Drug License in Bihar is a legitimate declaration which is expected to do organizations connected with the drug business, drugs and beauty care products. The Bihar State Pharmacy Council (authorizing authority) issues drug permit in the province of Bihar. This office directs the assembling, deal and dispersion of medications in the territory of Bihar by carrying out applicable focal Drug and Pharmaceutical regulation in the state. In this article, we take a gander at the nitty gritty methodology of acquiring drug permit in the province of Bihar.
A drug license is a permit granted by the government to a person or a company for dealing with drugs and pharmaceuticals. It is mandatory for all businesses involved in the manufacture, sale, and distribution of drugs and pharmaceuticals in India. The drug license is issued by the State Drug Control Authority and is governed by the Drugs and Cosmetics Act, 1940 and Rules, 1945.
Meaning and Definition: The drug license is a legal document that allows a business to deal with drugs and pharmaceuticals. The license is granted by the government to ensure that the drugs and pharmaceuticals being sold or distributed are safe, effective, and of high quality.
Legal Provisions: The drug license is governed by the Drugs and Cosmetics Act, 1940 and Rules, 1945. The act defines the regulations and procedures for obtaining the license, the conditions for manufacturing, storing, and distributing drugs, and the penalties for non-compliance.
Process: The process for obtaining a drug license in Bihar involves the following steps:
Application: The applicant must submit an application form along with the required documents to the State Drug Control Authority.
Inspection: The authorities will inspect the premises where the drugs will be manufactured or stored to ensure compliance with the regulations.
Approval: If the application and inspection are satisfactory, the authorities will grant the drug license.
Renewal: The license needs to be renewed periodically as per the regulations.
Advantages: The drug license provides several advantages, including:
Legal Compliance: A drug license ensures that the business is compliant with the regulations, and any non-compliance can result in legal penalties.
Quality Assurance: The license ensures that the drugs and pharmaceuticals being sold or distributed are of high quality and safe for consumption.
Credibility: The license enhances the credibility of the business and assures customers that the products being sold are legitimate.
Disadvantages: The disadvantages of obtaining a drug license include the following:
Costs: The process of obtaining and renewing the drug license can be expensive.
Time-consuming: The process of obtaining a drug license can be time-consuming, and the business may need to wait for a few months to receive the license.
Types: The drug license can be classified into the following types:
Manufacturing License: This license is required for businesses involved in the manufacture of drugs and pharmaceuticals.
Wholesale License: This license is required for businesses involved in the wholesale distribution of drugs and pharmaceuticals.
Retail License: This license is required for businesses involved in the retail sale of drugs and pharmaceuticals.
Cost involved: The cost involved in obtaining a drug license in Bihar can vary depending on the type of license and the nature of the business. The fees for the license are prescribed by the government and are subject to change. The cost of the license can range from a few thousand rupees to several lakhs of rupees.
Time involved: The time involved in obtaining a drug license in Bihar can vary depending on the type of license and the nature of the business. The process can take anywhere from a few weeks to a few months.
Documents required: The documents required for obtaining a drug license in Bihar include the following:
- Application Form
- ID Proof of Applicant
- Address Proof of Applicant
- Proof of Ownership or Lease Agreement of Premises
- Blueprint of the Layout of the Premises
- List of Machinery and Equipment
- Qualification and Experience Certificate of the Technical Staff
- Financial Plan and Bank Statement
- Undertaking of the Technical Staff
- Compliance Certificate from a Chartered Accountant or Company Secretary
Permitting is compulsory to carry on with work in Drugs and Cosmetics in India. The arrangements for this has been made in Drugs and Cosmetics Act, 1940 which is pertinent to entire of India. It is an Act to unite every one of the regulations connecting with drugs and beauty care products, which laid out the Drugs Control Department. In 1964, the Act was altered to incorporate Ayurvedic and Unani drugs. Anyway a specific business element might require various sorts of medication permit in view of their business.
Sectioin 3(b) of the Drugs and Cosmetics Act,1940 characterizes “drug” to incorporate all medications and gadgets for the utilization of people or creatures inside or remotely, and all substances intended to be utilized for or in the determination, relief, treatment, or counteraction of any problem or sickness in creatures or individuals, including arrangements applied on the human body to repulse bugs like mosquitoes; it additionally incorporates everything substances that can be utilized for the annihilation of bugs and all parts of a medication – like void gelatin cases. The definition was corrected in 1964, to incorporate Ayurvedic and Unani Drugs.
Kinds of Drug Licenses Issued in Bihar:
Following are the various kinds of licenses gave relying on the sort of business for which the permit is gotten:
Producing Drug License
Every one of the makers of allopathic, beauty care products, ayurvedic items or some other meds or medications as indicated under the Drugs and Cosmetics Act 1940. This is the state permit that is given by the specific state government where the unit is arranged.
Advance Drug License
The producer of medications who don’t have land on his own somewhat able to fabricate utilizing his image name on the land to which permit is now given.
Import Drug License
Any vendor bringing in the items for the assembling of medications or is occupied with the matter of bringing in drugs in India will get this permit.
Multi-Drug permit is gained by the element working in more than one state having numerous units.
Wholesale Drug License
Deal drug permit is gained by the substance occupied with whether discount or retail business for circulation of medications in India.
Discount Drug License
Wholesalers doing the matter of drugs will get discount drug permit from the focal medications standard control association. Discount drug permit determines specific least prerequisite on the individual applying for this permit, for example,
1. Degree and confirmation in drug store
2. Least 1-year experience in drug managing
Retail Drug License
This permit is acquired by retailers occupied with the matter of drugs, independent drug specialists, and so on by applying to the State Pharmacy Council.
Notwithstanding, any infringement of the medicinally characterized cutoff points might affect the strength of the individual utilizing it. In this way it expects to be controlled by the public authority through monumental tough regulation and guidelines during the time spent assembling and conveyance of medications and meds in India. When you have Drug License from the public authority, you can manage tranquilizes in any case not.
Arrangement of Drug License
Drug License is arranged into following classifications:
– Producing License: To produce allopathic or homeopathic medications and beauty care products can be allowed exclusively in perceived modern region of the State dependable.
– Deal License: It is additionally arranged into two distinct classes:
Retail Drug License
Discount Drug License
– Advance Drug LicenseLicense: This sort of permit is given to an individual who needs to profit the assembling offices possessed by another licensee.
Assuming a drug store business is working in more than one state in India, it is expected to get drug permit from each state which it is working.
Types of Drug Licence:
Drug License is classified into following categories:
– Manufacturing Drug License: To manufacture allopathic or homoeopathic drugs and cosmetics can be granted only in recognized industrial areas of the State responsible.
– Sale License: It is further classified into two different categories:
- Retail Drug License
- Wholesale Drug license
– Loan License: This type of licence is issued to a person who wants to avail the manufacturing facilities owned by another licensee.
If a pharmacy business is operating in more than one state in India, it is required to obtain drug licence from each state which it is operating.
Step by Step ONLINE procedure for applying new drug license (Retail & Wholesale)
- Visit the portal
- Click on drop box and select State
- Apply for USER ID and Password (You will get USER ID and Password on your Registered Mobile)
- Enter user name and password
- After that click on submit button
- Change your Password for privacy and security (available on right top corner of your screen)
- Click on Update my details (available on left top corner of your screen) and correct, if required
- Once corrected click on update button
- Go to Menu and click on Prepare/Edit online application
- Click on New Inward (available on right top corner of your screen)
- Click on Ok button
- Click on Storage type and select at least one from them (compulsory)
- Click on Document type from drop box and select Aadhar Card (compulsory) and fill Aadhar No.
- Click on Inward type from drop box and select Fre-addl/Fresh license
- Click on RP IN RETAIL /CP IN WHOLESALE button (Not required for Form 20C & 20A/21A)
- Click on ADD button and fill all the details. Upload Photographs and Documents. (Certificate will consist of Registration Certificate of pharmacist from state pharmacy tribunal and Current renewal)
- and Save Click on CON button and then on ADD button. Fill all the details and Save
- Take a print out of self-declaration of RP/CP and proprietor. Get it signed by registered pharmacist and proprietor/authorized signatory Keep it for uploading with other documents when required
- Click on Back button
- Click on By Firm & Print Form
- Print Form 19/19A/19B/19C and Log out
- proprietor/authorized signatory should sign system generated Form 19/19A/19B/19C
- Keep it for uploading with other documents when required
- Payment of fee through (E payment gateway)
- Print and upload Challan
- After receiving the Challan receipt & Login with User ID & Password
- Click on By Firm (Left Top Corner)
- Click on Payment Entries
- Click on New (Right Top Corner)
- Select payment type FRAS Payment and fill all details. (Upload scanned copy of deposited Challan by
- using Choose file option) then Save
- Click on Upload document and upload all the required document then click on Close button
- Click on Additional information/Undertaking
- Click on Undertaking Button of the same screen, fill and click on E-Sign button
- Click on Additional form information button and then on Back button
- Certify and e-Send Application to Dept—-Licensing Authority
- Licensing authority will forward it to Drug Inspector—5 working Days-Drug Inspector
- Drug Inspector will verify the document and premises—-Drug Inspector
- Drug Inspector will submit his report to Licensing Authority—15 working Days Licensing Authority
- After viewing the report Licensing Authority will grant or reject the License—10 working
- Days-Licensing Authority
- Final License must print within three days from Dt.Of Grant by Applicant
Frequently Asked Questions
Qus: 1. What does a wholesale license do?
Ans: Although the wholesale license allows you to not pay tax on your purchases, depending on the state, you must charge your retail customers sales tax. However, depending on the state, wholesale licenses may receive different names and functions, such as resale permit license, seller’s permit or resale certificate.
Qus: 2. How do I renew my drug license?
Ans: Documents Check List for Renewal of Licence
Submit the completed application with the following enclosures in the office of Drug Licensing Authority of your district within 15 days of online registration for renewal:
- Duly filled Form 19/19A/19AA/19C (Take out printout put signature)
- Original Treasury challan after depositing the requisite fees
- Original affidavit of proprietor/authorised partner/authorised director or authorised person of pvt ltd or ltd Company or Trust or Society regarding no change in Name of the firm, Constitution(in case of Proprietorship or Partnership firm), premises since grant of licence.
- Documents related to Registered Pharmacist :
- Copy of Diploma Pharmacy
- Copy of Registration Certificate from Pharmacy Council of Uttar Pradesh
- Copy of renewal of Registration
- Copy of Appointment and Joining Letter
- Original affidavit of Pharmacist
- Documents related to Competent Person (For wholesale licences)
- Copy of Educational qualification certificate(s) including High School Certificate
- If the competent person is a registered pharmacist then all the documents as enlisted at S.No. 11 above
- Original affidavit of Competent Person
Qus: 3. What does an unlicensed drug mean?
Ans : A special unlicensed medicine is one that is manufactured without a marketing authorization (MA) from the Medicines and Healthcare products Regulatory Agency (MHRA). An MA (or product licence) is granted by the MHRA only once a medicinal product has been proven to be safe and effective.
Qus: 4. What are branded drugs?
Ans: Branded medicines are medicines which have a name given to them by a company for the purpose of advertising. The names of branded medicines are different from the International Nonproprietary Name (INN), also known as the generic name.
Qus: 5. What is the generic name of a drug?
Ans: Medical Definition of Generic name, drug Generic name, drug: The term “generic name” has several meanings as regards drugs: The chemical name of a drug. A term referring to the chemical makeup of a drug rather than to the advertised brand name under which the drug is sold.
A medicine license or drug license is a legal permit issued by the regulatory authorities to allow an individual or entity to manufacture, store, distribute, and sell medicines and drugs. The license is required to ensure that the drugs or medicines being sold in the market are safe, effective, and of good quality.
The drug license is regulated by the Central Drugs Standard Control Organization (CDSCO) and the State Drug Control Administration. In Bihar, the Bihar State Drug Control Administration (BSDCA) is responsible for regulating and issuing drug licenses.
The legal provisions for drug license registration in Bihar are governed by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. The act and rules provide guidelines and regulations for the manufacture, storage, sale, distribution, and import of drugs and medicines.
The process of obtaining a drug license in Bihar involves the following steps:
Application: The applicant must submit an application for the drug license to the concerned authority. The application must contain all the necessary details such as the name of the business, address of the business, and the details of the drugs and medicines to be manufactured, stored, or sold.
Premises: The applicant must ensure that the premises where the drugs and medicines are manufactured, stored, or sold comply with the rules and regulations prescribed by the regulatory authorities.
Personnel: The applicant must ensure that the personnel employed in the business have the necessary qualifications and experience as prescribed by the regulatory authorities.
Inspection: The regulatory authorities may conduct an inspection of the premises and verify the details provided by the applicant.
License fee: The applicant must pay the prescribed license fee to obtain the drug license.
The advantages of obtaining a drug license include legal protection, credibility, and increased trust among the customers. However, there are also some disadvantages such as the cost involved in obtaining the license and the need to comply with the strict regulations and guidelines prescribed by the regulatory authorities.
The cost and time involved in obtaining a drug license in Bihar may vary depending on the type of license and the size of the business. The documents required for drug license registration in Bihar include:
Proof of premises ownership or rental agreement
Proof of identity and address of the applicant
Proof of qualifications and experience of the personnel
Details of the drugs and medicines to be manufactured, stored, or so