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 and region of India. Additionally, if the business is running in more than 2 states, it has to obtain a retail drug license in every state in which the business is being operated.
In layman’sterms, you can say it is not legally possible to step into a business dealing with drugs or cosmetics unless you have not obtained the license under the Drugs and Cosmetics Act, 1940.
It is necessary for the businessman who is dealing in the business of drugs and cosmetics to comply with all the rules and regulations of such license at all the time during their business. It is obligatory to maintain all the records/registers/forms in the specified manner and authorities shall be informed of all the changes made in the business activity.
Retail Drug License
What are the Benefits of Obtaining the Retail Drug License?
The benefits of obtaining the Retail Drug License are-
- Compliance with the Law
All the individual or individual having the drug license shall be compliant with the provisions of 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 marks no danger to health.
- Proper Access and Control by the Authority
Retail drug license helps the authority in accessing and controlling the sale of medicines in India that eventually enhances business reputation and trustworthiness.
- Proof of Genuineness
A Retail Drug License plays a vital role, as it works as proof of the genuineness and builds a brand image of the company.
What are the Key Criteria that an Applicant shall keep in Mind while applying for a Retail Drug license?
All pharmacies must obtain a drug license. State Drug Control Organization is responsible to issue the license to the wholesale pharmacies as well as to the retail pharmacies. Though, the rate of approval for a retail license is quite low in comparison to a wholesale license.
- Competent Individual/ entity having a Qualification proof that is Certification and degrees.
- Compliances with the law.
- Site of the Medical Shop.
- Registration Pharmacy Council
- Storage space for drugs and related articles
- Inspection by the Authority
What Documents are Required to Obtain Retail a Drug License?
The documents required to obtain a Retail Drug License are as follows:-
- Constitution of the firm (MOA/AOA)
- Identity proof of partner/ proprietor/director
- If you own a property, then a copy of the property paper
- In case of rented property, a copy of the rent agreement
- Site plan and key plan of the premises
- Refrigerator invoice details
- Affidavit regarding the compliance of MPD(Master Plan of Delhi) 2021 (if premises are situated on DDA residential flat/plot/building)
- Additional Documents for Retail Sale Registered Pharmacist
- Proof of qualification
- Registration of local pharmacy council
- Appointment letter.
Documents of Shareholders/Directors
- If the director owns the property, then the registered Sale Deed/registered GPA/conveyance deed in the name of the owner will be needed.
- In the case of unregistered Sale Deed/unregistered GPA, make sure to submit electricity bill/water bill/property tax receipt.
- In the case of a village, the Khasra, Khatauni documents are accepted.
- Rent agreement in case of the rented property along with the rent receipt,
- No objection certificate from the owner of the premises
- Key plan and site plan of the area duly attested by the mapmaker of the municipality.
What is the Registration Procedure for Obtaining Retail Drug License?
The procedure for filing the Retail Drug License is mentioned below-
- Creating the ID and Password
The very first step is to create the ID and Password by the applicant by providing all the requisite details.
This is the second and most important step in the process of obtaining a drug license. As an applicant, all you have to do is prepare all the documents which include preparation of the key plan, and site plan, and submitting various affidavits and declarations.
- Application Filling
You can fill the drug license application online. All you have to do is scan and upload all the documents at the time of filling the application. However, later on, the inspector will verify your documents.
- Inspector Visit
After the application for the issue of drug license is recorded, the equivalent is set apart for inspection and from that point; the drug inspector will personally visit the shop to check the authenticity of your documents and information.
- Grant of License
Once the inspection is done and all the information and documents provided by you are furnished to be correct then the controller of drugs issues the Drug License.
What Penalties are Levied in case of Non-Compliance in Obtaining the License?
According to clause (c) of Section 18 of Drugs and Cosmetics Act:-
If 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 punishable with imprisonment for a term which shall not be less than 1 year, but which may extend to 3 years, and with fine which shall not be less than Rs.5000/-
Elucidate the Infrastructural Requirements to obtain a Drug License
To obtain a drug license, the applicant must provide an independent shop with enough area, the details are mentioned below:
- For the award of the permit in Form 20 or Form 21 or both, the premises are of a region of at the very least 10 square meters,
- For the award of the permit in Form 20-B or Form 21-B or both, the premises are of a region of at the very least 10 square meters, and
- For the award of permit (I) in Form 20 or Form 21 or both, and (ii) in Form 20-B or Form 21-B or both the premises are of a region of at the very least 15 square meters.
What is the Multi-State Operation?
If a business is working in multiple states, it needs to 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 at more than one spot, theapplication ought to be made, and a permit ought to be given, regardingeach such spot aside from transient merchants.
When the permit is conceded to the business, all such Licensee must guarantee that all the condition in the drug license is consented at constantly throughoutthe business. All the records/registers/Forms must be kept up in the way specified by the licensing authority and authorities ought to be kept educated for all the progressions or adjustments in the business activities.
CorpBiz Procedure for Retail Drug License
Kindly utilize the steps given above to integrate legally and securely a Retail Drug License and get the benefits in the form of better-quality sales and satisfied customers. Our CorpBiz experts will be at your disposal for assisting you with guidance concerning Retail Drug Licensing and its compliance for the smooth functioning of your Drug business in India. CorpBiz professionals will assist you in planning seamlessly at the least cost, confirming the successful conclusion of the process.
It is advisable that an attorney with “Retail Drug License experience” must be appointed to overwhelm many of the potential pitfalls that creep around within Retail Drug License and to understand the requirement in detail. The elementary information would be mandatory from your end to start the process. The Attorney will begin working on your request once all the information is provided, and the payment is received.
CorpBiz is one of the platforms which coordinate to fulfill all your legal and financial requirements and connect you to consistent professionals. Yes, our clients are pleased with our legal service! Because of our focus on simplifying legal requirements, they have consistently regarded us highly and providing regular updates.
Our clients can also track at all times the progress on our platform. If you have any questions about the Retail Drug License process, our experienced representatives are just a phone call away. CorpBiz will ensure that your communication with professionals is charming and seamless.
- Proper Interaction with its clients related
- Proper Documentation is required for the License and follow-up
- Realistic Expectations.
- Applying for the license along with the Declaration to the Drug Control Department
- Ensures Continuous follow up with the Drug Control Department.
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.