E-drug: Drug Registration system in Sri Lanka (cont)
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This is a general reply to E-drug. It gives the background and (lengthy!)
answers to questions that were raised by Dr. Andreas Wulf on the drug
registration system in Sri Lanka. Please see the bottom of the email for
the questions that were raised by Dr. Wulf.
The drug registration and regulatory system in Sri Lanka began in the early
1960s which was even before the beginning of British Drug Regulation. The
main impetus for the drug regulatory system was cost but an equal concern
was quality. The regulatory system was headed by Professor Senaka Bibile,
a British trained Clinical Pharmacologist who is considered the father of
Pharmaceutical Policies in Sri Lanka and is also given a very honoured
place in the Developing World. Further details of the activities from 1960
to 1977 can be obtained from the publication given at the end.
The drug regulatory system in Sri Lanka has been continuous from the early
1960s to the present. The standard requirements for registration in any
developed country are enforced in Sri Lanka too. For example, the
manufacturer must provide a certificate on GMP according to WHO criteria.
The product must be registered in the country of manufacturer.
Registration is only for 5 years and is renewed after that. Renewal of
registration is not routine and outdated combination products have been
rejected. Over the counter analgesics (aspirin & paracetamol) are allowed
only as a single items, no combinations. In the European Continent I have
seen these frequently combined with Vitamin C though I can find no evidence
in any textbook of Pharmacology for this combination.
The criteria for a drug to be registered in the country are rather strict.
For example, we use the United States, Canada, United Kingdom, Netherlands,
Scandinavian Countries, Australia and New Zealand as our reference Drug
Regulatory Authorities. Note that France, Italy, Germany, India, Malaysia
are not considered to be reference Drug Regulatory Authorities due to their
rather loose criteria for drugs. As an anecdote, Sri Lanka was the only
country that did not register mibefradil as it had no advantages over the
existing calcium blockers and there were concerns about the adverse
effects. Fifty-three countries (including all the reference Drug
Regulatory Authorities as well as the others mentioned above) had
registered mibefradil. Six months after mibefradil was introduced into the
world-wide market by Roche, it was voluntarily withdrawn world wide in June
1998. As we said at that time "Possicor-(the brand name of mibefradil)
World Cup, Rest of the World 53, Sri Lanka 1, but Sri Lanka won" .
Most of the products available on the local market are from the Essential
Drugs List and are supplied by a local manufacturing company (the States
Pharmaceuticals Manufacturing Corporation) or imported from the Indian sub
continent. The SPMC is a government owned institute which manufactures 43
essential drugs in full compliance with GMP. It is the major supplier of
essential drugs to Sri Lanka and the Drug Regulatory Authority is quite
satisfied with its quality.
The approximate recall rate is about 4% for all drugs that have been issued
by the Medical Supplies Division (MSD) of the Ministry of Health. The MSD
which supplies the government sector procures its drugs from SPMC and
abroad. This is about the average for most developed countries.
The Achilles heel of drug regulation in Sri Lanka is poor supervision of
pharmacies as we do not have the required human resources (pharmacists) and
the Food and Drug Inspectors who inspect the pharmacies. However
purchasing from the government owned drug outlets is a very good guarantee
of quality. Please note that the government sector has played an enormous
part in ensuring availability and quality of drugs both in the government
as well as the private sector. Further details can be obtained from the
publication given above and a reference given later.
A recent study of samples from pharmacies of 10 essential drugs done as a
part of a Ph.D. project revealed no problems with these 10 essential drugs.
The assay was done in the United Kingdom. Our general impression is that
poor quality is not a problem in the Sri Lankan pharmaceutical scene.
There are of course anecdotes, but these remain anecdotes and do not
indicate a general trend.
I will now mention two incidents where the Drug Regulatory Authority
interacted with German pharmaceutical manufacturers. The readers may make
their own conclusions from these two events. The first event was with Helm
("the Pharmaceutical Manufacturer in the Autonomous Pharmaceutical Zone of
Hamburg"). For registering an oral penicillin product, they submitted an
obviously forged stability test where the results of the tests for 2
different doses (250 & 500mg - I think) were identical (which could have
occurred rarely) but the batch numbers were identical too! Helm is now one
of the pharmaceutical companies that is black listed by the Drug Regulatory
Authority of Sri Lanka. This episode happened a few years ago.
The second episode was with regard to Pro-viron the Schering product of
mesterolone. The PIL had an indication for impotence and general debility.
Although the DRA had no problems with the manufacture and quality of the
product, it did not agree with the indications and requested that these
indications be deleted from the PIL. The DRA also pointed out that these
indications were not in the British National Formulary as well as in the
PIL the company had in the United Kingdom. Schering then refused to change
the PIL saying that it was company policy not to alter a PIL. It was
unclear on what basis they made the statement. The DRA then rejected the
application for registration. After this rejection Schering then agreed to
delete these indications and provide a new PIL. One wonders what happened
to the policy of not changing a PIL world wide!
I hope I have given sufficient information on the drug registration process
in Sri Lanka. I have given some references in addition and must declare a
self interest them as I am an author in one of them! However readers are
invited to make their own assessments.
Prof. K Weerasuriya
Secretary, Drug Evaluation Sub Committee
Ministry of Health
Sri Lanka
THE TWO REFERENCES
Lall S & Bibile S. The political economy of controlling transnationals: the
pharmaceutical industry in Sri Lanka (1972-76). World Development 1977, 5,
677-98 - the article also appeared in Int. Journal of Health Services
(1978) 8 (2) 299-328.
A Search for Balance: Pharmaceuticals in Sri Lanka. Pioneering Steps in a
Receptive Environment and Subsequent Accommodations, Weerasuriya K,
Development Dialogue, 1995:1, 54-94
ORIGINAL QUESTION
Dear collegues,
I'm looking for some reliable information about the drug-regulatory and
-controlling policy in Sri Lanka; some german supporters of health
projects in Colombo got problems with their larger donor organisation
because they bought the necessary drugs (mainly essentials) in Colombo
and the board questioned the quality of these drugs (without concrete
indications, just a general suspicion against "these underdeveloped
countries"). Is there anyone with some experience about that?
Best regards
Andreas Wulf
medico international
Obermainanlage 7
60314 Frankfurt/Main
Germany
Tel: +49/69/944 3835
fax: /43 60 02
e-mail: medico.wulf@t-online.de
[I assume you used the WHO good donation guidelines? Of course, every
country has the right to set regulatory criteria for incoming donations.
Can some Sri-Lankese E-druggers explain what they are? WB]
CLARIFICATION TO THE ORIGINAL QUESTION
Dear Dr Krisantha Weerasuriya,
you might have read my second note in the edrug, (which was a little
clearer, I hope), the question was indeed about the quality of drugs
registered in Sri Lanka. The german people who support some small health
projects in Colombo bought some nessesairy (mostly essentials) drugs in the
lokal pharmacies and the german funding-organisation refused to reimburse
their spendings because of doubts on the quality of these drugs - the Sri
Lankian partners had no complains about the quality of the drugs they
received - I think it is a simple eurocentric "better to by german drugs".
Unfortunately I have no concrete information about what drugs were bought
where and when - but I think it should be sufficient to refer to the
general drug regulatory system in Sri Lanka and I thought about such a
reference.
Best regards
Andreas Wulf
Dr Krisantha Weerasuriya tel/fax +94 1 695230
Department of Pharmacology email <phrm_cmb@slt.lk>
Faculty of Medicine, Kynsey Road
University of Colombo
P O Box 271
Colombo 00800, SRI LANKA
personal email <kw_twcp@slt.lk>
personal fax +94 1 573170
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