Retail Drug License, Wholesale Drug License and AYUSH Manufacturing License — complete pharma compliance.
All services include expert assistance, document review and government filing. Starting ₹499.
A drug license is a mandatory approval under the Drugs and Cosmetics Act, 1940, granted by the State Drug Controller (SDC) and the Central Drugs Standard Control Organisation (CDSCO). Without a valid drug license, no person or business may manufacture, sell, stock, distribute, or exhibit any drug or cosmetic product for sale in India. This applies to retail pharmacies, wholesale distributors, hospital pharmacies, and AYUSH manufacturers alike.
The licensing structure distinguishes between retail (Form 20/21), wholesale (Form 20B/21B), and manufacturing operations, each with separate eligibility requirements around premises area, cold storage, and the mandatory presence of a registered pharmacist or qualified person. AYUSH manufacturing licences additionally require compliance with the Drugs and Cosmetics Rules as amended for Ayurvedic, Siddha, Unani, and Homeopathic preparations.
State Drug Controllers conduct premise inspections before issuing a license. Our team prepares all documents, schedules the inspection, and follows up with the authority to ensure timely grant.
Any entity dealing in drugs, medicines, or cosmetics at any stage of the supply chain requires a drug license.
Retail pharmacies and medical stores selling prescription and OTC medicines directly to consumers require a retail drug license under Form 20/21.
Companies and individuals distributing drugs to retailers, hospitals, and other licensees require a wholesale drug license under Form 20B/21B.
Manufacturers of Ayurvedic, Siddha, Unani, or Homeopathic medicines require an AYUSH manufacturing license from the State Licensing Authority.
In-house pharmacies in hospitals, nursing homes, and clinics must hold a separate drug license even though they are part of a licensed healthcare facility.
E-pharmacies and online medicine delivery platforms require a valid retail drug license for each state in which they supply medicines to consumers.
Commercial and private laboratories conducting drug testing and quality analysis require approval from CDSCO and the State Drug Controller.
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Retail, Wholesale & AYUSH. Starting ₹4,999. Inspection support included.
Our team reviews all documents before submission to minimise rejection or delays from the Drug Controller.
Valid registration certificate of the pharmacist with the State Pharmacy Council, along with educational qualifications (B.Pharm/D.Pharm).
Registered rent agreement or ownership documents for the pharmacy/warehouse premises, showing the minimum prescribed area is met.
For pharmacies stocking Schedule H drugs and vaccines, details of refrigeration equipment with make, model, and temperature range must be submitted.
Identity and address proof of all proprietors, partners, or directors of the applicant entity.
A scaled floor plan showing the layout, dimensions, storage areas, dispensing counter, and refrigeration placement.
List of all refrigerators and cold storage units at the premises with technical specifications confirming compliance with storage requirements for temperature-sensitive drugs.
End-to-end application management including inspection coordination by our compliance team.
We verify the pharmacist's registration with the State Pharmacy Council and confirm all qualification documents are in order before proceeding with the application.
We advise on premises setup requirements — minimum area, storage arrangements, refrigeration — and coordinate with you to ensure the premises is ready before the Drug Controller's inspection.
Application filed with the State Drug Controller using the correct form (Form 20 for retail, Form 20B for wholesale) along with prescribed fee payment and supporting documents.
The authority reviews the application. Queries are responded to by our team. An inspection date is scheduled for premises verification.
Drug Inspector visits the premises to verify compliance. On satisfactory inspection, the drug license is granted. Processing typically takes 30–45 working days for retail/wholesale, and 60–90 working days for AYUSH manufacturing licenses.
Our fees are inclusive of all documentation support and inspection coordination. Government fees are additional and vary by state.
The applicant must have a registered pharmacist on the premises who holds a B.Pharm or D.Pharm degree from a recognised institution and is registered with the State Pharmacy Council. The premises must also meet the minimum area requirements specified by the State Drug Controller.
Form 20 is the application form for a retail drug license and Form 21 is for a wholesale drug license under the Drugs and Cosmetics Rules, 1945. These must be filed with the State Drug Controller along with prescribed fees and supporting documents including pharmacist credentials and premises proof.
Yes. A registered pharmacist must be present during all business hours at retail premises. The pharmacist cannot be shared between two separate drug license holders at different locations — they must be exclusively associated with one premises.
No. Retail and wholesale drug licenses are separate. If you wish to conduct both operations from the same premises, you must obtain both licenses separately from the State Drug Controller.
Drug licenses are typically valid for 5 years from the date of issue. Renewal must be filed before the expiry date — late renewal attracts a penalty fee. If the license has lapsed for more than the prescribed period, a fresh application may be needed.
Operating without a valid drug license is an offence under Section 18 of the Drugs and Cosmetics Act, 1940. The penalty can include imprisonment of up to 3 years and/or a fine. State Drug Controllers can also seal and confiscate goods found at unlicensed premises.
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