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ComplyKart Services

Drug Licence

Package inclusions:

  1. Consultancy with Expert

  2. Documents preparation

  3. Follow up with Department

  4. Registration Certificate

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Fees

Fees and packages for Drug Licence

Every requirement is a little different, so we quote after a short discussion — the consultation itself is free.

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Drug Licence

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Overview

DRUG LICENSE

The Drug License is mandatory under the Drugs & Cosmetics Act, 1940 and it is applicable to all over India. Drug license is the permission grant by the government to deal with pharmaceutical industries like drugs and cosmetics in India, doing this without the permission of the government is a cognizable offence. There are stringent regulations over manufacturing and distribution of drugs and medicines in India, in order to prevent their abuse and misuse, which are listed under the Drugs and Cosmetics Act, 1940. In 1964, Ayurvedic and Unani drugs were also included in this Act.

The time frame for obtaining and granting drug license by the authority is 30 days after becoming eligible under this act. Once the Entity has obtained Drug License, it is required to ensure the condition mentioned in license are duly complied during the course of business. All the records and registered required to be maintained in prescribed manner as mentioned by authorities and they must be informed of any changes in the business activities of license holder. Since the Drug Control Authorities are state governed, separate application should be made for each state. The retailer or wholesaler are required to have a self-occupied premise of atleast 15 sq. meters for being eligible for Drug License.

ComplyKart is among the best drug License consultant committed to provide 100 percent success to business.

Types of Sale Drug License

There are mainly two types of License that are issued for the Pharmaceutical business:

1.Retail Drug License (RDL)

  It is granted for a Chemist or Standalone Pharmacy Shop awarded to people registered with state pharmacy council.

2. Wholesale Drug License (WDL)

  It is granted to the people who are into wholesale distribution of drugs.

The other types of License are:

  1. Manufacturing License

  2. Loan license

  3. Restricted license for general stores on the basis of type of sale

Multi-State Operation

If the business is operating in more than 2 state then obtain drug license for each state and they have to maintain all the registers records and forms in the manner specified by the authority.

Import Drug License

To obtain drug import license the person has to file the various forms such as Form 8, Form 9, and Form 10 at the CDSCO portal along with the prescribed fees.

Conditions for Drug License

Pharmacist with competency

Medicines should be handled by a competent person, therefore a qualified pharmacist will be given Retail license and wholesale license will be given to a graduate with 1 year experience and an undergraduate with 4 (Four) years.

Area of Premises

To apply for a retail license, the carpet area of premises must be of 10 square meters and for retail and wholesale both license, the minimum area should be 15 square meters with proper open areas.

Clean Storage for Drugs

Refrigerator facility is must for Drug license as few of the medicines specially vaccines need to be kept at freezing temperature. The drugs must be kept at a cool storage facility with clean ad properly ventilated premises.

Prior Inspection

When you apply for Drug License, the Drug Inspector of your jurisdiction will visit to verify the documents submitted and also check the premises where Drug is to be kept.

Benefits

Benefits of drug license

Open each benefit to see what it means for you.

Legal Requirement

Having a Drug License is mandatory to acquire by someone willing to run a retail or wholesale Drug selling business or even the manufacturer of Medicines.

Safety

After obtaining the drug license the entity feels safe in producing any types of medicine or drugs because Government take necessary measures to control over the entity.

Reduce Risk

The customer feels safe and secure in buying drugs from the registered entity or from the entity who have drug license.

Improves Communication

The retailer will not hesitate in dealing with the person like whole-seller who obtained the license with the authority and it will improve the communication between the different chain of marketing.

Transparent

With the help of drug license the intention to make the process of drug license transparent and user friendly will be achieved.

Documents

Documents required for a drug licence

Clear, current documents matter more than a long checklist. Names, dates of birth and addresses should match across every record — that's what the MCA checks first. Tick what you already have below.

0 documents marked ready Tick what you already have. This checklist resets when you leave the page.

Premises and constitution

Verified against MCA requirements

Pharmacist and professional documents

Verified against MCA requirements

What is a CIN?

Every Private Limited Company gets a unique 21-character Corporate Identification Number from the MCA. It's proof your company legally exists. You'll need it for bank accounts, tax filings, and contracts. We handle the entire application — you just provide the documents above.

Not sure if your documents are ready?

Send us what you have. A ComplyKart expert will review them for free and tell you exactly what's missing — no obligation.

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Questions Founders ask us about documents

What if my address proof is old?

Utility bills and bank statements must be less than 2 months old. If yours are older, get a fresh copy — the MCA rejects stale proofs.

Do I need original documents?

No. Clear scans or photos work for the entire process. We never ask you to courier originals.

What if directors live in different cities?

That's normal. Each director uploads their own documents separately. Our system keeps everything organised.

I'm outside India. Can I still register a company?

Yes. India allows 100% foreign ownership in most sectors, and the entire process happens online. You need one Indian resident director, and your passport + address proof must be apostilled — we'll guide you through both. NRI founders and foreign investors do this with us regularly.

Check if you're eligible →

How long does registration actually take?

7 to 10 working days from the day your documents are verified. Name approval takes 2-3 days, MCA incorporation another 5-7. We track every stage and update you.

Can I start if I'm missing one document?

Yes. Start now with what you have — we begin name reservation and DSC while you arrange the rest. Most founders are missing one proof; it rarely blocks the timeline.

Process

Drug licence process — step by step

You’ll see each stage, what’s pending and what we need from you — so filings don’t bounce back.

Step 1 of 7

Choose retail vs wholesale

Retail licences (Forms 20, 21) require a registered pharmacist on the premises. Wholesale licences (Forms 20B, 21B) require a competent person.

Arrange a qualified pharmacist

A retail drug licence is granted only with a full-time registered pharmacist on staff.

Apply to the State Drugs Control Department

Drug licences are issued by each state's Drugs Control Department or FDA.

Premises inspection

The drug inspector verifies storage conditions, refrigeration, and record-keeping arrangements.

Licence issuance

Typically 30-45 working days after a satisfactory inspection.

Display and record-keeping

Display the licence at the shop and maintain purchase and sale records for at least 5 years.

Renew before expiry

Drug licences are valid for 5 years. Apply for renewal before expiry.

Why ComplyKart

How ComplyKart helps in this entire process

You should know who’s doing what. Open a stage to see how the work is shared.

01

Consulting & Strategy

We have a selective team of Professionals who are expert in their respective fields. Our Drug License experts will give...

02

Client’s Growth

Our services are aimed at achieving growth for clients. We provide necessary guidance for understanding the Drug License...

03

Competence is our strength

We make every effort to stay updated with the rules and regulations by Drug License Department. This enables us to deal...

04

Always there for you

The assurance of a dedicated workforce including support staff and managers can be a promising factor in the drug Licens...

05

Post Registration Compliance

Once the Drug License is approved by the authority we help you to comply with certain rules to keep your business runnin...

Consulting & Strategy: We have a selective team of Professionals who are expert in their respective fields. Our Drug License experts will give you the best consulting and prepare the strategy for your company

For NRI founders & foreign investors

If a founder or investor is outside India

You don't need to fly down. Most of our foreign-founder incorporations are completed without the founder ever visiting India — 100% foreign ownership is allowed in most sectors, and the entire process happens online.

Before you start

  • 100% foreign ownership is allowed in most sectors — no Indian partner needed
  • One Indian resident director is required by law — we help you find a compliant way forward
  • Check whether your sector permits automatic-route foreign investment
  • Your passport + address proof need an apostille, not an embassy visit
  • Map ownership, beneficial ownership and pricing early

After incorporation

  • Receive funds through permitted banking channels
  • Complete RBI/FEMA reporting (FC-GPR, FLA) and keep the bank evidence
  • Coordinate tax and ongoing compliance advice early

Set up Business in India by a Foreigner →

Free 15-minute eligibility call. No obligation.

What clients say about working with us

Real stories from businesses we've worked with.

Trademark Registration
Our Trademark was applied in all the classes with a short span of time by Complykart Trademark Experts and I can say the level of expertise and commitment they carry is remarkable. It's an A+ from my side. We are now sticking to ComplyKart only.
Rajat KhanejaKnovalt
Company Registration
I found the professionalism of the staff at complykart.com, a pleasure to work with. As a foreigner to India, they took the time to explain the documentation and assisted in every question I raised. I was pleased that complykart.com made it easy for my Business.
Ravi Sharma360Mart Trading
Merger & Acquisition
Trust, Commitment, Dedication and responsiveness are the best things with ComplyKart. Thanks for handling our Merger assignment with so much care. After my business disputes, complykart handles all things with own sense of understanding.
Rana RajeshAIL

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Last verified: 6 October 2026
Compliance rules change. If something on this page looks outdated, tell us on WhatsApp and we'll fix it — and your filing will always follow the current rules, not just what's written here.

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