Counterfeit and substandard quality of drugs: The need for an effective and stringent regulatory control in India and other developing countries

摘要

One of the latest threats facing the global pharmaceutical industry and healthcare is the presence of spurious/substandard drugs in the market. The World Health Organization (WHO) estimates that counterfeit drugs account for approximately 5-8% of the total worldwide trade in Pharmaceuticals. According to the WHO, 'a counterfeit drug is one which is deliberately and fraudulently mislabeled with respect to identity, composition, and/or source.' This definition of counterfeit includes not only completely fake drugs but also those that have been tampered with, adulterated, diluted, repackaged, or relabeled so as to misrepresent the dosage, origin, or expiration date, as well as those substandard drugs that are cheaply produced in order to make unlawful profits. The Center for Medicine in the Public Interest (USA) estimates that sales in counterfeit Pharmaceuticals will reach US dollar75 billion in 2010.