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Abstract: Generic drugs are
considered to be the cheaper alternative to the costly
patented / branded products, by providing precisely the
same medical benefits to the suffering mankind at lower
price as these are certified to be perfect substitute
for the original branded product. The generic drugs
contain the same active ingredient as the original
branded product on which they are based. A branded
product, for all purposes, is identical to & hence
interchangeable with the branded product. They must
contain same active ingredients with same strength as
the innovator drug product and must meet same pharmacopoeial standards.
Internationally, drugs patents and exclusive marketing
rights associated therewith are awarded for a period of
20 years, during this time, no other drug company is
allowed to manufacture or market the same drug. After
expiry of the patent, other companies are permitted to
manufacture and market the drug; their brands are known
as generic versions.
The quality requirement for the generics is by and large
same as for the corresponding branded product. The
generics are considered to be bio-equivalent to a
branded drug. Thus generics are identical to their
branded counterpart in dose, strength, route of
administration, safety, efficacy and intended use.
Generics also go through a rigorous scientific review to
ensure both safety and effectiveness. Sometimes generic
versions of a drug have different colors, flavors or
inactive ingredients and also does not look alike the
branded one because of trade mark laws. Some of the
generics are manufactured by the same pharmaceutical
company that make brand drug; others are produced by
pharmaceutical companies specializing in the
manufacturing of generics. All prescription drug
manufacturers must meet rigid FDA, WHO & GMP approvals,
as and where applicable.
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