https://www.taxtmi.com/article/detailed?id=15233 CDSCO is the national regulator responsible for approval, standards-setting and central oversight while states manage licensing and enforcement; cough syrups are thus jointly regulated. Recent NSQ findings flagged contamination by diethylene/ethylene glycol and other quality failures, prompting CDSCO risk based inspections, re testing, state bans, and orders to cease manufacture of unapproved FDCs. Regulators require testing of every lot of APIs, excipients and finished products under Schedule U, stronger vendor qualification, batch traceability, recall readiness, and adherence to GMP and central licensing for FDCs. en-us Tue, 14 Oct 2025 09:39:59 +0530 Tue, 14 Oct 2025 09:39:59 +0530 TaxTMI RSS Generator https://www.taxtmi.com/article/detailed?id=15233 CDSCO is the national regulator responsible for approval, standards-setting and central oversight while states manage licensing and enforcement; cough syrups are thus jointly regulated. Recent NSQ findings flagged contamination by diethylene/ethylene glycol and other quality failures, prompting CDSCO risk based inspections, re testing, state bans, and orders to cease manufacture of unapproved FDCs. Regulators require testing of every lot of APIs, excipients and finished products under Schedule U, stronger vendor qualification, batch traceability, recall readiness, and adherence to GMP and central licensing for FDCs. Articles Other Topics Tue, 14 Oct 2025 09:39:59 +0530 https://www.taxtmi.com/article/detailed?id=15233