Drug License

Overview:

The 1940 Drugs and Cosmetics Act mandates that any organisation intending to engage in the retail pharmaceutical sector in India get a retail drug licence. requires obtaining a retail drug licence.

What Is a Retail Drug Licence?

A drug licence gives authority to operate a drug/medicine or cosmetic business under the Drugs and Cosmetic Act. According to the 1940 Drugs and Cosmetics Act, such a licence is given by the Central or State Drug Standard Control Organisation.

Retailers who work as independent chemists or in the pharmaceutical industry are required to have this licence. By submitting an application to the State Pharmacy Council, you may also get the same.

Benefits of License: -

Proof of Genuineness: Consumer perception of brands that are authentic is enhanced.

Having access to and exercising control over the sale of medications (medicines) in India, which contribute to the development of a company's reputation, is helpful to the authorities.

Consumer confidence:

Licences reassure customers that a business is abiding by regulations and offering superior goods.

Holders of drug licences are required to abide under the 1940 Drugs and Cosmetics Act.

Better Quality:

The Act includes a number of regulations that are meant to guarantee that drugs meet the set requirements for quality. Regardless of the operational circumstances, the organisations holding drug licences are dedicated to providing consumers with high-quality medications. The manufacturer must make sure that each batch of the immunisation is correctly tagged with a price and ingredient table before administering the drug to the customer. One of the most notable advantages of a drug licence in India is this.

Eligibility Requirements:

A registered chemist or any other competent authority who has a degree and experience in the pharmaceutical industry, or in the presence of a person who has completed SSLC and has four years of experience in the pharmaceutical industry, may apply for a licence.

Registration Process:-

Documents Required for registration:-

MOA/AOA if Company, Partnership Deed if Firm, LLP Agreement if Limited Liability Partnership,

Identity Proof of Directors, Partners, Partners

Purchase Deed, Lease Deed, Rent Agreement of business premises.

Site plan and key plan of premises

Refrigerator invoice details for cold storage necessity

Additional document for Retail Sale Registered Pharmacist

Proof of qualification

Affidavit from local pharmacist council

Cost for License:-

Cost of Drug License varies depend upon category of drugs. Usually it varies from Rs.1500 to Rs.5000.

Gujarat Drug License

Act on Drugs and Cosmetics

The 1940 Drugs and Cosmetics Act states that the Gujarat drug licence is an important document. This law regulates the production, importation, and sale of medications and cosmetics, including those that are allopathic, homoeopathic, or even Ayurvedic, Siddha, or Unani.

Gujarat drug licence importance

The following details some of the importance of the Gujarat drug licence:

Drug and cosmetic sales, manufacturing, resale, and trade are all permitted under the Gujarat drug licence.
No one may operate a pharmacy in Gujarat or even begin to interact with any transactions without a medication licence from the state.
The pharmaceuticals and Cosmetics Act makes acquiring a drug licence necessary in order to safeguard India's excellent health by ensuring enough access to medications and pharmaceuticals.
Gujarat drug licence also makes sure that no one in Gujarat abuses or misuses the substance or medicines.
Without a drug licence, dealing with drugs or medications is a cognizable violation. To conduct their day-to-day operation, every merchant in the pharmacy sector requires their medicine incense.
The Gujarat drug licence includes the rules and regulations for anybody engaging with the drug trade.

Note:
Ensuring product quality is the duty of everyone who deals with pharmaceuticals and cosmetics. Any injury caused to a person who consumes a medication or medicine because of carelessness on the part of the drug's supplier or producer is an offence under the IPC known as a serious hurt crime. Therefore, having a Gujarat drug licence is required.

Gujarat Drug Licence: Who Needs It ?

The following sort of company requires a Gujarat drug licence. A drug licence must be held by any sole proprietorship, partnership firm, limited liability company, corporation, or business firm headquartered in Gujarat that is physically distributing the medication in the state:

Businesses that sell cosmetics meant to be used topically, topically applied topically, topically applied topically, topically applied topically, topically applied topically, topically applied topically, topically applied topically, or topically applied topically must have a Gujarat Drug licence.

To deal with drugs used either internally or externally on people, a drug licence is essential.
Gujarat drug licence is also required for the production and distribution of medicines or cosmetics used on the human body to deter insects like mosquitoes.

A drug licence is required for businesses that employ medications to kill insects that spread illnesses to humans.

Dealing with empty gelatine capsules also requires a Gujarat drug licence.

Gujarat drug licence is required to produce, store, and distribute medications for the mitigation, treatment, or prevention of illness or disorder in people or animals.

The Essential Conditions for Obtaining a Gujarat Drug Licence

The provisions of the Drug and Cosmetics Act state that the merchant must fulfil the conditions listed below in order to get a Gujarat drug licence.

Localised Recruitment

Ten square metres are the bare minimum needed to set up a pharmacy or medical store. A minimum space of fifteen square metres is needed if a store's operation involves both the wholesale and retail selling of medicines. A business location or another location apart from a home may be used to award a drug sales licence.

Storage Building

It is essential to have a refrigerator and air conditioner on the property since some medications, such insulin injections and immunisations, need refrigeration.

Technical Staff

During the hours that the retail store is open, a registered chemist who has been recognised by the Gujarati government must be present when sales of pharmaceuticals are made.

A registered chemist, any competent authority who has a degree and experience in drugs, or a person who has completed their SSLC and has four years of experience in the drug/medicines industry, as specifically approved by the Health and Family Welfare Department, may make wholesale drug purchases.

Drug Licence Classification in Gujarat

Gujarat Drug Licences fall into the following categories according to the needs of the pharmaceutical industry:

Sales Permit Manufacturing Permit Sales Permit

Persons or organisations involved in the selling of medications or medicines in Gujarat are awarded sale licences. The following two categories of drug sales licences are further categorised.

To operate and sell medicines or drug products in Gujarat, you must have a retail licence.

A person or organisation involved in the wholesale distribution of medications or pharmaceuticals is granted a wholesales licence.

Manufacturer's Permit

A manufacturing licence is given to an individual or group of organisations engaged in the production of medications, medicines, and cosmetics. Additionally, the Gujarati government gave a licence for manufacturing loans.

Licencing Organisation

The Gujarat government's department of health and family welfare grants manufacturing drug licences in accordance with the terms of the drug and cosmetics act. The licence for the selling of pharmaceuticals and cosmetics is issued by the State Drug Control Directorate. The Assistant Commissioner FDCA is the designated authority for awarding Gujarat drug licences.

Gujarat's drug licence is valid for 45 days from the application date.

Validity Information

The Gujarat drug licence issued for the purpose of conducting drug-related business is valid for five years from the date of issuance. The licence may be renewed once it expires.

Suitable Charge

The cost of a drug licence in Gujarat can vary depending on the kind of substance. Typically, depending on the kind of medications, the charge ranges from Rs. 1500 to Rs. 500 to Rs. 250.

Sl. No Type of Services Fee (in Rs.)

1 Certificate for no conviction 50

2 Certificate for performance 50

3 Certificate for capacity 50

4 Certificate for registration-cum-membership 50

5 Certificate regarding intermediate 50

6 Certificate for free Sale 50

7 Certificate regarding market product 50

8 Certificate whether a particular item is a drug or otherwise 50

9 Certificate regarding consumption 50

10 Certificate validity of the license 50

11 W.H.O., G.M.P. original certificate 1000

Sl. No	Type of Services	Fee (in Rs.)
1	Certificate for no conviction	50
2	Certificate for performance	50
3	Certificate for capacity	50
4	Certificate for registration-cum-membership	50
5	Certificate regarding intermediate	50
6	Certificate for free Sale	50
7	Certificate regarding market product	50
8	Certificate whether a particular item is a drug or otherwise	50
9	Certificate regarding consumption	50
10	Certificate validity of the license	50
11	W.H.O., G.M.P. original certificate	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:
Use XLN INDIA.

Step 1: the applicant must log in to the XLN INDIA web site. Select Gujarat from the drop-down menu on the main page, then click the sales login icon.

Step 2: of registration: A new page will be reached by clicking the link. You must apply for a user ID and password on this website, and you will get them on your registered mobile phone.

Step 3: After acquiring user login credentials, enter the username and password to access the online site. Select "Submit" from the menu.

Step 4: Login to the Portal You may change your password for security and privacy after you've logged in to the XLN online portal. On the right top corner, there is a password modification option.

Step 5: After entering your password, choose Update My Details and make any necessary changes. Once the programme has been fixed, choose Update to continue.

Give Specifics

Step 6: Go to the menu and choose the option to "Prepare or edit online application."

Step 7: Next, choose the new inner choice and then press OK.

Step 8: From the drop-down list, choose the Storage type. At least one choice from the list must be chosen.

Step 9: Choose the Aadhaar card as the kind of document from the drop-down list and enter the Aadhaar number in the box given.

Step 10: From the drop-down menu, choose Fre-add/Fresh licence under the inbound type heading. The RP in Retail and CP in Wholesale button should be clicked.
Step 11: You may submit all the information for the Gujarat drug licence by selecting the Add option.

FTP Documents

Step 12: Upload all necessary evidence. The certificate must include a pharmacist's valid renewal and registration certificate from the Gujarat pharmacy tribunal. Click the save button after the papers have been uploaded.

Step 13: You must provide all further information by selecting the ADD option after pressing the CON button.

Step 14:Take a printout of your self-declaration as an RP or CP and proprietor in step 14. Get the owner, registered chemist or other approved signatory to sign it.

Step 15: By using the aforementioned technique, you may submit any other necessary papers as needed.

Step 16: Click the back button after uploading the accompanying papers. Click on by company and print the application on this new page.

Note: After making payment, keep the application secure for uploading with additional supporting papers.

Fees are paid using an electronic payment gateway.

Step 17: You may use the portal's e-payment gateway option to make the payment. The e-challan will be shown when the money has been received successfully. Take a print of the electronic challan.

Post a Challan

Step 18: Log in to the online site after obtaining the challan to upload the e-Challan. After logging in, choose the "By firm" option. Click on New after selecting payment entries.

Step 19: Choose the FRAS payment type and provide the necessary information. Use the 'Choose file' option to upload a scanned copy of the depository challan, then choose the Save option.

Step 20: use the Upload option to upload your application and any other papers. When finished, use the Close button.

Additional Details

Step 21: Choose the choice for further details or an endeavour. Complete all fields, then press the "sign" button. Select the Back button after selecting the button for the extra form.

Application sent to the licencing authority

Step 22: You must certify and electronically submit your application to the department, or licencing body. Within five days, the licencing body will forward the application to the relevant drug inspector for review.

Site Verification

Step 23: The drug inspector verifies the paperwork and the location, and he then submits his report to the licencing authority within 15 working days.

Step 24: The responsible licencing body will issue or refuse the licence within ten days after seeing the report.

Amount of the application

on order to monitor the progress of their application on the dashboard, applicants need periodically log into the site. The status will also be accessible in the Inbox, where you can see whether the department has sent you any questions and respond appropriately.

Licence picture

You are able to print the Gujarat drug licence by logging onto this page. Three days after the license's issuance date, it must be printed.

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: The following application forms are available on this website; by selecting the appropriate businesses, you may print them off.

Forms of Allopathic Drugs

Homoeopathic Drugs Forms

Cosmetic Drugs Forms

Ayurvedic Drugs Forms

Additional Forms For Own & Loan Licence Units
Step 2: You need to submit the application form along with the documents to FDCA-District office.

Step 3: The District office's Drug Inspector assigns the application to the District office's Deputy Commissioner.

Step 4: The Deputy Commissioner sends the Assistant Commissioner the application. A field examination will be done by the Assistance Commissioner. Following verification, the drug inspector will send the report to the FDCA's Assistance Commissioner.

Note: If the application covers more than two product categories, the senior drug inspector at the FDCA HO, the district officer, and the deputy commissioner will all perform the inspection.

Step 5: The inspection report will be sent by the assistance commissioner to the FDCA headquarters.

Step 6: After reviewing the report, the senior drug inspector at FDCA HO provides suggestions to the deputy commissioner.

Step 7: The junior commissioner at FDCA - HO receives suggestions from the deputy commissioner at FDCA HO after reviewing the report.

Step 8: The junior commissioner at the FDCA HO examines the report and presents suggestions to the commissioner.

Step 9: If the applicant is submitting an application via the FDCA for the first time, he will be invited to a GMP interaction to help him become more aware of public health.

Licences are issued by FDCA. The FDCA headquarters is where the applicant may get the Gujarat Drug licence.

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