Documents Required For Drug Retail License
Drug licensing is a laborious process, especially in light of the pandemic. The severity of the difficulty involved in acquiring a drug license is indicated by the stringent regulatory standards established for issuing one. The fundamental regulatory framework that controls the entire drug licensing lifecycle is the Drugs and Cosmetics Act of 1940.
Conditions to Apply for a Drug License
For those who want to obtain a drug license, there are a number of requirements that must be met. It is crucial to make sure that all conditions are met given the low success rate of drug license grants, particularly for applicants seeking retail sales permits.
The Three Primary Requirements Are As Follows:
- Existence of necessary space: This requirement relates to the pharmacy's location or, in the event of a wholesale business, its point of sale.
- Adequate drug storage space: Some medications need to be kept at low temperatures in order to be effective.
- Trained and competent personnel: It is necessary to have qualified employees on board before submitting a licensing application.
Document Required for a Retail Drug License
The availability of proper buildings, cooling facilities, and qualified employees are the fundamental prerequisites for submitting an application for a drug license. The main document needed is a Form 19 that has been completed. This application seeks approval for a license to distribute, sell, stock, or offer to distribute medicines. These medications must not, however, be ones that are on Schedule X. Form 19A must be filled out by dealers who want to sell drugs in a retail setting without the help of a licensed person. To store, sell, or distribute homeopathic medications, Form 19B is necessary. People who want to sell Schedule X drugs must fill out Form 19C in the meantime.
List of Documents for New Retail Drug License
01. Form No. 19
02. Challan Rs. 3000/-
03. Affidavit of proprietor on stamp paper of 20 Rs.
04. Educational certificate copies of proprietor (Self attested)
05. Self attested copies of Identity proof of proprietor (Domicile/ driving license/ Voter ID card)
06. Affidavit of Regd. Pharmacist.
07. Educational certificate copies of Regd. Pharmacist (Self attested)
08. Self attested copies of Identity proof of Regd. Pharmacist (Domicile/ driving license/ Voter ID card)
09. 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.
All Documents in PDF format scanned in GRAYscale.
List of Documents for New Wholesale Drug License
(Drug License No. 20B, 21B)
(Proprietor + Competent person)
01. Form No. 19
02. Chillan Rs. 3000/-
03. Affidavit of proprietor on stamp paper of 20 Rs.
04. Educational certificate copies of proprietor (Self attested)
05. Self attested copies of Identity proof of proprietor (Domicile/ Driving license/ Voter ID card)
06. Affidavit of Competent person.
07. Educational certificate copies of competent person (Self attested)
08. Self attested copies of Identity proof of competent person (Domicile/ Driving license/ Voter ID card)
09. Experience certificate of 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.
All Documents in PDF format scanned in GRAYscale.
Help With Obtaining a Retail Drug License from Regalguru
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Also read about:
How to get Wholesale drug license