Sunday, September 13, 2009

FAKE v/s SPURIOUS DRUGS IN INDIA

FAKE v/s SPURIOUS DRUGS IN INDIA

In India, Fake is a commonly used word that means "Not Genuine." This word is not specifically mentioned in our laws governing medicines. "Spurious", as defined in the Drugs and Cosmetics Act (Section 17B) is not limited to fake products but also includes other cases such as products that use unauthorized names, manufacturers etc. Implication: A strip of 10 pure and genuine paracetamol tablets will be deemed to be "spurious" if it uses the name Crocin without permission from trade mark holder GSK. In many raids where the aggrieved informer is a manufacturer of the original product, primarily and at least initially the issue relates to unauthorized use of brand names.Thus manufacturers use the legal definition to their commercial benefit even when public health may or may not be at stake. How many of the "spurious" products were found to be fake as well? Is the definition exaggerating the figures of really fake drugs?Should the definition of Spurious drugs be amended?


WHO WILL SPEAK ON THIS


Large drug industry associations (IDMA, OPPI) provide estimated percentage figures of fake drugs. Methodology and conclusions are neither listed nor supported with evidence. Concrete examples are often not given .Why should the drug companies shy away from giving specific details? Recently duplicate copies of a popular and very widely used cough remedy flooded certain markets in eastern India. The company found that its product's sale was either stable or going up all over the country except certain markets in eastern India. The Company took action with local police help but did not involve drug controller. The reason? Media coverage of the existence of duplicate products would have led to boycott of the brand by patients and doctors all over India!

URGENT NEED OF CREDIBLE , RELIABLE DATA

Currently fake drugs are discovered through random sample collections by state drug inspectors. On receipt of complaints by aggrieved manufacturers. Rarely by patients. These are inadequate measures to determine the correct prevalence of the problem.. National level scientifically structured large sample collection and testing is urgently required. CDSCO has probably already started the process.

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