Introduction: Drug Distribution
The license for drug distribution is mandatory looking at the interest of the general public. In this Blog, we shall discuss the procedure and other licensing requirements by the Drug Distributor. Due to the irregular distribution of drugs, the danger associated with the distribution of Counterfeiting Drugs, or the distribution and sale of expired drugs or outdated drugs the Government provides a Drug license which is the legal permit for businesses of Drugs and Cosmetics.
Table of Contents
- Introduction: Drug Distribution
- What is Drugs
- Type of Drug License in India
- Prerequisites For The Grant Of A Drug Distribution License
- Filing Procedure of the Drug Distribution License
- Step-by-Step Procedure
- Document Required For The Drug Distribution License
- Consent Fee To Be Paid For The Drug Distribution License
- Renewal of Drug Distribution License
- Documents Required for the Renewal
- Fine and Penalties
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India holds one of the biggest numbers of Pharmaceutical companies in the World, the wholesale Market, and Pharmaceutical Manufacturers are widely available in India. The Indian government has sole responsibility and control over them and holds the licensing authority with them along with a strong licensing procedure. The government regulates Drug Distribution through the Drugs and Cosmetics Act, of 1940.
What is Drugs
The meaning of Drugs as per the Drugs and Cosmetics Act, 1940, Section 3(b), A ‘drug’ means
- All medicines for the internal or external use of habitats and other equipment to be used for the Prevention, Treatment, diagnosis, and mitigation of any disease including medication applied on the human body for repealing insects like mosquitos;
- Such substances can affect the structure and function of humans and are being used for the destruction purpose of insects from the human body or animals;
- Such other devices are intended to be used internally or externally in the mitigation, diagnosis, prevention, or treatment, of disease or disorder in human beings or animals.
The regulatory organization for the licensing of Drug Distribution is the Central Drugs Standards Control Organization (CDSCO) being representative of the Drugs Controller General of India (DCGI) and the State Drug Standard Control Organization (SDSCO). The regulatory bodies grant licenses with specific criteria and binding terms to which the operator have to comply for the cooperation of the business on a mandatory basis.
Type of Drug License in India
- Manufacturing Drug License
- Wholesale Drug License
- Import Drug License
- Retail Drug license
- Loan Drug License
- Sale Drug License
- Multi-drug license
- Restricted drug license
Prerequisites For The Grant Of A Drug Distribution License
The Distributor of the drugs has to follow certain procedural qualifications for the drug distribution license, these are:
- The size of a located site must be at least 15 square meters
- For the preservation of the drugs safely, the distributor must have Fridge.
- Individuals with a Pharmacy degree or having relevant expertise are only eligible to obtain a distribution license.
- The applicant must have a degree at the time of applying along with a minimum of one year of experience.
- The individual must have 4 years of experience in Drug Trafficking
- The license should be placed at a conspicuous place at the site location
- The site location must be safe and secure
- The appropriate equipment must be available in the warehouse.
Read Our Blog: How to Apply for a Wholesale Drug License 10 Steps
Filing Procedure of the Drug Distribution License
- Submission of application
The Drug Distribution License shall be submitted in the online format, along with all the scanned copies of the required documents, subsequently, after submission of the application, the required fee shall be paid.
- Inspection from Drug Inspector
The submitted documents go to the concerned drug inspector, who visits the site and inspects the authenticity of the documents.
- Grant of permission
- The drug licensing authority approves the Drug Distribution License, which can be downloaded from the official website.
- Go to the official website of the State Drugs Standards Control Organization to apply.
- Click on the right top to Register yourself by filling in the required credentials such as Email id & mobile number, and subsequently complete Aadhar card KYC authorization.
- Click on the ‘apply online for license’ after getting registered.
- Select the registration type that you want such as ‘Drug Distribution.
- Select the application form that needs to be applied.
- Fill in the required details, make the payment and submit the application.
- The registered application shall get the unique Registration number for further processing.
- The Official Inspector shall approve the application.
- The license shall be granted to the application.
- The time required for the application approval shall be 15 days from the date of submission of the application.
Read Our Blog: A Complete Process Wholesale Drug License in India
Document Required For The Drug Distribution License
While you are going to fill out the application, make sure of the availability of the following documents. Along with others;
- Form 19 (two applications)
- Verified ID card (of the applicant)
- Photographs of the (Proprietor, Pharmacist)
- Cover letter (for the marketing deal)
- Declaration form of the applicant
- Detailed layout of the site.
- Ownership proof (lease agreement, rent agreement, etc)
- The real estate tax bill
- Partnership deed
- Board agreement
- The list of directors
- Affidavit of the Pharmacist and Proprietor attested by the public notary
- The Challan of the application fee shall be attached if you are applying offline.
- Qualification certificate
Consent Fee To Be Paid For The Drug Distribution License
The applicant shall have to pay Rs. 3000 as the basic application fee at the time of registration, subsequent charges might differ from State to State and ranges from Rs. 0-10000. The renewal license fee shall be paid along with the application form which is similar to what is required for the grant of a license, however, the late fee shall be applicable if the renewal application is not filed timely for the next 6 months.
Renewal of Drug Distribution License
- For the grant of a Renewal License, the applicant has to fill out Form 19 application for Drug distribution except those mentioned in Schedule X.
- The applicant shall have to fill out renewal application form 19C for the drugs specified in Schedule X.
- The applicant selling Homeopathic drugs has to fill out Form 20E for the renewal of the license.
- Form 21C shall be applicable for the renewal of the license to distribute drugs.
- Form 24 shall be applicable for the renewal of or grant of license for the Distribution of Drugs other than Schedule C, C1, and X.
- Form 27 shall be applicable for the grant of license for the distribution of drugs prescribed in Schedule C and C1 other than those specified in Schedule X and Part XB.
Documents Required for the Renewal
- Last licensing or renewal certificate.
- Latest Ownership agreement (rent agreement)
- Address proof of the applicant
- The affidavit of the Pharmacist, Employees against the violation of drug laws.
Fine and Penalties
The individual who is operating the business with the grant of the license in a particular State shall be liable to imprisonment, or to pay fines or civil penalties as the case may be deemed by the Court. Additionally, the State Board holds the right to deny the license based on the General welfare or Public interest in the State.
In normal circumstances, for the Company, to obtain a “Drug Distribution License” in their State. Requires a submission to be made which is quite an extensive application form, payment of application fee, submission of documents like Projects policies and procedures, and surety. The Company requires to show background checks and balances as well. The application can be made in the State where the Residential License is applicable in the name of the applicant, and for subsequent business operation, the applicant can obtain a non-residential license wherever he is operating the business.
Feel free to contact our Experts for the Drugs Distribution Registration procedure, you can reach out to us directly for the same. We make the Registration process easy and hassle-free, along with your ease of doing business.
To do business in pharma industry including Ayurvedic & Unani drugs, one must get a Drug license to operate legally. As per Drugs Act, 1940, License is mandatory throughout India. A particular license is required based on business requirement.
CDSCO Online Registration
Team Corpseed will help you to get CDSCO online registration / DCGI approval for your products as per CDSCO guidelines. Under the Drugs and Cosmetics Act, CDSCO has many responsibilities which includes approval of Drugs.
FDA Wholesale License
The wholesale company usually does not sell directly to the end user. FDA Wholesaler License often purchase large quantities directly from the manufacturer or importer.
This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.
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