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Abstract: In pharmaceuticals, quality is of
maximum importance and is guided and controlled strictly
by several bodies at several levels. Among all the drug
products being produced in India, if there is no
difference in the quality between branded generics and
generics, then, there should be no significant
difference between the number of drug products declared
as “nsq” (not of standard quality) by the Drugs Control
Department in an year, in branded generics and in
generics. This analysis was done on data downloaded from
drugscontrol.org and on data obtained from Drugs Control
Administration, Hyderabad. The products were categorized
into branded generics and generics. Clearly the number
of “nsq”s from branded generics is more than from
generics. All the names of the drug products declared as
“nsq” were taken and Current Index of Medical
Specialties (CIMS) was searched to see whether the name
has been indexed by CIMS. CIMS may be considered as
indicative of an “image” in the market. When the
products declared as “nsq” were classified in the way
indicated above, interesting results emerged. Almost all
the drug products declared as “nsq” were products not
listed in CIMS. All the companies whose products have
“no image” are not large scale companies. At present
only government hospitals purchase generics and all
private hospitals purchase branded generics; this is
done on the premise that branded generics are superior
to generics. The results of this analysis clearly negate
the popular belief that branded generics are better than
generics with respect to quality.
Introduction
Quality is a phenomenon that is experienced and is
expected in the content of deliverables and services.
The consumers look for goods conforming to these quality
specifications. In pharmaceuticals, quality is of
maximum importance and is guided and controlled strictly
by several bodies at several levels. In India the
Schedule M of the Drugs and Cosmetics Act 1940 gives the
guiding principles for quality assurance. Guidelines for
good manufacturing practices are also given by WHO and
FDA. For specific products and specific drugs quality
standards and requirements are given by the Indian
Pharmacopoeia. For some products where such standards
are not available in Indian Pharmacopoeia, other
standard books, such as the United States Pharmacopoeia
are referred.
If among all the drug products being produced in India,
there is no difference in the quality between branded
generics (BG) and generics (G), then, there should be no
significant difference between the number of drug
products declared as “nsq” (not of standard quality) by
the Drugs Control Department in an year, in branded
generics and in generics. This analysis was done on data
downloaded from drugscontrol.org and on data obtained
from Drugs Control Administration, Hyderabad, under the
Right to Information Act, 2005 and is being presented in
this paper.
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