ISLAMABAD: Pakistan Phar­m­­acist Association (PPA) has asked the Drug Regulatory Authority of Pakistan (Drap) to ensure quality reagents in labs and take action against illegal practices in diagnostic reagents and strengthen the enforcement of relevant laws to safeguard interest of patients.

In a letter written to Drap, PPA Vice President Shifa Khan Bangash said that medical devices are one of the key health technologies playing a pivotal role in the healthcare system and are the mainstay of the diagnostic facilities leading physicians to accurate diagnosis and ensuring optimum patient outcome.

The diagnostic reagents and rapid diagnostic kits are crucial medical devices in this context and the quality of which directly correlates with the accuracy of diagnosis and can help or otherwise mislead the physician in taking appropriate decision regarding treatment of patient.

The erroneous diagnostic tests usually mislead decision-taking physician/surgeon about the treatment which may even result in death of patients.

Hence, he said, the quality of reagents affects the disease burden in either way and can thus correlate with healthcare economics, the letter said.

In this context, the letter said, it is imperative to draw your kind attention towards the rising incidents of illegal import and unlicensed manufacturing and unethical practices such as relabeling and misbranding the diagnostic reagents thus posing a serious threat to public health.

The quantum of repercussions and implications of such malpractices in this segment is of such magnitude that requires immediate attention and action at appropriate levels, the letter said.

Some of key measures that need to be taken immediately are establishing the provincial field force i.e. drug inspectors must actively monitor the illegal practice of printing counterfeit labels of well-known brands and re-labeling to produce and sell substandard and fake diagnostic reagents of leading brands. This practice is rampant in the country and thus posing a serious threat to public health.

All manufacturers of such reagents/kits and relevant distributors must be inspected frequently and must be required to issue proper warranty in accordance with the provisions of the Medical Devices Rules, 2017, without any fail, the letter said.

The manufacturers must be required to hold valid licences and ensure that each reagent they produce is registered with Drap as per provisions.

Inspectors should routinely verify that manufacturing facilities operate within their licensing scope and are not involved in un-authorised production.

The sale of diagnostic reagents must be restricted to entities with valid drug sales licences. Inspectors should be directed to verify that all distributors, wholesalers, and retailers possess a valid licence and take action against unlicensed sellers, including the confiscation of products and ensuring prosecutions, the letter said.

Drap, in collaboration with provincial authorities, should design and initiate awareness campaigns to educate stakeholders about these regulations.

The letter further said that a centralised reporting mechanism/complaint cell should be established to allow the public and industry professionals to report violations confidentially, it stated.

Drap, being the prime regulator of medical devices, is also expected to take necessary measures at its level and coordinate closely with provincial drug control administrations to implement these actions and take swift corrective measures where needed, the letter said.

Published in Dawn, January 31st, 2025