Drug License (DL)

To start the Pharma business, a drug license is required. The central drugs standard control organization and state drugs standard control organization issue the drug license in India.

Normally, the drug control organization issues two types DL one is Retail drug license which is issued to a person who runs a chemist shop and another one is a Wholesale drug license which is issued to a person who wants to sell drugs on a wholesale level.

In some states, retail drug license is issued only to that person who possesses the degree or diploma in Pharma from the recognized university.

What are different types of Licenses Issued for the Pharmaceutical Business?

Based on the requirement of the pharmaceutical business, an applicant must apply for the issue of a specific drug license. There are various licenses, for example:

• Drug Manufacturing License
• Wholesale Drug License
• Retail Drug License
• Import of Drugs or Cosmetics
• Import of Medical Equipment
• Export of Medicines etc.

The requirement for obtaining Drug license

Following are the requirements for obtaining a Drug License:

• Area - The minimum area required to start a Pharmacy, Medical shop or Wholesale outlet is 10 square meter and for wholesale and Retail minimum 15 square meters is required.
• Storage facility - Certain drugs such as vaccines, sera, insulin injection etc. need to be stored in the refrigerator. So it is mandatory that there must have a refrigerator and air conditioner in the premises.
• Technical Staff -
  • Wholesale – The sale of the drug by wholesale shall be made either in the presence of registered pharmacist or in the presence of a competent person who shall be a graduate with 1 year experience in dealing in drugs or a person who has passed S.S.L.C with 4 years experience in dealing in drugs, specially approved by the department of drug control.
  • Retail – The sale of the drug by retail must be made in the presence of registered pharmacist approved by the department, a Registered pharmacist is required throughout the working hours.

Documents required for Drug license

Application form no. 19 to be submitted in a prescribed form.

• Covering letter signed with the name and designation of the applicant.
• Challan of fee deposited.
• Declaration form in prescribed format.
• Key plans for the premises.
• Site plan for the premises.
• Affidavit of proprietor, partner, and pharmacist etc.
• Freezer purchase bill with address.
• Ownership or rent agreement deed of premises.
• Electricity bill of the premises.
• Firm registration receipt in case of a private limited firm.

List of Documents for New Retail Drug License

(Drug Licence No. 20, 21)
(Proprietor + Regd. Pharmacist)

1. Form No. 19
2. Challan Rs. 3000/-
3. Affidavit of the proprietor on stamp paper of 20 Rs.
4. Educational certificate copies of the proprietor (Self-attested)
5. Self-attested copies of Identity proof of proprietor ( Domicile/ Driving license/ Voter ID card)
6. Affidavit of Regd. Pharmacist.
7. Educational certificate copies of Regd. Pharmacist (Self-attested)
8. Self-attested copies of Identity proof of Regd. Pharmacist ( Domicile/Driving license/ Voter ID card)
9. Blueprint of Plan layout of proposed area/ premises.
10. Electricity bill of proposed area/ premises.
11. Copy of Refrigerator bill.
12. Rent agreement ( 50 Rs. Stamp paper)
13. Ownership document of the premises including the copy of tax receipt of proposed area/ premises.
14. Covering letter.
15. Photo 5-5 each of Regd. Pharmacist and proprietor.

Note: All Documents in PDF format scanned in GRAY scale.

List of Documents for New Wholesale Drug Licence

(Drug Licence No. 20B, 21B)
(Proprietor + Competent person)

1. Form No. 19
2. Challan Rs. 3000/-
3. Affidavit of the proprietor on stamp paper of 20 Rs.
4. Educational certificate copies of the proprietor (Self-attested)
5. Self-attested copies of Identity proof of proprietor ( Domicile/ Driving license/ Voter ID card)
6. Affidavit of Competent person.
7. Educational certificate copies of Competent person (Self-attested)
8. Self-attested copies of Identity proof of Competent person ( Domicile/Driving license/ Voter ID card)
9. Experience certificate of a competent person. (Experience certificate of 4 years after 12th or experience certificate of 2 years after graduation in original)
10. Blueprint of Plan layout of proposed area/ premises.
11. Electricity bill of proposed area/ premises.
12. Copy of Refrigerator bill.
13. Rent agreement ( 50 Rs. Stamp paper)
14. Ownership document of the premises including the copy of tax receipt of proposed area/ premises.
15. Covering letter.
16. Photo 5-5 each of Competent person and proprietor.

Note: All Documents in PDF format scanned in GRAY scale.

After the documents are submitted the inspection is carried out by the local drug authority for the accuracy and correctness of the details submitted with the application.

Retail / Wholesale Drug License Application Form

Qualification and Eligibility to Get the Retail & Wholesale Drug License

A person who applies for drug licenses should possess one of the following qualifications:

• Registered pharmacist under the state Pharma council
• Minimum 1 year experience as a salesman in a registered wholesale drug licensed firm after graduation or
• Minimum 4 year experience as a salesman in a registered drug licensed firm after senior secondary examination.

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