RETAIL DRUG LICENSE
A drug license is a license that is expected by any business managing drugs or means to begin a business in the field of Pharma. According to the Drugs and Cosmetics Act, of 1940, each individual who wishes to deal in the pharma business, needs to get this license.
Have you ever wondered what it takes to run a pharmacy in India? One of the most important aspects of operating a legitimate health care facility is obtaining a retail drug license. This license is essential for any pharmacy to legally sell medicines and other health-related products. But what exactly is a retail drug license, and how can one obtain it in India? In this article, we’ll take a deep dive into the world of retail drug licensing, exploring what it means, why it’s important, and the steps involved in obtaining one in India. So, buckle up and join us on this informative and exciting journey!
Introduction to drug license in India
In India, the government has strict rules for granting licenses for the manufacturing and selling of drugs and medicines to ensure everyone has equal and fair access to them. The Drugs and Cosmetics Act 1940 defines drugs as all medicines and substances used for or in the diagnosis, mitigation, treatment or prevention of any disorder or disease in animals or human beings, including Ayurvedic and Unani drugs. All pharmacists, wholesalers, retailers, manufacturers, sellers, dealers, and importers of drugs, cosmetics, Ayurvedic, Siddha, and Unani drugs must mandatorily obtain a drug license under this act to ensure that access to medicines and drugs is restricted and regulated to prevent abuse or misuse.
MEANING OF DRUGS:
As per the Drugs and Cosmetic Act, every one of the medicines and gadgets that are utilized by people and creatures inside and remotely is a drug. That multitude of substances goes under the classification of the drug utilized for diagnosis, treatment, and avoidance of disease. Ayurvedic and Unani drugs were remembered for the Act in 1964 through an amendment.
KINDS OF DRUG LICENSE:
• SALE DRUG LICENSE: A Sale License is given for the offer of drugs and it has the accompanying bifurcations:
1. • Wholesale Drug License: Wholesalers who are taken part occupied with drugs will obligatorily gain a wholesale drug license from the CDSCO (Central Drugs Standard Control Organization).
2. • Retail Drug License: This License is procured by the retailers participating either in the drugs business, independent drug specialists, and so forth. The equivalent is procured by applying to the State Pharmacy Council
• MANUFACTURING DRUG LICENSE: given to a business that manufactures drugs comprehensive of allopathic/homeopathy medicines.
• LOAN DRUG LICENSE: License given to a business that doesn’t claim the manufacturing unit, however, utilizes another licensee’s manufacturing offices.
• IMPORT DRUG LICENSE: License given for the import of drugs.
• MULTI-DRUG LICENSE: License given to businesses that own drug stores in various states with a similar name.
CONCERNED AUTHORITY:
The concerned expert for getting a Drug license is the Controller of Drugs and Cosmetics and as the drug license is area explicit so it must be acquired adversary each state where the business is being completed.
NECESSITY FOR GETTING A DRUG LICENSE:
Minimum Area Requirement – in the event of wholesale outlet or Medical Shop: Minimum area of 10 sq. meter. If wholesale+ Retail: Minimum area of 15 sq. meter
Storage Facility – A refrigerator and air-conditioner on the premises are a must.
Specialized Staff – In the event of wholesale business, the offer of Drugs will be made before the registered pharmacist or any graduate having an experience of at the very minimum 1 year in dealing in Drugs or any individual who has passed the intermediate level of schooling and having the experience of somewhere around 4 years in dealing in drugs.
FOR A RETAIL DRUG LICENSE INDIVIDUAL OUGHT TO BE:
- Proof of qualification i.e. final degree certificate/ provisional certificate with mark sheets.
- Registration with Pharmacy Council,
- Appointment Letter and Bio-data
DOCUMENTS REQUIRED FOR APPLYING FOR A LICENSE:
(Drug Licence No. 20, 21)
(Proprietor + Registered Pharmacist)
- Form No. 19
- Challan Rs. 3000/-
- Self-attested copies of Identity proof of Registered Pharmacist (Domicile/Driving license/ Voter ID card)
- Self-attested copies of Identity proof of proprietor (Domicile/ Driving license/ Voter ID card)
- Photo 5-5 each of the Registered Pharmacist and proprietor.
- Affidavit of the proprietor on stamp paper of 20 Rs.
- Educational certificate copies of the proprietor (Self-attested)
- Educational certificate copies of Registered Pharmacist (Self-attested)
- Affidavit of Registered Pharmacist.
- Blueprint of a Plan layout of the proposed area/ premises.
- Electricity bill of proposed area/ premises.
- Rent agreement (1000 Rs. Stamp paper)
- Ownership document of the premises including a copy of the tax receipt of the proposed area/ premises.
- Copy of Refrigerator bill.
- Covering letter.
PROCESS FOR ACQUIRING FOR WHOLESALE DRUG LICENSE:
- DOCUMENTATION-
Documentation is a pivotal component in the entire licensing process. Right documentation makes the cycle bother-free and prompts an effective award of the license. The rundown of reports expected for the Wholesale/Retail deal drug License relies upon the candidate’s sort and business movement.
- GENERATION OF USER ID AND PASSWORD-
The candidate is to register for a user ID and password. When The user ID and password once created are sent to the registered mail ID of the candidate.
- APPLICATION RECORDING-
The candidate applies for the award of a Drug license to the individual Drug Controlling Power of the state. For each sort of license, a different application is recorded using various structures recommended for it. There is no arrangement for one central endorsement/license covering all states. The candidate is to record separate applications for each store.
- INSPECTION OF THE PREMISES-
Before the award of a drug license, the drug monitor having a locale of the region visits the premises where the drug license is required and checks the points of interest outfitted with the application, and takes an estimation of the premises. He likewise checks the region of the premises, whether it is on the blended land application or in a business.
- INVESTIGATION OF APPLICATION-
The concerned Drug Overseer confirms the details and the records transferred in the web-based application with his perceptions on his visit. He might bring an explanation up in the application. The candidate should answer the explanation within 3 days of it. Non-outfitting a good answer might prompt the dropping of the application.
- ISSUE OF LICENSE-
After a good check of the documents and the details, the Drug Control division gives the Drug License. The given license is legitimate for quite some time and is substantial from that point onward, likely to its restoration.
WHAT IS THE COST OF A DRUG LICENSE IN INDIA?
The application charges for getting a license differ from Rs.1,500 to 500 relying upon the kind of utilization. In any case, there might be extra charges that the candidate needs to pay for getting lab tests, tests or inspections by the Central Drugs Research Laboratories or State Drugs Labs or tests or investigation by the Pharma copoeial Lab for Indian Medicine (PLIM) or the public authority expert for acquiring the license. The Drugs and Cosmetic care products Rules, 1945 recommends the expenses for each license application and various tests for various items.
Documents required for obtaining a retail drug license
Obtaining a retail drug license in India is mandatory for any business entity dealing with drugs and cosmetics. The process of obtaining a drug license is stringent and requires compliance with the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945. To obtain a retail drug license, the applicant must provide certain documents, such as a completed application form, proof of ownership/tenancy of the premises, a layout plan of the premises, proof of qualifications of the person in charge, and a fee payment receipt. These documents may vary depending on the state government’s Food Safety and Drug Administration Department.
Penalties for operating without a valid drug license
Operating a pharmaceutical business without a valid drug license in India can lead to severe penal provisions and punishments. Obtaining a drug license is mandatory for any person or entity dealing with drugs, medicines or cosmetics. Under the Drugs and Cosmetics Act of 1940, the government exercises control over the entire process from manufacture to the sale of drugs. Failure to obtain a license can lead to costly mistakes and disruptions in business activities. The purpose of the drug license is to regulate and monitor the quality of drugs sold in India to ensure they are not misused.
The drug license process is a simple yet lengthy process that involves getting a permit from the respective state authority to start a pharmaceutical business. The license is issued to manufacturers, wholesalers, retailers and distributors who are engaged in the business of pharmaceuticals or activities related to the pharmaceutical industry. To obtain a license, there are certain key factors to be considered such as a minimum working space of 10 square meters, proper storage for medicines and vaccines, qualified and experienced personnel, and approval by the state drug license authority.
There are two types of drug licenses in India: manufacturing drug license and sale drug license. Manufacturing drug license is issued to the manufacturers of allopathic, ayurvedic and cosmetic products, while sale drug license is acquired by wholesalers and retailers involved in the distribution of drugs in India. Sale drug license includes wholesale drug license and retail drug license. A wholesaler must obtain a wholesale license to sell drugs to a person or retailer for further sale, while a retail license is required for the retail sale of drugs to end consumers.
Penalties for operating without a valid drug license in India can lead to imprisonment for a term of six months to five years and/or a fine of ten thousand to ten lakh rupees. The government takes strict action against individuals or entities that are found to be dealing in drugs without a license due to the potential risks associated with the misuse of drugs and medicines. Therefore, obtaining a drug license is not only mandatory but also a critical aspect of running a pharmaceutical or related business in India.
3. Types of Drug Licenses in India
In India, there are three significant classifications of Drug License, which may be further divided into different categories.
The first type is the Manufacturing Drug License, which is required for manufacturing Allopathic, Ayurvedic, Cosmetics products, or other drugs under the Drugs and Cosmetics Act 1940.
The second type is the Loan Drug License, issued to those who want to manufacture products and services with their brand name but do not have their own land for manufacturing drugs.
The third type of license is the Multi-Drug License, which must be acquired by those entrepreneurs who operate in more than one state.
4. Requirements for Retail Drug License
To obtain a retail drug license in India, there are specific requirements that applicants need to fulfill. The area of the premises where drug sales are to take place should be at least 10 square meters and sufficiently ventilated. If both wholesale and retail operations are being conducted by one unit, the premises’ area must be at least 15 square meters. Cooling facilities such as refrigerators and air conditioners are necessary, given that specific medications require storage at lower temperatures. Competent personnel, such as a registered pharmacist or an SSLC-qualified individual with four years of experience in drug dealings, must also operate the business.
5. Procedure for Obtaining Retail Drug License
To sell drugs and medicines at the retail level in India, it is mandatory to obtain a retail drug license. The process of obtaining a retail drug license involves a thorough verification of the necessary documents and fulfilling the specific requirements set by the government. The process is initiated by obtaining a form from the state drug control department or the central drug standard control organization. The form must be filled with relevant details and submitted with the required documents. Following verification and inspection of the premises, the drug license is issued. It is important to comply with all the guidelines and regulations after the license is issued.
6. Pre-requisites for Applying for Retail Drug License
To obtain a retail drug license in India, certain pre-requisites must be fulfilled. These include having a premises with a minimum area of 10 sq.m. and a height of 2.75 m. Additionally, the premises must have adequate storage facilities such as cold storage and deep freezer for storing drugs and medicines. The applicant must also provide a system-generated application form for the relevant drug sale, a site plan and key plan of the premises, and relevant documents such as partnership deed, trust deed, and memorandum and articles of association for companies. The applicant must also provide photo ID proof of the proprietor, partner, or director of the firm, along with affidavits regarding non-conviction of both the individual and the firm under the Drugs & Cosmetics Act 1940. Finally, a system-generated affidavit from the registered pharmacist/competent person must also be provided.
7. Validity and Renewal of Retail Drug License
A retail drug license is essential for any individual or enterprise involved in the retail sale of drugs or cosmetics for human consumption in India. This license is mandatory for standalone pharmacists, ayurvedic shops, hospitals, educational medical or research institutes, and other retailers. After obtaining the license, the validity period ranges from one to five years, depending on the state government’s regulations. Retailers must ensure that their licenses do not expire as it can lead to the suspension or cancellation of their permits, leading to legal complications. Therefore, it is crucial to keep track of the license’s expiry date and apply for renewal in time.
The renewal of a retail drug license in India is crucial for the uninterrupted operation of the retail pharmacy business. The authority responsible for issuing drug licenses is the Central Drugs Standard Control Organization (CDSCO) or the State Drugs Control Administration (SDCA). The renewal process usually takes thirty to sixty days, depending on the state government’s regulations. Retailers need to submit their renewal applications with the necessary documents well before the permit’s expiration. Failure to renew the license can result in the cancellation of permission, leading to legal action and penalties.
The renewal of a retail drug license requires the submission of several documents, such as the owner’s passport-sized photograph, evidence of application fee payment, a self-attested copy of the registered plant layout, a copy of the utility bill as certified office proof, the educational background and experience letter of the registered pharmacist, and invoices of refrigerators and other necessary equipment for the business. Retailers must ensure that they have all the necessary documents to avoid any inconvenience during the renewal process.
The validity and timely renewal of a retail drug license are crucial criteria for retail pharmacies in India to continue their operations. Retailers must apply for renewal well in advance to avoid any discrepancy or delay in the permit’s issuance. Maintaining a valid drug license ensures compliance with the law, protection of public health, and a seamless and successful operation of the business.
8. Benefits of Obtaining Retail Drug License
Obtaining a retail drug license is crucial for individuals or organizations who want to engage in selling and distributing drugs and medicines in India. Compliance with the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945 is mandatory for obtaining this license. One benefit of obtaining this license is that it creates a legal foundation for drug-related activities and helps the business comply with regulations. This license guarantees pharmaceuticals made by the producer are real, ensuring consumers, establish trust, and credibility in the market. Additionally, it opens up significant business opportunities for expansion and growth, which is one of the main advantages of having a retail drug license in India.
Frequently Asked Questions about Retail Drug License in India
What is a retail drug license?
A retail drug license is a mandatory license that needs to be obtained by anyone who is involved in the retail sale of drugs, medicines, and cosmetics in India.
Who needs to obtain a retail drug license?
Any individual or business that is involved in the retail sale of drugs, medicines, and cosmetics to the end consumer needs to obtain a retail drug license in India.
What are the different types of retail drug licenses?
There are two types of retail drug licenses in India – wholesale drug license and retail drug license. A wholesale drug license is required for the wholesale sale of drugs to retailers, while a retail drug license is mandatory for the retail sale of drugs to the end consumer.
What are the requirements for obtaining a retail drug license?
To obtain a retail drug license in India, the applicant needs to fulfill certain requirements such as having a minimum area of 10 square meters for the retail store and employing staff with relevant experience in the medical sector.
What is the validity of a retail drug license?
A retail drug license is valid for a period of 5 years from the date of issue and needs to be renewed before its expiration.
What are the consequences of operating a retail drug store without a valid license?
Operating a retail drug store without a valid license is a punishable offense under the Drugs and Cosmetics Act of 1940. The offender may face imprisonment and/or a fine.
What are the documents required for obtaining a retail drug license?
The documents required for obtaining a retail drug license in India include proof of ownership/tenancy of the retail store, educational qualification certificates of the applicant, and a valid proof of identity and address.