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OpEdNews Op Eds    H3'ed 3/21/25

Danger of substandard and falsified medical products is real and growing

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Minimum Inhibitory Concentration (MIC) of antimicrobial medicines is the lowest concentration of an antimicrobial at which a disease-causing pathogen's (such as bacteria, virus, fungi or parasite) growth is completely inhibited. "The sub-therapeutic concentrations of antimicrobial medicines can actually result in antimicrobial concentrations below MICs," said Dr Mathew. In such cases, not only does the person suffer and the risk of infection spread increases, but risk of AMR also shoots up.

"When there is no active pharmaceutical ingredient in medicines, then these so-called 'medicines' (classified as falsified medical products) lead to persisting infections, leading to greater morbidity, greater likelihood of emergence of drug resistance, further spread of infections, loss of income, increased healthcare spending, economic losses to the country. It also fuels public mistrust in formal systems of medicine," added Dr Mathew.

No treatment and AMR

"Suboptimal dosing or treatment duration can allow bacteria to adapt and develop resistance, which can lead to increased transmission of drug-resistant strains during longer infectious periods. Poor quality antimicrobials can result in treatment failure and development of AMR, depending on the product content," said Dr Mathew. In addition, health systems must effectively rule out any possibility of shortages and stockouts of medicines needed by the people.

Governments should engage communities in QC

Leena Menghaney advocates for engaging affected communities in the process of ensuring Quality Control (QC) of medicines, instead of government's drug regulatory authorities doing so without any equitable community engagement. "Communities can alert drug regulatory authorities and health programmes on substandard and falsified medicines," she said.

She shared a recent example to illustrate her point: "In 2024, networks of people living with HIV in India came forward to report that after a new batch of medicines had come, pills of the lifesaving antiretroviral therapy were very bitter and breaking. We used these testimonies to write to the drug regulatory authorities in India, and the National AIDS Control Programme of the Ministry of Health and Family Welfare. Within a week, action was taken. These medicines were withdrawn, and supply was reinstated from a WHO pre-qualified medicine supplier."

Bioequivalence and stability are important too

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