Bihar Drug License:- A license is necessary for conducting business activities concerning pharmaceuticals, drugs, and cosmetics. The Bihar State Pharmacy Council serves as the licensing authority for issuing drug licenses in Bihar. The council is responsible for monitoring the manufacturing, selling, and distribution of drugs in the state by enforcing central drug and pharmaceutical laws. This article provides a comprehensive guide on the process of obtaining a drug license in Bihar.
Drugs & Cosmetics Act 1940
The Drugs & Cosmetics Act of 1940 lays down specific regulations for the import/export, production, and distribution of drugs and cosmetics, which must be done under Licenses and permits. The legislation guarantees that only qualified individuals can participate in the manufacture, distribution, and sale of drugs and cosmetics. Its primary purpose is to safeguard against poor-quality medications so that the medical profession can maintain its high standards of patient care.
License Conditions
- Any person who wants to sell, stock, display, or offer drugs for distribution or sale must have a license issued by the appropriate authority. The license can come in six different forms, known as Form 20, 20B, 21B, 20F, 20G, or 21. However, this license should not be granted or extended unless the issuing authority has given approval.
- No individual should receive a license in the form of 20A or 21A unless it has been authorized by the appropriate licencing authority.
- No individual is allowed to obtain a license for Form 20C or Form 20D for 4 homeopathic medicines unless authorized by the issuing authority.
Eligibility Criteria
Any individual, group of persons, partnership firm Any individual or corporation interested in establishing a medical store for retail or wholesale purposes must obtain a drug license from the Inspector of Drugs in their respective jurisdiction. The individual or company must also have a separate store with enough space to gain permission for the Drug License.
Documents Required
The documents required for the application of Retail, Wholesale Drug License and Manufacturer License should be uploaded by the applicant as enlisted below.
- Application in Statutory form
- License Fee/Challan
- The applicant must submit a declaration in the prescribed format to apply for a new license for the sale of drugs.
- Residential certificate
- Voter ID Proof
- The Aadhar card can serve as evidence of a person’s residential address.
- Evidence of the educational credentials possessed by the candidate.
- Proof of applicant’s date of birth
- A photo identification document issued by the government.
- The applicant is required to provide four coloured photographs in passport size.
- The partnership agreement is a legal document that outlines the terms and conditions of a partnership firm. It includes details such as the names of partners, their contributions to the partnership, the duration of the partnership, profit and loss sharing ratios, and the process for decision-making within the firm. A partnership deed is essential to ensure that all partners have a clear understanding of their roles and responsibilities, and to prevent disputes and conflicts from arising in the future.
- A document in the designated format declaring one’s authorization.
- Legal Proof of ownership
- Purchase receipt of the refrigerator
- A current property tax receipt is required to obtain a Non Judicial Stamp.
- In order for a qualified individual who is a licensed pharmacist to be considered, certain paperwork must be provided.
- A legal document in the required format that attests to the approval and registration of a pharmacist.
- A document indicating that a pharmacist has officially registered and obtained a license to practice their profession will be provided to them. This document will need to be periodically updated and renewed to ensure that the pharmacist’s registration remains current.
- The applicant is required to submit four coloured photographs that are passport size.
- To prove that someone is experienced, certain documents are necessary. These documents are necessary if the person is skilled and knowledgeable about a particular task.
- A sworn statement in a specific format confirming agreement and a licensed pharmacist.
- Educational qualification certificate
- I have worked in the sales of drugs for four years and can provide a certificate attesting to my experience in this field.
Note: The applicant must attest copies of all documents themselves. If the documents are related to a competent person or registered pharmacist, they must be self-attested by that person.
The act of renewing a license for retail or wholesale purposes is called the Renewal of Retail License/ Wholesale License.
- Application in Statutory form
- Renewal Fee/Challan
- Declaration in the prescribed format.
- A photocopy that has been signed by the individual of their Drug License or the previous certificate of renewal for the licenses.
- The present certification that validates the registration of a pharmacist.
Fee Structure
The table below displays the fees associated with the application of a new drug license, license renewal, and registration of license certificate.
Application Form | License Form | Grant Application Fee | License Fee (INR) | Renewal Application Fee | An extra charge of INR per month will be imposed after. the expiry of License | Duplicate License Fee |
19 | 20B | Rs. 1500 | Rs. 1500 | Rs. 1500 | Rs. 500 | Rs. 150 |
19 | 20B | Rs. 1500 | Rs. 1500 | Rs. 1500 | Rs. 500 | Rs. 150 |
19 | 20 | Rs. 1500 | Rs. 1500 | Rs. 1500 | Rs. 500 | Rs. 150 |
19A | 20 | Rs. 1500 | Rs. 1500 | Rs. 1500 | Rs. 500 | Rs. 150 |
19A | 20 | Rs. 500 | Rs. 500 | Rs. 500 | Rs. 250 | Rs. 150 |
19A | 20A | Rs. 500 | Rs. 500 | Rs. 500 | Rs. 250 | Rs. 150 |
19C | 20F | Rs. 500 | Rs. 500 | Rs. 500 | Rs. 250 | Rs. 150 |
19C | 20G | Rs. 500 | Rs. 500 | Rs. 500 | Rs. 250 | Rs. 150 |
19AA | 20BB or 21BB | Rs. 500 | Rs. 500 | Rs. 500 | Rs. 250 | Rs. 150 |
19B | 20C or D | Rs. 250 | Rs. 250 | Rs. 250 | Rs. 50 | Rs. 50 |
The method of applying for a drug license through offline channels is explained below.
To acquire a Drug license, applicants have to complete certain procedures, including submitting a physical application form.
Approach the District Head Office
Step 1: To apply for a license to sell drugs, the person applying can go to either the main office or the district offices of the licensing authority.
Get Application Form
Step 2: To obtain a license, you must obtain the designated application form from the appropriate authorities that corresponds with your license category. This form should be completed with all required information.
Note: The application form for a drug license can be obtained by downloading it from the official website of Bihar. A copy of the form is provided here for your convenience.
Step 3: You must now affix the completed additional forms to the appropriate license category for which you have requested.
Attach Required Documents
Step 4: Subsequently, you are required to affix all the essential papers listed in the aforementioned checklist.
Make Payment
Step 5: You are required to submit the designated fee (challan) at the office according to the fee schedule outlined in the above table.
Submit the Application Form
Step 6: You are required to give the application, necessary paperwork, and an authentic challan copy to the Assistant Drug Controller (ADC) located at the relevant District Drugs Control Office in your vicinity.
Step 7: Once the application form has been submitted, it is important to obtain an acknowledgement receipt which can be utilized at a later time to track the progress of the application.
Issue of Drug License
Step 8: The Licensing Authority will approve the license application if they are convinced that all requirements for obtaining or renewing the license have been satisfied and the conditions of the license have been met.
Rejection of Application
In case ADC identifies any deficiencies with the application, they will return it to the applicant. The reasons for this may include the following:
- Due to legitimate reasons, the request was denied.
- To progress the application, he requires more information/documents to be given.
The process of renewing involves three entities, namely the retailer, wholesaler, and manufacturer.
You have to renew the Drug License to get rid of penalties. You can apply for the renewal of drug license in the concerned authority. You have to submit the renewal form along with the requested documents. Then the process of renewal will be completed upon the payment.