Amid recent cases of toxic cough syrups, the Central Drugs Standard Control Organisation (CDSCO) has begun a nationwide inspection drive to check compliance, quality, and safety standards of all cough syrup manufacturers.
States and Union Territories have been asked to list all units under their jurisdiction, marking one of the largest coordinated audits involving CDSCO and state FDAs.
Priority inspections will target firms previously flagged as “Not of Standard Quality,” with special focus on raw materials like Propylene Glycol (PG) and Diethylene Glycol (DEG). Use of industrial-grade solvents will invite strict penal action.
Joint CDSCO–state teams will verify Good Manufacturing Practices (GMP), traceability of ingredients, and ensure all units are registered on the Online Drug Licence System. Packaging and labelling checks especially warnings such as “NOT TO BE USED FOR CHILDREN UNDER 4 YEARS” will also be enforced.
The crackdown follows lapses at Tamil Nadu’s Sresan Pharma, where 364 violations were found, including DEG contamination that caused multiple child deaths. Maharashtra FDA has separately initiated action against dealers selling syrups without prescriptions.
CDSCO is also drafting new guidelines for DEG/EG testing in all syrup formulations to strengthen oversight and rebuild trust in India’s pharma exports.
