DCGI & CDSCO Quality Compliance: What Pharmaceutical Distributors Must Verify

Operating a legal pharmaceutical distribution business in India requires strict adherence to central (CDSCO/DCGI) and state drug regulatory authorities.

1. DCGI Drug Approval Verification

Distributors must verify that all fixed-dose combinations (FDCs) in their product portfolio have approved rationales listed on the official DCGI registry, avoiding banned or unapproved formulations.

2. Schedule M & WHO-GMP Good Manufacturing Practices

Schedule M of the Drugs and Cosmetics Act governs cleanroom standards, HVAC air changes, validation protocols, and analytical quality control across pharmaceutical manufacturing units.

3. Good Distribution Practices (GDP) & Record Keeping

Maintaining batch trace registers, temperature-controlled warehousing, and proper tax invoices protects distributors during state drug inspector audits.