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Wholesale Drug License Renewal: Forms and Procedure

calendar21 Apr, 2022
timeReading Time: 3 Minutes
Wholesale Drug License Renewal Forms and Procedure

A drug license is not one of those licenses that are easy to come by. It is among the few licenses that attract countless norms and legalities in order to come to effect.  The same is also true for the Wholesale drug license renewal process. In this write-up, we shall be discussing the Wholesale drug license renewal process in detail.

Procedure for Wholesale drug license renewal

For renewing a Wholesale Drug License ,the applicant should follow the below-mentioned procedure carefully. The renewal certificate is granted electronically by the Department.

  1. To secure renewal certificates via Form 21C (for Schedule X Drugs/ Allopathic Drugs) and 20-E (for Homoeopathic drugs), applicants must file an application via forms 19,19B and19C respectively and form for additional data. The application form is available on the state drug controller authority.
  2. Applicants should pay the requested fee via e-challan. The fee for Homoeopathic License and Schedule X license should be paid to the Head of accounts,
  3. Using the firm’s login credential, the license holder has to log in to State’s drug controller portal and create a new application by selecting the option called on “New Inward”. After that, the applicant must upload the requested documents pursuant to sales norms, which will become accessible post login; and e-send the application.
  4. Post generating application; take the print of the e-form 19/19B/19C. Make sure to note the inward ID after application filling for future reference. The Inward ID generated by the portal needed to be cited on the covering letter while furnishing hard copies of the application.
  5. Furnish a hard copy of all documents, along with a true copy of the e-challan paid towards the application fees to the entry clerk within 72 hours of e-send of application.

Process after file submission

1. The physical copy of the application received inward section.

2. Entry clerk shares the file with the Account department for vetting of the amount paid via challan.

3. Post vetting of amount, the account section shall forward the respective file offical for further processing.

4. The respective official places the application in the licensees’ file and vets all the documents, and shares the same with the Director for allotting to the ADC/ Drugs Inspector

5. The Director examines the application and shares it with the ADC/ Drugs Inspector for further processing; electronically. The physical copy also moves as the e-form moves.

6. Drugs Inspector/ADC shall examine the documents and accordingly vet the facility. Drugs Inspector/ADC shall propose for the issue of a renewal certificate if the requested documents are furnished and the facility was found satisfactory on inspection.

7. Depending on the inspection’s findings, Drugs Inspector/ADC shall propose

  1. Issuance of a renewal certificate
  2. Grant of show cause letter
  3. Grant of corrective letter

And share the file with the Deputy Director/ Assistant Drugs Controller/

8. ADA/Deputy Director shall share recommendations and send the file to the Director.

9. In the case of 7(a), the final renewal registration is accorded by the Director of licensing authority. And the file is forward to the Dispatch Clerk.

10. In the case of 7(b), the license holder provides clarification in writing to the Clerk online.

11. Application is shared by the Entry Clerk with the dealing hand.

12. Dealing Hand files the applicant’s response and share the same with the Drugs Inspector.

13. If the License holder confers

a) Satisfactory clarification/reply, the Drugs Inspector shall propose for issuance of renewal certificate and share the file with the respective ADC/ Dy. Director, which is also recorded electronically.

b) If clarification is found unsatisfactory, the Drugs Inspector shall propose for face-to-face hearing by the Director and share the file with the ADC/ Deputy Director.

14. ADC/Dy. Director shall forward the file to Director with his findings.

15. In case of (a), the Director shall confer the Renewal Certificate to the license holder, and the final certificate is granted by the Director via online mode. In Incase of (b), the license holder is called for face to face hearing.

16. In continuation of 13(a), the electronically signed license is printed and sent to the Dispatch clerk. In case of 13(b), post f2f hearing, a Warning/Suspension is issued to the license holder.

17. License holder shall collect the renewal registration from the Technical Section of the Directorate of Food & Drugs Administration.

Note 1) Validity of renewal registration-valid up to 5 years from the issuance of license subjected to the norms specified in the license and the guidelines of the Drugs & Cosmetics Act, 1940[1] and the Rules thereunder.


In conclusion, we can say that the Wholesale drug license renewal is a tedious process that involves various complicated steps and a copious amount of paperwork. Indulging in the renewing process without any prior knowledge may increase the chance of committing a mistake, which eventually leads to the cancellation of the application. To ease the things, we recommend you avail of professional-grade assistance from an expert firm like Corpbiz.

Read our Article:How one can apply for Wholesale Drug License in India?

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