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THE PHARMA REVIEW (DECEMBER 2008)

Spurious Drugs / Counterfeit Drugs - An Overview

G.L. Singal

Abstracts: The menace of spurious / counterfeit drugs is escalating every day, endangering life of innocent ailing human beings. This burning problem for the health care providers, may be un-intentional or deliberate, yet it remains dynamic inspite of stringent penal provisions under the Indian legislation for cases of detection of spurious/counterfeit drugs. Counterfeiting of medicines is a world wide phenomenon and India is not an exception to it. As the lust of money is increasing, we are deviating from our moral values/ethics & responsibilities. Right to health, which includes right to quality medicine has been considered as a fundamental right in our constitution, therefore, the state is duty bound to provide quality medicines to its people.

 

The Drug and Cosmetic Act 1940 and Rules 1945, a central legislation regulating the manufacture, sale, and quality of drugs and formulations in India provide definition of 'Spurious Drug' under its section 17-B.

  • If it is manufactured under a name which belongs to another drug; or

  • If it is imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lacks of identity with such other drug; or

  • If the label or container bears the name of an individual or company purporting to be manufacturer of the drug; which individual or company is fictitious or does not exist; or

  • It has been substituted wholly or in part by another drug or substance or

  • If it purports to be the product of manufacturer of whom it is not truly a product.

Counterfeit drugs are an upcoming social evil. According to WHO estimates about 25% of the medicines consumed in developing countries are believed to be counterfeit. However, no systematical and scientifical study data is available on the extent of this menace. 'Counterfeit drug' is one which is deliberately and fraudulently mislabeled with respect to identity and / or source, as per WHO. Counterfeiting can apply to both branded and generic drug products and counterfeit medicines may include products with the correct therapeutically active ingredients but fake packaging; with the wrong ingredients; without active ingredients or with insufficient active ingredients. In developed countries, counterfeiters generally target newer, costly and top selling drugs like hormones, steroids, antihistamines, psychiatric medicines and anticancer drugs. In developing countries, drugs used to treat life - threatening conditions such as malaria, tuberculosis and HIV / AIDS are generally counterfeited.

 

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