E-drug: Nimesulide (cont)
-------------------------
[the Lancet (Volume 353, Number 9170 19 June 1999) discussed Nimesulide
as well. Interestingly, the Sri Lankese Regulatory Authority referred to
E-drug as one of its sources for deciding on the application of Nimesulide.
WB]
Registration of new drugs in developing countries
Sir--A Figueras and colleagues (April 24, p 1447) [1] describe fulminant
hepatic failure with nimesulide, a selective inhibitor of COX-2. They
also mention the difficulties associated with the registration of a new
drug in developing countries. Sri Lanka too has been confronted with this
issue.
Nimesulide is registered in many countries (Spain, Italy, Portugal,
Switzerland, and Greece) and is the best selling pharmaceutical product
in Portugal.[2] There were six applications to the Sri Lankan Drug
Regulatory Authority (DRA) by various manufacturers in 1998. However,
nimesulide was not registered in Canada, the USA, the UK, Scandinavia,
Australia, and New Zealand. The Sri Lankan DRA considers these countries
to be the reference DRAs and tends to consider only those drugs (the
chemical entity, not the product) that are registered by these
authorities.
Various arguments were given by the applicants to make nimesulide the
exception: it was an old drug, registered in Italy in 1985,[2] had been
assessed thoroughly, and there were many publications on it. A limited
literature search found more than 30 publications. Nevertheless, the Sri
Lankan DRA decided to be cautious and await further reports. This
decision was made easier by the fact that nimesulide did not have clear
advantages over other NSAIDs.
During late 1998 and early 1999, there were reports of adverse events
with nimesulide.[2-4] None of the applicants for registration informed
the Sri Lankan DRA about these events. The DRA came to know about
fulminant hepatic failure with nimesulide through an e-mail discussion
group ("E-drug") in May. The paediatric nimesulide preparation has now
been withdrawn from sale in Portugal[3] and Israel.[4] These discoveries
were fortuitous--the DRA simply does not have the funds to subscribe to
medical journals or the personnel to monitor reports. Nimesulide is now
unlikely to be registered in Sri Lanka because of these reports.
As Figueras and colleagues underline, the World Trade Organisation and
the International Conference on Harmonisation are driving the procedures
for registration of drugs. What should a developing country with little
or no information exchange, and inadequate regulation of drugs do, when
the harmonised dossiers of the new drugs are submitted for registration?
In the few situations in which the new drug has a clear advantage over
existing drugs, it should properly be assessed and registered promptly.
However for the "me-too" drugs with no advantage over existing drugs,
which make-up most of the applications, such speed may not be needed.
There is a simple way to decide on "me-too" drugs; the approved product
information (indications, adverse effects) for an existing drug from a
reference DRA would show little or no difference from that of the newer
"me-too". Sri Lanka used this method and did not register mibefradil,[5]
the caution was well placed since the drug was subsequently withdrawn
worldwide.
An important issue in registering new drugs in developing countries is
whether health or trade should come first. Registering new drugs without
delay would help trade and free circulation of goods; adopting a cautious
attitude would serve health. Should not the government ensure that
citizens are healthy before they begin to trade?
K Weerasuriya
*Department of Pharmacology, Faculty of Medicine, University of Colombo,
Colombo 00800, Sri Lanka; and Drug Evaluation Sub Committee Ministry of
Health, Colombo
email <<phrm_cmb@slt.lk>
1 Figueras A, Estevez F, Laporte J-R. New drugs, new adverse reactions,
and bibliographic databases. Lancet 1999; 353: 1447-48.
2 Nimesulide ADR controversy in Portugal. Scrip 1999; no 2406: 8.
3 Portugal suspends paediatric nimesulide. Scrip 1990; no 2431: 20.
4 Israel nimesulide suspension inquiry. Scrip 1999; no 2434: 23.
5 Weerasuriya K. Mibefradil: the sole exception. Lancet 1998; 351:
1829-30.
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