E-DRUG: WHO PQ now charging application fees (4)
[While there is perhaps some misunderstanding of the intentions of the WHO PQ
program, Balkrishna raises some valid concerns about what an enlarged PQ
program might mean for countries ? that the emphasis should be more on
strengthening existing regulatory authorities so as to obviate the need for
prequalification. While that is a situation we would all like to see, the
reality is not there yet and, contrary to Balkrishna's argument, perhaps this
will act as an incentive to NRAs to become SRAs so that there is no need of PQ
of medicines originating from their countries? Any thoughts from colleagues on
either side of the debate?
Note: some editing of the submitted message to improve readability. DB]
WHO prequalification of GFATM medicines and manufacturers followed on from
the UN prequalification (PQ) of vaccines / manufacturers. The idea was
acceptable because it was intended for UN procurement and for similar
organizations like GFATM. The scope was limited. But what is being raised now
is something different.
WHO on one hand collaborates with member countries to enable them to
have effective regulatory capability and on the other is taking over part of
regulator's scope. This represents duplication of effort as well as
underestimation of regulators.
The PQ program as it is appears to be a vertical program of the essential
medicine department in WHO HQ. While it invites [NRA] regulatory inspectors to
join their inspection it is unlikely to have desired impact at organisational
level of the NRA. The situation - NRAs are either not capable or creditable and
the PQ program seems to re-enforce this message by entering into the NRA
If the PQ program assumes the PQ activities at a global level as is being
talked about the PQ team will need to be present in countries with a
pharmaceutical manufacturing base just like one of the SRA (stringent
regulatory authority), USFDA inspection team and USP does in India.
What if the WHO PQ team fails to handle every individual manufacturers request?
What if the country NRAs become less strict considering the takeover of
inspection by WHO PQ team.
After all whatever manufacturers spend will be passed on to consumers. If PQ
products are purchased by consumers on an out-of pocket basis, is it not going
to mean expensive commodities particularly in low-income countries
like Nepal? What if the market has PQ and non-PQ products to offer to
consumers? What if the NRA does a similar PQ job at a lower cost? Is there
any limitation in the scope of PQ program? So there are many concerns.
I would appreciate if these concerns are clarified!
Senior Drug Administrator
Department of Plant Resurces