LAHORE: The Punjab government is going to make large-scale central procurement of disposable products, including drug-eluting stents (DESs) for all the 11 public sector cardiac care institutes in the province, giving preference to the medical devices approved by the US Food and Drug Authority (FDA).

The decision has caused resentment among dozens of other medical firms whose products have been registered with the Drug Regulatory Authority Pakistan (DRAP), but were not considered for the Rs18-20 billion procurement process for not having FDA approval.

They urged the Punjab chief minister to intervene and provide all the companies a fair and equal opportunity to participate in the bidding process.

According to the documents, the Punjab government has to procure 92,000 DESs, 120,000 PTCA wires, 85,000 guiding catheters and 80,000 balloon catheters.

For this purpose, the government has invited sealed bids (technical and financial) from the firms engaged in trading and manufacturing, and registered with relevant authorities and tax departments, to conclude the framework contract for supply of disposable items (related to cardiology, cardiac surgery and Electrophysiology etc.)

A senior official of the health department told Dawn the Punjab government has been making procurement of FDA-approved cardiac stents through the central purchase policy since 2019.

Sharing the background, he said the central procurement policy was introduced for the first time in 2017 when some cardiac stent scandals surfaced in the Punjab Institute of Cardiology (PIC) and Mayo Hospital Lahore.The matter was also taken up by the Supreme Court which had directed the Punjab government to review the procurement process to avoid such situations in future.

Following this, the then provincial government had introduced the central procurement policy in the light of the recommendations of the then Chief Minister Inspection Team (CMIT) which had proposed abandoning of institutional tenders.

In 2019, for the first time an approval was granted for the purchase of the single category FDA-approved ‘budget stents’ of higher classification for all the 11 cardiac institutions.

Following the previous practice, the Punjab government has restricted the purchase of the major cardiac items, to the FDA approved devices only in order to ensure quality, keeping in view patients’ safety and health.

The fresh procurement process was initiated to meet the growing requirement of cardiac patients visiting the government-run cardiac institutes in Punjab, for year 2024.

About the reservations expressed by other companies having products registered with DRAP, he said there were above 60 companies selling cardiac products, and it was hard to conduct such an extensive and highly-technical scrutiny processes involving such a large number of firms, having their warehouses across the country.

As per the Provincial Procurement Regulatory Authority (PPRA) policy, he said, the three companies having FDA-approved medical devices were asked to join the bidding process and they are taking part in the procurement.

Because of the tough competition, he hoped, the prices of the stents and other devices would be far lower than the market rates.

However, other companies rejected the claim, saying that the firms with the DRAP-registered products had a strict scrutiny process and were selling their medical devices of “international standards” in the private sector all over the country.

They say they have the Conformité Européene (CE) Mark certification, with European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985.

“The CE marking represents a manufacturer’s declaration that the products comply with the EU’s New Approach Directives”, a representative of a firm says.

He says the these issues were also raised in the last pre-bidding meeting held on May 21 in Lahore.

One of the representatives told Dawn that the total proposed budget of the tender was Rs15 billion, based on the tender estimate price, but it is expected to touch Rs18-20 billion.Out of this budget, he said, Rs12 billion will go to the FDA-approved brands alone, while the remaining budget will be left for the rest of the companies, including those having both CE and the FDA recognition. He alleged that the government was keen to oblige the American brands.

“When DRAP has registered all other products, allowing their sale in Pakistan, why Punjab government is limiting the procurement only to FDA-approved brands,” he asked.

“If you compare the prices of a single product i.e Balloon Catheter, the price if the FDA-approved brand ranges between Rs14,000 to Rs17,000, while that of the CE-marked DRAP-registered product is between Rs9,000 to Rs10,000”, he says, arguing that Rs400 million could be saved in the purchase of a single product.

Published in Dawn, June 1st, 2024