Standard Dugs, Generic Drugs, Or Fake Drugs.
What’s The Difference?
GLOBAL HEALTH
Aboubakar YARI1; Venus YARI1: and Myra YARI2
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Affiliations:
- Biotech tropicana,IncHEALTH
- Marketing Body, Biotech tropicana Corporation
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UNDER DEVELOPMENT
Faked drugs:
WHO also reports that the US Food and Drug Administration estimates that more than 10 percent of medicines in circulation in both developed and developing countries is counterfeit (products that are deliberately and fraudulently mislabeled with respect to identity or source).
Faked drug:
Mislabeled with respect to identity or source.
Standard drugs:
Complied with panel set standards
Characteristics:
Often high cost. For example will need refrigeration therefore energy for maintenance.
Generic drug:
Modified to reduce cost and complexity: yet complied with panel set standards.
Characteristics:
For example modified to be maintained without refrigeration in remote areas where energy is not available. Saving in infrastructure (refrigeration) and energy will impact cost for same profit. Often lower cost but equivalent to standard with respect to metabolism.
Regulatory Bodies:
Authority of regulatory bodies is key to protecting populations form faked drugs.
The regulatory body will require company to submit the drug for evaluation by an appropriate scientific panel before issuing authorization to sale.
Once authorized a law enforcement officer should not be permitted to interfere with a scientific decision. A law enforcement officer should act only with an order issued by a regulatory body acting like a judge in the case of drug distribution.
Examples of regulatory bodies:
US FDA
World Health Organization (Geneva headquater): for developing countries; provides technical assistance to country level regulatory bodies: Many developing countries will not be having adequate human scientific resources to objectively evaluate the drug at country level. The World Health Organization maintains panels of experts in various universities across the globe that supervises scientific issues for them. .
Cooperation is not qualified to evaluate drugs that are complex chemical structures.
Implementation Programs: Applications.
- Nations agencies will maintain a country level application centre for coordination of headquarter approved programs with governments. For example WHO will have a representation in each country. For a program like drug development and technology innovation the headquarter must first approve for the country application centre to act. Approval of the headquarter may be obtained either directly by submitting application to them or stepwise by requesting the country representation to send the application to the headquarter. For a private company the country representation may accept or deny at its own discretion. The country representation is accredited to the government not to private institution.
Discussions:
Levels of cost and complexity reductions in generics:
Innovation design
Development
Implementation
Alternative basis of cost reductions:
Labour cost:
An engineer in country A working toward standard drug SD is earning 20 values currency per hour for many years.
- engineer in country B with equivalent qualification, working toward generic drug GD is earning ten times less at 2 values currency for same length of time. At the end of the product line cost of standard drug SD is manifold more than cost of generic GD due to difference in labour cost. Standard drug SD and generic drug GD 100% identical with respect to chemical and other drug properties. Company CB in country B can afford to sell at lower cost than company CA in country A for same profit. Non expert mat treat generic GD as of inferior value than standard drug SA, or even faked, because it costs less.
Good drug or bad drug: A decision of drug regulatory bodies
- drug X a good drug or a bad drug? Drug has a file on innovation, development, manufacturing, and any additional data in an office of the regulatory body in country C that approved the sale of drug to populations. Should country D permit the sale of drug X to its populations? It is the responsibility of the drug regulatory body in country D to collaborate with the drug regulatory body in country C to obtain the file of drug X. Based on analysis of the file drug X plus any additional investigation step, the drug regulatory body in country C can issue a decision on whether to permit the or not the sale of drug X to its populations. If sale of drug X in country D is approved by regulatory in country D then drug X is treated as good drug. Where any file on drug Y cannot be obtained then drug Y is treated as a faked drug, and the sale of drug Y to populations should not be permitted. Then it is the responsibility of regulatory body in the country of sale to issue an order for law enforcement to clear the faked drug Y from the market. For example, Benin republic operates a drug regulatory body called CAME. Then it is the responsibility of CAME to obtain the file of any drug on the market in Benin republic from the regulatory body of the country of made of the drug. CAME is also responsible to approve the sale or issue an order for law enforcement to clear any without a file from the market in Benin republic. Benin republic is part of a larger free market called ecowas. Then the drug regulatory bodies in ecowas territories should maintain a drug regulation panel for streamlining drug sales within the ecowas free market zones. The establishment of the African Center for Disease Control (cdcAFRICA) in the African Union system provides a nucleus for an expansion to an all Africa drug regulation system with regional offices in economic communities such as ecowas in western Africa and sadc in southern Africa.
Access to drugs, development. And sustainability
- link between access to essential drugs and development is well established. Sick communities cannot contribute to the development of their nations. Worse they will consume wealth produced by healthy segments of their nations. See the report of the UN millennium scientific task force in “prescription for healthy development”. The Biotech tropicana Systems are not involved in drug regulation activities. The Biotech tropicana Systems innovate and commercialize biotechnologies, particularly for developing countries. Consistent with our internal development strategies, the Biotech tropicana Systems would recommend a drug regulation strategy that is sustainable for developing countries. Solutions to current drug crisis should be designed to increase the capacity of institutions involved to address greater challenges in mid and long terms. Developing countries should design their drug regulations systems to develop domestic human capital through technology transfers and collaborations. National drug regulation bodies should coordinate their strategies with regional and continental institutions to improve control on drug movement in and out of country and regional borders. .
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