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What Is The Complete Process Of Drug License Renewal

What Is The Complete Process Of Drug License Renewal

Drug license renewal is more complex to obtain if you don’t have the right assistance. It is among the very few requests that require a myriad of laws and norms to be at the point of. This is the same as the Wholesale renewal of a drug license. In this article, we will discuss the Wholesale renewal process for drug licenses in greater detail.

Procedure For Wholesale Drug License Renewal

For drug license renewal, applicants must carefully follow the steps below. This renewal is issued electronically by the Department.

Step 1: To obtain renewal certificates through forms 21C (for Schedule X Drugs/ Allopathic Drugs) and 20-E (for Homeopathic drugs), applicants need to submit an application using forms 19,19B and 19C and conditions for additional information. The application forms are available on the state drug controller's website.

Step 2: The applicants must pay the fee through an electronic challan. The prices are for Homoeopathic License, and Schedule X licenses must be payable to the head of Accounts. You can also reach CA services to get help.

Step 3: With the login credential of the company, the license holder is required to access the State's portal for drug control and create a new account by clicking"New Inward "New Inward." Then the applicant has to upload the documents requested under the sales regulations that will be available the following login. Finally, they must e-mail the application.

Step 4: Post-generating application; print the form's print 19/19B/19C. Note the inward ID following the application being filled out to be able to refer back later. It is essential to note that the Inward Identification generated from the portal must be pointed out on the cover letter before making your application documents.

Step 5: Duplicate all the documents, together with a copy of the e-challan, that has been paid toward the application fee to the Clerk of entry within 72 hours of the e-send of the application.

Process After File Submission

1. The original physical replica of the application was received from the inward section. The entry clerk shares the entry file with the Account department to vet the amount paid through the challan.

2. After vetting the amount, the account section will forward the appropriate file officially to be processed further. The official responsible for the application places the application into the file of the licensee and scrutinizes the application documents. 

3. The Director looks over the form and passes this to ADC/ Drugs Inspector for further processing. This is done electronically. Physical copies also move when the electronic form moves. The drugs Inspector/ADC must review the documents and inspect the facility. The drugs Inspector/ADC will propose the drug license renewal certificate if all required documents are supplied and the facility has been found satisfactory upon inspection.

4. Based on the findings of the inspection, The Drugs Inspector/ADC will make a recommendation based on the results of the:

  1. Issue of renewal certificates
  2. Grant of show cause letters
  3. Letter of correction

5. Then share the file with the Assistant Director/ Deputy Director Drugs Controller or the Assistant Drugs Controller. The ADA/Deputy Director will share their suggestions and forward the recommendation to the Director.

6. In the event of 7(a), the online drug license renewal registration for the last time is approved by the Director of the licensing authority. The file is sent to the Dispatch Clerk. In the event of 7(b) 7(b), the license holder is required to provide clarification in writing to Clerk online.

7. The application is shared with the Entry Clerk using the person who deals with it. Dealing Hand files the applicant's response and shares the information with the Drugs Inspector.

When the License holder grants:

If there is a) satisfactory clarification or response, the Drugs Inspector must suggest issuing online drug license renewal certificates and sharing the information with the relevant ADCor Dy. Director. The data is kept electronically.

b) If the clarification needs to be more satisfactory, the Drugs Inspector should suggest a face-to-face meeting with Director and give the report to the ADC or the Deputy Director.

ADC/Dy. Director will forward the file and provide his findings.

If the license holder is in (a) in the event of (a), the Director will confer the renewal Certificate on the licensee. Then, the final certificate is issued by the Director in online mode. If (b) the license holder is summoned for a face-to-face hearing.

In the continuation of 13(a), electronically signed licenses will be printed and then dispatched to the Dispatch clerk. If there is a violation of 13(b), the post-f2f hearing warning/suspension is issued to the license holder.

The license holder should get the drug license renewal registration from the Technical Section of the Food & Drugs Administration Directorate.

NOTE 1) Renewability of registration - valid up to 5 years following the date of issuance, subject to the conditions specified in the license and rules of the Drugs & Cosmetics Act, 1940, and the powers that go with it.


In the end, it is safe to affirm that the Wholesale renewal of a license to practice medicine is a lengthy procedure that requires various complex steps and many documents. The process of renewing without knowing the process beforehand could increase the likelihood of making an error that eventually causes the cancellation in the case of an application. To make things easier, use the assistance of an experienced firm such as Legalpillers.

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