Spurious & Falsified Drug Alert: Tablet Novidat 500 mg B#FIM063 (Ciprofloxacin) not Manufactured by M/s Sami Pharmaceuticals Karachi
Latest developments, a significant alert of an important medication has been formally announced by the Government authorities after the DTL Multan (WHO Prequalified) test report no. TRA-01-105008237/DTL dated 21-12-2024, wherein Tablet Novidat 500 mg (Ciprofloxacin) Batch #FIM063 not Manufactured by M/s Sami Pharmaceuticals Karachi, was declared as spurious and falsified. This post aims to furnish general public with critical information regarding this alert, including its consequences for both patients and healthcare professionals, as well as the necessary actions that one should take if anyone finds himself affected by this situation. It is imperative to stay informed in order to safeguard health and overall well-being of society at large.
This Alert has been initiated due to absence of active pharmaceutical ingredient i.e. Ciprofloxacin against the labelled claim of the said tablet. This product Tablet Novidat 500 mg (Ciprofloxacin) Batch #FIM063 is manufactured by some unknown criminal and distributed by them through black market means, as authorities briefed. The provincial Inspector Tehsil Lodhran, having sufficient reasons that he believed, took the sample and sent it Drugs Testing Laboratory Multan, earlier mentioned, for test and analysis. The Firm was also contacted by the concerned officials, whereon M/s Sami Pharmaceutical denied the manufacturing of instant batch and also verified it as spurious and falsified one.
Risk Associated with use of Spurious and Falsified Novidat 500 mg (Ciprofloxacin) Batch #FIM063: Using these spurious tablets can lead to several potential risks, including:
- Ineffective treatment: Counterfeit Ciprofloxacin tablets may have the wrong quantity of the active ingredient or no active ingredient in any given tablet. The resistance which bacteria produces may lead to poor management and control of the infection, it might take time to heal or actually get worse or even get aggravated.
- Adverse reactions: Accurate imitations of Ciprofloxacin tablets can itself be toxic or contain impurities which are capable of leading to adverse effects. Some of them are skin related like rash, itching, sweating and breathing difficultly, others are related to the gastrointestinal tract like nausea, vomiting and diarrhea, neurological effects like seizures, dizziness, and hallucinations. Occasionally, the reaction may even be dangerous to the life of the individual.
- Antibiotic resistance: Pretender Ciprofloxacin is also dangerous due to the possibility to be administered in improper dosages or even in products without the antibiotics at all, resulting in insufficient bacterial elimination. The remaining bacteria develop resistance to the antibiotic, the next treatments don’t work and the bacteria can spread to other people and become resistant.
- Complications and prolonged hospital stays: When an infection is left unchecked, or worsens as a result of ingesting falsified Ciprofloxacin tablets, patients may need more extensive or longer, medical treatment at additional medical costs and with further negative consequences for their overall health.
- Loss of faith in healthcare system: The effects of the drug counterfeit may result in incomes that the public has lost confidence in the healthcare system which delivers the government or healthcare provided medicines or the efficacy of medicines that prevent or cure diseases.
Action initiated: – In the Instant case all pharmacists and chemist working at distributions and pharmacies have been advised to immediately check their stocks and stop supplying this batch of product. Besides, authorities also directed the retailers/pharmacies/distributors to identify customers, and notify them at once, about the product alert of this product. It was also stressed that, intimation to customers may be enhanced by including a copy of alert notification through email/sms/copy or any other means.
The officials, further directed the corner concerned, that the remaining stock should be quarantined and returned to the supplier/ company under intimation to regulatory authorities. Moreover, Regulatory field force of DRAP and Provincial Regulatory authorities/Departments have also been informed regarding the subject matter of Spurious and Falsified Novidat 500 mg Batch #FIM063. Likewise, it also has been directed to field force to increase vigilance within the supply chains of institutions/pharmacies/healthcare facilities that are likely to be affected by this affected batch of product. Supplementary to this, an advice for consumers / general public was also issued stating therein, consumers should stop using this Spurious and Falsified Novidat 500 mg Batch #FIM063.
Conclusion
The recent alert concerning spurious drug associated Spurious and Falsified Novidat 500 mg Batch #FIM063, emphasizes the importance of vigilance in managing medications, both among healthcare professionals who prescribe them and patients who utilize them! Always prioritize staying informed about potential dangers linked with prescribed medications; possessing such knowledge can indeed be life-saving.