E-drug: GMP and how to get the reliable suppliers
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A New Approach to GMP (?), how to beat the unreliable producers (?).
Can we do something together (?)
We are restarting the Essential Drugs Programme in the Republic of
Yemen, once an exemplary programme with the support of WHO in the
former Southern Republic, but unfortunately destroyed during the civil
war.
The war also resulted in a total breakdown of infrastructure. Medicines
and medical appliances were hardly available for a number of years
through the official channels. Smugglers and traders stepped in and
supplied what was needed or perceived to be needed. Fortunes were
made overnight. Now the government wants to put order in this chaos
again and is passing strict laws regulating all elements of the drug
supply chain (we can send you documentation if you are interested).
One element is of course which supplier can be trusted to provide
safe, effective, good quality and affordable (this is a poor country)
essential pharmaceutical products. The answer should be every
company that can hand over a GMP certificate of its country and a
Free Sale Certificate. However everyone who is buying and selling
drugs knows that it is not that simple. Some countries only pay
lip-service to the heavy responsibilities following these requirements;
in some countries one can buy certificates etc. Several production and
trading companies make good use of this situation and buy drugs from
these countries (good and bad) and stick a label from a well-trusted
country on it.
Unfortunately WHO cannot make the GMP regulations stick due to the
way it is organised and we are all the lesser for it. So is there a way
we can know those companies that can be relied upon? (within all
limits of reason as even the biggest and most state of the art
companies can make mistakes).
Over the years I have listened to several arguments from all sides;
also in various forums. None of them satisfied me as in one way or the
other they all seem to be initiated by some interest group. A sample of
these arguments is:
* Don't buy generic: you don't know what you get;
* Don;t buy from country A or B as their drugs are all
sub-standard (laughter and yeah-yeah);
* Essential drugs are sub-standard;
* Only the inventor companies have the know-how to develop and
therefore produce drugs at the required standards, and to buy
otherwise is close to criminal as the population is put at risk.
* Only companies with ISO 9000 (etc.) are safe.
I was fortunate enough to visit over the years a number of good
countries and an equal number of bad counties and although I am not
a qualified auditor on these matters my personal conclusion is that
there are good companies in the bad counties and some doubtful
companies in the good countries.
With this in mind Yemen is now requiring that every company from
every country (we should not ignore the politics that is involved in
such a move) will be audited (we call it international inspection) by
qualified auditors, to verify the GMP claims made by the company. We
appointed 10 of these on the basis of recommendation by certain
national Health, Medicine control agencies and Inspectorates. We have
asked the inspectors not to audit to a level as if the company
inspected should meet standards based on the latest designs of the
latest brand name company, but to inform us whether the company is
able to meet our requirements to provide safe, effective, good quality
and affordable essential pharmaceutical products. This is now going on
for the first year, and we get, of course, various responses. Some
companies are happy to cooperate; some say their country's GMP
should be sufficient. Some grumble about the cost as these inspections
are not cheap and the impact of inspection for Yemen only, is of
course limited. For the time being the way we are working seems to be
the only way to clean out our file of registered companies (there are
many).
On the other hand, since I know that the problem is present in many
countries, one cannot help wondering whether others would like to
obtain our results or would like to adopt the method and exchange
information. A type of international consumers organization for drugs
and medical supplies? It would certainly save everyone a lot of time,
headache and sleepless nights. And we could lay to rest a lot of myths
and accusations.
I would like to receive response on this approach from concerned
national consumers to see whether we could organism this
professionally and internationally. It could bring great export
opportunities for serious third world producers.
Regards,
Gerrit Weeda
Yemen Drugs Action Programme
P.O.Box 16033
Sanae, Republic of Yemen
tel.: 967.1.414661
fax. 967.1.415144
e-mail: yemdapmoph@y.net.ye
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