E-DRUG: The important world of drug prequalification
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[To make things worse, WHO announced today (19 Nov) that a third Indian generic company (Hetero) has withdrawn 6 ARVs from the WHO PQ list. See
http://mednet3.who.int/prequal/hiv/hiv_suppliers.pdf
The withdrawals could however be explained as that the WHO PQ system is getting more effective, even though in the short term this causes problems for patients and ART projects.
WB]
Lancet 20 November 2004
Editorial
The important world of drug prequalification
On Nov 9, Ranbaxy Laboratories in India voluntarily withdrew all its seven antiretroviral drugs from WHO's prequalification scheme. This list of drugs is a little known (outside the world of essential drugs) but vital part of drug delivery in the developing world. Earlier this year, three of Ranbaxy's and two of Cipla's (also in India) antiretrovirals were also de-listed.
What is the prequalification scheme, and why is it important? The scheme is run by the Quality Assurance and Safety: Medicines (QSM) team, part of WHO's Essential Drugs and Medicines Policy department. Much of QSM's work is the development, harmonisation, and promotion of international standards to ensure quality, safety, efficacy, and rational use. In particular, QSM manages the prequalification of drugs and manufacturers for antiretrovirals for WHO, UNICEF, UNAIDS, and UNFPA, antituberculosis drugs for WHO and the Stop TB Partnership, and antimalarials for WHO and Roll Back Malaria.
Both the drug and the manufacturing site have to be prequalified. Once on the list, the drug and manufacturer are considered eligible to supply drugs. Manufacturers are inspected for compliance with good manufacturing practices. The inspectors are from drug regulatory authorities from the European Union, Canada, and Switzerland, and they work with regulators from the developing countries where the medicines will be used. The prequalification assessment also evaluates in-vivo bioequivalence tests done by the manufacturer, and QSM also provides local training.
Ranbaxy withdrew its antiretrovirals after finding discrepancies in the documentation about the drugs' bioequivalence. The company hopes to resubmit new data by the end of this year. The withdrawals earlier this year came after inspections at contract research organisations showed serious discrepancies between the original bioequivalence data and the results presented, and because of non-compliance with good clinical and laboratory practices.
WHO is, of course, presented with an immediate dilemma, because an alternative supplier is not always available. Thus WHO recommends that patients continue using the de-listed product, because the risk of withholding treatment is higher than that of providing medicines whose bioequivalence is not proven but which have otherwise been prequalified. A switch to non-prequalified drugs is not recommended.
So the latest news of the withdrawal of much-needed antiretrovirals from the prequalification list is both bad and good. Bad, obviously, for the patients and health carers affected locally. But good news because it shows that this little known part of WHO is effective and has teeth that can bite rapidly. QSM is a small team at WHO's headquarters that knows the importance of training local drug regulatory authorities, and has the ability to use international inspectors in local sites. And prequalification status means that some of the most important drugs are being made safely available in parts of the world where they are most needed.
The Lancet