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NAFDAC orders withdrawal of AIDS drug
Chukwuemeka OKORO
NATIONAL
Agency for Food, Drug Administration and Control (NAFDAC) has ordered immediate
withdrawal from the markets, the anti-AIDS drug
Trivoro-Ins 40.
NAFDAC said yesterday that its order was
directed at Rambaxy (Nigeria), the local representative of the trademark owners,
Rambaxy India.
The agency�s hammer followed the World
Health Organization�s (WHO) delisting of three drugs touted to be HIV remedials,
including two by Rambaxy India.
From its Geneva, Switzerland base, the WHO
said the three medicines, incidentally all of Indian origin, had not met all
international standards for being catalogued as AIDS remedies or curatives.
A message on the WHO web service,
authenticated by its top scientific officers Daniela Bagozzi and Andre van Zyl,
stated that two of the de-listed medicines are by Ranbaxy Laboratories of Dewas,
while the third is by Cipla of Kurkumbh, both companies in India.
But, in Abuja yesterday, NAFDAC ordered
Rambaxy Nigeria to immediately withdraw its anti-retroviral (ARV)
Trivoro-Ins 40.
The world�s health-care sector watchdog
(WHO) said in the message that, "Lamivudine 150mg plus Zidovudine
300mg tablet, Lamivudine 150mg plus Stavudine 40mg plus
Nevirapine 200mg (all tablets from Rambaxy) and Lamivudine 150mg
table/Lamivudine 150mg plus Zidovudine 300mg tablet (both by Cipla),
have been removed from the list of prequalified products" for the management of
HIV/AIDS.
In Abuja yesterday, NAFDAC said its order
to Rambaxy for withdrawal of the drug was with immediate effect.
World Health Organisation explained in the
message that, the delisting programme was part of the continuous effort to
rigorously monitor the quality of medicines, and ensuring systematic inspections
of contract research organizations which have done bioequivalence studies for
prequalified medicines, starting with products for priority diseases.
During the most recent inspection a
contracted laboratory which had done bioequivalence studies for three AIDS
medicines had been found non-compliant with international standards of good
clinical and laboratory practices, the WHO said.
As a result, the three anti-retrovirals,
which are manufactured by Ranbaxy, will be removed from the list until such a
time as Ranbaxy can submit data of new studies providing unequivocal evidence of
the products� bioequivalence with the originator medicines, the organisation
stated.
The antiretrovirals in question are the
triple fixed-dose combination pill containing lamivudine, stavudine and
nevirapine in two different strengths and a lamivudine plus
zidovudine tablet.
The recent inspections follow another
inspection which took place late May, when similar non-compliance was found at a
laboratory contracted by Cipla to do bioequivalence studies of two AIDS
medicines.
However, another WHO inspection of a
contract research organization has found that the bioequivalence tests for
triple fixed-dose combination lamivudine, stavudine and nevirapine
tablet manufactured by Cipla were carried out properly in compliance with
requested standards. This product will therefore continue to be included in the
list of WHO prequalified products.
While the three Ranbaxy products to be
removed from the list meet quality specifications, proof of bioequivalence is
missing, in view of non-compliance with good clinical and laboratory practices
as well as data handling requirements found in the contracted laboratory.
This effectively means that the medicines
may or may not offer the same therapeutic benefits as the originals on which
they are based.
Meanwhile, a NAFDAC statement noted that
the exercise was entirely routine and should not be seen as any big deal.
"In the regulatory control of drugs meant
for life threatening diseases or those with narrow therapeutic margins, they
will always require WHO prequalification to assure safety, quality and efficacy
before they can be considered for licensing in member countries.
"One of the parameters for
prequalification is the systematic inspection of contract research organization
which have done bioequivalence studies for the medicines as part of the
requirements.
"Where such laboratories are found to be
non-complaint with international standards of good clinical and laboratory
practices such products will be delisted.
"This is necessary to compel the
manufacturer to do that which is needed and such action are routine, and the
products would usually be put back on the list once that is done," the statement
clarified.
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