E-DRUG: Ceiling for drug registration (4)
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Each country has an unique scenario with reference to drug supply, and drug regulatory staff constraints. The overall picture is not clear from your e mail. However to restrict the number of players for each product dosage form will send wrong signals to newer entrants and small scale generic manufacturers.
Afterall competition is desirable in any market driven economy , and the price of drugs will stabilise automatically with healthy competition. As regards rational use of medicines it is mostly the physician/pharmacist who drive the choice of medication, more often the physician in developing countries. Thus the subject of rational use of medicines may not fit well with the subject of registration of generic products.
E-DRUG: Ceiling for drug registration (5)
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I was very interested to see the oriignal posting from Gamal in Sudan. I think he has developed a system that can be a good reference for many settings.
In smaller countries where there is a National Essential Medicines List associated with National Standard Treatment Guidelines, overseen by a National Therapeutics Commitee, in operation, the numbers of medicines in any one class is limited in the interests of ensuring a reliable supply of the most appropriate medicines.
It is up to the Chief Phamacist or Senior Procrement Officer (or equivalent) to make sure that the medicines or the list are available and good quality and affordable in the country. Therefore a limited number of registered medicines is the way to go. The best options are researched. The person in change of procurement can recommend the acceptance and registration of a product from a different source any time if that suggested product has been researched thoroughly (availability, quality, GMP, price etc) and is shown to have advantages over the previous product.
best wishes
Beverley Snell
Centre for International Health
Macfarlane Burnet Institute for Medical Research and Public Health
P O Box 2284 Melbourne 8001, Australia
Telephone 61 3 9282 2115
Fax 61 3 9282 2144
email <bev@burnet.edu.au>