Overview of Wholesale Drug License
To start a business of drugs or cosmetics, one needs to obtain Drug License. Without a drug license, no one can conduct a business related to selling drugs or cosmetics.
The procedure and the qualifications required for a drug license are given under the Drugs and Cosmetics Act, 1940. The laws relating to drugs and their sale or manufacture are dealt with under the said Act, and the Rule is made thereunder. Having a pharmaceutical business without such a License will be an offence. Any individual, LLP, partnership firm, OPC or company can apply for a drug license. The License can be renewed as it is valid for up to five years.
The Ministry of Health and Family Affairs issued the Cosmetic Rules in December 2020, which states that a drug license is mandatory for importing cosmetics into India. For being an authorized agent of drugs and cosmetics in India, any company or individual has to obtain a wholesale drug license. The wholesale drug license is granted by a licensing authority of that particular state of the applicant—wholesale means selling the drugs to the individual retailers for further sale of such drugs.
Basic Requirements for Wholesale Drug License
- The shop/office should be a minimum of 15 square meters.
- The shop/office should have an air-conditioner and refrigerator.
- There are few states where the wholesale drug license is issued to only a company or entity with a qualified person with a degree/diploma from a reputed college/university.
- The wholesale drug license can be issued in the presence of a registered pharmacist or competent person and under his supervision. Such a person should have 1-year experience in the field related to drugs or an SSLC passed with four years of experience in the field related to drugs.
- After obtaining the drug license, the person having it should display it on the outer side of the premises of his shop/office for future reference.
Benefits of obtaining the Wholesale Drug License
The benefits of obtaining the Wholesale Drug License are given below, which are as follows:
- The Authority Can Keep Track of The Working
A wholesale drug license helps the authority keep track of the working and regulating the dealing of medicines in India, ultimately enhancing business reliability and trustworthiness.
- Admissibility Of Business
A person must file a Wholesale drug license application as it provides admissibility to the business. Also, it is unlawful to engage in the dealing of drugs in India without obtaining the License.
- Proof Of Authenticity
A Manufacturing Drug license plays a vital role, as it works as a proof of authenticity and builds an image of the company in the market.
- Enhances Consumer Base
A drug license certificate proves to your consumers that the business is following strict quality measures while manufacturing drugs. Also, the License demonstrates to the consumers that the medicines and drugs are safe and constitute no deadly chemicals.
Documents required for Manufacturing Drug License
An applicant needs to provide the below-mentioned documents for a Wholesale Drug License: -
- MOA and AOA in case of a company, partnership deed in case of a partnership and LLP agreement in case of an LLP.
- Identity proof of a director/partner/proprietor.
- Copy of documents related to property, such as proof of ownership or rent agreement.
- No Objection Certificate (NOC) from the owner of the property, in case the premises are rented property.
- Site plan and key plan
- Copy of board resolution
- Proof of refrigerator, cold storage, air-conditioner, etc.
- Proof of payment of a fee (copy of challan)
- Affidavit stating that the director/partner/proprietor has never been convicted.
- Affidavit from the pharmacist or the competent person
- A cover letter containing the name and designation of the applicant.
- Application in Form 19 with the declaration form
- Appointment letter, qualification certificate and the experience certificate of the pharmacist or the competent person.
- Qualification of the applicant.
Registration Procedure for Obtaining the Wholesale drug license
State Licensing Authority grants the wholesale License. The process is long and will take 30-60 days to complete.
These are the following steps to be followed to obtain a wholesale drug license from the state licensing authority of any state in India:
- Step 1-Creation of User Id and Password
The applicant has to create an account over the online state licensing portal/ website of the concerned state with a user ID and Password by giving a request letter in which you should not forget to mention details of the firm.
- Step 2-Filling of the Application, uploading documents and fees
The applicant should fill the Application in Form 19 at the online portal or website with all the requisite documents. All the documents need to be uploaded as scanned copies in black and white format. The licensing authority may ask for more documents whenever required. After uploading all the documents, the applicant has to pay the fee as prescribed by the government. If any objection arises in the Application Form due to incomplete information, the fees, once paid, will be returned by the government.
Step 3- Inspection of the premises
After proper submission of the application form, it will be sent or emailed to the director. He will forward the Application to the drug inspector for the inspection of the premises, i.e., the shop/office of the applicant, by personally visiting there and scrutinizing/verifying the documents uploaded with the Application.
- Step 4-Issuance of License
After a satisfactory inspection of the shop/office and verification of the documents by the drug inspector, the director of the licensing authority will issue the drug license.
Penalties in case of Non-Compliance
According to the Drugs and Cosmetics Act, if a person himself, or by any other person, manufactures for sale or distribution, or sells, or stocks or exhibits for sale any drug without a valid drug license, then he shall be punishable with imprisonment for a term of not less than one year which may extend to 3 years, and with fine of not less than Rs.5000/-.
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Frequently Asked Questions
The applicant’s shop/premises should have an adequate area of not less than 10 square meters. The person in charge (Competent Person) must be a Registered Pharmacist/who has passed Matriculation or its equivalent with four years’ experience in dealing with Drugs or who holds a degree of a recognized university with one year’s experience in dealing with Drugs.
The books of accounts, registers, forms, and other documents shall be maintained in such manner as may be specified by the licensing authority at the time of issue of such license. It is the responsibility of the license holder to intimate every change and modification that occurred in its business.
The applicant’s shop /premises should have an adequate area of not less than 10 sqr. Meters, should be equipped with proper storage facilities for preserving the properties of drugs, and applicant (Competent Person) must be a Registered Pharmacist with Pharmacy Council.
- Wholesale Drug License
- Manufacturing License
- Sale License
- Retail Drug License
- Import License
- Multi-drug License
- Restricted Drug License
- Loan License
- Proof of qualification i.e. final degree certificate/provisional certificate with mark sheets
- Experience Certificate
- Appointment Letter and Biodata
- Compulsory for drugs, medicine, or cosmetics business,
- Granted for a commercial premise,
- Shall comply with the requirement and conditions imposed by law and authorities,
- Shall display all the time in the place of business.
Various provisions dealing with Drug licenses are given under Drugs & Cosmetics Act, 1940 & rules thereunder. Information can also be sought in person from the drug inspectors seated in Drugs Control Department.
Yes, a drug license is necessary for every unit operating in any part of India. For instance, if the drug business has its unit in two separate states, it shall get the license for both such an operational unit.
Any person/company/partnership firm/LLP/OPC can apply for Drug License at Drug Controlling Authority.
- If you own a property, a copy of the property papers,
- If the property is rented, a copy of the rent agreement