How to get Wholesale Pharmaceutical Drug License?

India holds a place of remarkable distinction in the realms of the drug business. The country is reported to be the world’s largest provider of generic drugs. In addition to it, the Indian pharmaceutical sector caters to more than 50% of the global demand for various vaccines. The business of such magnitude and significance needs to be operated with proper guidelines and structure, substantiating the need for regulation. In India, the provisions pertaining to drug control and administration are provided for in the Drugs and Cosmetics Act of India, 1940 among other pertinent State and Central regulations.

DM Pharma is an exporter of ethical and generic medicines worldwide. Our products are manufactured in WHO, GMP, GLP, and ISO certified manufacturing units in Baddi, Himachal Pradesh. Products are processed under the counsel of professionals using optimum quality raw material and are appreciated for optimum tone and longer shelf life. We would help you to know how you can get the wholesale Pharmaceutical drug license.

What is the need for a drug license in the Pharma Sector?

The Drugs and Establishment Act of 1940 establishes that no drug business can be operated in India without obtaining a license for this purpose. These regulations apply to all drugs. The manufacturers or sellers of a drug will be held accountable for any harm caused by its consumption or utilization. This proves that unregistered or illegal conduct of trade is detrimental not only to the health and welfare of the citizens (which holds more importance than the latter) but also to the life of the business as the law-books doesn’t include any lenient provisions for these defaults.

Normally, the drug control organization issues two types DL one is Retail drug license which is issued to a person who runs a chemist shop and another one is a Wholesale drug license that is issued to a person who wants to sell drugs on a wholesale level.

 The Requirements to obtain a drug license 

Before applying for the drug license you need to fulfill the basic requirements. You need to follow the conditions to obtain a drug license.

·         The size of the premises should be 10 Sq. Meter for retail and wholesale outlets. In the case of combined wholesale and retail, you need to have 15 square meters. It is mandatory for all.

·         A refrigerator, air conditioner and good ventilation system for the premises.

·         There should be a presence of any of the one person:

1.       A Registered Pharmacist under State Pharmacy Council.

2.       A graduate with min 1-year experience in drug sales and marketing with a reputed Pharma company.

3.       A person having 4 years of experience in Pharma marketing and has passed S.S.L.C.

4.       A person approves by the department of drug control is also eligible.

Documents required getting a Wholesale Drug license

Your license form will need to attach a set of documents for attestation and proof. The documents intended to fill or attach may vary from state to state. Below is the indicative list of documents that are attached to the form of a drug license.

· Application form as per your need.

· You will also need written proof of Rent Agreement of Ownership papers of premises. This is the basis of possession of the premises.

· Blueprint of premises site plan and key plan.

· Declaration form

· Covering Letter from the applicant stating the purpose of application with a sign, name, and designation.

· Fee challan submission.

· Copy of the documents like purchase bills (like a refrigerator, air conditioner, etc), electricity bills.

· Original copy of the Incorporation Certificate, AOA and MOA.

· Partnership Deed (If)

· Affidavit and a copy of a full-time employment appointment letter of the registered pharmacist or competent person (following Drugs and Cosmetics Act, 1940).

· Property tax receipt.

· Rs 2 stamps (4 will be required).

Starting a wholesale Pharmaceutical Business is not very complex, but you need to prepare for it. Once all the formalities are completed, it should not be a big issue.