According to the World Health Organization (WHO), a counterfeit medicine is a pharmaceutical product “which is deliberately and fraudulently mislabeled with respect to identity and/or source”. This definition of counterfeit medicines falls within the broader concept of “substandard medicine” but the two categories should not be confused. The category of substandard medicines includes medicines that may present an unintentionally incorrect package or have an incorrect quantity or ratio of ingredients. The difference with counterfeit medicines is that substandard medicines may not have an intentional attempt but result from inaccurate production due to inadequate resources and structures. Globally 10–15% of the supplied medicines are counterfeit. The prevalence is higher in developing countries in where up to 30–60% of medicines on the market are counterfeit. India is a major supplier of poor quality medicines producing 35–75% and China 20% of fake/counterfeit medicines globally.
Counterfeit/sub-standard/poor
quality medicines are a major cause of therapeutic failure, serious adverse
events, deaths, economic burden, medicine resistance, and loss of public
confidence in medicines and health services. Many factors contribute to the increased prevalence of
substandard and counterfeit medicines, including corruption. Besides, weak or absent medicine regulatory
authority, proliferation of small pharmaceutical companies, complex
transactions involving many intermediaries, a lack of good manufacturing
practices (GMP) are other reasons in most developing countries. Though the WHO
has issued guidelines for combating Counterfeit/sub-standard/or poor-quality
medicines, most developing countries are struggling to implement them.
Bangladesh context
In Bangladesh, where out-of-pocket healthcare expenditure is high for medicines, counterfeit/sub-standard/low-quality medicines pose a greater threat to public health. Such medicines range from pain killers to antibiotics to even anti-cancer medication. According to a media report in 2009, 24 children died of acute renal failure after taking adulterated Paracetamol syrups made by a local medicine company. Diethylene glycol, a chemical used in the dyeing and leather tanning industries, was detected in the syrup. In the same year, government authorities visited 193 pharmaceutical companies, examined their performance levels, and divided them into A, B, C, D, E and F categories. According to their report, companies ranked A-C produced medicines in compliance with the GMP, an international standard for medicine quality control; those ranked D-F did not.