Wholesale Drug License Registration in India

Whether you are planning to enter the Pharma Industry or launch a Healthcare Entity, obtaining a Drug License from the respective Authority is something you can't afford to miss. According to the Drugs and Cosmetics Act, a drug license is usually allotted by the State of Central Drug Standard Control Organization.

About CDSCO

The Central Drugs Standard Control Organization (CDSCO) administers the Drugs and Cosmetics Act to control substandard drugs and regulate the import, manufacturing, distribution, and sale of drugs and cosmetics through licensing. The D&C Act's Section 26B, which gives the CDSCO the Authority to control, regulate, or prohibit the manufacturing of medicine in the public interest, has recently been the subject of several notices.

What is a Drug as per CDSCO?

Medications as Drugs

All medications intended for internal or exterior usage in humans or animals, as well as all compounds used in the treatment, mitigation, or prevention of any disease or ailment in humans or animals, including preparations to ward off insects like mosquitoes.

Physio-altering Drugs

Drugs that the Central Government occasionally specifies by notification in the Official Gazette. Such substances (other than food) are intended to affect the structure or function of the human body or to be used to destroy 10 [vermin] or insects that cause disease in human beings or animals.

Medical Ingredients

Drugs, including chemicals and empty gelatin capsules, are intended to be used as medicinal ingredients.

The Central Government may, from time to time, following consultation with the Board, specify such devices intended for internal or external use in the diagnosis, treatment, mitigation, or prevention of sickness or disorder in humans or animals.

Types of Drug Licenses in India

Below are different types of drug licenses for the Medical Stores being issued by the concerned Authority. 

1. Retail Drug License

Retailers selling medications, independent pharmacists, etc., can apply for this License with the State Pharmacy Council. This usually refers to a drug license for a medical shop or a medical shop license.

2. Wholesale Drug License

This drug license is given by the central drugs standard control authority to wholesalers involved in the pharmaceutical business. The person applying for a wholesale drug license online should meet the following eligibility criteria:

• Professional diploma or degree in pharmacy
• At least one year of experience in drug sales

3. Import Drug License

As its name indicates, this License is sought by dealers who want to import raw materials for manufacturing drugs or import ready-to-sell drugs in India.

4. Loan Drug License

The drug manufacturer is willing to use his brand name to manufacture on a property for which a license has already been granted but does not own his land.

5. Drug Manufacturing License

Every manufacturer of allopathic, cosmetic, Ayurveda, or any other pharmaceuticals or remedies as defined by the Drugs and Cosmetics Act of 1940. This is the state permit granted by the particular state administration where the property is located.

6. Multi-Drug License

This drug license is meant for businesses operating in multiple states and units.

In this article, we are going to answer the question of how to get a drug license in India. We will also detail the specific requirements for wholesale and retail Drug Licenses in India.

Wholesale & Retail Drug License: What makes them prominent?

One of India's two most prominent Pharma Licenses is Retail License. But what are Retailers? Retailers are generic store owners with delible expertise in selling medications for generic purposes. Every independent pharmacist can open a Retail Store by acquiring a Retail Pharma License. You can apply for a Retail License with the State Pharmacy Council.

But, such is not the case with acquiring a Wholesale Pharma License in India. CDSCO, or the Central Drugs Standard Control Authority, issues the Wholesale Pharma License. The wholesalers involved in the pharmaceutical business envisioning to open a chain of pharmaceutical stores across a geographical area opt for the said License. But, the applicant must keep a few things in mind before applying for a Wholesale Drug License online. First, the applicant must hold a diploma or degree in pharmacy and a minimum of a year's experience in drug sales and distribution.

This article specifically focuses on the wholesale and Retailer License registration procedures. But before applying for the requisite License, let us learn a bit about the required eligibility.

Eligibility Criteria for Wholesale or Retail Drug License Registration in India

The requisite criteria for obtaining a Wholesale or Retail License for Medical Stores in India are detailed in the following points:

• The premises must be at least 15 square meters in size
• To keep the vaccinations, insulin injections, sera, and other supplies, the applicant's premises must have an air conditioner and a refrigerator
• A license is given to someone who possesses a pharmacy degree or diploma from an accredited university
• A pharmacist must be a graduate with one year of drug-selling experience
• The License must be visible on the property

Requirements for setting up a Drug Facility

What qualifications are for getting a wholesale or retail license in India? Some essential qualifications are required from Wholesale or Retail License holders in India.

Property Area

Setting up a pharmacy or medical store requires a minimum of 10 square meters. However, if they are running both a wholesale and a retail operation, a minimum of 15 square meters is needed.

Storage

Implementing cold storage, freezers, or similar facilities should provide proper storage for medications and vaccines, as they need to be kept in cool areas.

• Personnel with technical and expert knowledge
• Retail pharmacies must have a competent staff with these skills

State-specificity in Drug License procurement

Depending on their line of work, companies that deal in medications or medicines may need a variety of Drug Licenses. A single drug dealer must obtain Drug Licenses with several units in more than one state since they are region-specific. Every location where drugs are kept and sold must apply for a drug license, except migrant vendors.

Case of License Revocation or Suspension

Holders of drug licenses must ensure that the product conforms to all rules and regulations. The License granted defying these terms and conditions may be revoked or suspended. In addition, authorities must be notified of any business-related changes or modifications. These are some qualifications required for online Wholesale or Retail Drug License registration.

Documents Required for Online Wholesale Drug License Registration in India

The documents required to apply for a Wholesale Drug License in India are mentioned below. Requirement of documents is different for applicants as per the nature of the service they require. Below is the list of complete documents: 

Documents Required for Fresh Application:

• Online fee deposit receipts.
• Application Form No. 19/19A/19B/19C as applicable.
• Site plan and key plan of the premises.
• For company, Constitution of the firm, Memorandum and articles of association and Copy of resolution Passed.
• For Partnership firm, partnership deed, duly attested by Notary Public, and Trust deed, in case of trust / society.
• Photo ID proof of proprietor / partner / director of the firm.
• Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.
• Affidavit regarding compliance of MPD 2021, if the premises are located on DDA residential flat / plot /building
• Conversion charge receipt issued by MCD with relevant documents in support of commercial use as per MPD 2021 viz; copy showing the Name of notified commercial / mixed use road/street.
• Affidavit from the Regd. pharmacist/competent person.
• For Wholesale Licence Competent person :
  
  
  • Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets
  • Experience Certificate,
  • Appointment Letter and Bio-data.
•  
• Premises :
  
  • If Owned: Either Registered. Sale Deed / Registered GPA / Conveyance Deed in the name of owner, or Unregistered Sale Deed / unregistered GPA supported with Electricity Bill / Water Bill / property tax receipt.
  • If Rented: Rent Receipt and either Regd. Rent Agreement, or Unregistered Rent Agreement along with ownership documents of the landlord, as stated above.

*In case of a village, Khasra Khatauni documents will be considered.

Documents Required for Application of Additional Wholesale License

• Fee deposit receipts.
• Application Form No. 19/19A/19B/19C as applicable (System Generated)
• Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.
• For additional Retail Sale license :
  • Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets of Registered Pharmacist.
  • Registration of Delhi Pharmacy Council.
  • Appointment Letter and Bio-data.
  • System Generated Affidavit.

Documents required for Application of renewal of Retail/Wholesale license

• Fee deposit receipts.
• Application Form No. 19/19A/19B/19C as applicable (System Generated)
• Conversion charge receipt issued by MCD with relevant documents in support of commercial use as per MPD 2021 viz; copy showing the Name of notified commercial / mixed use road/street.

Documents required for Change in Registered Pharmacist

• Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets of Registered Pharmacist.
• Registration of Delhi Pharmacy Council.
• Appointment Letter and Bio-data.
• System Generated Affidavit

How to apply online for a Food and Drug License in India?

To apply online for a wholesale or retail license, the applicant must follow the given basic procedure to obtain the required Food and Drug License in India:

1. After determining the type of food and drug license required, an online application must be submitted along with the receipt of the requisite wholesale or drug license fee.
2. After successfully filing and submitting the wholesale or retail license registration form, the applicant will get a unique registration number that will be used for future reference.
3. All the necessary documents need to be submitted to the officer of the Licensing Authority within 15 days of registration.
4. Then the visit of a pharma inspector is done who verifies the authenticity of the submitted documents and facts stated in the license application.
5. The wholesale or retail License is eventually issued once the verification of documents is done satisfactorily by the pharma inspector.

Drug License Fee structure:

The licensing fee depends on the nature of the sought permit. Also, as always in the legal procedure, additional hidden charges, along with the requisite wholesale or retail drug license fee, must be paid for obtaining various lab tests or analyses as per the Central or State Drugs Laboratory's norms. In certain cases, the Pharmacopoeial Laboratory for Indian Medicine mandates testing procedures for the applicant to obtain the requisite drug license.

The drug license fee depends on several factors, such as the following:

• Type of drug license sought
• Location of the Pharmacy
• Scale of the Business
• Central or State Regulatory Requirements 

Therefore, the aforementioned factors are considered before deducing the amount for paying the drug license fee to the Authority. If you wish to know the drug license fee in Delhi for wholesale or retail shop owners, then connect with the CDSCO experts at Registrationwala.

How can Registrationwala help you get a Wholesale or Retail Drug License in India?

At Registrationwala, we have a team of skilled and experienced professionals who first understand your specific license requirements for both wholesaler and Retailer, the nature of the business, and other specifications, and then provide full-fledged support in license procurement. In addition, we ensure that your drug license registration is done proficiently so that it gets approved quickly without any hassle. So, apply for a wholesale or retail license online with Registrationwala.

When you apply for an online wholesale or Retail license, you get the following:

• Professional License registration support
• Peace of Mind
• Quick License Approval
• A team of Industry Experts

So, connect with our experts right away, and get the best advice on wholesale or retail license registration.

FAQs

Q. How can one apply for retail drug license renewal online?

A. The process of renewing wholesale drug licenses is completely online. Follow the below mentioned steps to renew the certificate from the department.

• For Schedule X Drugs/ Allopathic Drugs fill Form 21C and For Homeopathic Drugs fill Form 20-E. And for additional data fill the forms 19, 19B, and 19C. All these forms are available on the state Drug Controller Website.
• Pay the fees through e-challan. The fee for Homeopathic License and Schedule X license should be paid to the Head of Accounts.
• Choose an option of “New Inward”to create a new application on the State's drug Controller Portal. Use the firm’s login credentials.
• After login, upload the requested documents and e-send the application.
• Take print of e-form and note the inward ID for future reference. The inward ID will be generated by the portal which should be cited on the application and hard copies.
• Comply all the hard copies of documents, with a true copy of e-challan paid for the application. This must be done within 72 hours of e-sending the application.

Q. Who Can Apply for a Wholesale Drug License?

A. A person who fulfills the following qualification requirements can apply for a wholesale drug license:

• Must be a registered pharmacist under the state Pharma council.
• Have minimum 1 year experience as a salesman after graduation in a wholesale drug license.
• Have a minimum of 4 years of experience as a salesman in a registered drug license firm after senior secondary examination.

 

Q. What are cost of wholesale drug license?

A. The cost of drug license in online payment is Rs. 6000/- + for fees of License and Inspection fees of Rs. 1500/-. This cost is for getting a Drug license in Delhi.

 

Q. What are the documents required for wholesale drug license registration in India?

A. Same as the documents required for a Retail Drug license in India, the required documentation is as follows:

• Copy of AOA, MOA, and COI
• CTC of Board Resolution
• Appointment Letter etc.

Q. What area is required for attaining the wholesale drug license in India?

A. As one of the prominent Wholesale and Retail Drug License requirements, one is area specifications for office space. For example, every pharmacy/medical store requires 10 square meters of office space, but for running wholesale and retail operations, at least 15 square meters is required.

Q. How can one apply for retail drug license renewal online?

A. After paying for the Drug License Fee as applicable in Delhi, the drug distributor license holder worries about premature license expiry. To secure yourself from such setbacks, you can avail of Drug License renewal services at Registrationwala. Our Experts will brief you on the entire procedure. 

Q. What is the procedure for online drug license verification in India?

A. The procedure for drug license verification is quite simple. The verification can be done online on the State's Drug Authority portal. Just enter the Drug License number to verify its details on the website. You can also download the wholesale sale drug license verification procedural manual from the respective portal. 

Q. Is the requirement for Wholesale Drug License registration documents the same as retail drug license registration?

A. Yes, irrespective of the license category, the documentation requirements for all types of drug licenses are the same.

Q. Which Drugs are Banned in India for Wholesale Drug License?

A. There are multiple drugs which are banned from wholesale drug licenses. 10 drugs are prohibited for import some of them are Nialamide, Practolol, Amidopyrine, Rimonabant, etc. Check the complete banned list of drugs here.