Drug License Registration in India – Process, Documents, Fees and Eligibility

Types of Drug License in India

There are different types of Drug License in India. The most common are Retail Drug License and Wholesale Drug License. The correct licence depends on whether you want to sell medicines to customers, supply them to other businesses or manufacture them.

1. Retail Drug License

A Retail Drug License is required for medical stores and pharmacies that sell medicines directly to customers.

For example, if you want to open a chemist shop in Delhi and sell medicines to patients, you generally need a Retail Drug License.

A retail medical store must have a registered pharmacist and proper arrangements for storing medicines.

2. Wholesale Drug License

A Wholesale Drug License is required for businesses that buy medicines and supply them to other businesses, such as medical stores, hospitals and authorised medicine dealers.

For example, if you buy medicines from a pharmaceutical company and supply them to 20 medical shops, you generally need a Wholesale Drug License.

A wholesale business must have suitable premises and a person who meets the required education or experience conditions.

3. Drug Manufacturing License

A Drug Manufacturing License is required for businesses that manufacture medicines.

For example, a company planning to manufacture tablets, capsules or syrups needs the relevant manufacturing permission.

Manufacturing licences have different requirements for factory premises, equipment, staff and quality control.

4. Restricted Drug License

A Restricted Drug License allows the sale of certain medicines under specific conditions.

It does not give permission to sell every type of medicine.

5. Other Drug Licences

Separate licences or approvals may be required for homoeopathic medicines, Schedule X drugs, drug imports and certain other activities.

Difference Between Retail and Wholesale Drug Licence

Drug licences in India are governed by the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. They are granted by the State Licensing Authority (the state Drugs Control Department).

Some states add their own conditions, such as restrictions on licensing premises in residential areas. Check with your State Licensing Authority.

What Are the Drug Licence Forms?

When applying, you will see several form numbers. Each is used for a particular type of medicine sale.

Which forms do you need?

• A medical store usually needs Form 20 and Form 21: Form 20 for general medicines, and Form 21 if it also sells Schedule C/C(1) products such as vaccines, insulin or other injectables.
• A wholesale business usually needs Form 20B and Form 21B for the same reason.
• A business that sells Schedule X drugs also needs Form 20F (retail) or Form 20G (wholesale).
• A business doing both retail and wholesale from one premises may need all four: 20, 21, 20B and 21B.

Choose the correct forms before you submit the application. A wrong choice can cause delays or rejection.

Eligibility Criteria for Drug Licence Registration

You can apply for a drug licence if you want to open a medical store, start a wholesale medicine business or carry out another medicine-related activity that needs a licence.

An individual, proprietorship, partnership firm, LLP or company can apply, as long as the business meets the requirements for its licence type. You do not need a large pharmaceutical company. A person planning a small medical shop can apply if the premises, staff and documents meet the rules.

Eligibility for a Retail Drug Licence

To open a medical store or pharmacy, you generally need a retail drug licence. The basic conditions are:

• Premises of at least 10 square metres.

• A registered pharmacist (registered with the State Pharmacy Council).

• Proper storage, including refrigeration for medicines that need it.

• The required business and premises documents.

• Premises that meet local rules for running a medical store.

Can I open a medical store if I am not a pharmacist?

Yes. You can own a medical store without a pharmacy qualification, but you must appoint a registered pharmacist to supervise the sale and dispensing of medicines.

Eligibility for a Wholesale Drug Licence

To buy medicines from companies and supply them to medical stores, hospitals or other authorised businesses, you generally need a wholesale drug licence. You must have:

• Premises of at least 10 square metres.

• Proper storage arrangements.

• A competent person in charge (see below).

• The required business and premises documents.

Who Can Be the Competent Person for a Wholesale Licence?

The licensing authority must accept the person’s qualification and experience.

Can a 12th-pass person start a wholesale medicine business?

Yes. The owner does not need a specific qualification, but the business must have a competent person who meets the conditions above. If the owner will act as the competent person, the owner must meet those education and experience requirements. A Class 12 pass with 4 years’ experience in dealing with drugs can qualify.

Minimum Premises Area

Premises Height and Location

Premises must be suitable for storing and selling medicines. Height and location requirements differ by state and local building rules, so check with your State Licensing Authority. Some states, including Delhi, also set a minimum ceiling height. Licences are generally granted for commercial or independent premises. Some states do not allow licences on residential plots or flats, so confirm before taking a property.

Can I Apply from a Rented Shop?

Yes. You will generally need a rent agreement, rent receipt and supporting property documents. The authority may also ask for the owner’s ownership documents. Rented premises must meet the same area, storage and location requirements as owned premises.

Medicine Storage Requirements

Some medicines need refrigeration, while others must be protected from heat, sunlight or moisture. Have the storage equipment needed for the medicines you plan to sell or distribute.

Is GST Registration Required?

GST registration and a drug licence are separate. GST relates to tax, while a drug licence permits specified medicine-related activities. Whether you need GST registration depends on your business and the applicable GST rules.

Documents Required for Drug License Registration

Before applying for a Drug License, you should collect the required documents. The exact list depends on the state, business type and licence category.

For common retail and wholesale applications, the following documents are usually needed.

Documents of the Business Owner

• PAN Card
• Aadhaar Card or other accepted identity proof
• Passport-size photographs, where required
• Business registration documents
• Partnership deed, if applicable
• Company or LLP registration documents, if applicable
• Authorisation letter or board resolution, where required
• Required declarations or affidavits

Documents of the Shop or Office

• Rent agreement or ownership proof
• Rent receipt, if the premises are rented
• Supporting ownership documents of the landlord, where required
• Address proof of the premises
• Shop layout or site plan
• Key plan showing the location
• Documents showing that the premises can be used for the business, where required

Documents of the Pharmacist

For a Retail Drug License, the following documents are commonly required:

• Educational qualification certificates
• Valid Pharmacy Council registration certificate
• Appointment letter
• Identity proof
• Biodata
• Required declaration

Documents of the Qualified Person for Wholesale License

For a Wholesale Drug License, you may need:

• Educational qualification certificates
• Experience certificate, where required
• Appointment letter
• Identity proof
• Biodata
• Required declaration

Other Documents

Depending on the application, the department may also ask for details of medicine storage facilities, fee payment receipts and other supporting documents.

Important: The document list for a Retail Drug License may be different from the list for a Wholesale Drug License. Delhi and other states may also have different document requirements.

Compliance Calendar LLP can help you understand which documents are required for your application.

Drug License Registration Online Process

You can apply for a Drug License through the online system used by the concerned State Drug Control Department.

Many drug licensing services are available through ONDLS. Some states may also use their own systems for certain services.

Here is how the process generally works.

Step 1: Choose the Correct Drug License

First, decide whether you need a Retail Drug License, Wholesale Drug License or another licence.

For example, if you want to sell medicines directly to customers, you generally need a retail licence. If you want to supply medicines to medical stores, you generally need a wholesale licence.

Step 2: Arrange Your Shop and Staff

Make sure your shop or office meets the required conditions.

For a retail medical store, arrange for a registered pharmacist. For a wholesale medicine business, arrange for an eligible qualified person.

Step 3: Collect Your Documents

Prepare the business documents, shop papers and pharmacist or qualified-person documents.

Check that the names, addresses and other details are correct.

Step 4: Apply Through the Online Portal

Visit the drug licensing portal used by your state.

Create an account, select the correct service and fill in the application form.

For common retail and wholesale licences, Form 19 is generally used.

Step 5: Upload Documents and Pay the Fee

Upload the required documents and pay the government fee.

Make sure the documents are clear and readable.

Step 6: Department Verification and Inspection

After you submit your application, the Drug Control Department checks the details.

A drug inspector may visit your shop or office to check whether it meets the requirements.

What Does a Drug Inspector Check?

During the inspection, the officer may check:

• Whether your shop has enough space.
• Whether the premises are suitable for the business.
• Whether medicines can be stored safely.
• Whether the required pharmacist or qualified person is available.
• Whether the documents match the application details.

For example, if you have applied for a Retail Drug License, the inspector may check the shop area, storage facilities and pharmacist details.

If the department finds a problem, you may need to correct it or provide more information.

Step 7: Get Your Drug License

If your application meets the requirements and the department approves it, your Drug License will be issued.

You can then start the medicine-related activities allowed under your licence.

Why Can a Drug License Application Get Delayed?

A Drug License application may be delayed if the documents are incomplete or the shop does not meet the required conditions.

Common problems include incorrect business details, missing property documents, insufficient shop area, unsuitable medicine storage and problems with pharmacist or qualified-person documents.

Checking these details before applying can help avoid unnecessary delays.

How Many Days Does It Take to Get a Drug License?

There is no single processing time that applies to every Drug License application in India.

The time depends on the state, documents, inspection and department approval.

If the department asks for more information, the process may take longer.

Drug License in Delhi and Other States

If you want to open a medical store or start a wholesale medicine business in Delhi, you need to apply through the system used by the Department of Drugs Control, Government of NCT of Delhi.

The department checks whether your business meets the requirements for the licence you are applying for.

Drug License Registration in Delhi

Before applying for a Drug License in Delhi, make sure that:

• Your shop or office has enough space.
• The premises can legally be used for the business.
• You have the required pharmacist or qualified person.
• Your business and shop documents are ready.
• You have proper arrangements for storing medicines.

After submitting the application and paying the required fee, the department reviews the documents and may inspect the premises.

The licence is issued after the department is satisfied that the requirements have been met.

Additional Requirements for Drug License in Delhi

The Delhi Drugs Control Department may ask for documents showing that your shop is allowed to be used for the proposed business.

If your shop is located in a residential or mixed-use area, you may need additional property documents and proof that the business is allowed at that location.

For certain retail applications, Delhi's published checklist also refers to CCTV requirements under the relevant guidelines.

It is important to check the latest Delhi checklist before applying.

What Is ONDLS Drug License?

ONDLS stands for Online National Drugs Licensing System.

It is an online platform used for various drug licensing services in India.

Depending on the state and service, you may be able to apply for a licence, check application details, verify a licence or download documents through ONDLS.

State-Wise Drug License Registration Authorities

Drug licensing rules apply across India, but retail and wholesale licences are generally handled by state departments.

The online application process and document requirements may differ from one state to another.

Compliance Calendar LLP provides assistance with Drug License Registration in Delhi and other parts of India.

Drug License Registration Fees in India

The government fee for a Drug License depends on the type of licence and the forms required.

For common retail and wholesale sale licences, the standard government fees are shown below.

For example, if you need both Form 20 and Form 21 for your retail medical store, the standard government fee is generally ?3,000.

Similarly, if you need both Form 20B and Form 21B for your wholesale medicine business, the standard government fee is generally ?3,000.

These amounts apply to the common licence categories listed above. Other licence forms and special categories may have different fees.

Are There Any Other Charges?

Yes. Apart from the government fee, you may need to spend money on preparing your shop, arranging medicine storage, appointing staff and getting professional help.

If you take assistance from Compliance Calendar LLP, our professional charges will depend on the work required.

You can contact our team for a quotation based on your business and licence type.

Drug License Verification and Download

After getting a Drug License, you may need to check its details or download a copy.

For example, a medicine distributor may want to verify the Drug License of a medical store before supplying medicines.

How to Verify a Drug License Online

Drug License Verification is used to check the licence details available in government records.

You can generally follow these steps:

1. Open the official ONDLS portal or the relevant state drug licensing website.
2. Look for the Drug License Verification option.
3. Enter the licence number or other details requested.
4. Submit the information.
5. Check the available licence details.

Depending on the system, you may be able to see the business name, licence number, address, licence type and current status.

If the licence is not available on ONDLS, check the official website of the state that issued it.

How to Download a Drug License

If your licence was issued through an online system, you may be able to download it from your account.

The general steps are:

1. Visit the official licensing portal.
2. Log in using your registered details.
3. Open your approved application or licence section.
4. Find the download option.
5. Download the available licence document.

The exact steps may be different for each portal.

What Is ONDLS Login?

ONDLS Login allows registered users to access supported online drug licensing services.

You should use the official portal and keep your login details secure.

Drug License Renewal and Retention Fee

Many medical store owners search for Drug License Renewal when they want to continue their business after five years.

However, the rules for common retail and wholesale drug licences have changed.

For sale licences covered by Rule 63 of the Drugs Rules, 1945, the licence continues to remain valid if the required retention fee is paid every five years, unless it is suspended or cancelled.

This means you do not normally need to apply for a completely new licence every five years for these covered licence categories.

What Is a Drug License Retention Fee?

A retention fee is the amount paid to keep the covered Drug License valid.

The fee is generally equal to the fee charged for granting the licence.

For example, if the standard government fee for your licence form is ?1,500, the normal retention fee for that form is also ?1,500.

What Happens If You Pay Late?

If you do not pay the retention fee on time, an additional late fee applies.

Under the relevant rule, the late fee is 2% of the licence fee for every month or part of a month, for up to six months.

If the required payment is not made within the allowed period, the licence is treated as cancelled.

Do You Need to Follow Any Rules After Getting the License?

Yes. Getting a Drug License is only the beginning.

You must continue to keep medicines properly, maintain the required records and follow the rules for selling and storing medicines.

You must also have the required pharmacist or qualified person.

If you change your shop address, pharmacist, business ownership or other important details, you may need to inform the department or apply for the required change.

Important: Different rules may apply to manufacturing licences and other special licence categories.

Why Choose Compliance Calendar LLP for Drug License Registration?

Applying for a Drug License can be confusing when you are starting a medical shop or wholesale medicine business for the first time.

You may not know which licence to choose, what documents to prepare or how to apply online.

Compliance Calendar LLP helps businesses understand these requirements and complete the application process.

How We Can Help You

Retail Drug License: We help people who want to open medical stores and pharmacies.

Wholesale Drug License: We assist medicine distributors and wholesale businesses with their licence applications.

Drug License in Delhi: We help businesses understand the Delhi Drug License Registration process and required documents.

Document Preparation: We guide you on the documents needed for your business and licence type.

Online Application: We assist with the application process through the relevant government portal.

Drug License Verification: We help you understand how to check licence details through official systems.

Drug License Renewal and Retention: We provide guidance on applicable retention-fee payments and licence-related changes.

Get Help with Your Drug License

Are you planning to open a medical store or start a wholesale medicine business?

Contact Compliance Calendar LLP for help with Drug License Registration, documents and online applications.

Call: +91 9988424211

Email: info@ccoffice.in

Office: 3rd Floor, A-1, Acharya Niketan, Mayur Vihar, New Delhi – 110091