Fake medicines can badly impact health

While investigations have unearthed a dirty nexus between those indulging in supplying spurious drugs without Active Pharmaceutical Ingredients APIs to governmentrun civil and rural hospitals the moot issue remains understanding the impact of such drugs on the health of the common man To explore this read on for insights from health experts in part two of the threepart report on fake medicinesQuality control of pharma products is challengingAPIs in medicines or formulations are chemical compounds specifically chosen for their therapeutic effects on the body APIs are crucial to the efficacy and safety of pharmaceutical products Whether derived from natural sources or synthesised chemically their quality significantly impacts outcomes Poorquality APIs can lead toReduced Efficacy Substandard APIs may not perform as intended resulting in treatment failures disease progression or complicationsSafety Concerns Contaminants impurities infections or degradation products in lowquality APIs can cause adverse reactions and toxicityInconsistent Potency APIs failing to meet quality standards can lead to variations in patient responsesRegulatory Issues Medicines with poorquality APIs often violate regulatory standards making them illegal for distribution in IndiaSpurious Medicines Substandard APIs can result in spurious medicines which may be falsified misbranded or improperly formulated posing significant public health risksldquoAPI testing involves several key processes including identity purity assay stability microbial and chemical testing These are part of broader quality assurance programs conducted in laboratories often audited by regulatory agencies to ensure compliance with Good Manufacturing Practices GMPrdquo said Dr Subhash Hira Professor of Global Health at the University of Washington and former health advisor to the Indian Ministry of HealthDr Subhash Hira Professor of Global Health at the University of WashingtonDr Hira added ldquoThe frequency at which Indian pharmaceutical companies fail API quality tests varies depending on factors like specific APIs regulatory standards and adherence to GMP While comprehensive statistics are unavailable lapses in compliance often lead to regulatory action including import bans warnings or recallsrdquoRegulatory bodies such as the Drug Control Standards Organization DCSO in India the US Food and Drug Administration FDA and the European Medicines Agency EMA closely monitor API quality Noncompliance can result in severe consequences Dr Hira concludedLack of investigationldquoEvery medication contains APIs and inactive ingredients or excipients While most excipients are considered inert some may interact with molecular targets and alter pharmacology in ways not evident in traditional animal studies Examples of excipients include stabilisers like lactose and xanthan gum antioxidants such as propyl gallate and detergents like sodium lauryl sulfaterdquo explained Dr Ketan Vagholkar professor of surgery at DY Patil Medical CollegeDr Ketan Vagholkar professor of surgery at DY Patil Medical CollegeldquoSpurious or substandard drugs often lack the active ingredient in the required concentrations containing only excipients that provide no therapeutic benefit In some cases excessive excipient concentrations can harm patients Drug regulatory authorities must periodically investigate companies selling such substandard drugsrdquo Dr Vagholkar emphasisedIndia vs Western standardsDr Rajeev Jaydevan a renowned gastroenterologist from Kochi Kerala and CoChairman of the National IMA COVID Task Force explained ldquoIn Western countries stringent patent laws and regulatory oversight ensure consistent medicine quality making spurious drugs rare However in India concerns about the quality of available medicines persist Doctors here often avoid unfamiliar manufacturers and prefer prescribing medicines they trust based on their experience The growing issue of spurious drugs marketed as generics is alarming and needs immediate attentionrdquoDr Rajeev Jaydevan gastroenterologist CoChairman of the National IMA COVID Task ForceWhen asked how to identify spurious drugs Dr Jaydevan noted ldquoWithout laboratory testing itrsquos impossible for a doctor to determine if a drug contains the required API For minor illnesses the bodyrsquos natural recovery might falsely create the impression of a drugs effectiveness For example a spurious paracetamol tablet may appear effective because the fever subsides naturally misleading the patientrdquoOn the effects of spurious drugs Dr Jaydevan said ldquoThese medicines may contain toxins like industrial chemicals or nontoxic fillers like starch or talc They fail to treat the underlying illness leading to misdiagnoses of drug resistance Patients may undergo prolonged treatment with higher doses adversely impacting their healthrdquo he concluded