Urgent Health Alert: Gujarat Orders Massive Cough Syrup Recall Over Quality Concerns

In a significant move to safeguard public health, the Gujarat Food and Drug Control Administration (FDCA) has issued a stringent directive for two pharmaceutical companies, KP Drugs and Pharmaceuticals, and Shivam Lifescience, to immediately recall multiple batches of their cough syrups from the market.

The order comes after these products were found to be of 'not of standard quality' (NSQ), raising serious concerns about their efficacy and safety.

The crackdown by the Gujarat government highlights its unwavering commitment to ensuring the quality and safety of medicinal products available to its citizens.

This proactive measure follows a rigorous inspection and testing process that revealed critical deficiencies in the manufacturing and composition of these commonly used over-the-counter medications.

Specifically, KP Drugs and Pharmaceuticals, based in Ahmedabad, has been ordered to recall all unexpired batches of its 'Cufpet-P' (paracetamol and phenylephrine hydrochloride oral solution IP) and 'Cufpet-DMR' (dextromethorphan HBr, phenylephrine Hcl and chlorpheniramine maleate syrup).

Both products were flagged as 'not of standard quality' during the regulatory checks. The immediate recall affects products manufactured by the firm and distributed across the market.

Similarly, Shivam Lifescience, operating from Waghodia in Vadodara, faces a similar fate. The FDCA has mandated the recall of all unexpired batches of their 'Pholk-D' syrup, which contains a blend of pholcodine 10mg, promethazine 2.5mg, phenylephrine 5mg, and paracetamol 125mg.

This product, too, was found to be 'not of standard quality', prompting urgent action from the authorities.

Responding swiftly to these alarming findings, the FDCA has not only ordered the comprehensive recall of all affected batches but has also instructed both firms to cease the production of these specific drugs.

Furthermore, the regulatory body has confirmed that First Information Reports (FIRs) will be filed against the involved companies, signaling serious legal consequences for failing to adhere to quality standards and endangering public welfare.

This decisive action by the Gujarat FDCA underscores the critical importance of stringent quality control in pharmaceutical manufacturing.

It serves as a stark reminder to drug manufacturers of their paramount responsibility to ensure that every product reaching consumers meets the highest benchmarks of quality and safety. The government's unwavering stance aims to rebuild trust and protect the health of millions.