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.