Drug license registration process in india (Mumbai)

Drug license registration process in india

How to Obtain Drug License Registration in India? Drug licenses under Drugs & Cosmetics Act 1940 regulate manufacturing, retail, wholesale, and distribution of pharmaceuticals via CDSCO and state controllers. Noida pharmacies/wholesalers apply through UP FDA portal for Form 20/21 (retail), 20B/21B (wholesale), or 25/28 (manufacturing).​ Eligibility Requirements Appoint registered pharmacist (B.Pharm/D.Pharm); minimum premises: 10 sqm retail, 15 sqm wholesale, 120 sqm manufacturing. Secure GST, Shop Act, fire NOC; no criminal record under drug laws.​ Step-by-Step Application Process Register on state portal (fsdaup.gov.in for UP) or CDSCO SUGAM; select license type. Fill Form 19 with applicant/business details, pharmacist affidavit, premises layout. Upload documents: ID proofs, qualification certificates, GST/PAN, storage proofs (fridge/AC). Pay fees (₹3, 000-₹15, 000 based on type/state); submit online/offline.​ Inspection and Approval Drug inspector verifies premises (storage, records, hygiene) within 30-60 days. Rectify objections; license issued for 5 years (renew 3 months prior). Display at site.​ Key Documents Checklist Application Form 19 + fee challan. Proprietor/partner Aadhaar/PAN, pharmacist registration. Premises ownership/lease + site plan. Affidavit (no conviction), GST certificate.​ AccountsWaale streamlines Noida drug license filing—documentation, inspections, compliance ensuring approval in 45 days.