Odisha Drug License

Odisha Drug License

Odisha Drug License

Drug license is a legal document which is required to do businesses related to the pharmaceutical industry, drugs & cosmetics. Odisha drug license is issued by the Food Safety and Drug Administration Department of the Odisha State Government. The Drugs Control Administration (DCA) regulates the manufacture, sale and distribution of drugs in the state of Odisha by implementing relevant central Drug and Pharmaceutical legislation in the state. In this article, we look at the detailed procedure for obtaining Odisha drug license.

Drugs and Cosmetics Act, 1940

This Act regulates the import/ export, manufacture, distribution and sale of drugs & cosmetics, and clinical Research of Drugs and Cosmetics through licensing in India. It also ensures that the drugs and cosmetics that are sold in India is safe, conforms and effective to state quality standards. This Act aims to establish Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC) for Allopathic and allied drugs and cosmetics.

Eligibility Criteria

Any individual, group of persons, partnership firm or company willing to open a retail medical store or wholesale medical outlets, has to get drug license from Inspector of drugs of its jurisdiction. The person will have to provide with an independent shop with an adequate amount of area to get permission for retail or wholesale Drug License.

Conditions for Granting Drug License

There are two kinds of drug license, the retail license and wholesale license of for drug distribution or sale in India. For obtaining a drug license, there are certain conditions that applicant will have to follow.

  • The area in premises of which a retail or wholesale license is to be granted must not be less than 10 square meters.
  • In respect of the application for the grant of drug license in Form 20 or Form 21 individually or both, the licensing authority will satisfy itself that the premises of an area of not less than 10 meters.
  • In respect of the application for the grant of drug license n Form 20-B or Form 21-B individually or both, the licensing authority will satisfy itself that the premises of an area of not less than 15 meters.

Documents Required

The below listed are the documents to be uploaded by the applicant while applying for the Retail, Wholesale Drug License and Manufacturer License.

  • Proof of Residence
  • Identity Proof
  • Refrigerator Receipt
  • Qualifying Exam Certificate
  • Distributor Declaration
  • Experience Certificate (If Any)
  • Khatian/ Documentary proof in support of Ownership of land
  • Specimen Signature of RP/CP
  • Tenancy/ House rent Agreement
  • Location and layout sketch map of premises
  • Character Antecedent Verification Certificate
  • Location and layout sketch map of premises
  • Declaration of RP/CP
  • Affidavit of RP/CP

Renewal of Drug License

  • Online deposition of fees via treasury portal.
  • Tenancy/house rent agreement certificate by notary or NOC for a further period of minimum five years.
  • Self-declaration of a competent person in a prescribed format with signature and date.
  • Declaration of the firm regarding the changes
  • Resolution of Board of Directors

Additional Requirement in Case of Loan License

  • Consent letter from the Principal manufacturing unit
  • Copy of valid drug license of manufacturing unit
  • The production capacity of the drug for which applied for loan drug license
  • Copy of GMP (if any)

Fee Structure

The below-tabulated shows the charge/ fees for the applying of a new Drug license, renewal of license and the registration of license certificate.

Application FormLicense FormGrant Application FeeLicense Fee (INR)Renewal Application FeeAdditional Fee (INR) per Month or part thereof within 6 months after expiry of LicenseDuplicate License Fee
1920BRs. 1500Rs. 1500Rs. 1500Rs. 500Rs. 150
1920BRs. 1500Rs. 1500Rs. 1500Rs. 500Rs. 150
1920Rs. 1500Rs. 1500Rs. 1500Rs. 500Rs. 150
19A20Rs. 1500Rs. 1500Rs. 1500Rs. 500Rs. 150
19A20Rs. 500Rs. 500Rs. 500Rs. 250Rs. 150
19A20ARs. 500Rs. 500Rs. 500Rs. 250Rs. 150
19C20FRs. 500Rs. 500Rs. 500Rs. 250Rs. 150
19C20GRs. 500Rs. 500Rs. 500Rs. 250Rs. 150
19AA20BB or 21BBRs. 500Rs. 500Rs. 500Rs. 250Rs. 150
19B20C or DRs. 250Rs. 250Rs. 250Rs. 50Rs. 50

Application Procedure for Drug License – Online Method

The applicants must follow the following steps to obtain a Drug license by submitting the application form online.

Visit the LMS portal

Step 1:  Firstly, the applicants have to visit the Licensing Management System (LMS) portal for obtaining drug license.

Step 1 - Odisha Drug License
Step 1 – Odisha Drug License

New Applicant’s Login Page

Step 2:  In case if you’re a new user, then you will have to register yourself with the portal by clicking on the ‘New Applicant’ tab to avail the license services.

Step 2 - Odisha Drug License
Step 2 – Odisha Drug License

Step 3: Upon clicking on the ‘New Applicant’ button, the applicant’s registration page will be displayed as shown below:

Step 3 - Odisha Drug License
Step 3 – Odisha Drug License

Step 4: Then you have to fill out all the below following information

  • Applicant’s Full Name
  • Mobile Number
  • ID Proof (Driving License, PAN, Voter ID, Passport, Adhaar) Number
  • Registered for- Retailer/ Wholesaler/ Manufacturer
  • Apply for- New License/ Registration or Renew
Step 4 - Odisha Drug License
Step 4 – Odisha Drug License

Step 5: After clicking on the Submit Button, you will get a confirmation Code on your registered mobile number. Then you have to put that received code in the Confirmation box and click on “Final Submit” button, which will direct you to the registration page for Retailer/ Wholesaler/ Manufacturer/ Pharmacist.

Login to Portal

Step 5: Once you got registered successful with the portal, log in to the LMS portal using your user id and user password.

Step 5 - Odisha Drug License
Step 5 – Odisha Drug License

Step 6: In case if you’re an Existing Applicant, you can log in to the system directly.

Application Process – Retail Drug License

Step 7: After completing the above process, the Retailer registration form will be displayed on the screen. The applicant’s name and the mobile number will be prefilled.  Now you have to fill the following information in the form.

  • Name of the firm
  • Applicant Type- Proprietor/Partner/Pvt. Ltd/ Limited
  • Upload your photo (within 150 KB in jpg/jpeg format)
  • Upload your ID proof (within 100 KB in jpg/jpeg format)
  • Choose your District/ Zone and Police Station
  • Valid E-Mail to be provided
  • Enter security captcha
step 7 - Odisha Drug License
step 7 – Odisha Drug License

Step 8: After updating all the details, click on the “Apply” button. Now you will receive your user id and password for the further registration process.

Step 9: Then click on the “Proceed” button, where you will be taken to the login page. You have to enter your received login id and password. Now enter the security captcha as shown and click on the “Login” button.

Step 10: Now click on the “New Apply” button for the new registration of retailer.

Step 10 - Odisha Drug License
Step 10 – Odisha Drug License

Step 11: In this page, select the Apply for License (Retailers /Restricted Retailers/ Homeopathic Retailers).

step 11 - Odisha Drug License
step 11 – Odisha Drug License

Step 12: After selecting any of the options, you have to fill out all the requested details. Then click on the ‘Apply’ button for further registration.

Note:  The Forms will be displayed to the License Category on which you have chosen already at the start.

Step 13: Upon clicking on the apply button, the following page will be displayed

Step 13 - Odisha Drug License
Step 13 – Odisha Drug License

Step 14: In this page, you have to fill all the text box fields (All the Fields are Mandatory).

Step 15: After filling all the fields, you need to click the “Save” button.

Upload Requested Documents

Step 16: Now you have to upload the photocopy of the documents (Only pdf/jpg/jpeg files allowed).

Step 17: After uploading all the documents, have to check the button of Declaration and have to click on the “Save” button.

step 17 - Odisha Drug License
step 17 – Odisha Drug License

Step 18: You will receive a message stating “Your application has been registered”. You can also make a print of it by clicking on the ‘Print’.

Step 18 - Odisha Drug License
Step 18 – Odisha Drug License

Application Process – Wholesaler Drug License

Step 19: The registration process up to get the user id and password is the same as the process of retailer registration. After the login the following page will be displayed:

Step 19 - Odisha Drug License
Step 19 – Odisha Drug License

Step 20: Now click on the “New Apply” button for new registration of Wholesale.

Step 21: In this page, select the Apply for License (Wholesalers, Wholesaler Motor Vehicle, Homeopathic Wholesalers).

Step 21 - Odisha Drug License
Step 21 – Odisha Drug License

Step 22: After selecting any of the options, you have to fill out all the requested details. Then click on the ‘Apply’ button for further registration.

Note:  The Forms will be displayed to the License Category on which you have chosen already at the start.

Step 23: Upon clicking on the apply button, the following page will be displayed

Step 23 - Odisha Drug License
Step 23 – Odisha Drug License

Step 24: In this page, you have to fill all the text box fields (All the Fields are Mandatory).

Step 25: After filling all the fields, you need to click the “Save” button.

Upload Requested Documents

Step 26: Now you have to upload the photocopy of the documents (Only pdf/jpg/jpeg files allowed).

Step 27: After uploading all the documents, have to check the button of Declaration and have to click on the “Save” button.

Step 27 - Odisha Drug License
Step 27 – Odisha Drug License

Step 28: You will receive a message stating “Your application has been registered”. You can also make a print of it by clicking on the ‘Print’.

Application Process – Manufacturer License

Step 29: The registration process up to get the user id and password is the same as the process of retailer registration. After the login the following page will be displayed:

Step 29 - Odisha Drug License
Step 29 – Odisha Drug License

Step 30: In this page, select the Apply for License (Allopathy, Homeopathy, Cosmetic, Blood Bank).

Step 31: After selecting any of it, you have to click on the Apply button for the further registration process.

Step 31 - Odisha Drug License
Step 31 – Odisha Drug License

Step 32: In this page, you have to fill all the text box fields (All the Fields are Mandatory).

Step 33: After filling all the fields, you need to click the “Save” button.

Upload Requested Documents

Step 34: Now you have to upload the photocopy of the documents (Only pdf/jpg/jpeg files allowed).

Step 35: After uploading all the documents, have to check the button of Declaration and have to click on the “Save” button.

Step 35 - Odisha Drug License
Step 35 – Odisha Drug License

Step 36: You will receive a message stating “Your application has been registered”. You can also make a print of it by clicking on the ‘Print’.

Renewal Process (Retailer, Wholesaler, Manufacturer)

The Process of Applying renewal is the same for the wholesaler/retailer/ Manufacturer; in the renewal page, you have to select the Zone, Range and the registration number. Then click on the GO button. Now fill all the requested information, and click on the apply button. On clicking on the apply button, the registration process starts. The forms will be displayed as per the license category has already chosen. After uploading all the documents, have to check the button of Declaration and have to click on the “Save” button. You will get a pop-up message stating “Your application has been registered”. You can also make a print of it by clicking on the ‘Print’ for future reference.

Renewal of License - Odisha Drug License
Renewal of License – Odisha Drug License

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Post by Sinduja Shankar

IndiaFilings is India's largest online compliance services platform dedicated to helping people start and grow their business, at an affordable cost. We were started in 2014 with the mission of making it easier for Entrepreneurs to start their business. We have since helped start and operate tens of thousands of businesses by offering a range of business services. Our aim is to help the entrepreneur on the legal and regulatory requirements, and be a partner throughout the business lifecycle, offering support at every stage to ensure the business remains compliant and continually growing.