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In a significant development, Pakistan drug regulatory authority has seized a batch of contaminated propylene glycol solvent, initially labeled as manufactured by Dow Chemical, Thailand. The move, prompted by concerns about the safety of pharmaceutical products, emphasizes the critical role regulatory bodies play in ensuring public health and safety.
Dow Chemical’s Silence Raises Questions
Despite the alarming situation, Dow Chemical, Thailand, has remained tight-lipped, declining to comment on the issue. This lack of response raises questions about accountability and transparency within the pharmaceutical supply chain.
A Global Concern: Toxic Propylene Glycol and Child Deaths
Recent events in Indonesia, Gambia, and Uzbekistan, where over 300 children have tragically lost their lives since 2022, shed light on the potential dangers of toxic propylene glycol. Authorities suspect that contaminated propylene glycol used in cough syrups could be a contributing factor to these heartbreaking incidents.
WHO’s Warning: India’s Cough Syrups under Scrutiny
The World Health Organization (WHO) has connected deaths outside Indonesia to cough syrups manufactured in India. This revelation underscores the need for international cooperation and stringent quality control measures in the pharmaceutical industry.
Investigating the Contaminated Propylene Glycol Batch
In response to the alarming situation, Pakistan’s drug authority has taken swift action. The regulatory field force has seized the contaminated batch of propylene glycol and initiated a comprehensive investigation into the entire supply chain. The objective is to trace the origins of the batch and prevent further distribution of potentially harmful products.
Ethylene Glycol: A Silent Threat Unveiled
Upon analysis of a sample by the Central Drug Laboratory in Karachi, an unacceptable level of Ethylene Glycol was detected in the seized propylene glycol batch. Ethylene Glycol poses serious health risks, affecting the central nervous system, heart, and potentially causing fatal kidney damage. This revelation underscores the importance of stringent quality control measures to safeguard public health.
Recalling Products: A Proactive Measure
In light of the findings, Pakistan’s drug authority has issued an alert, mandating the recall of all products manufactured from the same contaminated batch of propylene glycol. The recall extends to both local and export markets, reflecting the authority’s commitment to preventing the distribution of compromised pharmaceuticals.
Unanswered Questions: Local Impact of the Contaminated Chemical
While the immediate focus is on the seized batch, questions linger about the potential use of any amount of the imported chemical in local cough syrup production. Clarity on this matter is crucial for understanding the full extent of the issue and implementing targeted solutions.
Regulatory Directives: Holding Dow Chemical Accountable
The drug authority’s directives go beyond the seized batch. It has instructed that finished products from any other batch of propylene glycol sourced from Dow Chemical, Thailand, be put on hold. This proactive measure aims to prevent the circulation of potentially harmful pharmaceuticals and holds manufacturers accountable for the safety of their products.
In conclusion, the swift and decisive actions taken by Pakistan’s drug regulatory authority highlight the importance of robust regulatory frameworks in safeguarding public health. This incident serves as a global reminder of the need for stringent quality control measures throughout the pharmaceutical supply chain to prevent the circulation of contaminated products.
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