Retail Drug License Fees in India – Documents, Eligibility & Application Process

To open a medical shop or pharmacy in India, there is more than just having the premises and purchasing medicines. Companies have to get a valid retail drug license issued by the State Drugs Control Department in order to sell medicines to their clients. This allows ensuring that all pharmaceuticals will be stored, processed and sold in accordance with the necessary provisions of the Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945.

Before initiating the procedure of applying for the Retail Drug License, one has to understand what kind of fees are associated with this type of licenses and what kind of documentation is necessary.

This article provides detailed information about the retail drug license documentation, its fees, eligibility requirements, and registration procedure, as well as the benefits of professional help in this matter.

What Is a Retail Drug License?

A Retail Drug License refers to an authorization granted by the State Drugs Control Department or the concerned licensing body. The license authorizes the entity to directly sell medicines to consumers through a pharmacy, chemist shop, or medical store.

There are different kinds of retail drug license and the same shall be issued under the following heads:

Form 20 – Retail sale of drugs not included in Schedules C, C(1) and X.

Form 21 – Retail sale of drugs in Schedules C and C(1) but not Schedule X.

Form 20F – Retail sale of drugs in Schedule X.

Forms 20A and 21A – Retail sale license of restricted nature for eligible general stores.

Depending upon the kind of medicines to be sold, the license shall apply. Thus, before applying for a retail drug license, one should determine the correct license form.

Retail Drug License Fees in India

Retail drug license cost varies according to the category of the license and the State in which the pharmacy operates. While Drugs Rules, 1945 have set out the amount of fee to be paid, state portals may have different conditions regarding payment.

For instance, the standard retail drug license fee prescribed under Form 19 is ₹1,500. The application fee for Schedule X drugs under Form 19C is ₹500.

The following table provides an indicative fee comparison:

State-specific variation: The amount payable for an ordinary retail license under the rules of Odisha is ₹1,500, whereas, according to Goa's published checklist, for a Goa retail drug license application, the amount payable is ₹3,000. Kerala's published procedure also lists ₹3,000.

These amounts are government fees and not the total costs of establishing a pharmacy. Applicants will have to consider other costs like professional fees, document preparation charges, premises-specific charges, and so on.

Before making payment of the retail drug license registration fees, it is imperative to confirm the latest fee schedule from the concerned state drug control portal. One may approach the retail drug license consultant to identify the right fee category to avoid mistakes in payment.

Types of Retail Drug Licenses

The applicable application forms and license categories depend on the medicines the pharmacy intends to sell.

Documents Required for Retail Drug License

Document submission is very important in securing a pharmacy license because the licensing body evaluates the identity, constitution, premises, and qualifications of the pharmacist in the applicant’s application before giving the license.

The following are commonly required retail drug license documents:

Additional documents would be required depending on whether the pharmacy establishment is a proprietorship, partnership, or company.

For example, a company would require its certificate of incorporation, Memorandum & Articles of Association, and board resolution.

Applicants should check the relevant state portal before submitting their retail drug license application to avoid missing documents or unnecessary delays.

Eligibility Criteria for Opening a Retail Pharmacy

Before making an application for the Drug Retail Pharmacy License, there are certain conditions that need to be fulfilled as per the Drugs Rules, 1945.

1. Registered pharmacist: There needs to be a registered pharmacist employed in the retail pharmacy with the required qualifications and registration as prescribed by law. This person will supervise the sale and dispensation of medicines.

2. Proper premises: Adequate premises are needed to maintain the quality of the medicines sold at the retail pharmacy, with proper storage and other conditions. Usually, the minimum area is 10 square meters for retail and 15 square meters for premises that do retail and wholesale business.

3. Proper storage facilities: Medicines need to be stored in accordance with their prescribed conditions, and there might be a need for refrigeration in some cases.

4. Legal constitution of business: The applicant needs to have valid business documents regarding premises and business to prove the legitimacy of the proposed pharmacy.

How to Apply for a Retail Drug License Online?

One can normally apply for a Retail Drug License through one's own state's drugs control department's portal. Normally, the process is as follows:

• Document preparation: Get the identity proof documents, premises documents, pharmacist certificates, and business registration documents.
• Choosing application form: Choose Form 19 or any other relevant form depending on the category of medicines.
• Online application form filling: Fill in the details of the business, the pharmacist, and the premises.
• Payment of government fee: Pay the relevant retail drug license registration fees using the prescribed payment portal.
• Upload of supporting documents: Upload all the required documents in the required format.
• Inspection and verification: The licensing authority performs a premises inspection and verifies the qualifications of the pharmacist and other details provided.
• Approval of the license: If all the conditions are fulfilled, then the concerned authority will issue the concerned drug license.

Applicants applying for a retail drug license online must make sure that all the information provided is in concurrence with their documents. Otherwise, one might be asked for clarification.

The processing time varies from state to state. For instance, Odisha has a timeline of 40 working days for retail pharmacy license applications.

Step-by-Step Retail Drug License Registration Process

Step 1: Arrange Pharmacy Premises

Select a suitable commercial premises with a minimum area of 10 square metres. Ensure proper ventilation, storage facilities, and refrigeration arrangements wherever necessary.

Step 2: Appoint a Registered Pharmacist

Appoint a qualified and registered pharmacist who will supervise medicine sales and dispensing in accordance with applicable regulations.

Step 3: Prepare Required Documents

Collect the applicant's identity documents, business registration documents, pharmacist certificates, premises ownership or rent documents, site plan, and other required declarations.

Step 4: Submit the Online Application

Visit the respective State Drug Control Department portal or applicable online licensing system. Complete the prescribed application, generally Form 19 for retail drug licenses in Forms 20 and 21, and upload the required documents.

Step 5: Pay the Government Application Fee

Pay the applicable government fee through the designated payment facility and save the payment receipt for future reference.

Step 6: Drug Inspector Inspection

The concerned Drug Inspector may inspect the pharmacy premises to verify the shop area, storage arrangements, documents, and pharmacist availability.

Step 7: Approval and License Issuance

After successful verification and fulfilment of licensing conditions, the State Licensing Authority issues the Retail Drug License in the applicable prescribed form.

Common Mistakes to Avoid During Drug License Registration

Such small mistakes might influence the licensing process. The following are common mistakes that should be avoided:

• The submission of incomplete and/or outdated documents for the retail drug license application.
• Assigning a pharmacist who does not have the proper State Pharmacy Council registration.
• Submission of incorrect information about premises or the site plan.
• The submission of the incorrect application form.
• Not having appropriate medicine storage facilities.
• Not taking into consideration the licensing requirements of the particular state.
• Submission of documents with inconsistent information about the business.

Why Choose a Retail Drug License Consultant?

Licensing of pharmacies requires documentation, eligibility criteria, fees to the government, and working with the authority that gives the license. Seeking professional help can make the process easier, especially for first-time pharmacy owners.

A good consultant who is licensed to offer retail drug license services will be able to help with determining the right type of license to obtain, filling out forms, verifying the documents, and helping with the process of obtaining approval.

Professional retail drug license services can also assist with state requirements, documenting pharmacists, and answering questions asked by the department.

Using experienced retail drug license services means that you are minimizing mistakes in your documentation and delays in the application. A good retail drug license consultant can help from the documentation stage to the final stage of approval.

Conclusion

Applying for a Retail Drug License is one of the major legal aspects to consider if you plan to run a pharmacy or medical store in India. This section highlights the details about the required fees, qualifications, and documentation process for applying.

There could be differences in government fees and documentation in different states; hence, it is advisable to check the current guidelines first. Whether you are opening a new store or expanding your existing business, professional help can go a long way in registering the business.

PSR Compliance provides professional services for retail drug license registration, documentation and compliance. Get in touch with PSR Compliance for retail drug license services and learn how to get a retail drug license online.

Frequently Asked Questions (FAQs)

1. What is the fee for a retail drug license in India?

The fee charged under Form 19 is ₹1,500 under the Drugs Rules, 1945. However, state-wise fees might vary. Check the current fee structure of the licensing authority before paying the retail drug license fees.

2. What documents are required for a retail drug license?

Required documents for a retail drug license include identity proof, premises ownership or lease deed, site plan, qualifications and registration certificate of the pharmacist, documents for business constitution, and payment receipt of the application fee.

3. Is a pharmacist compulsory for opening a medical store?

Yes. Usually, there is a requirement to have a registered pharmacist for running a retail pharmacy.

4. Can I apply for a retail drug license online?

Yes. Many State Drug Control Departments offer an online application facility. One can make an online application for a retail drug license through the prescribed form submission along with other documents.

5. How long does it take to obtain a retail drug license?

The processing time varies depending on the state, completeness of the application, and inspection, if any. For instance, Odisha takes 40 working days for retail pharmacy license applications.