Doctors raise alarm over inconsistent APIs and lax quality control in India’s pharma industry
APIs are crucial to the efficacy and safety of pharmaceutical products. Representation pic/iStock
While investigations have unearthed a dirty nexus between those indulging in supplying spurious drugs without Active Pharmaceutical Ingredients (APIs) to government-run 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 three-part report on fake medicines.
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Quality control of pharma products is challenging!
APIs 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. Poor-quality APIs can lead to:
Reduced Efficacy: Substandard APIs may not perform as intended, resulting in treatment failures, disease progression, or complications.
Safety Concerns: Contaminants, impurities, infections, or degradation products in low-quality APIs can cause adverse reactions and toxicity.
Inconsistent Potency: APIs failing to meet quality standards can lead to variations in patient responses.
Regulatory Issues: Medicines with poor-quality APIs often violate regulatory standards, making them illegal for distribution in India.
Spurious Medicines: Substandard APIs can result in spurious medicines, which may be falsified, misbranded, or improperly formulated, posing significant public health risks.
“API 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 (GMP),” said Dr Subhash Hira, Professor of Global Health at the University of Washington and former health advisor to the Indian Ministry of Health.
Dr Subhash Hira, Professor of Global Health at the University of Washington
Dr Hira added, “The 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 recalls.”
Regulatory 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. Non-compliance can result in severe consequences, Dr Hira concluded.
Lack of investigation
“Every 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 sulfate,” explained Dr Ketan Vagholkar, professor of surgery at DY Patil Medical College.
Dr Ketan Vagholkar, professor of surgery at DY Patil Medical College
“Spurious 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 drugs,” Dr Vagholkar emphasised.
India vs. Western standards
Dr Rajeev Jaydevan, a renowned gastroenterologist from Kochi, Kerala, and Co-Chairman of the National IMA COVID Task Force, explained, “In 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 attention.”
Dr Rajeev Jaydevan, gastroenterologist, Co-Chairman of the National IMA COVID Task Force
When asked how to identify spurious drugs, Dr Jaydevan noted, “Without laboratory testing, it’s impossible for a doctor to determine if a drug contains the required API. For minor illnesses, the body’s natural recovery might falsely create the impression of a drug's effectiveness. For example, a spurious paracetamol tablet may appear effective because the fever subsides naturally, misleading the patient.”
On the effects of spurious drugs, Dr Jaydevan said, “These medicines may contain toxins like industrial chemicals or non-toxic 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 health,” he concluded.
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