The documents required for a wholesale drug license in India include Form 19, identity proof, business address proof, and the competent person’s qualification and experience documents. The State Licensing Authority verifies these details and inspects the premises before issuing the wholesale license on Form 20B and 21B.
The Drugs and Cosmetics Act, 1940, grants the wholesale drug license. Unlike a retail license, it does not require a registered pharmacist but requires a competent person with valid qualifications and experience documents. Errors such as mismatched names, incomplete documents, or unclear scans often cause delays or rejection.
This guide lists all the documents required for a wholesale drug license, categorized by business type and format rules.
Key Takeaways
- The core documents for a wholesale drug license are Form 19, identity proof, premises proof, and the competent person’s qualification and experience documents.
- A wholesale license requires a competent person, a graduate with 1 year of drug experience, or a non-graduate with 4 years of experience. A registered pharmacist can also qualify as a competent person.
- The competent person’s documents are the most scrutinized part of the application and the leading cause of rejection if the qualification and experience don’t match.
- Only the constitution document changes by business type, such as a partnership deed, LLP deed, or Certificate of Incorporation. Proprietors need only a self-declaration.
- The premises must be at least 10 square metres (15 for combined retail and wholesale), with a refrigerator bill and storage declaration for cold-chain drugs.
- The license is applied for on Form 19 and granted on Form 20B (general drugs) and 21B (Schedule C and C1).
- Name mismatches across documents and unclear or improperly scanned uploads often lead to drug license application rejection.
Complete Wholesale Drug License Documents List: Quick Checklist
The table below summarizes all documents required for a wholesale drug license in India, with the format rules applied by the State Licensing Authority:
| Category | Documents Required | Format Requirements |
|---|---|---|
| Covering Letter | A letter to the Licensing Authority listing the license applied for and enclosed documents | On the firm’s letterhead, signed |
| Application Form | Form 19, filed online | Licenses granted on Form 20B (general allopathic drugs) and 21B (Schedule C and C1) |
| PAN & Identity Proof | PAN card, one ID (Aadhaar, voter ID, passport, or license), and photographs of proprietor, partners, or directors | Self-attested; names must match |
| Business Constitution Proof | A letter to the Licensing Authority listing the license applied for and the enclosed documents | Sale deed (owned) or rent agreement with the owner’s NOC (rented), plus electricity bill |
| Competent Person Documents | Qualification certificate, experience certificate, appointment letter, full-time employment affidavit, and a relieving letter from any previous firm | Statutory fee is ₹1,500 each for Forms 20B and 21B; varies by state |
| Premises Proof | Sale deed (owned) or rent agreement with the owner’s NOC (rented), plus electricity bill | Premises must be at least 10 sq m, or 15 sq m for combined retail and wholesale |
| Premises Height & Space | A declaration or plan confirming the premises meet the prescribed height, space, and ventilation norms | As per state requirements |
| Site & Key Plan | Blueprint layout showing carpet area, storage racks, refrigerator location, and entry or exit | Must be clearly marked |
| Storage Proof | Refrigerator purchase bill and cold-storage declaration | Cold-chain drugs at 2–8°C; others below 25°C |
| Affidavit | Affidavit of non-conviction under the Drugs and Cosmetics Act, 1940 | On non-judicial stamp paper |
| Fee Challan | System-generated fee receipt | The top cause of rejection is incomplete |
Note: Upload all documents as clear PDF scans, often in grayscale, as several state portals require. Blurred or mismatched uploads are a common cause of drug license rejection.
Documents Required for the Competent Person in a Wholesale Drug License
A wholesale drug license does not need a registered pharmacist, but it does require a competent person to supervise the sale. The following documents are required:
1. Qualification Proof
The competent person must meet one of three qualification paths:
- Registered pharmacist: A pharmacist registered with the State Pharmacy Council. No additional experience is required.
- Graduate route: A graduate in any discipline with at least one year of experience dealing with drugs.
- Non-graduate route: Passed Class 10 (SSLC) or senior secondary, with at least four years of experience dealing in drugs.
Submit the final degree or qualification certificate with mark sheets, self-attested.
2. Experience Certificate
- An experience certificate is mandatory and proves the one-year or four-year requirement.
- It must be issued by a licensed retail or wholesale drug firm where the person previously worked.
- The experience period must match the qualification route claimed.
Note: Drug Inspectors verify the certificate against the previous firm’s active drug license. The certificate must clearly mention the Drug License numbers (Form 20/21 or 20B/21B) of the employer to be valid.
3. Appointment Letter
- Provide the appointment letter and acceptance letter confirming employment at your premises.
- The letter must be on the firm’s letterhead.
- It must be signed by both the employer and the competent person.
4. Affidavit of Full-Time Employment
- The competent person must submit an affidavit on non-judicial stamp paper declaring full-time, exclusive employment at your premises.
- A competent person already tied to another active license cannot be appointed at the same time.
5. Identity and Address Proof
- Submit one self-attested identity document (Aadhaar, voter ID, passport, or driving license).
- Provide proof of present and permanent residential address.
- Attach a recent passport-size photograph.
Most state portals (such as the ONDLS portal) also require a signed Bio-Data form detailing the applicant’s complete employment history in chronological order.
Note: The qualification and experience documents must align exactly with the route claimed. A mismatch between the qualification and the experience period is one of the most common reasons wholesale applications are returned.
Documents Required for a Wholesale Drug License by Business Type
The core documents required for a wholesale drug license are the same for every business type:
- PAN card of the applicant or business entity.
- Identity and address proof of the proprietor, partners, or directors.
- Business premises proof (ownership or rental documents).
- Competent person’s qualification, experience, and appointment documents.
- Site plan, refrigerator bill, and affidavit of non-conviction.
However, each business structure must submit its own constitution document to establish the entity and confirm who is authorized to sign the application. The constitutional documents required are:
- Proprietorship: No separate constitution document is required. A self-declaration is enough since the license is in the proprietor’s name. Most portals (like ONDLS) also require a system-generated Self-Declaration Form digitally signed by the proprietor to register the trade name.
- Partnership Firm: Applicants must submit a copy of the registered partnership deed along with a list of partners and their residential addresses. The deed must be duly notarized or registered and must clearly name the managing partner authorized to sign the application. It must also mention the Principal Place of Business, matching the exact address of the drug license premises.
- Limited Liability Partnership (LLP): The LLP agreement and the registration certificate from the Registrar of Companies, with a designated partner as the authorized signatory.
- Private or Public Limited Company: Submit the MOA, AOA, Certificate of Incorporation, and a board resolution authorizing a director to sign the application. Also include a list of directors with their residential addresses.
- Trust: The trust deed, a list of trustees with residential addresses, and a resolution authorizing the signatory.
- Society: The society’s registration certificate and by-laws, signed by the authorized office-bearer.
Premises and Storage Documents for a Wholesale Drug License
To get a wholesale drug license, you must submit documents proving you have suitable premises and proper storage for medicines. The State Drug Inspector verifies these during the premises inspection. The following documents are required:
1. Premises Ownership or Rent Proof
- If owned: The registered sale deed, conveyance deed, or General Power of Attorney (GPA) in the owner’s name.
- If rented: A registered rent or lease agreement, plus the owner’s No Objection Certificate (NOC) and ownership proof.
- A recent electricity bill, water bill, or property tax receipt as supporting proof.
2. Site Plan and Key Plan
- Authorities require a signed blueprint (by a registered architect or licensed civil draftsman) showing the carpet area with a north direction arrow. It must also mark storage racks, the refrigerator, and the entry/exit points.
- The plan must clearly mark the storage racks, refrigerator location, and entry or exit points.
- The premises must be a minimum of 10 square metres, or 15 square metres for combined retail and wholesale.
3. Refrigerator and Cold Storage Proof
- Purchase invoice of the refrigerator showing the premises address. The refrigerator must be a commercial or a high-quality domestic model with a digital temperature display.
- Photograph of the installed refrigerator at the premises, as required by the state portal.
- Declaration on storage conditions and temperature maintenance, including confirmation of a power backup system (inverter or online UPS) to maintain cold-chain continuity.
4. Storage Condition Compliance
- Cold-chain drugs must be stored between 2°C and 8°C.
- Other medicines must be stored below 25°C or 30 °C.
- The premises must also have a clear vertical ceiling height of at least 2.75 metres (approx. 9 feet).
Common Reasons for Wholesale Drug License Document Rejection
The State Licensing Authority returns or holds wholesale drug license applications when documents do not meet the prescribed requirements. Here are the most common reasons for rejection, along with how to fix each one:
- Incomplete or Mismatched Competent Person Documents: Authorities most often reject applications when the competent person’s qualifications and experience do not match the claimed route. A registered pharmacist needs no experience, a graduate needs one year, and a non-graduate needs four years, so make sure the experience certificate matches the qualification you’ve submitted.
- Name Mismatch Across Documents: The authority flags applications when the name differs across the PAN, identity proof, and constitution papers. Check that the name is identical on every document before uploading.
- Address Proof Not in the Firm’s Name: Authorities reject premises proofs when the rent agreement or utility bill is in someone else’s name. Applicants must attach the owner’s NOC and ownership proof whenever the premises are rented.
- Wrong or Missing Constitution Documents: Authorities reject applications when the constitution document does not match the business type or the signatory lacks authorization. Submit the correct document for your entity, and make sure the constitution names the person signing.
- Inadequate Premises or Storage Proof: Authorities hold the application when the premises fall below the minimum area or do not include a refrigerator. Confirm 10 square metres (15 for combined retail and wholesale) and submit the refrigerator bill and storage declaration.
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