Are Discount Drugs of Inferior Quality?
"Most people believe that if something costs more, it has to be better
quality..."says Gary Buehler, Director of FDA's Office of Generic Drugs.
"In the case of generics (discount drugs), this is not true. The standards
for quality are the same for brand name and generic products." (1)
When a brand name product has a generic competitor, this simply means that
the brand name product has been around long enough for its patent to expire,
which then allows generics (copy discount drugs) to be made. Most often generics
will be the discount drugs found in these markets, and almost always they will
be less expensive prescription drugs when compared to their brand name counterparts.
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Despite their lower price, manufacturers of generic prescription drugs are
required to meet rigorous quality standards before they can sell their generic
'discount drugs'. Value Pharmaceuticals pharmacies source high quality generic
products only from pharmaceutical manufacturers that comply with these strict
international regulatory standards. The quality standards of the lower cost
generic products available on the Value Pharmaceuticals site are as high as
they are for the most expensive original brand name drugs .
While the active ingredients in generic prescription drugs are the same as
the active ingredients in their brand name counterparts, there may be differences
in their appearance. (For example, the shape or the colour of a tablet.)
Sometimes different non-active ingredients may used to produce the final product.
(For example, the non-active base in creams or diluents in nasal sprays.) However,
the active ingredients, which give a drug its intended effect, are the same
in generic prescription drugs and their brand name counterparts. None of these
differences should alter the clinical effect of any approved generic discount
drug.
The Current Use of Generic Prescription Drugs
The U.S. drug regulatory authority, the FDA, has approved more than 7000 generic
discount drugs for use in the U.S. The approval process that all of these generic
prescriptions drugs have completed is extremely intensive and multi-faceted.
It covers quality, performance and labelling. Also, while these generics will
inevitably become the country's discount drugs, the manufacturing facilities
where they are to be made, are required by the FDA to be as good as those used
to manufacture brand name drugs. This standard applies no matter where in the
world the manufacturing facility is located.
Almost half of the prescriptions filled in 2002 in the U.S. were for generic
drugs (1), these being the discount drugs of the country. This strong and growing
demand for generic prescription drugs is testimony to their widespread acceptance
by the health authorities, health professionals, and patients.
Value Pharmaceuticals pharmacies source high quality generic products only
from pharmaceutical manufacturers that comply with strict international manufacturing
standards. This means that any generic product supplied to a Value Pharmaceuticals
customer has complied with robust internationally accepted quality standards.
Most of the generic products available from Value Pharmaceuticals are sourced
from western European countries.
Some of the generic products are sourced from internationally approved pharmaceutical
manufacturers from India and these are identified during the ordering process.
The key companies that our suppliers source Indian generic pharmaceuticals from
are:
The links provided will take you to the respective company websites which have
information to show that their manufacturing facilities have been inspected
to meet the robust standards of the FDA as well as other internationally recognised
regulatory authorities.
Some Technical Facts About The Generic Drug
Approval Process
In the U.S and most developed countries generic drugs must show that they:
- Contain the same active ingredients as the brand name drug (inactive ingredients
may vary)
- Are identical in strength, dosage, form, and route of administration
- Are used for the same condition(s)
- Are bio-equivalent (that is, they are available to the same extent in the
body when taken or administered)
- Meet the same batch requirements for identity, strength, purity, and quality
- Are manufactured under the same strict standards of the FDA's good manufacturing
practice as required for brand name products. (1)
Useful Links
To read more about the FDA standards for generic drugs click on the following
links. http://www.fda.gov/opacom/factsheets/justthefacts/18generic.html
http://www.fda.gov/cder/about/whatwedo/testtube-17.pdf
To view our Product Catalogue, including the selection of generic drugs we
offer, please click here.
1. US Food and Drug Administration, "FDA-Approved Bargain Drugs: Generic
Products Must Meet High Standards", February 2002