If you are planning to start a pharmaceutical business, the first thing you need to proceed with is a drug license. The government of India has strict laws for granting drug licenses to drug and cosmetic manufacturers and sellers. A drug license is a grant given by the authority under the Drugs and Cosmetics Act 1940. There are two types of licenses a pharmacy owner can apply for. They are retail drug licenses and wholesale drug licenses. With this drug license, you can sell a wide range of drugs that includes allopathic, homoeopathic, ayurvedic, and Unani drugs.
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Meaning of Drugs
According to the Drugs and Cosmetic Act, all the medicines and devices that are made for the use of humans and animals internally and externally is a drug. All those substances come under the drugs category that is used for diagnosis, treatment, and prevention of disease. Ayurvedic and Unani drugs were included in the Act in 1964 through an amendment.
Types of Drug License
To carry out a pharmaceutical business, you need the following types of licenses.
Businesses dealing with the manufacturing of allopathic and homoeopathic medicines are granted a manufacturing license.
Pharmacies dealing with the sale of the drugs are issued sale license. You can get three types of sale license-wholesale drug license, Retail Drug license, and restricted drugs.
This drug license is issued to a business that does not have its own manufacturing setup but uses the facilities of another licensee.
A license granted for the import of drugs is an import license.
This drug license is given to the medical stores having many shops in various states with a common name.
Pharmacist: A pharmacist is a professional with a degree in pharmacy. You need to have an affidavit from a registered pharmacist. Drug license for a medical store can be given to a competent person with a graduate degree and 1-year experience.
Space: You need to provide a space not less than 15 square meters for getting a retail/wholesale drug license.
Storage: Medicines need specific storage facilities. So you should have proper storage facilities like refrigerators and air conditioners.
Documents Required for The New Application of Retail/Wholesale Drug License
MOA for a company/partnership deed/LLP agreement
Property papers or the rental agreement of the premises
Proof of proper storage
Copy of Board resolution
Proof of depositing fee/Challan copy
Affidavit of non-conviction
Affidavit form a registered pharmacist
Pharmacist's proof of qualification, registration, and appointment letter in case of retail drug license
Pharmacist's proof of qualification, experience certificate, and appointment letter in case of retail drug license
Documents Required for The Application of Additional Retail/Wholesale License
Drug application form generated from the system for relevant drug sale
Affidavit of non-conviction
Proof of qualification of the pharmacist
Pharmacist's registration with Delhi Pharmacy council
Appointment letter and Bio-data of Pharmacist
A system-generated affidavit
Online drug license fee deposit receipt.
Documents Required for Application of Renewal of Retail/Wholesale License
A drug application form is generated from the system for a relevant drug sale.
Conversion charge receipt is given by MCD.
Online drug license fee receipt.
Documents Required for Change in Pharmacist
Certificate of qualification
Appointment letter and Bio-data
Affidavit by a competent person
Documents Required for Addition/Reduction in Premises
Revised documents of the space
Registered sale deed for owned space
Rent receipt/agreement for rented space
Changed site plan
List of Drug License Application Form
It is an Application for issuing or renewing a drug license to sell or distribute drugs. Drug license form 19 does not include the drugs listed in schedule X.
It is an Application for issuing or renewing a restricted drug license to sell, stock, or distribute by retail. It is done by those dealers who don't engage the service of a qualified individual.
It is an Application for a drug license to sell, stock or distribute Homoeopathic medicines.
It is an Application for granting or renewing a drug license to sell, stock, and distribute drugs listed in Schedule X.
It is an Application for granting or renewing a drug license to manufacture for sale or for distribution of drugs. The drugs listed Schedule C, C (1) and X cannot be sold.
It is an Application for granting or renewing of a loan drug license to manufacture or distribute the drugs. The drugs listed Schedule C, C (1) and X cannot be sold.
It is an Application for granting or renewing of a licensee to repack for sale or distribution. The drugs listed Schedule C, C (1) and X cannot be sold.
It is an Application for granting or renewing a drug license to manufacture and distribute homoeopathic medicines.
Application for permitting or renewing of a drug license to manufacture or distribute drugs listed in Schedule X. Drugs listed in Schedule C and C(1) cannot be sold.
Application for granting or renewing a drug license to manufacture or distribute drugs listed in Schedule C and C (1).
The Time Frame for Drug License Application Approval
For grant of licenses for the sale of drugs or application disposal
For change/ addition/deletion of a registered pharmacist
For change/addition/deletion of competent person
For grant of sale licenses for homoeopathic medicine of application disposal
For grant of sale licenses for allopathic medicine or application disposal
For grant of sale licenses for drugs listed in schedule X or application disposal.
For Drug Manufacturing License
75 days are required to grant a license for the manufacturing of drugs or cosmetics. The time frame is counted from the date of receipt of the application.
How to Apply for A Drug License
You can apply for a drug license online. Follow these steps to fill the drug license application form.
Go to the food safety and drug administration website of the state. Register yourself with an ID and password. Now, login and fill the online drug license application form. Pay the government fee and upload scanned copies of the documents needed.
On receiving the application, the drug inspector will plan a visit to verify the documents and the premises.
If verification is successful and all the documents are found to be correct then the drug license is issued.
Download drug license online with valid e-signatures and official seal from the website.
E- Payment of Drug License
Step 1: Visit the e-payment websites of the states.
Step 2: Select the department as drug control and select the type of license.
Step 3: Enter your details in the payment gateway.
Step 4: Click the submit button and proceed with payment.
Frequently Asked Questions
What is a drug license?
A drug license is permission provided by the Indian government for manufacturing or selling drugs and cosmetics. There are two types of drug shop licenses for sale and distribution. They are a retail license and wholesale license.
How to apply for a drug license?
Visit the official website of food safety and drug administration of your state and apply online. You can register yourself and upload all the documents needed.
Is it necessary to get a drug license before the commencement of the drug business?
Yes, it is necessary to get a drug and cosmetic license before starting a business dealing with drugs.
For the grant of a drug license, does my shop be located on commercial premises?
You will be granted a drug shop license only when your premises are at a commercial complex or other space independent of residence.
What are the different types of licenses issued for the pharmaceutical business?
There are six types of drug licenses. They include drug manufacture license, wholesale drug license, retail drug license, import of drugs, loan license, and multi-drug license.
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