Counterfeit drugs mimicked legitimate brands but lacked proper active ingredients, posing serious health risks. Past incidents involved fake versions of medications like Glenmark's Telmisartan and Sun Pharma's Pantoprazole, unrelated to the original manufacturers
Published Dec 03, 2024 | 7:00 AM ⚊ Updated Dec 03, 2024 | 7:00 AM
Counterfeit medications not only undermine public trust but also jeopardize patient safety. (Sumit Jha/South First)
The Central Drugs Standard Control Organisation (CDSCO) recently flagged 93 medications as either “spurious” or “not of standard quality” (NSQ), including essential drugs like antibiotics, cough syrups, diabetes medications, and blood pressure pills.
The CDSCO found 56 drug samples tested in the central drug laboratories in October as not of standard quality (NSQ). Besides, 34 drug samples tested by state drug regulators have also been identified as NSQ, and three drug samples picked by the Bihar Drugs Control Authority in October have been identified as spurious.
They were manufactured by unauthorised and unknown manufacturers, using brand names owned by another company.
The Central Drugs Standard Control Organisation (CDSCO) has flagged three medications—Pantoprazole Gastro-resistant and Domperidone Prolonged-Release Capsules IP (PAN-D), which treats acid reflux; Cefixime Tablets IP (TAXIM-O 200), used for bacterial infections; and Rosuvastatin Tablets IP (Rosuvas 10), prescribed for cholesterol management and heart disease prevention—as spurious in its October 2024 alert.
These counterfeit drugs were designed to imitate legitimate brands but lacked the correct or complete active ingredients, posing serious health risks. Similar incidents in the past have included counterfeit versions of medications such as Glenmark’s Telmisartan and Sun Pharma’s Pantoprazole, with no connection to the original manufacturers.
The announcement is part of CDSCO’s monthly initiative to monitor and identify counterfeit or non-compliant pharmaceutical products. Notably, this month’s alert did not specify the original manufacturers’ names, a detail included in previous reports.
The flagged drug samples were collected by drug inspectors in Bihar and Kolkata. Their classification as spurious followed failures in dissolution and assay tests, essential for verifying a drug’s efficacy and safety. In all three cases, the purported manufacturers denied producing the batches in question, strongly suggesting counterfeit activity.
“The actual manufacturer, as per the label claim, has confirmed that the impugned batch was not produced by them and is a spurious drug,” stated the CDSCO. However, the final determination awaits the outcome of ongoing regulatory investigations.
Preliminary findings revealed that the flagged batches were produced by unauthorised and unknown manufacturers who used brand names owned by other companies. The Union Health Ministry confirmed that a detailed investigation is underway to identify those responsible and ensure accountability.
Counterfeit medications not only undermine public trust but also jeopardise patient safety, underscoring the urgent need for stringent monitoring and enforcement in the pharmaceutical supply chain.
In October 2024, the Central Drugs Standard Control Organisation (CDSCO), in collaboration with state laboratories, identified 56 medications as Not of Standard Quality (NSQ).
These drugs failed to meet established parameters for quality, such as dissolution, assay, sterility, and weight uniformity, thereby classifying them as substandard. Although they are not counterfeit, such drugs can lead to diminished efficacy and potential health risks due to their compromised formulations.
Among the antibiotics and antibacterials flagged were medications like Ornidazole and Ofloxacin Tablets, Ciprofloxacin Injection IP, and Amoxycillin combined with Potassium Clavulanate, in both tablet and injectable forms. Other antibiotics, including Ampicillin for Injection, Ceftriaxone with Sulbactam, and Meropenem Injection, were also deemed substandard.
These are crucial medications commonly used to treat severe bacterial infections.
Drugs used for pain management and anti-inflammatory purposes were also part of the NSQ list. These included formulations such as Diclofenac Sodium combined with Paracetamol and Chlorzoxazone, as well as Aceclofenac combined with Paracetamol and Serratiopeptidase.
These are frequently prescribed for managing inflammation and pain but, in their substandard form, may not provide effective relief or could even pose risks to patients.
In the category of gastrointestinal treatments, widely used drugs like Pantoprazole and Domperidone capsules, Rabeprazole-based formulations, and Esomeprazole Tablets were flagged. Additionally, Metronidazole, an essential medication for treating infections in the stomach and intestines, was found to be of substandard quality.
Medications for cardiovascular conditions also featured in the list, including Amlodipine combined with Perindopril, Enalapril Maleate Tablets, and Telmisartan Tablets, which are crucial for managing high blood pressure and related conditions.
Similarly, Glimepiride, a key drug for diabetes management, was flagged, adding to concerns about the availability of reliable treatment options for chronic diseases.
Even critical drugs in oncology and hormonal therapy were not spared. Liposomal Amphotericin B Injection, Decitabine for Injection, and Paclitaxel Injection, all of which play a significant role in cancer treatment, were part of the substandard drugs list.
Additionally, Adrenaline Injection and Buprenorphine Injection, both vital in emergency and pain management scenarios, were found to fall short of quality benchmarks.
Other categories of flagged drugs included Natamycin Ophthalmic Suspension, used for treating eye infections, and dermatological treatments like Hydroquinone, Tretinoin, and Allantoin Cream. Sodium Fusidate Cream and Betamethasone Sodium Phosphate Injection, both used in skin conditions, were also identified as NSQ.
Anti-allergic drugs, like Fexofenadine Hydrochloride Tablets, used to manage seasonal allergies, were also flagged for failing quality tests.
While these drugs are not counterfeit, their failure to meet standards jeopardises patient safety and the effectiveness of medical treatments.
In October 2024, state laboratories across India, under the Central Drugs Standard Control Organisation (CDSCO), identified 34 drug samples as Not of Standard Quality (NSQ) and flagged seven of these as misbranded due to violations of labelling requirements under Section 17 of the Drugs and Cosmetics Act, 1940. These findings are part of a broader initiative to alert stakeholders about NSQ and misbranded drugs circulating in the market.
Drug inspectors collected samples from various sales and distribution points across states such as Telangana, Himachal Pradesh, and Kerala. These drugs underwent rigorous testing to assess their compliance with quality parameters outlined in the Drugs and Cosmetics Act. Failures were attributed to issues such as dissolution, disintegration, sterility, labelling non-compliance, and weight uniformity violations.
The NSQ list spans multiple therapeutic categories, including antibiotics like Cefixime and Ciprofloxacin tablets; pain management drugs such as Paracetamol in combination with Chlorzoxazone; and gastrointestinal treatments like Pantoprazole and Domperidone tablets. Cardiovascular medications, such as Telmisartan Tablets, and antiepileptic drugs, including Divalproex Sodium SR tablets, were also flagged for failing quality tests.
Additionally, the list highlights deficiencies in vitamins and nutritional supplements, such as Vitamin B Complex Tablets, and antihistamines and respiratory drugs, including Montelukast in various formulations. Other flagged medications include antifungal treatments like Itraconazole Capsules, CNS drugs such as Prochlorperazine Mesylate Injection, and hemostatic drugs like Tranexamic Acid Injection. Some widely used supplements, including ferrous ascorbate and folic acid formulations, were also listed as NSQ.
Several companies had multiple entries in the NSQ list. Modern Laboratories had five drugs flagged, including Vitamin B Complex Tablets and Itraconazole Capsules, while Tas Med (India) Pvt. Ltd. and Life Max Cancer Laboratories each had three entries. The latter included critical medications like Glimepiride Tablets for diabetes and Telmisartan Tablets for hypertension.
The inclusion of misbranded drugs in the alert points to gaps in compliance with labelling standards, further complicating efforts to ensure the reliability of medications.
The increasing prevalence of spurious and Not of Standard Quality (NSQ) drugs in India poses a grave threat to public health. A national drug survey conducted by the Ministry of Health and Family Welfare revealed that around 3 percent of retail drugs are NSQ, while 0.023 percent are classified as spurious. Though these percentages might appear small, their implications are severe, highlighting the persistent challenges faced by regulatory bodies in ensuring drug safety and efficacy.
Spurious drugs are counterfeit products designed to imitate legitimate brands. For instance, medications like Glenmark’s Telmisartan and Sun Pharma’s Pantoprazole were flagged as spurious, with no manufacturing connection to the original companies. These products are often devoid of active ingredients or may contain incorrect dosages, putting patients at serious risk.
The consequences of consuming such drugs can be life-threatening. Patients unknowingly ingesting counterfeit or NSQ medications may suffer from ineffective treatment, adverse reactions, or worsening of their medical conditions due to a lack of proper therapeutic effects. In cases where these drugs mimic trusted brands, they can erode confidence in the pharmaceutical system and worsen public health outcomes.
Since January 2023, over 1,267 drugs have been classified as NSQ or spurious. Alarmingly, some of these originate from well-known pharmaceutical companies, raising questions about manufacturing oversight and supply chain security. Monitoring alerts from regulatory agencies is vital for protecting public health.
For example, in August 2023, a CDSCO drug inspector flagged COLD OUT Syrup (Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/5 ml), a children’s medication produced by Fourrts (India) Laboratories. Testing revealed dangerous levels of Ethylene Glycol (2.23 percent) and Diethylene Glycol (0.17 percent), far exceeding the permissible limit of 0.1 percent (w/v). These toxic substances, often used in cold and cough syrups, are particularly hazardous for children, even in minute amounts.
A poignant reminder of this danger occurred with the tragic deaths of over 80 children in The Gambia, linked to a contaminated cough syrup containing excessive levels of these toxic compounds. Such incidents underscore the dire need for stringent monitoring of drug safety, particularly in pediatric medications.
Regulatory alerts play a crucial role in safeguarding consumers. By staying informed about flagged medications, patients and caregivers can avoid potentially harmful drugs. Alerts also empower healthcare providers to recommend safer alternatives and reinforce vigilance against counterfeit or substandard medications.
(Edited by Ananya Rao)
