Bihar Drug License

Bihar Drug License

Bihar Drug License

Drug License is a legal certificate which is required to do businesses related to the pharmaceutical industry, drugs & cosmetics. The Bihar State Pharmacy Council (licensing authority) issues drug license in the state of Bihar. This department regulates the manufacture, sale and distribution of drugs in the state of Bihar by implementing relevant central Drug and Pharmaceutical legislation in the state. In this article, we look at the detailed procedure of obtaining drug license in the state of Bihar.

Drugs & Cosmetics Act 1940

Drugs & Cosmetics Act, 1940 governs structured rules to regulate the import/ export, manufacture and sale or distribution of drugs and cosmetics through Licenses and permits. This Act ensures the manufacture, distribution and sale of drugs and cosmetics only by the qualified officials. It prevents the sub-standard of drugs, presumably for maintaining high standards of medical treatment.

License Conditions

  • A license in Form 20, 20B, 21B, 20F, 20G, or 21 to sell, stock, exhibit or offer for distribution or sale drugs should not be granted or renewed to any person unless the authority empowered to issue the license.
  • A license form 20A or form 21A should not be issued to any person unless the authority authorised to grant the license.
  • A license of Form 20C or Form 20D to 4 Homoeopathic medicines should not be granted to any person unless the authority empowered to issue the license.

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.

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.

  • Application in Statutory form
  • License Fee/Challan
  • Declaration for new drug sale license in prescribed format by the applicant
  • Residential certificate
  • Voter ID Proof
  • Aadhar card for proof of residential address
  • Proof of educational qualification of applicant
  • Proof of applicant’s date of birth
  • Government document with a photo for identification
  • Four passport size coloured photo of the applicant.
  • Partnership deed in case of partnership firm
  • Affidavit in prescribed format regarding consent
  • Legal Proof of ownership
  • Purchase receipt of the refrigerator
  • Non Judicial Stamp with updated property tax receipt
  • If the competent person is registered pharmacist following documents are required:
  • Affidavit in prescribed format regarding consent and registered pharmacist.
  • Registration certificate and renewal of registration (up to date) of Pharmacist
  • Four passport size coloured photo of the applicant.
  • If a competent person is an experienced person, following documents are required:
  • Affidavit in prescribed format regarding consent and registered pharmacist.
  • Educational qualification certificate
  • Experience certificate of four years dealing with the sale of drugs

Note: Photocopy of all documents should be self-attested by the applicant.  The documents relating to the competent person/registered pharmacist should be self-attested Doc by C.P./R. Pharmacist.

Renewal of Retail License/ Wholesale License

  • Application in Statutory form
  • Renewal Fee/Challan
  • Declaration in the prescribed format.
  • Self-attested photocopy of Drug license/Previous Renewal Certificate of licenses,
  • Current renewal certificate of registration of registered Pharmacist.

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 Fee

License Fee (INR)

 

Renewal Application FeeAdditional Fee (INR) per Month after the 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 – Offline Method

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

Approach the District Head Office

Step 1: The applicant can visit the respective district offices/head office to apply for the Drug license.

Get Application Form

Step 2: You have to get only the prescribed application form according to your License Category from the concerned officials. You need to fill in the application form with all the mandatory details.

Note: You may also download the application form in the official web portal of Bihar. The copy of the application form of drug license is given below for your ready reference:

Application & Approval Procedure for Retail or Wholesale Drug Licenses

Step 3: Now you have to attach the duly filled supplementary forms to your License Category for which you have applied.

Attach Required Documents

Step 4: After that, you have to attach all the necessary documents as prescribed in the above checklist.

Make Payment

Step 5: Now you have to pay the prescribed fee (challan) in the office as per the fee structure tabulated above.

Submit the Application Form

Step 6: Now you need to submit the application along with requisite documents and original copy of challan to the Assistant Drug Controller (ADC) at the concerned District Drugs Control Office of your area.

Step 7: After submitting the application form, collect the acknowledgement receipt that can be used later to check the status of the application form.

Issue of Drug License

Step 8: If the Licensing Authority is satisfied that all requirements pertaining to the grant or renewal of license have been complied with and that conditions of the license are met, shall grant the application.

Rejection of Application

If ADC founds the application incomplete/unsatisfactory, he will send it back to the applicant. This may be of following reasons below:

  • On account of rejection for valid reasons
  • For providing additional information/documents as required to process the application further at his end.

Renewal Process (Retailer, Wholesaler, 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.

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.