Tuesday, June 25, 2024

FDA-Only Products: Punjab’s Centralised Tender Conditioning Ignites Controversy

The government of Punjab has conditioned the cardiac disposables and consumables products only FDA-approved and disqualified a majority of the European, Chinese, and Japanese brands cardiac suppliers also approved by the Drug Regulatory Authority Pakistan (DRAP).

According to a recent tender document of the Specialized Healthcare and Medical Education Department Government of the Punjab, the provincial government has sought invitation bids from interested parties having the ability to supply FDA-approved disposables and consumables required during the treatment of heart-related surgeries in the public hospitals of Punjab.

According to other DRAP-approved cardiac suppliers, the Punjab government’s recent centralised tender conditioning of FDA-only products would not only disqualify a majority of DRAP-approved suppliers for cardiology supplies but has ignited controversy. The decision has also raised serious concerns over fair competition and equal opportunity.

The DRAP, established under the DRAP Act, 2012, serves as a regulatory body ensuring stringent quality standards for healthcare products in Pakistan. However, despite DRAP approval, government of Punjab’s condition to require US FDA approval only, creating a dispute over procurement practices.

Total proposed budget of the tender is Rs15 billion based on the tender estimate price, which is likely to go to Rs18-20 billion. Out of this budget, Rs12 billion will be awarded to FDA brands and the remaining budget will be for the rest of the companies including CE and FDA both.

There is a serious price difference between the US brands and other brands. For instance, Balloon Catheter FDA Brands prices range between Rs14,500-17,000 as other CE Marked Drap Registered products range between Rs9,000-10,000. So only this product can eat extra budget of Rs400 million let alone other products such as guide wire and stents where numbers can go far beyond, while this extra amount can be spent on the treatment of other patients.

The recent move by the Specialized Healthcare Punjab to centralise tenders for cardiology supplies across seven major institutes, including the Punjab Institute of Cardiology and Multan Institute of Cardiology, has further exacerbated tensions. Typically, tenders are issued individually by each hospital, allowing equal opportunities for participation. However, the centralised tender process has been criticised for its discriminatory pre-qualification and technical requirements that favour only a handful of companies.

Key grievances include the imposition of additional security deposits, with companies already having submitted bids and deposits for individual hospital tenders. The requirement for past experience specifically in Punjab-based teaching hospitals and the insistence on US FDA-approved products further limits competition and excludes new entrants from the bidding process.

Moreover, concerns have been raised about the transparency and fairness of the tender process, with allegations of malpractice and favouritism towards certain brands. The decision to disqualify other DRAP-approved suppliers in favour of US FDA-approved brands has sparked outrage among industry stakeholders, who view it as a deliberate attempt to monopolise the market and limit patient choice.

As the controversy continues to unfold, stakeholders urge the Punjab government to reconsider its tender policies and prioritise transparency, fairness, and healthcare accessibility.

When contacted, Dr Asim Javed, member committee of the Specialized Healthcare and Medical Education Department Government of Punjab, he said that the provincial government has taken this decision in the best interests of the patients, adding that cardiac-related issues are serious and the government aims to provide them the best medical care. He further said that other suppliers are not disqualified as they can still provide other supplies, however, the government in the tender has conditioned some cardiac supplies with FDA approved. He rejected the notion that it would negatively affect the fair competition principle, saying there are five to six such suppliers.

He said that the decision has been taken after detailed deliberation keeping in view the welfare of the patients and suppliers will ensure required supplies.

This correspondent tried to contact Special Secretary Specialized Healthcare and Medical Education Department Government of Punjab and Dr Hafiz Shahzad Latif, additional secretary of the department by email and telephone but they did not respond.


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