What Documents Are Required For Wholesale Drug License In India?

A Wholesale Drug License is a legal permit issued under the Drugs and Cosmetics Act, 1940, that allows businesses to sell, stock, or distribute medicines on a wholesale basis in India. Whether you are an individual entrepreneur or a company, obtaining this license is mandatory before starting any wholesale drug business. The process involves meeting specific premises requirements, having qualified staff, and submitting the right set of documents to the drug control authority.

What is a Wholesale Drug License in India?

A Wholesale Drug License in India is an official permit issued by the State Drug Control Department under the Drugs and Cosmetics Act, 1940.

It allows businesses to legally sell, stock, distribute, or supply medicines and pharmaceutical products in bulk to other businesses such as pharmacies, hospitals, or medical institutions, but not directly to consumers.

This license ensures that the wholesaler follows proper storage, handling, and distribution practices to maintain the quality and safety of medicines. Without it, dealing in drugs or medicines is considered illegal in India.

Who Needs A Wholesale Drug License In India?

A Wholesale Drug License in India is required by any person or business that wants to sell, stock, or distribute medicines in bulk. It is not only for big companies, even small wholesalers or distributors need it if they deal with medicines, vaccines, or pharmaceutical products.

Here’s who needs a Wholesale Drug License in India:

• Pharmaceutical wholesalers and distributors – who supply medicines to pharmacies, hospitals, or clinics.
• Medical supply companies – that deal with large-scale distribution of medical products.
• Stockists or agents – who store medicines in bulk before supplying them further.
• Hospitals or healthcare institutions – if they buy and store medicines in large quantities for distribution to their branches.
• Businesses importing medicines – if they plan to sell them in bulk to other businesses.

What Documents Are Required For Wholesale Drug License In India?

• Application form
• Proof of premises (rental agreement/ownership papers)
• Site plan of premises
• Proof of business constitution (Partnership deed, MOA/AOA, etc.)
• ID proof of owner/partners/directors
• Address proof of owner/partners/directors
• Appointment letter of pharmacist/competent person
• Qualification certificates of pharmacist/competent person
• Experience certificate (if applicable)
• Affidavit of full-time pharmacist/competent person
• Electricity/water bill of premises
• NOC from local authority (if required)
• Storage facility details (refrigerator/AC)
• Passport-size photographs
• GST registration certificate
• Declaration form

Are There Different Document Requirements For Wholesale Drug License For Companies And Individuals?

S.No.	Document	For Individuals	For Companies
1.	Proof of premises	Required	Required
2.	Site plan of premises	Required	Required
3.	ID proof	Owner’s ID proof	Directors’ ID proof
4.	Address proof	Owner’s address proof	Directors’ address proof
5.	Business constitution proof	Not needed	MOA, AOA, Incorporation Certificate
6.	Partnership deed	Only if the partnership	Only if partnership
7.	Appointment letter of pharmacist/competent person	Required	Required
8.	Qualification & experience certificates of pharmacist	Required	Required
9.	Affidavit of full-time pharmacist	Required	Required
10.	Utility bill (electricity/water)	Required	Required
11.	NOC from local authority (if needed)	Required	Required
12.	Storage facility details	Required	Required
13.	Passport-size photographs	Owner’s photo	Directors’ photos
14.	GST registration	Required	Required
15.	Declaration form	Required	Required

What Premises-Related Documents Are Required For Wholesale Drug License In India?

Here is the list of required documents for a wholesale drug license in India:

• Proof of premises ownership (Sale deed / Rent agreement / Lease deed)
• Site plan or layout of premises
• Electricity bill
• Water bill
• NOC from property owner (if rented)
• NOC from local authority (if applicable)
• Details of storage facility (cold storage, racks, etc.)
• Photographs of premises (inside & outside)
• Property tax receipt
• Trade license (if required by local authority)
• Fire safety certificate (if applicable)
• Pollution clearance certificate (if applicable)
• Affidavit regarding usage of premises for drug business only
• Structural stability certificate (if required by authority)

What Qualification And Staff-Related Documents Are Required For Wholesale Drug License In India?

• Educational qualification certificate of a registered pharmacist / competent person (Degree or Diploma in Pharmacy, or Graduation with experience)
• Registration certificate of pharmacist (issued by State Pharmacy Council, if applicable)
• Experience certificate (if applying as a competent person without a pharmacy degree)
• Appointment letter of a competent person
• Bio-data / Resume of a competent person
• ID proof of a competent person (Aadhaar, PAN, Voter ID, etc.)
• Passport-size photographs of a competent person
• Affidavit of full-time employment of a competent person
• Relieving letter from previous employer (if applicable)

Are additional documents required for renewal of a Wholesale Drug License in India?

Yes, for renewal of a Wholesale Drug License in India, along with the basic documents, you usually need some additional updated documents, such as:

• Copy of existing Wholesale Drug License
• Latest GST registration certificate copy
• Updated list of medicines handled (if applicable)
• Latest rent agreement or ownership proof of premises (if changed)
• Latest qualification & registration proof of competent person (if changed)
• Updated affidavit of competent person (full-time employment)
• Renewal application form with prescribed fee receipt
• Latest electricity bill or utility bill of premises
• Self-declaration of compliance with the Drug & Cosmetics Act & Rules
• Any inspection report issued by the Drug Inspector (if applicable)

How can ELT Corporate help you with the Wholesale Drug License process in India?

ELT Corporate can make the Wholesale Drug License process simple, fast, and hassle-free by offering complete end-to-end support, such as:

• Expert guidance on eligibility, document preparation, and compliance with the Drugs & Cosmetics Act.
• Document checklist & verification to ensure all papers are accurate and complete before submission.
• Application drafting & filing with the State Drug Licensing Authority.
• Liaising with authorities to handle queries, inspections, or deficiencies.
• Premises compliance support to meet infrastructure and storage requirements.
• Staff qualification verification to ensure competent person eligibility.
• Follow-up on application status until approval is granted.
• Assistance with license renewal and modifications when required.
• Advisory on regulatory updates to maintain ongoing compliance.
• Faster turnaround through professional handling and strong industry experience.