https://www.taxtmi.com/article/detailed?id=15226 Cough syrups in India must comply with the Drugs & Cosmetics Act and Rules; formulations deemed new drugs or fixed dose combinations require central approval and state licences are inadequate. Mandatory controls include batch-wise raw material and finished product testing, GMP adherence, vendor qualification, validated processes, stability studies, statutory labelling, deviation investigation and CAPA. Recent enforcement shows intensified inspections, recalls and directives targeting unapproved FDCs and contaminant screening; manufacturers must assess regulatory status, secure appropriate licences, and strengthen quality systems to manage safety and compliance risks. en-us Mon, 13 Oct 2025 08:54:15 +0530 Mon, 13 Oct 2025 08:54:15 +0530 TaxTMI RSS Generator https://www.taxtmi.com/article/detailed?id=15226 Cough syrups in India must comply with the Drugs & Cosmetics Act and Rules; formulations deemed new drugs or fixed dose combinations require central approval and state licences are inadequate. Mandatory controls include batch-wise raw material and finished product testing, GMP adherence, vendor qualification, validated processes, stability studies, statutory labelling, deviation investigation and CAPA. Recent enforcement shows intensified inspections, recalls and directives targeting unapproved FDCs and contaminant screening; manufacturers must assess regulatory status, secure appropriate licences, and strengthen quality systems to manage safety and compliance risks. Articles Other Topics Mon, 13 Oct 2025 08:54:15 +0530 https://www.taxtmi.com/article/detailed?id=15226