Retail Drug License
Every company that wants to deal, manufacture, sell, import, export any kind of drug in wholesale or retail in India, needs to have Drug License from the concerned authorities. Drug License is of many types but here in this article, we are going to guide you about the Retail Drug License. It is also one of the subtypes of the Sale Drug License. The classification of Drug Licenses depends on the categories of the drugs one wants to deal with. Every government wants easy access to medicines to its citizens but simultaneously government also has to take care of the safety of its citizens. Hence the government made a Drug License mandatory for those who want to do the business of the pharmaceutical industry. Anyone who is working without this license will be levied with heavy fines and penalties. The act which controls the process of manufacturing to the sale of the drug in India is the Drugs and Cosmetics Act, 1940.
What is a drug?
As per section 3(b) of the Drugs and Cosmetics Act, 1940, drugs mean all the medicines for internal or external use of human beings or animals. Also, all the substances intended to be used for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder in human beings or animals. It also includes preparations applied on the human body for the purpose of repelling insects like mosquitoes. Substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals are also considered drugs. Components of a drug including empty gelatin capsules are also come under the category of the drugs.
What is Drug License?
Anyone who wants to manufacture, sell, import, export any kind of drug in wholesale or retail in India has to take permission from the government of the respective state. Basically, that permission is given by the state government in the form of a license. This license is known as Drug License. In short, we can say that the permission of the state government to do pharmaceutical business in a particular state is called Drug License.
What is Retail Drug License?
Retail Drug License is mandatory for the pharmaceutical businesses that are doing business as retailers. Retailers are basically those who first purchase goods directly from the manufacturer or wholesaler in bulk or in large quantity. Then they sell the same to the consumer directly in smaller quantities for profit. For such kind of sale, they want permission from the concerned authority in the form of a Retail Drug License. Hence we can say that permission taken by the retailers to do the pharmaceutical business is called Retail Drug License.
Pre-requisite essentials to obtain Retail Drug License in India
- A person who wants a Retail Drug License must be a competent pharmacist.
- Second very important essential for the Retail Drug License is space. If you are only a retailer then the minimum size should be 10 sq. meters for your pharmacy. But if you are a retailer as well as a wholesaler then you need a minimum of 15 sq. meters space for your pharmacy.
- A proper storage facility is mandatory for the Retail Drug License because there are many drugs that need to be kept in cool places. Hence AC and refrigerators are a must for Retail Drug Business.
- The staff of the retail pharmaceutical business must be technically experienced and have depth knowledge about the business.
Procedure to get Retail Drug License
- Applicant has to sign up on the state drug licensing website of the respective state then registered himself for getting the Retail Drug License.
- After the registration process applicant has to upload his entire related document on the same website which is mandatory for the Retail Drug License.
- After the above two steps applicant has to make payment of the fees required for the Retail Drug License.
- Once the payment is done, the applicant has to generate the challan for further process to get Retail Drug License.
- After all the above formalities the state drug authorities will send the District Coordination Officer to inspect the ground reality.
- Once he verified that everything is correct and up to the mark, he will make the report for the grant of Retail Drug License for the concerned authority.
- Finally after the positive report of the District Coordination officer Retail Drug License will be granted.
Important document regarding Retail Drug License
Retail Drug License is provided by the government so that they can provide security to the people. After all, people are the consumers. Hence before providing any Drug License government takes care of documentation very strictly. Hence you should know the exact documents required for the Retail Drug Business. Following is the list of the documents required for the Retail Drug License-
- Passport size photo of the owner
- Address proof of the owner
- Identity proof of the owner
- Challan regarding the fees submission of the license
- Completely filled and signed application form
- Registered plant layout copy which must be self-attested
- Office proof
- Lease Agreement or Rent Agreement as the proof of the location
- No Objection Certificate from the landlord, which is also known as NOC.
- Educational background documents of the pharmacist
- Experienced related documents of the pharmacist
- Invoice of the refrigerator that is for the business purpose
- Invoice of the AC that is for the business purpose
Other important documents if you are starting the business in partnership
- Partnership deed
- Complete list of the partners
- Name, ID Proof, Address Proof and Passport Size photo of all the partners of the partnership firm
Additional documents required in case of Private or Public Company
- Certificate of incorporation of the company
- Memorandum of Association that is also referred to as MOA is required
- Article of Association is also must
- Document regarding the appointment of a person who will look into the daily matters of the company
- Copy of the board resolution
Documents regarding the pharmacist
- Copy of the diploma in the pharmacy of the pharmacist
- Experienced letter of the pharmacist
- Pharmacy council’s registration certificate is needed, which they provide to the pharmacist
- Affidavit of the pharmacist
- Educational certificates of the competent person
Renewal of the Retail Drug License
Retail Drug License is not a one-time license. It needs to be renewed after the expiry period, which is five years. Every five years owner needs to renew the Retail Drug License. Retail Drug License can be canceled or suspended before five years as well if it is found that the owner of the pharmaceutical business is doing something which is against the government norms.
Benefits of the Retail Drug License
- Retail Drug License provides safety to the consumers.
- It makes the owner of the pharmaceutical business more responsible.
- Retail Drug License will increase the liability of the owner of the business.
- Helps in curving down the misbranding of the drugs.
- With the help of Retail Drug License adulteration of the drugs will be stopped.
- Government can easily keep eye on the pharmacist's activities.
- Retail Drug License provides goodwill to the pharmacy as they have government licenses.
- Make the pharmaceutical market clean and safe.
- Retail Drug License is beneficial for the consolidated fund of the state.
- Check and balance on the business owners.
Are different Retail Drug Licenses needed for different states?
Retail Drug License is provided by the State authorities. Basically, Retail Drug License is a state license. Hence if you want to do pharmaceutical business in different states, you need different Retail Drug License for every such state, where you want to do business. If it is found that you are doing business in different states without having a Retail Drug License from the respective state, you will be penalized.
Getting Retail Drug License is not easy. The process involves various steps after which a Retail Drug License will be issued. Proper strict verification is done by the concerned authorities after that they will approve the issuance of the Retail Drug License. A single mistake can result in the disapproval of the issuance of the license. Hence expert advice like BizAdvisors is suggested.
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Frequently Asked Questions
Permission taken by the retailers to do the pharmaceutical business in a particular state by the concerned authorities is called Retail Drug License.
To get this license first you have to sign up on the website of the state license providing authority. After which you need to upload all the documents and pay the fees. Then the verification will be done by the authorities. If they approved you will get the license.