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Retail drug license

Nobody is authorized to distribute or sell drugs in case he or she has not obtained a retail drug license. This license has to be obtained from the Drug Inspector. You need to launch a chemist shop or medical store. It is possible to register only in the name of the person who has acquired a diploma or degree in pharmacy from an acknowledged institute or university. The space requirement is at least ten square meters, where you can start a pharmacy or medical shop. If the business combines both wholesale and retail, you would need a space of at least 15 square meters. Besides, you need to equip the medical store with an air conditioner and a refrigerator. As per the specifications of labelling, some of the vaccines and drugs like Insulin Injections and Sera should be kept in the refrigerator.

How to obtain a Wholesale Drug License?

The following steps need to be completed in order to obtain a wholesale drug license:
1. Obtaining the password and ID by registering with the XLN software.

2. Uploading these documents into the system

3. Submitting the application online

4. Submitting the entire application in the form of a hard copy

5. Drugs Inspector office/Assistant Drugs Controller (optional)

6. Getting the documents verified by the respective Drug Inspector

7. The Drug inspector will also carry out the inspection before licensing

8. After the completion of the pre-licensing inspection, the Drug Inspector comes up with the report. This is available in the software. It either recommends that the license should be granted, or rejected. Then the application is forwarded to the Assistant Drugs Controller.

9. You also need to forward the application’s hard copy, that you submit to the Assistant Drugs Controller to this authority.

10. The Assistant Drugs Controller validates the information in the software. In case it appears satisfying, the drug license will be issued.

11. The person applying for this license is entitled to get a print out of the license (e-signed) from the software, when he or she gets the auto-generated message.

Which documents should you submit to get your wholesale drug license?

You need to submit the following applications to obtain your retail drug license:

1. Application in any of the forms (19/19A/19B/19C)
2. Receipt of INR 3,000 made as online payment for registration
3. Registration certificate of the pharmacist
4. Document obtained from your local authority, showing that you own the premises
5. Pharmacist’s declaration
6. Affidavit in the given format
7. Option request
8. Cover letter with INR 5 court fee stamp
9. Attested copies of constitutional documents of the firm
10. Applicant’s identity proof
11. Previous certificates for renewal in copy/original form of the drug license is required, if you are applying for the renewal too
12. If you are applying with form 19AA, you need to provide an attested copy of the respective RC book apart from the application
13. Applicants using form 19A, the Chelan, the affidavit, the questionnaire, and the attested copies of constitutional documents of the suggested for, and identity proof would be required.