Jitendar Chauhan / 16th December, 2022

Wholesale Drug License – Form, Process, and Required Documents

Regulation/Guidelines

Drug, Medical Device, IVD,

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Summary:

A wholesale drug license allows the wholesaler to sell, store, exhibit, and distribute drugs in India. However, the applicant must fulfil the criteria laid down by the government authority.

As per the rules put down by the Drugs and Cosmetics Rules, a wholesaler who wishes to sell, exhibit, store, or distribute drugs in India must have a wholesale drug license.

The State Licensing Authority (SLA) grants this licence to the wholesalers. Individuals can issue wholesale drug licenses for products like drugs and biologicals..

Important Form For Wholesale Drug License Form 19, 20B, 21B

The following forms are involved in the process of application and approval for a wholesale drug license in India:

Form 19: The wholesaler can apply for the license via Form 19
Form 20B: The SLA grants license for drugs that are not given in Scheduless C, C(1), and X of the Drugs and Cosmetics Act and Rules via Form 20B
Form 21B: The SLA grants license for drugs that are mentioned in Schedule C, C (1), and X of the Drugs and Cosmetics Act and Rules via Form 21B

Eligibility & Wholesale Drug License Application Process

Sr. No.	Criteria
1	Any company, partnership, limited liability partnership, or organization can apply for the license
2	The premises must be minimum of 10 square metre area
3	The premises must have a refrigerator and air conditioning system for drugs that are required to be stored in a cool place
4	A pharmacist registerd with state pharmacy council can act as competent person
5	A diploma or degree from a university recognized by the government along with at least one year of experience in working with drugs or a Senior Secondary Leaving Certificate holder with four years of experience in working with drugscan act as competent person

Table 1: Criteria for applying for wholesale drug license in India

The criteria for obtaining the wholesale license are mentioned in Table 1. If the applicant fulfils these criteria, they can apply for the wholesale license via Form 19 by following these steps:

Visit the ONDLS portal
Create a login ID and password
Fill out the online application by using the prepare/edit application option
Select the storage type (CP in wholesale/CP in retail)
Submit Aadhar details
Add every mandatory detail
Upload the photographs and certificates of pharmacists
Save the application
Print out the self-declaration form
Take the signatures of the proprietors and pharmacists on the self-declaration form
Upload the documents
Print the form and take the signatures of proprietors and pharmacists
Pay the requisite fees through the state specific govt site
Upload the scanned copy of the challan
Submit the application form on the portal
Print the hard copy of the application and submit it to the SLA

The applicant must have all the necessary certifications and documents per the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945. The documents mandatory during the application process fora wholesale license is listed in Table 2.

Sr. No.	List of documents required
1	Filled Form 19
2	List of directors
3	Blueprint of layout and area of proposed premises in meter and total area in square meter
4	Ownership documents of the proposed premises
5	Challan fees (₹3000)
6	Affidavit of the proprietor on stamp paper of ₹20
7	Rent agreement on stamp paper of ₹50
8	Self-attested copies of the educational certificate of the proprietor
9	Self-attested copies of ID Proof of proprietor/Director/Partner
10	Affidavit and self-attested copies of the educational certificate of a registered pharmacist
11	Tax receipt of the proposed premises
12	Invoices for refrigerator and air conditioning system
13	Covering letter
14	3 photos each of the proprietor/Director/Partner and pharmacist

Table 2: List of documents required during the application process for a wholesale drug license

These documents must be in PDF scanned format in grayscale. Once the application is submitted, the drug inspector will conduct an inspection. If everything is in order, the Licensing Authority will approve the application and grant license within 21 Working days.

The wholesale license is valid for a lifetime unless the regulatory authority cancels or suspends the license. However, the license holder must submit a retention fee every five years.

Summary

An individual can apply for a wholesaler license via Form 19 on the official website or portal of the State Licensing Authority
The wholesaler can apply for the wholesale drug license if they fulfil the criteria laid down by the government authority
The applicant must also have all the necessary certifications and documents per the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetic Rules, 1945