The Pakistan Pharmacists Association (PPA) acknowledges the crucial role that medical devices and allied technologies play in the healthcare system, particularly in the prevention, treatment, and diagnosis of diseases.
As part of its ongoing commitment to the health and well-being of the nation, the PPA commends the Drug Regulatory Authority of Pakistan (DRAP) for its continuous efforts to maintain an uninterrupted supply of medical devices in the country.
In recent months, DRAP has taken several significant steps to strengthen the supply chain and registration processes for medical devices. The following initiatives, which have garnered appreciation from the PPA, are worthy of recognition:
The Medical Devices Board has convened nine (09) meetings in recent months, resulting in the clearance of approximately 5,000 pending applications, ensuring smooth processing for the medical device industry.
DRAP has facilitated the clearance of pending consignments at all customs ports following the submission of undertakings by consignees, in line with Rule 26 of the Medical Devices Rules. This step has led to the prompt clearance of hundreds of consignments, effectively preventing potential shortages in the market.
In a move to support the medical device industry, DRAP has simplified the criteria for registering least risk-bearing medical devices. This change has provided much-needed ease for the industry to register and enlist such devices, making the process more accessible.
DRAP has already processed and implemented an e-system in other divisions which shall be fully operationalized in Medical Devices Division in next couple of weeks that will enable the submission and processing of all registration applications and cases electronically. This system, set to be rolled out in the coming weeks, will streamline the processing of cases, enhance transparency, and provide a more efficient service to applicants.
The PPA fully appreciates the leadership of DRAP for its decisive actions, which have facilitated the seamless flow of medical devices across Pakistan, despite the country's reliance on imports in the medical device sector. These steps are vital in ensuring that healthcare providers have access to quality devices, essential for delivering timely and effective care.
The PPA strongly condemns recent claims from certain groups suggesting that there is a shortage of medical devices and accusing DRAP of inaction. These claims are baseless and devoid of merit, and appear to be driven by ulterior motives. Some elements are attempting to pressure DRAP into extending the registration deadlines, a move that could undermine patient safety and quality control in the medical device market.
However, in the interest of public health, the PPA urges DRAP authorities to resist any pressure to extend the registration period for medical devices. Granting such an extension would be harmful to the quality of medical devices in Pakistan and would undermine the efforts of companies that have already complied with legal requirements.
Allowing such an extension would be discriminatory to those adhering to the law, and it could inadvertently favor entities that prioritize commercial interests over patient welfare.
However, the PPA also urges DRAP to expedite the processing of all pending registration applications to facilitate the legitimate import and sale of medical devices in Pakistan. Prompt processing will ensure that high-quality medical devices are available to meet the healthcare needs of the nation.
The Provincial Drug Control Administrations should also initiate a crackdown against the un-registered medical devices at the earliest in order to safeguard the public health.
The PPA reaffirms its commitment to working collaboratively with DRAP to ensure the continued delivery of safe and effective medical devices to the people of Pakistan.
