How to get Wholesale Drug License in India?

Have you ever wondered how a major pharmaceuticals facility comes into being? Obviously, one needs the decided space, requisite drugs & chemicals for sales, and clinically trained workforce to run such a facility. But there is something more fundamentally indispensable to setting up a Drug-culture facility. It is the Drug License issued by the competent State or Central Drug Authority. Such permits ascertain the effectiveness and safety of the business and its pharma products for the general public. The Central/State Drug Authority issues various drug permits to interested Businesses. But this article will focus on a kind of Drug License, i.e.Wholesale Drug License, and its registration procedure with the Authority.

What is Wholesale Drug License in India?

Wholesale Drug License is the License issued to the entities wishing to engage in the sales and distribution of drugs as a B2B component, i.e., the Drug Wholesaler who sells pharmaceuticals to Drug Retailers in the general market. To avail of such a license from the Authority, the applicant pharma must qualify for the essential Drug License registration eligibility. Some of them are discussed in the next section.

Qualifications for procuring a Wholesale Drug License in India

Here, we have listed some of the licensing requirements for online Wholesale Drug License registration in India for your reference:

• The Wholesale Drug facility must be a minimum of 15 square meters.
• The Wholesale Drug facility must have an air-conditioner and refrigerator.
• Certain State authorities mandate the wholesale drug licensee, whether a company or an entity, must have a qualified workforce with a requisite degree/diploma from a reputed Medical Institution. Therefore, the applicant must arrange such manpower at its facility.
• The registered Drug Wholesaler must display a plaque outside its shop/office premises for future reference.

Note: Authorities issue a wholesale license in the presence of a registered pharmacist with experience in the drug field. He can also be an SSLC who passed with four years of experience in the pharma industry.

How to apply online for a Wholesale Drug license in India?

We have detailed the requisite procedural steps to apply online for a Wholesale Drug License in India in the following enumerations:

1. If you are determined in the type of drug license ought for your business as a Drugs Wholesaler, then you must apply for an online application for Wholesale Drug License registration at the Drug Authority official portal.
2. Upload the requisite documentation for furthering your candidature for the License along with the drug license processing fee payment.
3. After submitting the wholesale license registration application, you will get a unique registration number for future reference and application tracking.
4. If summoned or notified, you must submit all the necessary details to the officer of the Licensing Authority within 15 days of application filing.
5. Thereafter, the visit of a pharma inspector will be scheduled for your facility for further inspection. This inspection will verify the authenticity of the submitted details and facts stated in the application of the wholesale drug.
6. Finally, the Wholesale Drug License will be issued once the pharma inspector completes the inspection satisfactorily.

What if I run a Wholesale Drug Facility without the required permit?

As per the Drugs and Cosmetics Act, if an entity engages in any of the following activities relating to drugs without a valid wholesale drug license, then he will be punished with an imprisonment of not less than one year, extending to three years, and/or a fine of at least five thousand rupees:

• Drugs Manufacturing
• Drugs Sales or Distribution
• Stocking Drugs
• Sales Exhibition

Interested in Wholesale Drug License??

If you want to know further about the registration procedure for Wholesale Drug Licenses in India, refer to our Wholesale Drug License service page. To acquire the said License for your Drug Facility, register your basic details with us, and we will get in touch with you in no time. We have skilled CDSCO professionals at our disposal that can get you the requisite drug license in a cost- and time-effective manner.

Author: Dushyant Sharma

Hey there, I'm Dushyant Sharma. With the extensive knowledge I've gained in past 8 years, I have been creating content on various subjects such as banking, insurance, telecom, and all the important registration and licensing processes for various companies. I'm here to help everyone with my expertise in these areas through my articles.