Drug License

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.
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.

Drug license in Bihar

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 License
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.


Frequently Asked Questions

Qus: 1. How does a discount permit respond?

Ans: Although the discount permit permits you to not pay charge on your buys, contingent upon the state, you should charge your retail clients deals charge. Nonetheless, contingent upon the state, discount licenses might get various names and capacities, for example, resale grant permit, dealer’s grant or resale endorsement.

Qus: 2. How would I restore my Drug License?

Ans: Documents Check List for Renewal of License:

Present the finished application with the accompanying fenced in areas in the workplace of Drug Licensing Authority of your locale in something like 15 days of online enrollment for reestablishment:

Properly filled Form 19/19A/19AA/19C (Take out printout put signature)
Unique Treasury challan in the wake of saving the imperative expenses
Unique oath of owner/approved accomplice/approved chief or approved individual of pvt ltd or ltd Company or Trust or Society in regards to no adjustment of Name of the firm, Constitution(in instance of Proprietorship or Partnership firm), premises since award of permit.
Archives connected with Registered Pharmacist :
Duplicate of Diploma Pharmacy
Duplicate of Registration Certificate from Pharmacy Council of Uttar Pradesh
Duplicate of restoration of Registration
Duplicate of Appointment and Joining Letter
Unique oath of Pharmacist
Archives connected with Competent Person (For discount licenses)
Duplicate of Educational capability certificate(s) including High School Certificate
In the event that the able individual is an enrolled drug specialist, every one of the archives as enrolled at S.No. 11 above
Unique testimony of Competent Person
Qus: 3. What does an unlicensed medication mean?

Ans : A unique unlicensed medication is one that is made without a promoting approval (MA) from the Medicines and Healthcare items Regulatory Agency (MHRA). A MA (or item permit) is conceded by the MHRA just once a restorative item has been shown to be protected and compelling.

Qus: 4. What are marked medications?

Ans: Branded meds are meds which have a name provided to them by an organization for the motivation of publicizing. The names of marked meds are not the same as the International Nonproprietary Name (INN), otherwise called the nonexclusive name.

Qus: 5. What is the conventional name of a medication?

Ans: Medical Definition of Generic name, drug Generic name, drug: The expression “conventional name” has a few implications as respects sedates: The compound name of a medication. A term alluding to the compound cosmetics of a medication as opposed to the promoted brand name under which the medication is sold.

Licensing is mandatory to do business in Drugs & Cosmetics in India. The provisions for this has been made in Drugs & Cosmetics Act, 1940 which is applicable to whole of India. It is an Act to consolidate all the laws relating to drugs & cosmetics, which established the Drugs Control Department. In 1964, the Act was amended to include Ayurvedic & Unani drugs. However a particular business entity may require different types of drug license based on their business.

However, any violation of the medically defined limits may have a very serious effect on the health of the person using it. Therefore it requires to be regulated by the government via imposing stringent law and regulations in the process of manufacturing and distribution of drugs and medicines in India. Once you have Drug License from the government, you can deal with drugs otherwise not.

Classification 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:

  1. Duly filled Form 19/19A/19AA/19C (Take out printout put signature)
  2. Original Treasury challan after depositing the requisite fees
  3. 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.
  4. Documents related to Registered Pharmacist :
  5. Copy of Diploma Pharmacy
  6. Copy of Registration Certificate from Pharmacy Council of Uttar Pradesh
  7. Copy of renewal of Registration
  8. Copy of Appointment and Joining Letter
  9. Original affidavit of Pharmacist 
  10. Documents related to Competent Person (For wholesale licences)
  11. Copy of Educational qualification certificate(s) including High School Certificate
  12. If the competent person is a registered pharmacist then all the documents as enlisted at S.No. 11 above
  13. 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.

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