To obtain a drug license in India, applicants must submit forms 19/19A/19C, an affidavit of non-conviction, a site plan, and proof of premises (rent agreement/ownership). Crucial documents include qualified pharmacist certificates (registration, experience), ID proofs, refrigerator invoices, and payment challans, with a required area of 10-15 sq. meters.
Starting a pharmaceutical business does not begin with selling medicines. It begins with preparing the right documents. Government authorities first check your shop or premises, the qualification of the pharmacist or staff, proper medicine storage facilities, and whether all safety rules are being followed. These documents build trust and ensure that medicines are handled safely for public health. Because people always need treatment, the pharma sector remains stable even during economic slowdowns. It provides steady income, repeat customers, and good opportunities to expand distribution.
To legally manufacture, sell, stock, or distribute medicines, getting a drug license is compulsory. Knowing the required documents in advance helps you avoid rejection, saves time, and prevents extra expenses. In this guide, we explain the Documents Required for drug license in India in simple terms so new business owners can prepare properly and start their pharmaceutical business smoothly and with confidence.
Overview of Documents Required to Apply for a Drug License
To get a drug licence, you have to submit some basic documents. The exact list can change a little from state to state, but usually these are required:
- Filled application form
- A cover letter explaining why you are applying
- Your ID proof (Aadhaar Card or PAN Card)
- Address proof of the shop/medical store (rent agreement or property papers)
- Qualification proof of the registered pharmacist or qualified person
- Appointment letter of the pharmacist/employee (if hired)
- Shop layout or map (blueprint of the premises)
- Proof of refrigerator or cold storage (needed for certain medicines)
- Affidavit stating the owner/partners/directors have no criminal case under drug laws
- GST registration certificate copy
- Passport-size photographs of the applicant
In short, the government checks who you are, where the shop is, and whether a qualified pharmacist and proper storage are available before giving the licence.
Detailed List of Documents Required for Drug License in India
Below are the Essential Documents For Obtaining a License under the Drugs & Cosmetics Act, 1940 and Rules, 1945. The exact list varies slightly depending on the type of license (Retail, Wholesale, or Manufacturing), but the following are the Important Documents Required for a drug license in India across most states.
1. Constitution Documents of the Firm / Business
These verify the legal existence of the applicant entity.
For Proprietorship
- Aadhaar Card of proprietor
- PAN Card of proprietor
- Passport-size photographs
- Affidavit declaring ownership
For Partnership Firm
- Partnership Deed (notarised)
- PAN Card of the firm
- An authorisation letter naming the responsible person
- ID & address proof of all partners
For Company / LLP
- Certificate of Incorporation
- Memorandum of Association (MOA)
- Articles of Association (AOA)
- Board Resolution for Drug License
- PAN Card of company
- List of directors with ID proofs
These are mandatory Drug License Required Documents because the licensing authority must verify legal responsibility for the sale or storage of medicines.
2. Premises Related Documents
The drug department strictly inspects storage premises before approving. Required Documents to apply drug license in India:
- Ownership proof OR Rent Agreement
- Property Tax Receipt / Electricity Bill
- Site Plan & Layout Plan of premises
- Area proof (minimum required space) – Retail: 10 sq. meters, Wholesale: 10 sq. meters, Retail + Wholesale: 15 sq. meters
- The layout plan must clearly show – Storage racks, Refrigerator location, Entry/exit, Working area
This falls under Essential Documents For Obtaining a License because drug storage conditions affect the safety.
3. Pharmacist / Competent Person Documents
A qualified technical person is compulsory.
Retail Drug License (Form 20 & 21) requires Registered Pharmacist
Documents:
- Pharmacy Degree/Diploma certificate
- State Pharmacy Council Registration Certificate
- Appointment Letter
- Joining Letter
- Affidavit of full-time employment
- ID & Address proof
- Recent photographs
Wholesale Drug License (Form 20B & 21B) requires a Competent Person with experience
Qualification options:
- B.Pharm / D.Pharm OR
- 1 year experience (graduate) OR
- 4 years of experience (non-graduate)
Documents:
- Qualification certificate
- Experience certificate (mandatory)
- Appointment letter
- Affidavit of full-time employment
These are among the most important Drug License Required Documents, and licenses are rejected mainly due to errors here.
4. Storage Facility Proof
Medicines must be stored at specified temperatures.
Documents required:
- Refrigerator purchase bill
- Photograph of refrigerator installed at the premises
- Declaration regarding storage conditions
Temperature requirements:
- Cold chain drugs: 2°C to 8°C
- Normal medicines: Below 25°C
This is a critical part of the Document Checklist For Drug License because improper storage makes medicines unsafe.
5. Affidavits & Declarations
Mandatory legal declarations include:
- Non-conviction affidavit under the Drugs & Cosmetics Act
- Pharmacist full-time working affidavit
- Declaration of non-running of medical practice at premises
- Undertaking for compliance with drug laws
These ensure the applicant understands regulatory responsibilities.
6. Identity & Address Proofs
For the applicant and technical person:
Accepted ID proofs:
- Aadhaar Card
- Voter ID
- Passport
- Driving License
Accepted address proofs:
- Electricity bill
- Rent agreement
- Bank statement
These are basic but mandatory Important Documents Required for Drug License in India.
7. Business Registration & Tax Documents
- Authorities verify commercial legitimacy.
- GST Registration Certificate (usually required)
- Shop & Establishment Registration (in many states)
- PAN Card (firm/individual)
- Bank account details (cancelled cheque)
8. Additional Documents for Special Licenses
For Manufacturing License
- (Separate, stricter approval)
- Manufacturing site plan approved by the authority
- Technical staff qualification (B.Pharm / M.Pharm / Chemistry graduate)
- Equipment list
- Water testing report
- Pollution Control NOC
- Manufacturing formula records
- Stability data (if required)
For Restricted Drug License (for clinics/hospitals)
- Qualification of a doctor
- Clinic registration certificate
- Undertaking: medicines for own patients only
Drug License Online Application Process
India has moved mostly to digital applications through State Drug Control portals or the CDSCO SUGAM portal (for central approvals). Below is the Drug License Online Application Process / How to apply Drug License:
Step 1: Registration
- Visit the State FDA portal or the CDSCO SUGAM
- Create a login ID
- Verify mobile & email
Step 2: Fill Application Form
Select the correct form:
| License Type | Form |
| Retail | Form 20 & 21 |
| Wholesale | Form 20B & 21B |
| Restricted | Form 20A / 21A |
| Manufacturing | Form 24 / 25 / 28 |
Upload all Required Documents to apply drug license in India in PDF format.
Step 3: Fee Payment
Fees vary by state, but usually:
- Retail – Rs. 3,000 approx
- Wholesale – Rs. 3,000 approx
- Combined – Rs. 5,000 approx
Payment done online through the portal.
Step 4: Inspection
Drug Inspector visits premises and verifies:
- Area size
- Refrigerator working
- Pharmacist presence
- Records & storage
If satisfied, the inspection report approved.
Step 5: License Grant
A license is issued digitally with a license number and validity. Typical timeline is 20 to 45 days (varies by state).
Note – The document requirements may differ from one state to another. The government can also update or change the rules and required documents at any time, so always check with your local drug authority before applying.