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TN DCA orders full-scale seizure of contaminated Coldrif syrup
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Peethaambaran Kunnathoor, Chennai
October 08 , 2025
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Tamil Nadu's drug controlling authority, S. Gurubharathi, has launched a full-scale seizure operation against the contaminated syrup manufacturing company, Sresan Pharmaceuticals.
Speaking to Pharmabiz, Gurubharathi confirmed that circulars have been issued to all Assistant Drug Controllers (ADCs) and drug inspectors to execute a sweeping operation, that is, to seize all frozen products from Sresan Pharma, as well as from all wholesalers’ and retailers’ premises. This comprehensive seizure aims to eradicate all traces of the adulterated products from the supply chain, with all seized stock to be centralized at the Chennai headquarters and handed over to the Investigation Officer (IO).
The regulatory action was triggered by a high-stakes investigation following the tragic deaths of 15 children in the Chhindwara district of Madhya Pradesh. The investigation confirmed that the company’s product, Coldrif syrup (Batch No. SR-13), was adulterated and contained a lethal concentration of the poisonous compound diethylene glycol (DEG) at 48.6% w/v, rendering the product injurious to health.
The source of the contamination was traced to the firm's negligence in sourcing and testing. Sresan Pharma used non-pharmaceutical grade propylene glycol (PG) and failed entirely to test this raw material for the presence of toxic contaminants like diethylene glycol (DEG) and ethylene glycol (EG). Furthermore, the investigation revealed the firm purchased additional raw material quantities without proper purchase invoices, admitting to payment via cash or G-pay, confirming a major breach of legal supply chain accountability.
The joint inspection of the Kanchipuram manufacturing facility documented an appalling regulatory failure, logging 39 critical and 325 major deficiencies against mandatory GMP standards. Key critical failures included the non-existent quality assurance (QA) department, a failure to conduct process validation, and a lack of essential infrastructure like a functional purified water generation and distribution system and proper air handling units (AHUs), indicating a total disregard for manufacturing safety.
The facility was characterized as unhygienic and chaotic. Inspectors noted that the firm failed to follow GMP principles at any stage, with products stored under "extreme storage and unhygienic conditions." Raw materials were released for production without testing, and personnel lacked training, demonstrating a pervasive, systemic failure that put the public at severe risk.
Initially, the deputy director of drugs control issued a Stop-Production Order and a Show Cause Memo against Sresan Pharma. All remaining stocks of five different syrups were initially frozen at the manufacturer's site.
With the new directive from Gurubharathi, the authorities are now moving beyond the manufacturer's premises to aggressively clean the distribution network, ensuring that none of the contaminated stock remains available to the public and securing all evidence for the criminal investigation.
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