Gujarat Drug License

Gujarat Drug License

Gujarat Drug License

Gujarat drug license is a document of permission for carrying out businesses related to drugs, medicines and cosmetics. The government of Gujarat issues drug license to regulate the manufacture, storage, distribution and sales of drugs. Gujarat drug license is issued under the Drug and Cosmetics Act, 1940 to a person dealing with drugs. As per this act, it is mandatory to obtain a Gujarat drug license before the launching a drug business. In this article, we look at the procedure for obtaining Gujarat drug license in detail.

Know more about How to start a pharmacy business

Drugs and Cosmetics Act

Gujarat drug license is a crucial document according to the Drugs and Cosmetics Act; 1940. This act moderates the manufacture, distribution import and sale of drugs and cosmetics, which includes allopathic drugs, homoeopathic medicines, and even the Ayurvedic, Siddha or Unani drugs.

Importance of Gujarat Drug license

Some of the significance of Gujarat drug license is explained in detail below:

  • The Gujarat drug license permits market, manufacture sale, resale, trade of drug and cosmetics.
  • Without a Gujarat drug license, no person can do pharmacy business or even start to associate with any dealings in Gujarat.
  • For protecting good health of India through adequately accessing the medicines and drugs, the Drugs and Cosmetics act made it mandatory for obtaining a drug license
  • Gujarat drug license also ensure that the drug and drugs are not misused or abused by any individuals in Gujarat
  • Dealing with drugs/medicines a without a drug license is a cognizable offence. Every trader in the pharmacy industry needs to have their drug incense to carry out their day-to-day business work.
  • Gujarat drug license contains the rule and regulation for the person who is dealing with drugs business

Note: It is the responsibility of all individual dealing with drugs and cosmetics to maintain its quality. If any person consuming a drug or medicine suffers any harm from the negligence on the part of the seller or manufacturer of the medicine, the same is an offence, which is an offence of grievous hurt under IPC. Hence holding Gujarat drug license is necessary.

Who needs Gujarat Drug License?

Gujarat drug license is crucial for dealing with the following type of business. Any proprietorship, partnership firm, limited liability company, company or business firm located In Gujarat and is physically distributing the medicine in the state is required to hold a drug license:

  • Business with any cosmetics intended to be sprinkled, rubbed, poured or introduced into the human body or for beautifying, cleansing, promoting attractiveness, or altering the appearance of a human, must obtain Gujarat Drug license.
  • It is vital to get a drug license to deal with the drug which is used for internal or external in human beings
  • Manufacturing and distribution drugs or cosmetics applied to the human body to repel insects like mosquitoes also need Gujarat drug license.
  • Business with drugs used for the destruction or insects which cause diseases in human beings must get a drug license.
  • Gujarat drug license also mandatory for dealing with empty gelatin capsule.
  • To manufacture, store and distribute the drugs used for diagnosis, mitigation, treatment or prevention of disease or disorder in humans or animal, need Gujarat drug license

Click here to know more about the Medicine and drugs allowed for import without a licence

Basic Requirement for Obtaining Gujarat Drug License

According to the provision of Drug and cosmetics act, to get a Gujarat drug license the below-described requirements to be met by the trader.

Area Recruitment

The minimum area required for setting up a medical shop or pharmacy is ten square meter. In case of the store business combination with the wholesale and retail of drugs then the minimum area of fifteen square meters is required. License for the sale of drugs can be issued in the commercial premises or other premises independent of residence.

Storage Facility

It is vital to have an air conditioner and refrigerator on the premises because some medicines such as insulin injections, vaccines are needed to be stored in the refrigerator.

Technical Staff

Sale of drugs should be carried in the presence of a registered Pharmacist approved by the Gujarat Government who is required throughout the working hours in the retail shop.

The wholesale of drugs can be made either by a registered pharmacist or any competent authority who graduate and having experience in drugs or in the presence of an of person who has passed SSLC having experience of four years in drugs/medicines business, specially approved by Health and Family Welfare Department.

Classification of Gujarat Drug License

Based on the requirement of the pharmaceutical business, Gujarat Drug License can be classified in the following categories:

  • Sale License
  • Manufacturing License

Sale License

Sale license is issued to persons or agencies engaged in the sale of drugs or medicines in Gujarat. The sale drug license is further classified into the following two types.

  • Retail License: It is granted to run and sell drugs or drug products in Gujarat.
  • Wholesales License: It is provided to a person or agency engaged in wholesale of medicine or drugs

Manufacturing License

Manufacturing license is granted to a person or agencies involved in the manufacturing of drugs, medicines and cosmetics. The government of Gujarat also issued Manufacturing loan license.

Licensing Authority

The health and family welfare department, Government of Gujarat issues manufacturing drug license as per the provisions of drug and cosmetics act. State Drugs Control Directorate issues the license for sale of drugs and cosmetics. The prescribed authority for issuing Gujarat drug license is Assistant Commissioner FDCA.

Time Frame

Gujarat drug license is valid for 45 Days from the date of application.

Validity Details

The Gujarat drug license granted to carry out business related to the drug is valid for five years from the date of issue. After expiry, the license can be renewed.

Applicable Fee

The fee structure for Gujarat drug license will be varied according to the category of drugs. Usually, the fee varies from Rs.1500 or Rs. Five hundred or Rs.250 as per category of drugs.

Sl.No

Type of Services

Fee

1

Certificate for no convictionRs.50

2

Certificate for performanceRs.50

3

Certificate for capacityRs.50

4

Certificate for registration-cum-membershipRs.50

5

Certificate regarding intermediateRs.50

6

Certificate for free SaleRs.50

7

Certificate regarding market productRs.50

8

Certificate whether a particular item is a drug or otherwiseRs.50

9

Certificate regarding consumptionRs.50

10

Certificate validity of the licenseRs.50

11

W.H.O., G.M.P. original certificateRs.1000

Documents Required

Documents required for Obtaining Gujarat Drug license is as follows:

Documents for New Manufacturing Drug License

  • Applications in the prescribed form
  • Challan of rupees as prescribed to be paid under the correct head of account
  • Copy of approved plan
  • Copy of wholesale license
  • List of products
  • Draft labels
  • Manufacturing process
  • Stability data
  • Method of analysis
  • Manufacturing process
  • Flow sheet
  • Standard operating procedures for each product

Documents for New Manufacturing Drug License

  • Application Form
  • Additional Information Form
  • Partnership deed or MOA (Memorandum of Article of Association) and List of Directors, if any
  • Appointment Letter of a Registered Pharmacist
  • Consent Letter of a registered pharmacist with Details of the Previous Service, if any
  • Copy of registration certification issued by Gujarat State Pharmacy Council
  • Renewal Receipt of Gujarat State Pharmacy Council
  • Passport Size Photographs of the Pharmacists
  • An Affidavit of the Pharmacist on Rs.20 Stamp paper
  • Copy of Rent Receipt for the Premises and Necessary Proof for the Legal Possession of the Premises like Copy of the Registered Sales Deed
  • Rough Sketch of the Premises
  • Ration Card or PAN Card or Identity Card or Aadhar Card of all Partners or Directors and Pharmacist

Gujarat Drug License (Retail and Wholesale) Application Procedure

The procedure to obtain Gujarat sale drug license Gujarat is explained in step-by-step procedure here:

Access XLN INDIA

Step 1: Applicant needs to access the XLN INDIA  web-portal. From the home page select Gujarat from the drop-down menu and click on sales login button.

Image 1 Gujarat Drug License
Image 1 Gujarat Drug License

Registration

Step 2: The link will redirect to the new page. In this page, you have to apply for User ID and Password; you will get the user ID and Password on the Registered Mobile number.

Image 2 Gujarat Drug License
Image 2 Gujarat Drug License

Step 3: After obtaining user login credential, login to the web-portal by entering the username and password. Click on the submit option.

Login to Portal

Step 4: Once you login to this XLN web portal, you can change the password for security and privacy. The option for modifying the password is available on the right top corner.

Image 3 Gujarat Drug License
Image 3 Gujarat Drug License

Step 5: After entering a password, click on update my details and correct it, if needs. Once the application is corrected, click on update option to proceed further.

Provide Details

Step 6: You need access the menu and click on Prepare or edit online application option.

Step 7: After that click on the new inward option, click on the OK button.

Step 8: Select the Storage type from the drop-down list. You have to select at least one option from the list.

Step 9: You have to select the document type from the drop-down list and select the document as an Aadhaar card and provide Aadhaar number in the space provided.

Step 10: You have to select the inward type option from the drop menu and select Fre-add/Fresh license option. Click on the RP in Retail and CP in Wholesale button.

Step 11: By clicking on the Add option, you can furnish all details for Gujarat drug license.

Upload Documents

Step 12: Upload all supporting documents. The certificate should consist the registration certificate of a pharmacist from Gujarat pharmacy tribunal and current renewal. After uploading the documents, click on the save button.

Step 13: You need to furnish all other details by clicking on the CON button and then on the ADD option.

Step 14: Take the print out of the self-declaration of RP or CP and proprietor. Get it signed by the registered pharmacist and proprietor or authorised signatory.

Step 15: By following the method mentioned above, you can upload all the other required documents when needed.

Step 16: After uploading the supporting documents, click on the back button. In this new page, click on by firm and print application form.

Note: Keep the application safe for uploading with other supporting documents after making payment.

Payment of fee through E-payment Gateway

Step 17: You can make the payment through the e-payment gateway option available in the portal. Once the payment is successful, the e-challan will be displayed. Take the print out of the e-challan.

Upload Challan

Step 18: After receiving the challan, login to the web portal for uploading the e-Challan. After login to portal Click on ‘By firm’ option. Select payment entries and click on New.

Step 19: Select payment type as FRAS and provide the required details. Upload the scanned copy of deposited challan using ‘Choose file’ option and click on Save option.

Step 20: Click on the upload option for uploading application and all other documents, after uploading click on the Close button.

Additional Information

Step 21: Select the additional information or undertaking option. Provide all details and click on sign button. Select the additional form button and then select the Back button.

Forward Application to licensing authority

Step 22: You need to Certify and e-Send Application to Department, i.e. the licensing authority. Licensing authority will forward the application to concerned drug inspector within five days for verification.

Site Verification by Drug Inspector

Step 23: The drug inspector will verify the document and premises, and Drug Inspector will submit his report to the Licensing Authority within 15 working.

Step 24: After viewing the report, the concerned licensing authority will grant or reject the license within ten days.

Status of Application

Applicant should log in to the portal frequently to check the status of Application in the dashboard.  The status will also be available in the Inbox to check if any query raised by the department and should reply accordingly.

Print License

By login to this portal, you can print the Gujarat drug license. The license should be printed within three days from the date of issue.

Gujarat Drug License (Manufacturing) Application Procedure

The application procedure for obtaining the Gujarat Drug License (Manufacturing) is described in detail here:

The government of Gujarat is prescribed different Forms for Issuance of Manufacturing License According to the Nature of Drugs. The applicant can get the application form from the Health and Family Welfare Department.

Step 1: In this webpage, you can get the following types of application forms, by clicking on corresponding firms you can take print out of the same:

  • Allopathic Drugs Forms
  • Additional Forms For Own & Loan Licence Units
  • Homoeopathic Drugs Forms
  • Cosmetic Drugs Forms
  • Ayurvedic Drugs Forms

Step 2: You need to submit the application form along with the documents to FDCA-District office.

form-19

Step 3: Drug Inspector at District office allocates application to Deputy Commissioner at District office.

Step 4: Deputy Commissioner forward application to Assistant Commissioner. Assistance Commissioner will conduct a field inspection. After verification, drug inspector will forward the report to Assistance Commissioner – FDCA.

Note: If the application is for more than two categories of products, Inspection conducted jointly by Deputy commissioner – FDCA, Senior Drug Inspector at FDCA HO and District officer.

Step 5: Assistance commissioner will send the inspection report to the FDCA head office.

Step 6: Senior drug inspector at FDCA HO reviews the report and submits recommendations to Dy.commissioner at FDCA – HO.

Step 7: Deputy commissioner at FDCA HO reviews the report and submits recommendations to Junior Commissioner at FDCA – HO.

Step 8: Junior Commissioner at FDCA HO reviews the report and submits recommendations to Commissioner at FDCA-HO.

Step 9: If the applicant is applying for the first time with FDCA, he will be called for GMP interaction to sensitize the applicant towards Public Health.

FDCA issues the License. The applicant can get the  Gujarat Drug license from the FDCA head office.

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Post by Renu Suresh

Renu is experience content writer specialised in compliances and company rules.