The major public health issue related to the presence of Not of Standard Quality (NSQ) drugs in the market is multifaceted and concerning.
Published Sep 26, 2024 | 8:45 AM ⚊ Updated Sep 26, 2024 | 8:45 AM
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Recently, Nagpur Rural police in Maharashtra unearthed a racket that involved the sale of spurious drugs and the use of hawala channels to transfer large sums of money. Talcum powder and starch were used in manufacturing “drugs” by a unit in Haridwar, Uttar Pradesh, and sold as antibiotics to government hospitals in Maharashtra.
The problem is not confined to one or two states. Multiple batches of drugs used to treat common conditions like fever and bacterial infection were found substandard and flagged as Not of Standard Quality (NSQ) by the Central Drugs Standard Control Organisation (CDSCO) in an alert issued in August 2024.
Batches of widely prescribed Paracetamol, antibiotics such as Amoxicillin and Potassium Clavulanate tablets and Pantoprazole Gastro-Resistant capsules were flagged as NSQ. The alert, issued after extensive testing by laboratories, lists a range of pharmaceutical products found to be substandard or spurious.
Multiple batches of Amoxicillin and Potassium Clavulanate tablets (under brand names such as Clavam 625 and Mexclav 625) were found to have spurious identification and failed the assay of active ingredients. Similarly, Calcium and Vitamin D3 Tablets (marketed as Shelcal 500) did not meet the required standards for ingredient identification, dissolution, and assay.
Other drugs flagged include batches of Metformin Hydrochloride tablets (Glycimet-SR-500) and Pantoprazole Gastro-Resistant capsules, both of which were found to have dissolution issues and, in some cases, spurious substances.
The Heparin Sodium Injection, a critical medication used for preventing blood clots, failed tests related to sterility and bacterial endotoxins, posing serious health risks.
One of the most frequently cited drugs in the alert is the antibiotic combination Amoxicillin and Potassium Clavulanate tablets, featured under several brand names including Clavam 625 (manufactured by Alkem Health Science), Mexclav 625 (produced by Meg Lifesciences), and Renamega-CV 625 (by Malik Lifesciences).
This antibiotic combination, widely used for treating bacterial infections, failed to meet the required standards in multiple batches from different manufacturers. The recurrence of this drug in the NSQ list raises alarms about the quality control practices in place, particularly for antibiotics, which are critical in treating infections.
Inadequate dosing or spurious drugs can contribute to antimicrobial resistance (AMR), a growing global health concern.
Paracetamol tablets IP 500 mg, a staple medication in almost every household in India, is likely the most widely used. Known for its use as a pain reliever and fever reducer, paracetamol is prescribed for common conditions such as headaches, fevers, and minor aches. Given its broad application, the presence of substandard batches of this essential drug could have far-reaching consequences.
The widespread usage of paracetamol across different segments of the population, from rural to urban areas, highlights the need for stringent quality checks to ensure the safety and efficacy of such widely consumed drugs.
One of the most frequently listed drugs in the alert is Atropine Sulphate Injection I.P., which appeared four times with different batch numbers (AS-9055 and AS-9057). This injection is used for several critical medical purposes, primarily due to its anticholinergic properties.
Atropine is commonly administered to treat bradycardia (slow heart rate) and is used as a pre-anesthetic to reduce secretions during surgery. Additionally, it serves as an antidote for organophosphate poisoning, often caused by pesticide or nerve agent exposure, and is utilised in ophthalmology for pupil dilation during eye examinations.
The repeated listing of Atropine Sulphate in the NSQ alert points to serious concerns regarding its availability in safe and effective forms, given its life-saving applications.
The alert has identified several major pharmaceutical manufacturers in India whose products have been flagged for not meeting quality standards. Among these prominent manufacturers is Alkem Health Science, known for a wide range of medicines. Their products Clavam 625 and Pan-D (Pantoprazole and Domperidone Capsules) were specifically highlighted.
Meg Lifesciences, which specialises in health supplements and pharmaceuticals, found its place on the alert with its product, Mexclav 625 (Amoxicillin & Potassium Clavulanate Tablets) also receiving attention for quality concerns.
Pure & Cure Healthcare Pvt. Ltd, a significant manufacturer of health supplements and generic medicines, had their Shelcal 500 (Calcium and Vitamin D3 Tablets) and Montair LC Kid (Montelukast & Levocetirizine Tablets) flagged.
Scott-Edil Pharmacia Ltd., based in Baddi, Himachal Pradesh, is recognised as one of India’s leading pharmaceutical manufacturers. Their products, including Glycimet-SR 500 (Metformin Hydrochloride Sustained-release Tablets) and Heparin Sodium Injection, were noted for quality issues.
Similarly, Karnataka Antibiotics and Pharmaceuticals Ltd. (KAPL), a Government of India enterprise, had their Paracetamol Tablets IP 500 mg flagged.
Hetero Labs Limited, a significant player in the Indian pharmaceutical industry from Hyderabad known for generic medicines, was noted for their Cepodem XP 50 Dry Suspension (Cefpodoxime Proxetil and Potassium Clavulanate).
Lastly, Maxtar Bio-Genics, a large pharmaceutical manufacturer, had Fexofenadine Hydrochloride Tablets IP 120 mg flagged for quality concerns.
The most frequent NSQ Result cited in the August 2024 alert was related to issues with the assay of active ingredients, indicating that several drugs did not contain the correct quantities of active substances as specified, potentially compromising their efficacy.
Assay failures were noted across various drugs, including Amoxicillin and Potassium Clavulanate Tablets (such as Clavam 625, Mexclav 625, and Renamega-CV 625), Calcium and Vitamin D3 Tablets (Shelcal 500), Montelukast Sodium and Levocetirizine Hydrochloride Tablets (Montair LC Kid), and Escitalopram and Clonazepam Tablets (Klozaps-ES Tablets).
In addition to assay failures, other common issues included dissolution problems, where drugs did not dissolve as expected, affecting their absorption in the body, and spurious identification, where the drug’s identity did not align with the labeled ingredients.
The major public health issue related to the presence of Not of Standard Quality (NSQ) drugs in the market, as highlighted in the August 2024 alert, is multifaceted and concerning. Firstly, the reduced efficacy of treatments is a significant concern.
Medications that exhibit assay failures, meaning they contain incorrect quantities of active ingredients, may not provide the intended therapeutic effects. This is especially alarming for critical medications like antibiotics, such as Amoxicillin and Potassium Clavulanate, and Metformin for diabetes. Inadequate dosing can result in incomplete treatment, exacerbating the patient’s condition and contributing to the development of antimicrobial resistance (AMR).
Secondly, there is a risk of delayed recovery and complications associated with drugs that fail to meet dissolution standards. For instance, medications like Fexofenadine and Pantoprazole may not dissolve properly, hindering the body’s ability to absorb them effectively. This can lead to delayed symptom relief or complete treatment failure. For patients with chronic conditions, such as acid reflux or allergies, this may result in prolonged illness and further complications.
Another critical issue is the risk of harm from contaminated or spurious drugs. Medications flagged for problems like spurious identification or contamination, such as Heparin Sodium Injection and Atropine Sulphate Injection, pose significant health risks. Contaminated or incorrectly identified drugs can lead to adverse reactions, infections, or even fatal outcomes, particularly for vulnerable populations like children, the elderly, or critically ill patients.
Additionally, the repeated occurrence of substandard drugs can lead to a loss of trust in the healthcare system. Patients may become skeptical of prescribed medications, which can lead to non-compliance with treatments or the pursuit of alternative, potentially unsafe remedies.
Finally, there is a financial burden on patients. As individuals are compelled to purchase additional or alternative medications due to treatment failures stemming from NSQ drugs, their out-of-pocket expenses increase, which further strains public health resources, particularly in lower-income populations.
(Edited by Rosamma Thomas)
