India CDSCO compliance for online pharma — what changes?

India regulates online pharma under the Drugs and Cosmetics Act 1940 + Drugs and Cosmetics Rules 1945 + the (still-pending) New Drugs and Clinical Trials Rules. Key requirements for an online pharmacy / e-pharmacy on Magento:

• Drug License per state — Form 20 / 21 (retail), 20B / 21B (wholesale). Each state where you store / dispatch from = separate license. Magento store-view per state isn’t mandatory but the warehouse model + licensed-pharmacist mapping is.
• CDSCO registration for any imported drug; manufacturer’s CDSCO approval validated and stored as product attribute.
• Schedule H, H1, X drugs — all require pharmacist verification + photo of prescription + prescriber registration check (against State Medical Council registry). Schedule X (narcotics) requires state-level Drug Inspector pre-approval per shipment in some states — admin workflow needed.
• GST + e-invoicing — pharma SKUs across HSN classes 30 + 9018 + 9021. Five GST rates (0% / 5% / 12% / 18% / 28%) depending on category. E-invoicing under IRP mandatory for B2B if turnover >₹5cr/yr. Magento handles via the same e-invoicing IRP integration I ship for non-pharma India clients.
• DPDP Act 2023 + RBI tokenisation rules apply. Health data is "sensitive personal data" under DPDP — consent + audit trail + data-localisation requirements similar to HIPAA US.

Pending regulation worth watching: Draft Rules for Sale of Drugs by E-Pharmacy (2018 draft, repeatedly stalled). When (if) it passes, expect mandatory e-pharmacy registration with CDSCO, capped controlled-substance dispensing, and explicit Rx-validation rules. Magento implementations should be regulatory-config-driven so a future rule change is a config update, not a code change.

Major Indian e-pharmacies (1mg, Netmeds, Pharmeasy, Apollo 247) all run on custom-Magento or custom-Java stacks — not on Shopify, because the pharmacist queue + drug-license-per-state + Schedule H verification flows aren’t feasible on Shopify Apps.