ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) is actively working towards becoming a part of the World Health Organization (WHO) Listed Authorities (WLAs) – a status that would signify its adherence to the international standards in drug regulation and quality control, officials in the National Health Services, Regulations, and Coordination (NHS,R&C) said on Thursday.
“One of the critical steps DRAP has taken is the revamping and upgrading of the Central Drug Laboratory (CDL) in Karachi. This facility is now equipped with state-of-the-art technology and follows best practices recommended by both World Health Organization and the United States Pharmacopeia,” an official of the NHS told The News.
The WHO has recently approved the designation of 33 national and regional regulatory authorities as WLAs, which can be relied on for fulfilling the highest level of regulatory standards and practices for the quality, safety, and efficacy of medicines and vaccines.
The drug regulatory authorities of both Pakistan and India were not among the WLAs. Since the launch of the initiative in March 2022, a total of 36 regulatory authorities from 34 member states have now been designated as WLAs.
Officials in the Drug Regulatory Authority of Pakistan claimed that they are striving to become a part of the WHO Listed Authorities. They are preparing for a virtual audit in October this year, while a final audit by the WHO is expected in March 2025.
They noted that the Central Drug Laboratory in Karachi had undergone assessments for quality management system certification and was engaged in continuous collaboration with WHO for prequalification as a quality control laboratory.
“Furthermore, DRAP is focusing on strengthening its regulatory framework through various initiatives. These include improving pharmacovigilance, modernizing systems for better transparency, and implementing a 2D barcoding system to combat counterfeit medicines.
Additionally, DRAP is enhancing its human resources and infrastructure to meet international standards,” an official of the Drug Regulatory Authority of Pakistan said.
DRAP’s efforts to align with WHO standards involve significant upgrades to its laboratories, implementation of advanced regulatory practices, and continuous engagement with international health authorities.
These steps aim to ensure that the quality of medicines in Pakistan meets global standards, ultimately safeguarding public health.
Earlier this week, WHO announced that new WLAs include the US Food and Drug Administration (US FDA) and the European Medicines Regulatory Network (EMRN), which is composed of the European Commission, the European Medicines Agency (EMA), and the medicines regulatory authorities of 30 countries including Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden.
Furthermore, the Health Sciences Authority (HSA) of Singapore, which was previously designated as a WLA in October 2023, was approved for an expanded scope of functions.
The decision was based on the recommendation of the WHO technical advisory group on WLAs (TAG-WLA) following WHO performance evaluations confirming the consistency of advanced performance by these authorities in line with international standards and best regulatory practices for ensuring the quality, safety, and efficacy of medicines and vaccines.
The World Health Organization approval for the US FDA and EMRN includes all regulatory functions for the product streams of medicines, including multisource (generics) and new medicines (new chemical entities), biotherapeutics, and similar biotherapeutic products, and vaccines.
The World Health Organization approval for HSA includes an additional regulatory function of market surveillance and control. With this inclusion, HSA’s WLA status now covers all other regulatory functions for the product stream of medicines, including multisource (generics), new medicines (new chemical entities), and biotherapeutics and similar biotherapeutic products.