still, they were neither recorded nor addressed in the official meeting minutes. It maintained that its CE Mark-certified products are registered with the Drug Regulatory Authority of Pakistan (DRAP) and have been widely used in leading cardiac care centres across Punjab with a proven performance record.
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 maintain higher quality standards. However, following the hearing, the department requested that the issue be referred back for reconsideration.
In its decision, the PPRA emphasised that public procurement must uphold the principles of fairness, transparency and value for money. The authority observed that the differing treatment of internationally recognised certifications required a thorough review to determine whether the distinction was justified on clinical, safety or other objective grounds, or whether it unnecessarily limited market competition.
The PPRA directed the health department to establish an independent technical committee comprising impartial experts and departmental representatives to conduct an evidence-based assessment of whether limiting procurement exclusively to US FDA-approved products is clinically necessary. The committee has also been instructed to evaluate whether DRAP-registered products with European CE certification satisfy the required safety and performance standards and to provide M/s 4S International an opportunity to present its case before a final decision is reached.
Additionally, the authority ordered the immediate refund of the Rs50,000 security deposit submitted by M/s 4S International.
