Increasing incidence of spurious medicines supply in developing countries

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Fake drugs can not only prolong an illness but also cause associated harm

New Delhi, 17 December 2017: About 11% of medicines in the developing countries are counterfeit, if recent reports are anything to go by. These fake medicines are also responsible for the deaths of tens of thousands of children from diseases like malaria and pneumonia. About 65% of the fake medicines are those used for treating malaria and bacterial infections, says the research. What is alarming is that the number of children dying from pneumonia after receiving bad drugs is between 72,000 and 169,000.

Most of these counterfeit fake drugs are manufactured in an extremely polluted atmosphere. There is demand for these drugs all around the world — from South Africa and Russia to India’s neighbours such as Myanmar and Nepal. Among the various ways in which fake medication is manufactured include sticking fraudulent labels on expired products, filling vials with water, stuffing small amounts of real ingredients in packages of popular licensed brands, and putting chalk power in medicine packets.

Speaking about this, Padma Shri Awardee Dr K K Aggarwal, National President Indian Medical Association (IMA) and President Heart Care Foundation of India (HCFI) and Dr RN Tandon – Honorary Secretary General IMA in a joint statement, said, “Though efforts have been made to arrest the manufacture of such spurious drugs, the fact that they are still available at large is alarming. Some factors that contribute to this include lack of adequate regulations, shortage of drug inspectors, and a lack of lab facilities to check purity of drugs. Additionally, weaknesses in drug distribution system and lack of awareness among consumers exacerbate this situation further. Fake and substandard drugs are less effective and cause a disease to run longer. They can even lead to the need for a new prescription during treatment. These substandard drugs are also why there has been an increase in antibacterial resistance in India.”

A report by ASSOCHAM has also indicated that fake drugs constitute US$4.25 billion of the total US$14 to $17 billion of the domestic drugs market. If this market grows at the rate of 25%, it will cross the US$10 billion mark by 2017.

Adding further, Dr Aggarwal, said, “Spurious drugs are mainly the products which are deliberately and fraudulently mislabeled and manufactured to mislead and misrepresent the patients by concealing their identity, source of manufacture and its content to profiteer on the popularity of fast moving branded or generic medicines. It may or may not contain the active ingredients in the manner mentioned on the label.”

The following points can indicate if a drug is fake or spurious.

Law: Drug shall seem to be spurious if it falls within the definition as per Chapter IV, Sec. 17B of the D&C Act:

  • 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 lack 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
  • If it has been substituted wholly or in part by another drug or substance; or
  • If it purports to be the product of a manufacturer of whom it is not truly a product.