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THE PHARMA REVIEW (NOVEMBER 2009)

Study of Data on Drugs Declared as “Not of Standard Quality” By Drugs Control Laboratories

T.Vedavathi and J. Vijaya Ratna

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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