The Central Drugs Standard Control Organisation (CDSCO) and the Directorate General of Health Services (DGHS) have issued a circular emphasizing strict compliance with the Drugs Rules, 1945, for testing raw materials and finished formulations. Recent child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups, highlighted concerns about medicine quality.
Inspections revealed that some pharmaceutical manufacturers fail to test each batch of excipients, active, and inactive ingredients before production. The Drugs Rules, including rule 74(c) and rule 78(c)(ii), require licensees to test all raw materials and finished products in their own or approved laboratories.
Manufacturers must maintain proper records as per Schedule U. State and UT Drug Controllers are instructed to monitor compliance through inspections, issue circulars, and ensure manufacturers follow robust vendor qualification systems. Only reliable, approved suppliers should provide raw materials and excipients. This measure ensures the safety, quality, and efficacy of medicines, prevents the distribution of substandard drugs, and protects public health. Compliance and vigilant monitoring are critical to maintaining pharmaceutical standards nationwide.