Overview of Retail Drug License
Obtaining Drug License is mandatory for all retailers who want to indulge in the business of Drugs and Cosmetics in India. The Drug license is classified as below:
Further, Selling License is categorized into two segments-
- Retail Drug License.
- Wholesale Drug License.
The Provisions related to obtaining a Retail Drug License are defined in the Drugs and Cosmetics Act, 1940. These provisions are applicable in every state of India. If the business is running in more than two states, it has to obtain a retail drug license in every state in which the business is being operated.
It is necessary for the businessman having a business of drugs to comply with the rules and regulations of such a license. It is obligatory to maintain all the records/registers/forms in a specified manner, and authorities shall be informed of all the changes made in the business activity.
If a retailer has his shops or offices in multiple states, he should acquire a drug license in each state in which the business is being continued. Drug License is area explicit. If the medications are sold or loaded available to be purchased in more than one state, the application should be made, and a permit should be given regarding each state.
When the permit is conceded to the business, all such Licensee must guarantee that all the retail drug license conditions are constantly maintained. All the records/registers/Forms must be kept as specified by the licensing authority. The authority should be updated about all the progress and adjustments made related to the sale of drugs by the licensed retailer.
Pre-requisites for applying for a Retail Drug license
All pharmacies must obtain a drug license. State Drug Control Organization is responsible for issuing the License to the wholesale pharmacies and the retail pharmacies. Though, the rate of approval for a retail license is relatively low compared to a wholesale license. The followings are the pre-requites for obtaining a retail drug license in India:
The area of the shop/premises should have an area of not less than 10 square meters.
The shop/premises should have an air-conditioner and refrigerator to keep the vaccines, insulins, and other medicines or injections cold.
- Registered Staff
There should be a registered pharmacist, approved by the department, present every day during the working hours of the retail shop, and the sale of drugs should be made in the presence of him only.
Benefits of Obtaining the Retail Drug License
The benefits of obtaining the Retail Drug License are as follows:
- Compliance With the Law
All the individuals having a drug license shall be compliant with the Drugs and Cosmetics Act, 1940.
- Validates The Status of The Business
A person must file a Retail drug license application as it validates the status of the business, and also, it is unlawful to engage in the selling of drugs without obtaining the retail drug license.
- Enhances Confidence in The Consumers
A drug license (Whether Wholesale or retail drug license) proves to the consumers that the business is complying with strict quality measures while selling the drugs. Also, a valid license proves to the consumers that the medicines and drugs are safe and mark no danger to health.
- Proper Access and Control by The Authority
A retail drug license helps the authority access and control the sale of drugs in India, which eventually enhances the retailers' reputation.
- Proof Of Genuineness
A Retail Drug License works as proof of genuineness and builds a company's brand image.
Documents Required to Obtain Retail a Drug License
The documents required to obtain a Retail Drug License are as follows:
- 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 property owner, 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
- Qualification of the applicant.
- Appointment letter, qualification certificate form and the registration of local pharmacy council of the registered pharmacist.
- All the above-mentioned documents should be properly scanned in PDF format and grey-scale.
Registration Procedure for Obtaining Retail Drug License
The followings are the steps to follow while applying for the retail drug License:
- Creating The ID And Password
The very first step is to create the ID and Password of the applicant by providing all the required details on the online portal of the state licensing authority.
- Application Filling and Documentation
The applicant should prepare the required documents and then apply on the online application form provided on the website or portal of the state licensing authority. After filling out the application form, the applicant should scan and upload all the documents in the application.
- Inspector Visit
After the application for the issue of a drug license is submitted, the same is forwarded to the drug inspector for inspection. The drug inspector will personally visit the shop/retail premises to check the authenticity of all the information and the documents provided by the applicant.
- Grant Of License
Once the inspection is done and all documents and information are deemed satisfactory, the controller/appropriate authority of drugs issues the Retail Drug License for the applicant.
Penalties in case of Non-Compliance in Obtaining the License
According to clause (c) of Section 18 of the Drugs and Cosmetics Act, a person whoever himself, or by any other person on his behalf, manufactures for sale or distribution, or sells, or stocks or exhibits for sale any drug without a valid license as required, shall be punished with a term of imprisonment which can be extended to three years and also with the fine not less than Rs. 5000/-.
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Frequently Asked Questions
The applicant’s shop/premises should have a sufficient area of not less than 10 sqr.meters should be equipped with proper storage facilities for preserving the properties of drugs, and the applicant (Competent Person) must be a Registered Pharmacist with Pharmacy Council.
The applicant’s shop / premises should have an adequate area of not less than 15 sqr. mtrs.
The applicant’s shop/premises should have an adequate area of not less than 10 sqr.meters and person in charge (Competent Person) must be a Registered Pharmacist/who has passed Matriculation or its equivalent with four year’s 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.
Yes, a drug license is necessary for every unit operating in any part of India. For instance, in case the drug business has its unit in two separate states, it shall get the license for both such an operational unit.
Following are the features of a drug license:-
- Drug license is compulsory for drugs, medicine, or cosmetics business,
- The license shall be granted for a commercial premise,
- Drugs and cosmetics business shall comply with the requirement and conditions imposed by law and authorities,
- The license shall be displayed all the time in the place of business.
Any person/company/partnership firm/LLP/OPC can apply for Drug License at Drug Controlling Authority.
- Manufacturing Drug License
- Sale Drug License
- Import Drug License
- Multi-Drug License
In case a business is operating in more than two states, it has to obtain a drug license in every state in which business is being carried on. Drug license is location-specific, and hence within state application, all sites must be included.
Drugs and Cosmetic Act aims at ensuring the safety, effectiveness, and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule X can be imported into India only after obtaining a License.