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Industry deep-dive · Healthcare & Pharma

Clinical Establishments Act + Drug License + GST exemption

Healthcare in India enjoys GST exemption on consultation services (Notification 12/2017) but the layered regulation runs deep — Clinical Establishments Act registration in 12 states, Drug License (Form 20/21 for retail, 20B/21B for wholesale), Biomedical Waste Authorisation, NABH for hospitals, Manufacturing License for pharma. FilingLab handles end-to-end healthcare setup from clinics to pharmacies to small hospitals.

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The Healthcare & Pharma compliance overlay

1

GST exemption scope

Consultation by clinical establishments: exempt. Cosmetic surgery, dental aesthetics, hair transplants, wellness: TAXABLE at 18%. Doctors above ₹50L receipts: 18% GST applicable on non-exempt items.

2

Drug License tiers

Retail (Form 20/21 for pharmacies dispensing to consumers). Wholesale (Form 20B/21B for B2B distribution). Manufacturing (separate). State Drug Controller issues; we coordinate.

3

Biomedical Waste

All hospitals, clinics, labs need Biomedical Waste Authorisation (Form 1) from State Pollution Control Board. Annual renewal + monthly waste manifests.

4

Clinical Establishments Act

Mandatory in 12 states (TN partially). Provisional via state portal; permanent after audit. Annual fees ₹2,000-15,000 by tier.

FAQ

Is healthcare always GST-exempt?

No — only clinical establishment services + ambulance + diagnostic centres are exempt. Cosmetic / aesthetic procedures, gym/wellness, OTC product sales are taxable at 18%.

Drug license for online pharmacy?

Mandatory + separate e-pharmacy compliance under proposed rules. State Drug Controller issues retail license; e-pharmacy needs CDSCO clearance.