In a startling revelation, the Central Drugs Standards Control Organisation (CDSCO) has declared that over 50 widely used drugs, including paracetamol and vitamin D3 tablets, have failed quality tests, raising significant safety concerns for consumers.
Extensive List of Affected Medications
The CDSCO's latest monthly drug alert list has flagged 53 drugs as "Not of Standard Quality (NSQ) Alert," which includes a range of essential medications. Among these are paracetamol tablets, calcium and vitamin D3 supplements like Shelcal, antiacid Pan-D, anti-diabetic drug Glimepiride, and high blood pressure medication Telmisartan.
Other medications that failed the quality tests include vitamin C and D3 tablets, vitamin B complex, vitamin C softgels, and antibiotics such as Clavam 625 and Metronidazole. These drugs are manufactured by prominent companies like Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited, Karnataka Antibiotics & Pharmaceuticals Ltd, and Pure & Cure Healthcare.
Health Risks Associated with Substandard Medicines
Health experts warn that using these substandard medications can lead to severe health risks. According to Dr. Narendra Singhla, Lead Consultant – Internal Medicine at the CK Birla Hospital, Delhi, "When the levels of active pharmaceutical ingredients (APIs) are incorrect or when contamination occurs, these drugs may not effectively treat conditions like pain or fever and could even cause adverse reactions".
Prolonged use of such low-quality medications can result in liver damage and kidney complications, especially for individuals relying on these medications for chronic conditions. Dr. Singhla emphasizes the importance of stopping the use of these medications immediately if they are part of the recalled batches.
Manufacturing and Quality Control Issues
The failures have been attributed to substandard manufacturing practices, inadequate quality control, and contamination during production. The inconsistent levels of APIs in these medications amplify the problem, making them potentially harmful to consumers.
Responses from Pharmaceutical Companies
Interestingly, many of the pharmaceutical companies have denied responsibility for the substandard drugs, claiming that the batches in question are spurious. The CDSCO report notes that the actual manufacturers have informed that the impugned batches were not manufactured by them and are purported to be spurious, though this is subject to further investigation.
Safe Alternatives and Precautions
Consumers are advised to be vigilant and check the batch numbers and expiration dates of their medications. If a product is part of the recalled batch, it is crucial to consult a doctor or pharmacist for guidance. Affected products should be returned to the point of purchase or safely disposed of to avoid potential health risks.
For those relying on paracetamol for pain relief and fever reduction, alternatives such as Ibuprofen, Meprocin, Meftal, Diclofenac, and Nimesulide are recommended. Dr. Minesh Mehta, Consultant Intensive and Critical Care Specialist at Ahmedabad's Shalby Hospital, suggests these alternatives with strict quality control standards.
Natural Remedies and General Advice
In addition to pharmaceutical alternatives, natural remedies can also aid in recovery. Dr. Vibhu Kawatra, Pediatric Pulmonologist and Allergy Specialist at Delhi's Rainbow Hospital, recommends drinking plenty of fluids, such as water, herbal teas, and clear broths, to keep the body hydrated. Ginger or peppermint tea, willow bark, and turmeric are also suggested for their anti-inflammatory properties and ability to alleviate pain and reduce fever.
Regulatory Actions and Future Measures
This is not the first instance of such quality failures. In August 2024, the CDSCO banned over 156 fixed-dose drug combinations that were deemed harmful to humans. The current findings highlight the need for stricter quality control measures from manufacturers and greater transparency to ensure consumer safety.
In conclusion, the failure of over 50 drugs, including paracetamol and vitamin D3 tablets, in quality tests is a serious concern that necessitates immediate action from both consumers and regulatory bodies. Ensuring the authenticity and quality of medications is crucial to preventing prolonged health issues and potential adverse reactions.
