Ms. Monika Vishwakarma

Asst.Prof.

Faculty of Pharmacy, Kalinga University, Raipur, India

Substandard medicines (SM) refer to legally manufactured pharmaceutical products that do not conform to required quality standards, often labeled as “out-of-specification” medicines. According to the World Health Organization (WHO), SM are pharmaceutical products that fail to meet established quality benchmarks. This category includes both brand-name and generic drugs, which may contain inaccurate doses of active ingredients, incorrect or missing active compounds, or even counterfeit packaging. Substandard medicines represent a major public health risk, particularly in low- and middle-income regions, where these products contribute to negative health outcomes. Their usage has been associated with adverse effects, therapeutic failure, increased resistance to medications, worsening of diseases, and, in extreme cases, death. A 2017 WHO report estimates that about 10.5% of medicines sold in low- and middle-income countries, including India, fall under the substandard or falsified category (WHO, 2020) (see Figure 1). Additionally, the United States Trade Representative’s annual intellectual property report suggests that up to 20% of drugs available in the Indian market may be counterfeit, posing serious risks to patient safety (Office of the United States Trade Representative) (see Figure 2). Moreover, the Bureau of Pharma PSUs of India (BPPI), which administers India’s affordable medicine initiative PMBJP, found that 25 batches from 18 pharmaceutical companies have been flagged as substandard since January 2018 (see Figure 3). The presence of impurities or incorrect formulations in SM can arise during manufacturing, either due to lapses in quality control or cost-cutting efforts. These impurities compromise drug efficacy and safety, highlighting the need for stringent oversight in the manufacturing process. Tackling the SM issue requires detailed knowledge of potential impurities and their impacts on public health, as poor-quality medicines not only endanger individuals but also strain healthcare systems, increasing costs and eroding trust in available treatments. To shed light on this ongoing concern, recent reports and media coverage of substandard medicines (Figure 4) emphasize the need for strengthened regulatory mechanisms. Additionally, a range of studies and research efforts have documented the prevalence and risks of substandard medicines, as illustrated in Table 1. 

Figure 1: The World Health Organization reported in 2017 that approximately 10.5% of medicines sold in low- and middle-income countries, including India, are substandard or falsified. 

Figure 2: The annual report from the U.S. Trade Representative’s office on intellectual property protection and review of high-risk markets.

 

Figure 3: The report of Bureau of Pharma PSUs of India (BPPI)

 

 

 

 

 

 

 

 

 

 

 

Figure 4 Some of the media reports published on substandard medications. 

 

 

Figure 4: Some of the news reports on substandard medications in India

Table 1: Some of the research published on substandard medications 

Javorac et al., (2020) 

They conducted a review on the safety of medicines currently utilized in the treatment of COVID-19. They highlighted that combining various drugs in COVID-19 therapies may pose safety concerns and potential toxic effects on organs such as the liver, kidneys, heart, and retina.

Koech et al., (2020)

A study in Nairobi County, Kenya, assessed the quality of various amoxicillin formulations and their combination with clavulanic acid. Using the United States Pharmacopoeia as a reference, 53 samples were tested. Results showed that 23.1% of amoxicillin oral suspensions and 66.7% of amoxicillin/clavulanic acid suspensions failed to meet quality standards on the seventh day after reconstitution. Among amoxicillin capsules, 13.6% failed, while all amoxicillin/clavulanic acid tablets passed. However, 33.3% of amoxicillin/clavulanic acid tablets did not meet compliance standards, and 10.5% of amoxicillin capsules and 50% of amoxicillin/clavulanic acid tablets failed dissolving tests.

Abraham et al., (2021) A study was conducted to assess the quality and equivalency of doxycycline hyclate capsules and tablets across ten brands. While all brands met USP standards for dosage uniformity, active ingredient content, and dissolution, one brand failed hardness and friability tests. Only three brands showed disintegration characteristics similar to the reference, as indicated by fit factor analysis. Using model-dependent methods, the Weibull model best described drug release for all brands. Though most samples passed quality control, five out of eight brands had interchangeability issues, with only three brands being comparable to the reference.

Jean et al., (2020) A study evaluated the quality of antimicrobial drugs sold in street markets in Port-au-Prince by purchasing 258 packs from 28 locations. Raman spectroscopy of 196 packs revealed that Amoxicillin, Metronidazole, and Cotrimoxazole had over a 95% spectral match with authentic drugs. In contrast, six other antimicrobials (Cloxacillin, Tetracycline, Azithromycin, Erythromycin, Amoxicillin, and Clarithromycin + Clavulanic Acid) showed no significant match, indicating they were likely counterfeit or degraded.

 

Substandard medicines are global problem nowadays and in present scenario of Covid-19 pandemic a large number of medicines are formulated and consumed in massive amount by the patients  As the amount of drug consumption is high, it lead to heavy demand and supply of the drug on the pharmaceutical companies. Production of large quantity of drug may lead to compromise with quality and purity of the drugs and medicinal formulations. This further affects the health of the public consuming these medicines. Although the Quality Control and Quality Assurance teams of the pharmaceutical organizations work to maintain the quality standards of the formulated products, but there are many cases reported in the scientific publications, social and print media stating that consumption of some drugs leads to organ damage, heavy metal deposition in the body as well as non-uniform drug release pattern in the body.  It is well known that impurities or improper strength of the drug may lead to heavy damage to the public health. It’s our duty to make people aware that whatever they are consuming on the name of medicines are really safe for their health or not. In conclusion, the prevalence of substandard drugs presents a serious challenge to global healthcare, compromising patient safety, and undermining trust in medical systems. Addressing this issue requires collaborative efforts between regulatory bodies, pharmaceutical companies, and healthcare providers to enforce stringent quality controls and enhance detection methods. Only through coordinated, sustained action can we hope to mitigate the dangers of substandard drugs and ensure safe and effective medications for all.

References:

⦁ World Health Organization, https://www.who.int/news/item/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified

⦁ Office of the United States Trade Representative https://ustr.gov/about-us/policy-offices/press-office/press-releases/2024/january/ustr-releases-2023-review-notorious-markets-counterfeiting-and-piracy

⦁ Javorac D, Grahovac L, Manić L, Stojilković N, Anđelković M, Bulat Z, Đukić-Ćosić D, Curcic M, Djordjevic AB. An overview of safety assessment of the medicines currently used in the treatment of COVID-19 disease. Food and Chemical Toxicology. 2020 Jul 21:111639

⦁ Koech, L.C., Irungu, B.N., Ng’ang’a, M.M., Ondicho, J.M., Keter, L.K., 2020. Quality and Brands of Amoxicillin Formulations in Nairobi, Kenya. BioMed Research International 2020.

⦁ Abraham, W., Abuye, H., Kebede, S., Suleman, S., 2021. In Vitro Comparative Quality Assessment of Different Brands of Doxycycline Hyclate Finished Dosage Forms: Capsule and Tablet in Jimma Town, South-West Ethiopia. Advances in Pharmacological and Pharmaceutical Sciences 2021.

⦁ Jean-Baptiste, T., Carpenter, J.F., Dahl, K., Derameau, W., Veillard, R., Jacquet, J.R., Osselyn, P.L., Figueras, A., 2020. Substandard quality of the antimicrobials sold in the street markets in Haiti. Antibiotics 9, 407.