E-drug: White lists and WHO prequalification of AIDS Drugs
---------------------------------------------
I welcome the publication of the WHO Prequalification list. This is a major
step forward. There have been reasonable criticisms of the announcement
though not from the IFPMA!
It has taken a long time! There are other suppliers who could have been
included! Not all needed drugs are covered! BUT this is a first step, there
will be updates. It was more important to get the list right than to be fast
and have to remove a supplier that had been inadequately screened.
Two questions for WHO. Will the GMP inspection reports of the successful
companies be made available? I ask this because generally GMP inspection
reports are kept confidential. I cannot understand the logic for this
practice. If these reports could be circulated it would save other
inspectors going over well studied areas. It would also give regulatory
authorities more to go on than the WHO's word.
My second question relates to performance monitoring. The essence of a
"white list" is prequalification AND performance monitoring. Will WHO
provide any information on the performance of the listed companies. What I
would like to know is the volume of product shipped and details of the
largest recipients. I think that it is likely that some of the companies,
particularly the generic companies, would be willing to provide such
information.
My congratulations to WHO on undertaking this task. They have done the world
a great service in declaring that some generic drugs fully meet
international standards of quality. Hopefully this list will grow. But it
may be too much for WHO to do alone. If the details of GMP inspections by
international procurement agencies such as UNICEF, IDA, ECHO etc could be
shared such a "white list" of quality suppliers could be compiled. If it
could be combined with a performance monitoring reporting system then
procurement agencies and regulatory authorities in poor countries could have
a much better idea of which companies consistently provide quality products.
Richard Laing
Boston University School of Public Health
richardl@bu.edu
--
To send a message to E-Drug, write to: e-drug@usa.healthnet.org
To subscribe or unsubscribe, write to: majordomo@usa.healthnet.org
in the body of the message type: subscribe e-drug OR unsubscribe e-drug
To contact a person, send a message to: e-drug-help@usa.healthnet.org
Information and archives: http://www.healthnet.org/programs/edrug.html