Overview of Wholesale Drug License
YIn India if you want to deal, manufacture, sell, import, export any kind of drugs or cosmetics in wholesale or retail, you need to have Drug License from the concerned State authorities. Drug License is of many types but here in this article, we are going to guide you about the Wholesale Drug License. Form 20B and Form 21B are the forms through which one can apply for the Wholesale Drug License. The classification of Drug Licenses depends on the categories of the different types of drugs. For the safety of the citizens, the government made a license mandatory for those who want to do the wholesale drug business. Anyone found working without a it 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, the following will come under the category of drugs-
- Drugs mean all the medicines for internal or external use of human beings or animals.
- Substances 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 to the human body for the purpose of repelling insects like mosquitoes.
- Substances (other than food) whose intention is to affect the structure or any function of the human body or 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. Hence the permission taken by the state government to do pharmaceutical business in a particular state is called Drug License.
What is a Wholesale Drug License?
A wholesale Drug License is mandatory for the pharmaceutical businesses that are doing business as wholesalers. Wholesalers are basically those who sell in bulk or in large quantities. They basically sell to the retailers in large quantities for profit. For such kind of sale, they want permission from the concerned state authority in the form of a license. Hence we can say that permission taken by the wholesalers to do the pharmaceutical business in the form of license is called Wholesale Drug License.
Important document regarding Wholesale Drug License-
Following is the list of the documents required for the above mentioned license-
- Passport size photo of the owner
- Address proof, Office Proof, and 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
- 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 and experienced related documents of the pharmacist
- Invoice of the refrigerator and AC that is for the business purpose
- Partnership deed and a complete list of the partners with their name, ID proof, address proof, and passport size photo of all the partners of the partnership firm
- Certificate of incorporation of the company
- Memorandum of Association that is also referred to as MOA is required
- Article of Association is also must
- Copy of the board resolution
- 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
Procedure to get Wholesale Drug Licenses
- 1. Sign up on the website- Applicant has to sign up on the state drug licensing website of the respective state and then registered him for getting the Wholesale Drug License.
- 2. Upload Documents- After the registration process applicant has to upload his entire related document on the same website which is mandatory for the above mentioned license.
- 3. Payment of the Fees- After the above two steps applicant has to make payment of the fees required for the license.
- 4. Get Challan- Once the payment is done, the applicant has to generate the challan for further process to get a same license.
- 5. Verification- 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 Wholesale Drug License for the concerned authority.
- 6. Grant of License- Finally after the positive report of the District Coordination officer license will be granted.
Pre-requisite essentials to obtain Wholesale Drug License in India
- 1. Competency- A person who wants a license to sell drugs in wholesale then he or she must be a competent pharmacist.
- 2. Space- Second very important essential is space. If you are a wholesaler then you need a minimum of 15 sq. meters of space for your pharmacy. The place must be free from all types of rodents and proper cleanliness must be maintained. Proper hygiene must be maintained and there should be no contamination in the location.
- 3. Storage Facility- A proper storage facility is mandatory because there are many drugs that need to be kept in cool places. Hence AC and refrigerators are a must for the wholesale Drug Business.
- 4. Technical Staff Members- The staff of the wholesale pharmaceutical business must be technically experienced and have depth knowledge about the business.
- 5. GST Registration- After the latest change done by the government of India, now before starting the wholesale pharmaceutical business you must have to take the GST Registration number.
Renewal of the Wholesale Drug License
A Wholesale Drug License is not a one-time license. It needs to be renewed after the expiry period. It can be canceled or suspended before the expiry period as well if it is found that the owner of the pharmaceutical business is doing something which is against the government norms. For the renewal Form 21C is filled for the allopathic and schedule 10 drugs. Form 20E for the homeopathic drugs. For the additional information data Form 19, 19B and 19C will be required to be filled properly. Renewal of license is mandatory to process which cannot be ignored.
Benefits of the Wholesale Drug License
- It provides safety and security to the consumers in the market.
- It makes the owner of the pharmaceutical business more responsible and increases the liability also.
- It will help in curving down the misbranding of the drugs in the market full of mischievous activities.
- Adulteration of the drugs will be stopped through a Wholesale Drug License.
- Government can easily keep eye on the pharmacist's activities and can make the market clean for the customers.
- This license will provides goodwill to the pharmacy as they have government licenses.
- It is beneficial for the consolidated fund of the state.
- Check and balance the activities of the business owners and curve them from doing anything which is against the norms of the government.
- Make the market clean and safe for the use of the customers.
Are different Wholesale Drug Licenses needed for different states?
A Wholesale Drug License is provided by the State authorities. Basically, it is a state license. Hence if you want to do pharmaceutical business in different states, you need different 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 proper working license from the respective state, you will be penalized. Hence to save your business from penalties and fines always get a different license for different states.
Both getting a Wholesale Drug License and renewing it are not a child play. Both need a lot of formalities where mistakes cannot be afforded. Even one simple mistake can delay your license and you have to do all the work again. The rules and regulations regarding Drug Licenses are very strict because drugs are one of the very important things related to the health of the people. Hence to save your time and money; expert advice like BizAdvisors is suggested. They can help you to get this license easily, without any mistake.
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Frequently Asked Questions
Permission taken by the wholesalers from the government to do the pharmaceutical business in any particular state is called Wholesale Drug License.
Wholesalers are those business owners who sell in bulk or in large quantities. They basically sell to the retailers in large quantities for profit.
- Upload all the documents
- Then pay the fees.
- Verification will be done by the authorities.
- If authorities give approval you will get the license