How To Get a Drug License in India – Looking for steps to register for a drug marketing license in India? Want the steps to get a wholesale drug license in India? In this post, we will be discussing the requirements, documents, and other important points to obtain a drug marketing license in India for pharma PCD business.
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Introduction | Drug License
Drugs & Cosmetics Act, of 1940 made licensing of pharma compulsory. The law consolidates rules and regulations related to drugs, cosmetics, and medicines establishing a Drugs Control Department. The Central Drugs Standard Control Organization (CDSCO) is the head official of the Drugs Controller General India (DCGI). They are the main regulatory body for drug registration in India.
- Central Drug Standard Control Organization Or
- State Drug Standard Control Organization
The type of drug license depends on the business nature and transaction. Here are the characteristics of a drug license in India:
- It is compulsory to be owned by all kinds of drugs and cosmetic businesses.
- Every pharma business (drugs and cosmetics) needs to comply with the terms and conditions of the license.
- The drug marketing (Sales) license can be granted on two premises: commercial premises or other premises independent of residence.
- The license should be displayed at the center of the premises.
- It is mandatory to own a drug license in each state if you are operating in two or more states.
- Those who have migrated will need to fill out another form.
Drug Marketing License in India
The drug license can be found in three types. One is a manufacturing license, sales license, and loan license. The drug marketing license is of three types. Make sure that you fill out the right form of license and deposit it to the Drugs Control Department. One can apply for:
- Wholesale Drug License (WDL) (Generally issued to persons or agencies involved in wholesale distribution of pharma drugs and products)
- Retail Drug License (RDL) (Generally issued to stand-alone pharmacy and chemist shops)
- Restricted (Gen.Store) License
A valid drug marketing license can be obtained by filling out applications as per Drugs and Cosmetic Rules, 1934. You need to fill out the form and submit it to the licensing authority. The schedules drugs intended to distribute/ exhibit/sell/ sell/ stock/ or offer. Here is the list of application numbers to be filled by you:
- Drugs other than those included in Schedule X need to fill Form 19 or Form 19- A (retailing under a population of 5000 or less)
- Drugs specified in Schedules C, C (1), and X need to fill in Form 20, Form 20-A, or Form 20 –B
Requirements To Obtain A Drug Marketing License in India
Before applying for a drug license you will need to fulfill some basic requirements. You need to follow the conditions to obtain the license. Look at the minimum requirements for obtaining a drug marketing license in India:
- The premises should have a minimum square meter (Sq. Mtr.) of 10 for a chemist shop/ pharmacy or wholesale outlet. 15 square meters for retail and wholesale business.
- You must own a refrigerator and air conditioner for storage purposes like vaccines, insulin injections, sera, etc.
- A registered pharmacist under the State Pharmacy Council.
- In the case of a wholesaler or the presence of a registered pharmacist, a competent person shall be liable. He should be a graduate holding a minimum of 1 year of experience in sales and marketing of drugs.
- A person who has passed S.S.L.C. with 4 years of experience in pharma sales is also eligible.
Documents Required To Get A Drug License
Your license form will need to attach a set of documents for attestation and proof. The documents intended to be filled or attached may vary from state to state. Here is the indicative list of generic documents that need to be submitted along with the form for obtaining a drug license in India:
- Application form as per your need.
- Blueprint of key plan and site plan of the premises. You will also need a written proof of rent agreement of ownership of the premises. This is the basis of possession of the premises.
- Declaration form
- Covering Letter from the applicant stating the purpose of the application with sign, name, and designation.
- Fee challan submission.
- A copy of the invoice receipt for the purchased refrigerator and air conditioner.
- Copy of original Incorporation Certificate/ AOA / MOA / Partnership Deed
- A copy of the appointment letter with signature and affidavit of (Full-time working) registered pharmacist or competent person.
- Affidavit of non-conviction of partners/ proprietor/directors under Drugs and Cosmetics Act, 1940.
- In the case of a Private Limited Company, You need to submit a board resolution and a list of directors with a sign.
- Property tax receipt.
- Four Rs 2 stamps
Check all the documents and fulfill the requirements before submission. A drug is essential for all pharma businessmen. The laws and regulations may differ from state to state. You can ask the drug authorities for a better opinion about it.