DRUG LICENSE (DL)

For starting a Pharmaceutical business, a drug license is very much required. Both The central and state standard control organization issue the drug license in India.

generally, the drug control organization of a country issues two types  of  drug license (DL)

• First one is Retail drug license (RDL) which is issued to a person who runs a chemist shop or a medical shop
• Second one is a Wholesale drug license (WDL) which is issued to a person who wants to sell drugs on a wholesale market level.

In some regions, retail drug license (RDL) is issued only to that person who possesses the degree graduation or diploma in Pharmaceutical sector from any of the NAC recognized university.

DIFFERENT TYPES OF LICENSES ISSUED FOR  THE PHARMACEUTICAL BUSINESS?

Based on the requirement of the pharmaceutical business, an applicant must apply for the appropriate 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

THE REQUIREMENT FOR OBTAINING DRUG LICENSE

The below criteria shall be followed to obtaining a Drug License:

• Outlet Area – The optimum area required to initiate a Pharmaceuticals, Medical shop or Wholesale outlet is 108 square feet and for wholesale and for Retail atleast 162 square feet is required.
• Inventory and Storage facility – specific drugs such as , janumet, insulin injection etc. need to be stored in the refrigerator. So it is mandatory that there must have a refrigerator and air conditioner in there outlet.
• Working/Technical Staff– 

1. For Wholesale– The sale of the medicine by wholesale shall be made either in the presence of authorized and a experienced pharmaceuticalcist or in the presence of a competent person who had a graduate with 1 year experience in dealing with medicine/ drugs platform or a person who has passed S.S.L.C with 4 year experience in dealing in drugs
2. For Retail– medicine/drug sold by retail must be made in the presence of authorized pharmaceuticalcist approved by the pharmaceutical department, a registered pharmaceuticalcist is required throughout the working hours in the outlet.

DOCUMENTS WHICH ARE REQUIRED FOR ISSUING DRUG LICENSE

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

• Envelope signed with the name and position/designation of the applicant.
• Challan of fee deposited.
• Declaration form in prescribed format.
• Key plans for the premises.
• Site plan for the premises.
• Testimony of proprietor, partner, and pharmaceuticalcist etc.
• Freezer purchase bill with address.
• Ownership or rent agreement deed of premises.
• Electricity bill of the premises.
• Business registration receipt in case of a private limited business.

LIST OF DOCUMENTS FOR NEW RETAIL DRUG LICENSE

(Drug License No. 20, 21)
(Proprietor + Regd. Pharmaceuticalcist)

1. Form No. 19
2. Challan Rs. 3000/-
3. Self deceleration  of the proprietor on stamp paper of 20 Rs.
4. Educational certificate copies of the proprietor (Self-attested)
5. Attested copies of ID proof of proprietor (Driving license/ Voter ID card,etc)
6. Affidavit of Regd. Pharmaceuticalcist.
7. Educational certificate copies of Regd. Pharmaceuticalcist (Self-attested)
8. Attested copies of ID proof of Regd. Pharmaceuticalcist ( 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. Property document of the premises including the copy of tax receipt of proposed area.
14. Covering letter.
15. Photos 5-5 each of Regd. Pharmaceuticalcist and proprietor.

NOTE: EVERY DOCUMENT should be IN “PDF” FORMAT SCANNED IN GRAY SCALE.

LIST OF DOCUMENTS FOR NEW WHOLESALE DRUG LICENCE

(Drug License No. 20 B, 21 B)
(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. certificates of a competent person. (Working Experience certificate of 4 years after 12th or experience certificate of 2 years after graduation)
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 by the local drug authority for the accuracy and correctness of detail submitted with the application