After Cabinet decides to expand sources of medical products, WHO expands list of approved regulators; India and China not included

The trepidation expressed about a move by the Cabinet to procure
pharmaceutical drugs from non-conventional source markets appears to have
been warranted, as India and China are not listed among the World Health
Organisation (WHO) approved regulatory agencies for medical products.

At its weekly meeting last Wednesday, May 15, The Executive agreed that the
legal authority of the Pharmaceutical Council will have to be expanded in
order to allow medicines from jurisdictions other than the three main
suppliers to be accepted for lawful use in Antigua and Barbuda.
 
Reportedly, this country has relied almost exclusively on pharmaceutical
supplies from the drug-approval agencies of the United States, the United
Kingdom, and Canada. However, the Cabinet notes that other countries are
becoming exporters of pharmaceuticals and other treatments, including
stem-cell therapy, coming out of China, India and elsewhere.

In a May 20, 2024, article, it was reported that the WHO has approved
designation of 33 national and regional regulatory authorities as “WHO Listed
Authorities (WLAs).”

According to the Organisation, these authorities can be relied on for fulfilling
the highest level of regulatory standards and practices for quality, safety, and
efficacy of medicines and vaccines.
 
The updated listing brings the number of regulatory authorities designated as
WLAs from 34 to 36 member-states, since the launch of the initiative in March
2022.
 
The newly approved WLAs include: the U.S. Food and Drug Administration (US
FDA); 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 other countries,
including Austria, Belgium, Bulgaria, Croatia, Cyprus, France, Germany, Tthe
Netherlands and Spain.
 
Additionally, it was noted that “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.”
 
WHO sees its new listing as significant progress in the collective efforts to
improve access to safe, quality and effective medicines and vaccines.
 
Attaining WLA status indicates not only compliance with its standards, but
also a commitment to continuous improvement and excellence in regulatory
oversight – a commitment consistently demonstrated by the EMRN, HSA and
US FDA.
 
The move by the Cabinet to pursue other source markets is to be executed by
policy and not by parliamentary approval, and this decision has sparked
unease among medical professionals and residents.
 
Concerns have been expressed about the safety and manufacturing
procedures in some of these alternative countries, particularly India, which
has been criticized for unsanitary practices in food production and
preparation.