Wholesale Drug License Required Documents – A License works as a pillar of any business. It is a well-known fact that the business in the pharmaceutical sector runs on certain licenses and agreements. It is because it involves healthcare drugs that will further be consumed by the masses. On the other side, acquiring a drug license can be complicated at times. If you are a business aspirant who is looking forward to entering the pharmaceutical industry and wants to get complete information about the
Wholesale Drug License Required Documents, then this blog can help you out.
The central concern of the legal authorities lay on the assurance that every individual is getting hold of safe and effective medicines. This is the reason why the permit to manufacture, distribute, and supply is granted with extreme attentiveness. The governing bodies have strict rules for permitting licenses for the manufacturing and supplying of medicines in the market. It is necessary for the pharma individuals to know everything about the
Required Documents for Wholesale Drug License in order to run their legal business in the pharma market.
Detailed Information About a Drug License
A Drug License is the most essential document that works as legal permission to manufacture or sell the medicines and drugs. The Drug and Cosmetic Act, 1940 covers all the laws associated with the medicines, drugs, and cosmetics that are set up by Drugs Control Department. This act merely affirms that if the drugs are stocked at a specific place for sales, then the application must be made without any exception and the drug license must be issued.
The licenses boost the credibility and reliability of business in the pharmaceutical industry. The CDSCO (Central Drugs Standard Control Organization) and SDSCO (State Drugs Standard Control Organization) are responsible for the issuance of drug licenses in India. There are chiefly two types of drug licenses issued by the Drug Control Organization which includes:
- Wholesale Drug License: A Wholesale Drug License is issued to those individuals who want to sell drugs on the large-scale or wholesale level.
- Retail Drug License: A Retail Drug License is issued to an individual who runs a chemist shop.
Types of Drug Licenses Granted by the Legal Authorities
Other than Wholesale and Drug Retail Licenses, there are also some other drug licenses that are issued by the legal authorities for the pharma business. These include the following:
- Manufacturing License
- Multi-Drug License
- Loan License
- Import License of Medical Equipment
- Import License of Drugs & Cosmetics
- Export of Medicines
Requirements to be Fufilled to Obtain Wholesale Drug License
Other than Wholesale Drug License Required Documents, there are certain requirements that the applicant must meet in pursuance of a drug permits. Some of the essential requirements to obtain a drug license are as follows:
Qualification & Eligibility
In order to obtain a Wholesale Drug License, there is a specific qualification criterion that needs to be fulfilled by the applicant. The individual must have at least one year of experience in a registered firm dealing in the wholesale drugs business. For undergraduate aspirants, there is a minimum requirement of four years of experience.
Surface Dimensions
The
Total area required for retail wholesale drug stores together needs to be around 15sqm (square meters). Whereas, the minimum area that is required to start a pharmacy, chemist shop, or wholesale shop should be around 10sqm.
Drug Storage
There are certain drugs including vaccines, topical preparations, insulin, chemotherapy drugs, sera, etc., that need to be stored in a refrigerator or freezer. Therefore, a refrigerator and air conditioner are mandatory in the premises.
Specialized Staff
As a wholesaler, an individual will have to make the sales of the drug either in the presence of a registered pharmacist or in the presence of a qualified individual who is a graduate and holds at least one year of experience in drug dealings.
While as a retailer, the sale of the drugs must be done under the surveillance of a registered pharmacist validated by the department.
Wholesale Drug License Required Documents
By fulfilling the essential requirements of qualification, Total area required for retail wholesale drug store together, area, etc., there are certain Wholesale Drug License Required Documents that are generic but mandatory at the same. Mentioned below is the list of essential documents that an applicant will require to obtain a wholesale drug license in India:
- A covering letter self-attested with the name and designation of the applicant.
- An official Challan of the deposited fee.
- ID Proof of the applicant (Aadhar Card, PAN Card, Passport, Voter ID, etc.)
- Declaration form in the prescribed format approved by the Notary Public.
- Blueprint of the premises.
- Site Plan of the premises.
- Electricity Bill of the premises.
- An invoice receipt of the purchased freezer and air conditioner along with the address.
- An Affidavit of partner, proprietor, or pharmacist.
- A receipt of registration if it is a case of a Pvt. Ltd. Firm.
- Xerox copy of the latest renewal certificate.
- Ownership or rent lease of the premises.
Now that you are aware of Wholesale Drug License Required Documents, it will become quite easy for you to start your business in the pharma sector with legal approvals. We really hope that you have occupied all the required information that was mandatory to acquire a Wholesale Drug License. If you are still trapped in some doubts or want to go depth in the drug license process, then feel free to contact the Best PCD Pharma Company in India, Novolilly Pharmaceutical.