ISLAMABAD: In order to protect patient interests, the Pakistan Pharmacist Association (PPA) has requested that the Drug Regulatory Authority of Pakistan (Drap) guarantee high-quality reagents in labs, take action against illicit diagnostic reagent activities, and bolster the implementation of pertinent legislation.
“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 accurately diagnose and ensure optimum patient outcome,” PPA Vice President Shifa Khan Bangash wrote in a letter to Drap.
Rapid diagnostic kits and diagnostic reagents are essential medical instruments in this situation; their quality directly affects the precision of the diagnosis and can either assist or deceive the doctor in making the best course of action for the patient’s care.
Inaccurate diagnostic tests frequently mislead doctors and surgeons in making treatment decisions, which might even cause patients to die.
According to the letter, he said that the quality of reagents has an impact on the burden of disease in both directions and can therefore be related to healthcare economics.
The letter stated that in light of this, it is necessary to call your kind attention to the growing number of instances of illicit importation, unlicensed manufacturing, and unethical actions including misbranding and relabeling diagnostic reagents, which pose a major risk to public health.
According to the letter, the severity of the consequences and ramifications of such malpractices in this area necessitates prompt notice and proper action.
Establishing a provincial field force, or drug inspectors who actively monitor the illicit practice of printing counterfeit labels of well-known brands and re-labeling to produce and sell inferior and fake diagnostic reagents of leading brands, is one of the crucial actions that must be taken right away. The public’s health is seriously threatened by this widespread practice throughout the nation.
According to the letter, all producers of these reagents or kits as well as pertinent distributors must be subject to regular inspections and must be obliged to provide appropriate warranties in compliance with the Medical Devices Rules, 2017 without fail.
It must be mandatory for the producers to possess current licenses and guarantee that every reagent they manufacture is registered with Drap in accordance with the regulations.
Inspectors should regularly confirm that manufacturing facilities are not engaged in unapproved production and are operating within the parameters of their licenses.
Only organizations with active drug sales licenses may sell diagnostic reagents. According to the letter, inspectors should be instructed to confirm that all wholesalers, retailers, and distributors have a current license and to take measures against illegal merchants, including seizing goods and guaranteeing legal action.
To inform stakeholders about these rules, Drap should plan and launch awareness programs in coordination with provincial authorities.
The letter went on to say that in order to enable the public and industry professionals to report infractions in confidence, a centralized reporting mechanism or complaint cell should be established.
According to the letter, Drap, as the primary regulator of medical devices, must also take the required activities at its level, work closely with provincial drug control administrations to carry them out, and take prompt remedial action where appropriate.