Navigating Odisha's Drug Licensing maze? We've got you covered! Explore all license types, online application guides, & costs. Start, renew, or manage your license with ease.

If you want to run a business in pharmaceuticals, selling drugs, or cosmetics, you need a special permission called a drug license. In Odisha, this permission is given by the Food Safety and Drug Administration Department of the state government. The department that looks after how drugs are made, sold, and distributed in Odisha is called the Drugs Control Administration (DCA). They follow certain rules and laws about drugs and medicines set by the central government. This article explains in simple terms how to get a drug license in Odisha.

What is an Odisha Drug License?

An Odisha Drug License is a legal document issued by the Food Safety and Drug Administration Department of the Odisha State Government, authorizing individuals or businesses to manufacture, sell, or distribute drugs and cosmetics within the state. It’s essentially a permit that ensures compliance with the Drugs and Cosmetics Act and Rules of India, guaranteeing the safety and quality of drugs circulating in the market.

Obtaining an Odisha Drug License involves various steps and requirements depending on the type of license sought (retail, wholesale, manufacturing). The process typically involves:

1. Application: Submitting the required forms and documents online or at the designated office.
2. Inspection: A Drugs Inspector visits the premises to assess compliance with infrastructure, storage, and quality control parameters.
3. Grant of License: Upon successful inspection and verification of documents, the license is issued.

Who Needs an Odisha Drug License?

In Odisha, anyone who wants to engage in any of the following activities requires an Odisha Drug License

1. Manufacturing drugs and cosmetics: This includes any facility involved in the production, processing, or packaging of drugs or cosmetics, regardless of the scale of operation.
2. Selling drugs and cosmetics: This applies to any individual or business entity that sells drugs and cosmetics directly to consumers, through retail outlets like pharmacies or shops.
3. Distributing drugs and cosmetics: This includes wholesalers who purchase drugs and cosmetics from manufacturers and sell them to other businesses, such as pharmacies or hospitals.
4. Importing or exporting drugs and cosmetics: Any individual or business importing or exporting drugs and cosmetics into or out of Odisha needs a license.
5. Storing drugs and cosmetics: Entities responsible for storing drugs and cosmetics, such as warehouses or hospitals, require a license to ensure proper storage and handling practices.

Exemptions

There are a few limited exemptions to the requirement for an Odisha Drug License. These typically apply to:

• Traditional Ayurvedic and Unani medicines: These medicines are regulated under separate laws and may not require a license depending on the specific product and its intended use.
• Homeopathic medicines: Similar to Ayurvedic and Unani medicines, homeopathic medicines may have specific regulations and exemptions depending on the product.
• Research and development: Activities related to research and development of new drugs may have temporary exemptions or specific licensing requirements.

Eligibility Criteria for an Odisha Drug License

Anyone, whether an individual, a group of people, a partnership firm, or a company, who wants to start a retail medical store or a wholesale medical outlet, must obtain a drug license from the Inspector of Drugs in their area. To qualify for a retail or wholesale drug license, the applicant needs to have a standalone shop with a sufficient area.

Conditions for Granting Drug License

There are two types of drug licenses in India: retail licenses and wholesale licenses for drug distribution or sale. To obtain a drug license, applicants must adhere to specific conditions:

1. The premises for which a retail or wholesale license is sought must be at least 10 square meters.
2. For applications using Form 20 or Form 21, the licensing authority ensures that the premises are a minimum of 10 square meters.
3. For applications using Form 20-B or Form 21-B, the licensing authority ensures that the premises are a minimum of 15 square meters.

Documents Required

Applicants need to upload the following documents when applying for Retail, Wholesale Drug License, or Manufacturer License:

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

Renewal of Drug License

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

Requirement in Case of Loan License

• Consent letter from the Principal manufacturing unit.
• Copy of the valid drug license of the manufacturing unit.
• Production capacity of the drug applied for under the loan drug license.
• Copy of GMP (if any).

Fee Structure for Drug Licenses

Application Form	License Form	Grant Application Fee (₹)	License Fee (₹)	Renewal Application Fee (₹)	Additional Fee (₹) per Month or Part Thereof Within 6 Months After Expiry of License	Duplicate License Fee (₹)
19	20B	1500	1500	1500	500	150
19	20B	1500	1500	1500	500	150
19	20	1500	1500	1500	500	150
19A	20	1500	1500	1500	500	150
19A	20	500	500	500	250	150
19A	20A	500	500	500	250	150
19C	20F	500	500	500	250	150
19C	20G	500	500	500	250	150
19AA	20BB or 21BB	500	500	500	250	150
19B	20C or D	250	250	250	50	50

Application Procedure for Drug License – Online Method

Applicants need to follow these steps to obtain a drug license by submitting the application form online.

1: Visit the LMS portal

• Step 1: Initially, visit the Licensing Management System (LMS) portal to obtain a drug license.

2: New Applicant’s Login Page

• Step 2: If you’re a new user, register on the portal by clicking the ‘New Applicant’ tab to access license services.
• Step 3: Upon clicking ‘New Applicant,’ the registration page will display.
• Step 4: Fill in the required information:

1. Applicant’s Full Name
2. Mobile Number
3. ID Proof (Driving License, PAN, Voter ID, Passport, Aadhaar) Number
4. Registered for: Retailer/Wholesaler/Manufacturer
5. Apply for: New License/Registration or Renew

• Step 5: After submitting, receive a confirmation code on your registered mobile number. Enter the code in the Confirmation box and click ‘Final Submit’ to proceed to Retailer/Wholesaler/Manufacturer/Pharmacist registration.

3: Login to Portal

• Step 6: Log in to the LMS portal using your user id and password.
• Step 7: For existing applicants, log in directly.

4: Application Process – Retail Drug License

• Step 8: After logging in, the Retailer registration form appears. Fill in the required information:

1. Name of the firm
2. Applicant Type: Proprietor/Partner/Pvt. Ltd/Limited
3. Upload your photo (within 150 KB in jpg/jpeg format)
4. Upload your ID proof (within 100 KB in jpg/jpeg format)
5. Choose your District/Zone and Police Station
6. Provide a valid E-Mail
7. Enter security captcha

• Step 9: Click ‘Apply’ and receive your user id and password for further registration.
• Step 10: Click ‘Proceed’ and enter your login id and password. Enter the security captcha and click ‘Login.’
• Step 11: Click ‘New Apply’ for new retailer registration.
• Step 12: Select ‘Apply for License (Retailers/Restricted Retailers/Homeopathic Retailers).’
• Step 13: Fill in the requested details and click ‘Apply.’
• Step 14: Upon clicking ‘Apply,’ the page will display.
• Step 15: Fill all mandatory text box fields.
• Step 16: Click ‘Save’ after filling all the fields.

5: Upload Requested Documents

• Step 17: Upload photocopies of the documents (Only pdf/jpg/jpeg files allowed).
• Step 18: After uploading, check the Declaration button and click ‘Save.’
• Step 19: Receive a message stating ‘Your application has been registered.’ Click ‘Print’ for a hard copy.

6: Application Process – Wholesale Drug License

• Steps 19-27 repeated with ‘Wholesaler’ specifics

7: Application Process – Manufacturer License

• Steps 29-35 repeated with ‘Manufacturer’ specifics

Renewal Process (Retailer, Wholesaler, Manufacturer)

• Step 1: Navigate to Renewal Page

Access the dedicated renewal page designed for wholesalers, retailers, or manufacturers.

• Step 2: Select Zone, Range, and Registration Number

Choose the relevant Zone, specify the Range, and input the registration number associated with your license.

• Step 3: Click ‘GO’

Initiate the renewal process by clicking the ‘GO’ button.

• Step 4: Fill in Requested Information

Provide the necessary details requested on the renewal form.

• Step 5: Click ‘Apply’

Submit your renewal application by clicking the ‘Apply’ button.

• Step 6: Upload Documents

Upload the required documents essential for the renewal process, ensuring they comply with the specified file format.

• Step 7: Check Declaration Button

Confirm your adherence to regulations by checking the Declaration button.

• Step 8: Click ‘Save’

Save your renewal application by clicking the ‘Save’ button.

• Step 9: Receive Confirmation

A pop-up message will appear, confirming the successful registration of your renewal application.

• Step 10: Print Confirmation

Obtain a hard copy of the confirmation for future reference by clicking on the ‘Print’ option.

FAQs

Who can apply for an Odisha Drug License?

Eligibility depends on the type of license you're seeking: Retailer: Indian citizen with requisite qualifications and infrastructure. Wholesaler: Registered company or partnership firm with qualified personnel. Manufacturer: Manufacturing unit complying with Drugs & Cosmetics Act and Rules.

What documents are required for application?

Required documents vary based on license type, but generally include: Application form with applicant details. Proof of identity and address. Qualification certificates (pharmacist for retail). Shop/premises layout plan. Drug storage and security details. Fee payment challan.

How long is an Odisha Drug License valid?

All licenses are valid for five years from the date of issue.

How can I renew my Odisha Drug License?

Apply online or offline at least 60 days before expiry, attaching necessary documents.

What are the fees for obtaining a license?

Fees vary depending on license type and location. Check the Odisha Drug Control Administration website for current rates.:

What are the penalties for operating without a license?

Operating without a license can result in hefty fines, seizure of drugs, and even imprisonment.

How can I report a drug store operating without a license?

You can file a complaint online or contact the nearest Drug Control Officer.

What does the Odisha State Drugs Control Authority (OSDCA) do?

OSDCA regulates the manufacturing, sale, and distribution of drugs in Odisha, ensuring quality and public safety.

Are there any recent updates to the Odisha Drugs and Cosmetics Rules?

Stay updated by regularly checking the OSDCA website for notifications and announcements regarding rule changes.

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