Goa Drug License
Goa Drug License
Drug License is a legal document which is required to do businesses related to the pharmaceutical industry, drugs and cosmetics. The Directorate of Food and Drugs Administration (FDA) is responsible for the task of implementing and enforcing all the Food and Drugs related legislation that is manufactured and sold within the State. The Goa State FDA (licensing authority) issues drug license in the state of Goa. This department regulates the manufacture, sale and distribution of drugs in the state of Goa by implementing relevant central Drug and Pharmaceutical legislation in the state. In this article, we look at the detailed procedure of obtaining Goa Drug License.
Drugs and Cosmetics Act, 1940
This Act regulates the import/ export, manufacture, distribution and sale of drugs and cosmetics, and clinical Research of Drugs and Cosmetics through licensing in India. It also ensures that the drugs and cosmetics that are sold in India is safe, conforms and effective to state quality standards. This Act aims to establish Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC) for Allopathic and allied drugs and cosmetics.
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.
Conditions for Granting Drug License
There are two kinds of drug license, the retail license and wholesale license of for drug distribution or sale in India. For obtaining a drug license, there are certain conditions that applicant will have to follow.
- The area in premises of which a retail or wholesale license is to be granted must not be less than 10 square meters.
- In respect of the application for the grant of drug license in Form 20 or Form 21 individually or both, the licensing authority will satisfy itself that the premises of an area of not less than 10 meters.
- In respect of the application for the grant of drug license n Form 20-B or Form 21-B individually or both, the licensing authority will satisfy itself that the premises of an area of not less than 15 meters.
The below listed are the documents to be submitted by the applicant along with the application for grant of fresh Retail/ Wholesale License.
- Covering letter mentioning the details of the documents submitted.
- Application in respective Form- 19, 19B, and Form 19C dully filled and signed.
- Additional information data form duly filled and signed.
- Court fee stamps to be fixed on each application.
- e-Challan for Rs. 3000/- along with the details specified on the list attached, an additional fee of Rs. 250/- for homoeopathic license and Rs. 500/- for schedule X license (if requested).
- Blue Print plans of the premises drawn to scale
- Site plan of the premises on a blueprint.
- Certified copy of Lease Deed (if rented)
- Ownership Documents (if owned)
- Certificate copy of partnership deed (if in partnership firm)
- Description of the premises, with all details.
- Occupancy certificate (attested)
- House tax receipt (attested)
- NOC from the Municipality/ Panchayat (attested)
- Certificate copy of qualification certificates of registered pharmacist/ Competent person
- Certificate copy of Registration Certificate of the registered pharmacist issued by GSPC.
- Experience certificates of the registered pharmacist/ Competent person
- Appointment letter by the registered pharmacist/ Competent person
- Self-declaration from regarding sale of drugs
- Bio-data of the applicant mentioning the details of DOB, experience and details of occupation for the previous five years.
- Certified copy of power of attorney of the applicant (if applicable)
- Copy of refrigerator invoice
- Identity card copy of Proprietor/ Partners/ Directors/ Registered Pharmacists/ Competent persons.
Note: The carpet area required for the wholesale/ retail premises minimum is 15sqmts. The height required is 2.5 sq.mts. The applicant must obtain a book from the directorate by paying the necessary fees of Rs. 50/- on the grant of the license at the time of issuance of the license.
These are the documents to be submitted for the manufacturing Pharmaceutical Products.
- Covering Letter
- Application Form with a non-judiciary stamp of Rs. 2/-
- For Non-Biological Products
- Form 27/ 27A/ 27B/ 27D
- Site Master File
- Challan in original, indicating the paid license fee.
- Two copies of the site plan.
- List of machinery, instruments/equipment in quality control.
- Names of the competent technical staff
- NOC from Pollution Control Board
- List of Directors/ Partners of the firm
- Clearance from Drug Controller General
- Label text of the identical product available in the market.
- Copy of the documents indicating ownership, rental, lease title of the plot.
Renewal of Drug License
- Online deposition of fees via treasury portal.
- Tenancy/ house rent agreement certificate by notary or NOC for a further period of minimum five years.
- Self-declaration of a competent person in a prescribed format with signature and date.
- Declaration of the firm regarding the changes
- Resolution of Board of Directors
Additional Requirement in Case of Loan License
- Consent letter from the Principal manufacturing unit
- Copy of valid drug license of manufacturing unit
- The production capacity of the drug for which applied for loan drug license
- Copy of GMP (if any)
The below-tabulated shows the charge/ fees for the applying of a new drug license, renewal of license and the registration of license certificate.
|Sr. No.||Business||Type of license||Application Form||License Form||Fees for New licenses|
|New License Fees||Inspection Fees||Total Fees|
|1.||Retail sale||Non-biological drugs||19||20||Rs. 1500||Nil||Rs. 1500|
|Biological drugs||19||21||Rs. 1500||Nil||Rs. 1500|
|Schedule X drugs||19-C||20-F||Rs. 500||Nil||Rs. 500|
|2.||Wholesale||Non-biological drugs||19||20-B||Rs. 1500||Nil||Rs. 1500|
|Biological drugs||19||21-B||Rs. 1500||Nil||Rs. 1500|
|Schedule X drugs||19-C||20-G||Rs. 500||Nil||Rs. 500|
|3.||Restricted Drugs Sales||Non-biological drugs||19-A||20-A||Rs. 500||Nil||Rs. 500|
|Biological drugs||19-A||21-A||Rs. 500||Nil||Rs. 500|
|Motor Vehicle||19-AA||20-AA||Rs. 500||Nil||Rs. 500|
|4.||Homoeopathic drugs||Retail sale||19-B||20-C||Rs. 250||Nil||Rs. 250|
|Wholesale||19-B||20-D||Rs. 250||Nil||Rs. 250|
|5.||Drugs loan licenses||Non-biological drugs||24-A||25-A||Rs. 6000||Rs. 1500||Rs. 7500|
|Biological drugs||27-A||28-A||Rs. 6000||Rs. 1500||Rs. 7500|
|6.||Schedule X drugs manufacturing||Non-biological drugs||24-F||25-F||Rs. 6000||Rs. 1500||Rs. 7500|
|Biological drugs||24-F||28-B||Rs. 6000||Rs. 1500||Rs. 7500|
Application Procedure for Drug License – Offline Mode
Any individual, who wants to start Manufacturing of drugs, Retail (Medical Store) Drug and Wholesale drugs, must obtain licences from the Directorate under the provisions of Drugs & Cosmetics Act following the procedure is given below.
Manufacturing Drug Licences
The applicants must follow the given steps to obtain a Manufacturing Drug Licences 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 must get the Form 24 respectively along with additional information data.
Note: You may also download the application form in the official web portal of FDA Goa. The copy of the application Form 24 of manufacturing drug license is given below for your ready reference:
Fill in the Right Credentials
Step 3: You need to fill in the application form with all the mandatory details.
Step 4: Now you have to attach the duly filled additional forms to your License Category for which you have applied.
Attach Required Documents
Step 5: After that, you have to attach all the necessary documents as prescribed in the above checklist.
Step 6: Once all the documents are attached, you must verify the certificates/ documents from area Drugs Inspector or any Drugs Inspector of Food & Drugs Administration.
Step 7: Now you have to pay the prescribed fee (challan) in the office as per the fee structure tabulated above.
Step 8: To generate e-Challan you need to fill the challan form available with the department for requisite fees and get it verified from Drugs Inspector.
Submit the Application Form
Step 9: Now you need to submit the application along with requisite documents and original copy of challan to the Assistant Drug Controller (ADC) at the relevant District Drugs Control Office of your area.
Step 10: After submitting the application form, collect the acknowledgement receipt that can be used later to check the status of the application form.
Retail (Medical Store) Drug License and Wholesale Drugs License
The application procedure for the Retail (Medical Store) Drug License and Wholesale drugs License is the same as the process of Manufacturing Drug Licences Procedure.
Step 1: You have to get only the prescribed application form according to your License Category from the concerned officials. You must get the Form 19,19B and 19C respectively along with additional information data and Self-declaration form.
Note: You may also get the application form in the official web portal of FDA Goa. The copy of the application Forms of manufacturing drug license is given below for your ready reference:
Use the below links to download the Form 19,19B and 19C
Step 2: You need to fill in the application form with all the mandatory details.
Step 3: Now you need to attach the duly filled additional forms to your License Category for which you have applied.
Step 4: After that, you will have to attach all the necessary documents as prescribed in the above checklist.
Step 5: Once all the documents are attached, you must verify the certificates/ documents from area Drugs Inspector or any Drugs Inspector of Food & Drugs Administration.
Step 6: Now you have to pay the prescribed fee (challan) in the office as per the fee structure tabulated above.
Step 7: To generate e-Challan you need to fill the challan form available with the department for requisite fees and get it verified from Drugs Inspector.
Step 8: Now you need to submit the application along with requisite documents and original copy of challan to the Assistant Drug Controller (ADC) at the relevant District Drugs Control Office of your area.
Step 9: After submitting the application form, collect the acknowledgement receipt that can be used later to check the status of the application form.
Renewal Process (Retailer, Wholesaler, Manufacturer)
The Process of Applying renewal is the same for the wholesaler/retailer/ Manufacturer; for which you should fill the form 19,19B and19C respectively and form for Additional information data. Now fill all the requested information, and attach all the requested documents. Then the renewal process will be completed upon the payment.
Validity of Licence
Drug Licenses are valid up to 5 years from the issue of licence subject to the conditions specified in the licence and to the provisions of the Drugs & Cosmetics Act.
Post by Sinduja Shankar
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