Pharmacy License in India: How to Apply, Renew & Verify

Key Takeaways

• A pharmacy license, legally called a drug license, is mandatory before selling, stocking, or distributing medicines in India, issued by the State Drugs Control Department under the Drugs and Cosmetics Act, 1940.
• Retail licenses (Form 20/21) need a registered pharmacist, while wholesale licenses (Form 20B/21B) need a competent person, not a pharmacist.
• The premises must be at least 10 square metres (15 for combined retail and wholesale), with proper storage and a refrigerator for cold-chain drugs.
• The application is filed in Form 19 on your state’s portal, with around 18 states using the ONDLS system, and a drug inspector verifies your premises before the license is granted.
• A retail or wholesale license costs around ₹3,000 to ₹3,500 in government fees, and the whole process usually takes 15 to 30 working days.
• Since the 2018 rule change, drug licenses are valid perpetually, with no five-year renewal. You only pay a retention fee (equal to the grant fee) every five years to keep the license active.
• You can verify any pharmacy license on your State Drugs Control Department’s online portal by checking its status and the registered pharmacist.

Types of Pharmacy Licenses in India

The type of drug license you need depends on how you plan to sell, distribute, or produce medicines. The main types in India are:

1. Retail Drug License

For medical stores, chemist shops, and pharmacies selling medicines directly to consumers. It requires a registered pharmacist.

• Form 20: General allopathic drugs.
• Form 21: Schedule C and C(1) drugs like vaccines and insulin that need cold storage.
• Form 20F: For selling Schedule X (narcotic and psychotropic) drugs.

2. Wholesale Drug License

For businesses supplying medicines in bulk to retailers, hospitals, and institutions. It needs a competent person, not a registered pharmacist, who is a science graduate with one year of experience or a non-graduate with four years.

• Form 20B: Wholesale of general allopathic drugs.
• Form 21B: Wholesale of Schedule C and C(1) drugs.
• Form 20G: Wholesale of Schedule X drugs.

3. Manufacturing License

For producing drugs, formulations, or cosmetics. It is issued under CDSCO oversight and requires Schedule M (Good Manufacturing Practices) compliance and a qualified technical team.

• Form 25: Manufacturing of allopathic drugs.
• Form 28: Manufacturing of Schedule C and C(1) and specified drugs.

4. Restricted License

For general stores in areas without a regular pharmacy, selling a limited list of non-prescription medicines without a pharmacist.

• Form 20A: Authorizes the retail sale of restricted allopathic drugs, excluding medicines covered under Schedules C, C(1), and X of the Drugs Rules, 1945.
• Form 21A: Authorizes the retail sale of restricted medicines covered under Schedule C(1), excluding drugs listed under Schedule X.

5. Loan License

For manufacturers who produce drugs using another licensed manufacturer’s premises and equipment, rather than their own facility.

• Form 25A: Permits the manufacture of general non-biological drugs, excluding medicines covered under Schedules C, C(1), and X of the Drugs Rules, 1945.
• Form 28A: Allows the manufacture of biological products and parenteral medicines covered under Schedules C and C(1) of the Drugs Rules, 1945.

6. Import License

For importing drugs into India, granted by the CDSCO (central authority), not the state.

• Form 10: Import of drugs (other than those for examination, test, or analysis).
• Form 10A: Import of drugs for examination, testing, or analysis.

7. Online Pharmacy / E-Pharmacy License

For internet-based medicine sales. E-pharmacies must hold a valid drug license in their state of operation and comply with the Drugs and Cosmetics Act while dispensing according to valid prescriptions. The draft e-pharmacy rules propose a separate registration in Form 18AA. However, these rules are still pending finalization.

Note: Homeopathic medicine sellers need a separate license (Form 20C/20D), and selling Schedule X (narcotic and psychotropic) drugs requires an additional Form 20F/20G license.

Pharmacy License Eligibility and Requirements

To get a pharmacy license in India, you must meet specific eligibility criteria covering personnel, premises, storage, and business registration. 

The key requirements are grouped below.

Personnel:

• For a retail license, employ a pharmacist registered with the State Pharmacy Council (D.Pharm, B.Pharm, or Pharm.D) who is present during business hours.
• For a wholesale license, appoint a competent person, either a science graduate with one year of drug-handling experience or a non-graduate with four years.

Premises:

• Maintain a minimum carpet area of 10 square metres for a retail or wholesale license, or 15 square metres if you run both from one premises.
• Use suitable commercial premises (not residential in most states), with a clean, potable water source nearby.

Storage:

• Provide adequate shelving, ventilation, and lighting for safe drug storage.
• Install a refrigerator for drugs that need cold storage, such as vaccines and insulin.

Business Registration:

• Register your business entity, such as:
  • Proprietorship firm Registration
  • Pvt Ltd Company Incorporation

Note: Premises and pharmacist requirements may vary by state, so check your State Drugs Control Department’s rules before applying.

Documents Required for a Pharmacy License

The documents you need for a pharmacy license depend on whether you’re applying for a retail or wholesale license. Some documents are common to both, while others differ by license type. Below is what you’ll need:

Common Documents (For Both Retail and Wholesale)

• Identity and address proof of the proprietor, partners, or directors, such as PAN, Aadhaar, or passport.
• Proof of business entity, such as the partnership deed, Certificate of Incorporation, or Memorandum and Articles of Association (MOA and AOA).
• Premises ownership or registered rent agreement, with the owner’s No Objection Certificate (NOC) if the premises are rented.
• Site plan and key plan (layout) of the premises showing carpet area and storage.
• Latest electricity bill or property tax receipt as premises proof.
• Affidavit of non-conviction of the proprietor, partners, or directors under the Drugs and Cosmetics Act, 1940.
• Proof of cold storage, such as a refrigerator purchase bill, for drugs requiring temperature control.
• Online fee payment receipt or treasury challan.

Additional Documents For a Retail License

• Application in Form 19.
• Registered pharmacist’s qualification certificate (D.Pharm or B.Pharm).
• Pharmacist’s registration certificate from the State Pharmacy Council.
• Pharmacist’s appointment letter, acceptance letter, and photograph.

Additional Documents For a Wholesale License

• Application in Form 19A or 19B, as applicable.
• A competent person’s qualification certificate (science graduate or equivalent).
• Competent person’s experience certificate (one year for graduates, four years for non-graduates).
• Competent person’s appointment letter and photograph.

Note: Requirements vary slightly by state. Keep details like business name, address, and pharmacist or competent-person registration consistent across all documents, as mismatches are a common reason for rejection.

How to Apply for a Pharmacy License in India? Step-by-Step Process

Follow these steps to apply for a pharmacy license in India correctly and avoid rejection:

1. Confirm Your License Type and Eligibility

• Decide whether you need a retail (Form 20/21), wholesale (Form 20B/21B), or both, based on how you’ll sell.
• Confirm you meet the eligibility criteria: a registered pharmacist for retail or a competent person for wholesale.
• Check your state’s specific premises and qualification requirements before proceeding.

2. Arrange Premises and Personnel

• Secure commercial premises meeting the minimum area (10 sq m for retail or wholesale, 15 sq m for both).
• Set up proper storage, shelving, ventilation, and a refrigerator for cold-storage drugs.
• Hire your registered pharmacist (retail) or competent person (wholesale) and obtain their appointment documents.

Note: Get your premises checked by a drug license expert before signing a lease, as many applications fail due to space or storage issues. RegisterKaro can review your setup plan before you finalize. 

3. Gather Documents and Prepare Form 19

• Fill out the application in Form 19 (or Form 19A, 19B, or 19C, as applicable to your license type).
• Collect all common and license-specific documents, including ID, premises, and pharmacist proofs.
• Prepare the site plan and key plan showing the premises layout and carpet area.
• Ensure all details are consistent across documents to avoid query notices.

4. Apply Online on the State Portal

• Register your firm on your state’s drug licensing portal (around 18 states use the ONDLS system at statedrugs.gov.in).
• Fill in the applicant, premises, and pharmacist details in the online form. The portal generates your Form 19 application from these entries.
• Upload the required documents, scanned in black and white at 100 dpi, in the format and size your state portal specifies.
• Pay the government fee online (around ₹3,000 for a retail or wholesale license) and submit the application with the fee challan.

5. Premises Inspection by the Drug Inspector

• A drug inspector visits to verify your premises, cold storage area, and pharmacist’s details.
• Keep all original documents ready to show during the inspection.
• Respond promptly to any queries or shortfalls the inspector raises to avoid rejection.

6. Grant of the Pharmacy License

• Once the inspection is cleared, the State Licensing Authority grants your license.
• You receive your license on the relevant form, Form 20 and 21 for retail, or Form 20B and 21B for wholesale.
• You can now legally sell or distribute medicines under the conditions of your license.

Once granted, a pharmacy license remains valid permanently if you stay compliant and pay the retention fee every five years.

Note: The pharmacy license process usually takes 15–30 working days, depending on the state and inspections. Manufacturing licenses take 60–90 days due to GMP audits.

Read also: How to Start a Pharmacy Business in India

Pharmacy License Cost and Government Fees

A pharmacy license in India typically costs ₹3,000–₹4,000 in government fees, with the total varying by state, license type, and professional assistance. Here’s a breakdown of the typical costs:

Cost Component	Approximate Cost	What It Covers
Retail or Wholesale Drug License (Form 20/21 or 20B/21B)	₹3,000 – 3,500	Government fee for a retail or wholesale pharmacy license; varies slightly by state.
Restricted License (general stores)	₹1,000	For general stores selling specified non-prescription medicines in areas without a pharmacy.
Schedule X Drugs (if applicable)	₹500 – 700	An additional fee for selling narcotic and psychotropic drugs.
Professional / Consultant Fees	₹5,000 – 15,000+	Optional charges if you hire experts to handle the application.
Pharmacist Salary (recurring)	₹15,000 – 30,000 per month	A mandatory registered pharmacist for a retail pharmacy.

Note: Government fees differ from state to state. Under the permanent license system, the old renewal fee is replaced by a retention fee equal to the original license fee. Always check your State Drugs Control Department’s current fee schedule before applying.

Pharmacy License Validity, Renewal, and Verification

A pharmacy license once needed renewal every five years, but the rules changed in 2018. Under the current system, licenses work differently, so it’s important to understand how validity and renewal now apply: 

Validity of a Pharmacy License in India

A pharmacy license in India is now valid perpetually. Under the 2018 amendment to Rule 63 of the Drugs and Cosmetics Rules, drug licenses (Forms 20, 21, 20B, 21B, and others) no longer expire on a fixed five-year cycle. 

Once granted, your license remains valid indefinitely, unless it is suspended or cancelled, as long as you meet your compliance obligations.

Do You Still Need to Renew a Pharmacy License?

No, the traditional five-year renewal system has been replaced with a license retention fee that must be paid every five years to keep the license active. The retention fee is equal to the original grant fee, which is typically around ₹3,000 for a retail or wholesale license, depending on your state. 

In effect, you still need to take action every five years, but you only pay the fee instead of submitting a full renewal application. 

How to Pay the Retention (Renewal) Fee Online?

• Log in to your state’s drug licensing portal (around 18 states use the ONDLS system at statedrugs.gov.in).
• Select your existing license and choose the retention fee payment option.
• Pay the retention fee online before the due date and download the receipt for your records.

Note: If you miss the retention fee deadline, a late fee of 2% of the license fee applies for each month of delay, up to six months. Non-payment beyond that can cause your license to be deemed cancelled, so treat the five-year retention deadline as seriously as the old renewal.

How to Verify a Pharmacy License?

You can verify a pharmacy license in India by checking it on your State Drugs Control Department’s online portal, where licensed pharmacies are listed. Verification helps confirm that a pharmacy is genuine, legally authorized, and safe to buy from, which matters for customers, suppliers, and partners alike.

Here’s how to verify a pharmacy license:

• Visit your State Drugs Control Department or drug licensing portal (most states maintain an online database).
• Search using the license number, firm name, or pharmacist details.
• Check the license status, validity, license type, and the registered pharmacist’s name against the displayed records.
• Confirm the details match the pharmacy’s displayed license and that the license is active, not suspended or cancelled.
• On the ONDLS portal (statedrugs.gov.in), used by around 18 states and UTs, you can also check licenses issued through that system. 

Note: If the license is not found or details do not match, treat it as a red flag and report it to the State Drugs Control Department.

How to Cancel or Surrender a Pharmacy License?

You can cancel or surrender a pharmacy license by applying to the State Drugs Control Department with the reason for cancellation, such as business closure or relocation. The authority can also cancel it for non-compliance.

Here’s how voluntary surrender usually works:

• Submit a written application or letter to the State Licensing Authority or the local Director of Drugs Control requesting surrender of the license.
• State the reason, such as business closure, relocation, or discontinuation of the pharmacy.
• Clear all drug inventory from the premises, and declare that every medicine has been legally sold, transferred, or returned to distributors or manufacturers.
• Return the original license and clear any pending dues, retention fees, or applicable surrender or processing charges.
• Stop all sales and stocking of medicines once the cancellation is processed and confirmed.

Note: The authority can also cancel or suspend a license for reasons such as:

• Selling medicines without a registered pharmacist present.
• Stocking or selling expired, spurious, or banned drugs.
• Failing to pay the retention fee within the allowed period.
• Breaching the conditions of the license or the Drugs and Cosmetics Act.

Pharmacy License Requirements by State

The Drugs and Cosmetics Act, 1940, provides the national framework, but pharmacy licenses are issued and managed by each state’s drug control authority. As a result, portals, fees, and processing times vary by state, while core requirements such as a registered pharmacist, minimum premises, and proper storage remain similar. Here’s how a few major states compare:

State	Licensing Authority	Application Portal	Indicative Retail Fee
Maharashtra	FDA Maharashtra	ONDLS / state FDA portal	₹3,250
Delhi	Drugs Control Department, Delhi	Delhi DCD portal (statedrugs.gov.in)	₹3,000 (₹500 extra for an optional homeopathic license)
Karnataka	Drugs Control Department, Karnataka	Karnataka DCD portal	₹3,000 – 4,000 (Khata certificate mandatory)
Uttar Pradesh	Food Safety & Drug Administration (FSDA), UP	ONDLS (UP)	₹3,000 – 4,000
Tamil Nadu	Drugs Control Department, Tamil Nadu	State DCD portal	₹3,000 – 4,000

Common state-wise differences include:

• Licensing authority and portal: Around 18 state and UT drug control authorities now use the ONDLS system, while others still run their own dedicated portals.
• Government fees: The base retail fee is typically ₹3,000, though states like Maharashtra charge slightly more, and add-ons (such as a homeopathic license) increase the total.
• Premises conditions: While 10 square metres is the common minimum, some states or districts apply stricter area or layout rules, and Karnataka requires a Khata certificate for the premises.
• Inspection timelines: These depend on local drug inspector workloads. Maharashtra, for example, often takes around 30 days, while faster states may issue within 15 to 20 days.

Note: Always confirm the exact requirements, fees, and portal with the State Drugs Control Department where your pharmacy will operate, as state rules prevail over general guidelines.

Compliance Tips After Getting Your Pharmacy License

Getting your license is only the start; staying compliant keeps it valid and avoids penalties or cancellation. Follow these practices once your pharmacy is operational:

• Keep your registered pharmacist present during all operating hours.
• Ensure your Pharmacist-in-Charge (PIC) keeps their State Pharmacy Council registration updated and their active license card displayed at the premises.
• Maintain proper purchase and sale records, including for prescription drugs under Schedule H and narcotic or psychotropic drugs under Schedule X, which require stricter record-keeping.
• Strictly follow the ban on over-the-counter retail sales of Schedule X and narcotic substances, dispensing them only against a valid prescription.
• Never stock or sell expired, banned, or spurious medicines.
• Store drugs correctly, maintaining the cold chain for temperature-sensitive products.
• File GST returns on time and keep your GST registration active for the pharmacy.
• Display your license at the premises and pay the retention fee every five years.

Common Mistakes to Avoid When Applying for a Pharmacy License

A pharmacy license application can be delayed or rejected due to avoidable errors. The most common mistakes and their solutions are:

• Inconsistent documents: Mismatched business names, addresses, or pharmacist registration numbers across documents trigger query notices. Cross-check every detail before submitting.
• Finalizing premises before checking rules: Many applications fail because the premises didn’t meet the area or layout requirements. Verify the rules and get expert advice before signing a lease.
• Applying for the wrong form: Applying for Form 20 only when you’ll also stock Schedule C/C1 drugs (which need Form 21) leads to rejection. Confirm which forms your product range requires.
• Pharmacist on paper only: Some applicants list a registered pharmacist who won’t actually work at the shop, or who is already tied to another pharmacy’s license. This fails verification; ensure your pharmacist is genuinely employed, present during business hours, and not registered against any other license. 
• Inadequate storage or cold chain: Missing a refrigerator for Schedule C/C1 drugs fails inspection. Set up proper shelving, ventilation, and cold storage before the inspector’s visit.
• Missing the retention fee deadline: Forgetting the five-yearly retention fee can get your license cancelled. Track the deadline and pay on time.

Getting a pharmacy license involves strict documentation, premises rules, and a drug inspector’s inspection, where small errors cause delays. RegisterKaro handles your entire drug license registration end-to-end, from the right license type to filing and inspection. Contact us today to get your pharmacy license approved without the stress!

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