Eligibility Criteria for Wholesale Drug License
Before applying for a wholesale drug License , applicants must fulfil certain conditions.
1. Business Premises: The applicant must have suitable commercial premises for storing and distributing medicines. Generally, a minimum area of 10 square metres is required for wholesale operations. If retail and wholesale activities are conducted together, the minimum area is generally 15 square metres.
2. Competent Person: The business must appoint a competent person to supervise wholesale drug sales and distribution. The person should meet the prescribed qualification and experience requirements.
A competent person may be:
A registered pharmacist.
A graduate with at least one year of experience in dealing with drugs.
A person who has passed the required matriculation or equivalent examination with at least four years of experience in dealing with drugs.
The licensing authority evaluates the person's eligibility under the applicable rules.
3. Proper Storage Facilities: The premises must have suitable storage arrangements to maintain the quality of medicines. Temperature-sensitive medicines may require refrigerators or other appropriate storage equipment.
4. Business Registration: The applicant should have valid business constitution documents, such as proprietorship, partnership or company registration documents, as applicable.
Documents Required for Wholesale Drug License
Applicants generally need to prepare the following documents:
PAN card of the proprietor, partners or company.
Aadhaar card or other identity proof.
Passport-size photographs of the applicant and competent person.
Business constitution documents.
Proof of ownership or rent agreement of the premises.
Site plan and key plan of the premises.
Qualification certificates of the competent person.
Experience certificate, wherever applicable.
Appointment letter and consent of the competent person.
Refrigerator or storage facility details, where applicable.
Prescribed application forms and government fee receipt.
Required declarations and affidavits.
The exact document checklist may differ depending on the state and the category of drugs.
Wholesale Drug License Application Process
The application process generally involves the following steps:
Step 1: Arrange Business Premises
Select suitable commercial premises that meet the prescribed area and storage requirements.
Step 2: Appoint a Competent Person
Identify a qualified and experienced person who can supervise the wholesale distribution of medicines.
Step 3: Prepare Required Documents
Collect identity proofs, business documents, premises details, qualification certificates and other supporting documents.
Step 4: Submit the Application
Apply through the relevant State Drug Control Department or the applicable Online National Drugs Licensing System (ONDLS) portal. Form 19 is generally used for applications relating to wholesale License s under Forms 20B and 21B.
Step 5: Inspection and Verification
The Drug Inspector or concerned authority may inspect the business premises and verify the documents, storage facilities and competent person's details.
Step 6: License Approval
After reviewing the application and completing the required verification, the licensing authority may grant the applicable wholesale drug License if all conditions are satisfied.
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