Low-quality Medicines Cause a Serious Public health problem

In our country pharmaceutical industry is growing by leaps and bounds but unfortunately, at the same time, substandard and spurious drugs are also reaching our general public.

This is where the failures of medical treatment happen. Such drugs lead to many complications for the patient and even cause death. Especially when it comes to the antibiotic segment, it is a big threat to the healthcare system because it can inadvertently lead to healthcare failures, such as antibiotic resistance and the spread of disease within a community, as well as death or additional illness in individuals.

In 2009, the World Health Organization (WHO) defined ‘substandard’ drugs (also called ‘out of specification products’) as ‘genuine medicines produced by manufacturers authorized by the NMRA [National MedicineRegulatory Authorities] which do not meet quality specifications set for them by national standards. Each pharmaceutical product that a manufacturer produces has to comply with quality standards and specifications at release and throughout the product shelf-life required by the territory of use. Any formulation of a medication may be regarded as substandard if it has either too much or too little of the API (Active Pharmaceutical Ingredient) compared with the formulation specifications. Impurities can arise in formulations due to poor manufacturing procedures and storage conditions. Impurities can alter medication properties or be toxic. Probably the best-known cases of contamination involve diethylene glycol (DEG).

Generic drugs can aid the provision of healthcare to a wide patient population, particularly in our country. However, generic formulations should only be marketed if their quality is equivalent to that of the originator drug. Adverse events also occur due to drug–drug interactions with contaminants, the presence of excess API, contamination with poisonous substances, or allergic reactions to contaminants or substituted excipients.

Substandard medicines are also sold via the Internet, thus potentially affecting a wide patient population. Key to the improvement and maintenance of drug quality is the implementation of strong regulatory control. There is a need for pharmacovigilance programs to be in place to monitor the safety of marketed drugs constantly and to communicate any safety issues to manufacturers, healthcare providers, and patients.

The WHO has implemented several programs to try and address the problem of substandard drugs.