Drug License Apply Online at ₹4,999: Process & Fees 2026

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What is Drug License

A drug license is a mandatory legal authorization required to manufacture, sell, stock, distribute, or exhibit drugs and cosmetics in India. It is issued under the Drugs and Cosmetics Act, 1940, along with the Drugs and Cosmetics Rules, 1945 - the primary legislation governing the pharmaceutical and cosmetic industry across the country. The Act led to the formation of the Drugs Control Department, consolidating various laws related to drugs and cosmetics under a single regulatory framework. In 1964, an amendment extended its scope to include Ayurvedic and Unani medicines as well.

A business must obtain a drug license in every state where it operates. If a company runs operations in two or more states, it needs a separate license for each state. Similarly, if medicines are sold from multiple premises, a separate license is required for each location - though this rule does not apply to migratory or itinerant sellers. Our team of experienced drug license consultants can guide you through the entire process of obtaining your drug license, from documentation to final approval.

DRUG LICENCE COMPLIANCE

Why Do You Need a Drug License in India?

A drug license is official government approval granted to an entity to handle and distribute drugs. Securing this approval is essential before launching a pharmaceutical business.

LEGAL FRAMEWORK Drugs and Cosmetics Act, 1940

The definition and scope of “drug” are covered under Section 3(b) of the Act.

SEC. 3(b) Drug Definition
01
WHY IT MATTERS

Before You Start a Pharmaceutical Business

A drug license provides the required regulatory approval for eligible entities involved in activities such as handling and distributing drugs. It is an important compliance requirement before starting a pharmaceutical business.

Government Approval Required regulatory authorization for applicable drug-related activities.
Business Compliance Helps businesses operate within the applicable drug-control framework.
Regulated Activities Applies to activities covered by the Drugs and Cosmetics regulatory framework.
02
REGULATED SCOPE

What Does the Definition Cover?

The definition covers a broad range of substances and products used for medical, diagnostic, preventive and related purposes.

Medicinal Substances Drugs and materials used to treat, diagnose, prevent or reduce illness in humans or animals.
Preparations Applied to the Body Preparations used on the skin to keep away insects such as mosquitoes.
Materials Used in Medicines Materials that enter into the manufacture or preparation of medicines.
Empty Gelatin Capsules Empty gelatin capsules are included within the stated regulatory scope.
Medical Devices Medical devices covered by the applicable definition and regulatory provisions.
03 MEANING OF DRUGS

What Does “Drug” Mean Under the Act?

“

The Drugs and Cosmetics Act, 1940 defines a “drug” as any medication or device under Section 3(b).

Humans or animals can use it for internal or external purposes. A drug is any substance that helps diagnose, treat, or prevent diseases in people or animals.

This also includes substances applied to the body to ward off insects like mosquitoes.

1964
Scope Expanded Authorities revised the term to include Unani and Ayurvedic drugs.
Regulatory takeaway

If your business handles products covered by the applicable drug regulations, identifying the correct licence requirement should be part of your compliance planning before starting operations.

Why Is a Drug License Mandatory?

  • To prevent people from misusing medications and medical supplies, authorities must control access to them. Under the Drugs and Cosmetics Act of 1940, authorities require drug licenses. This applies to all pharmacists, wholesalers, retailers, producers, distributors, dealers, and importers of medicines. This includes cosmetics and Ayurveda, Siddha, and Unani medications.
  • The significance of a drug licence is to provide organizations or individuals with official approval to conduct operations related to medications and cosmetics. In India, businesses and individuals must obtain this authorization before dealing with medicines or cosmetics. Along with the Medication permit, they are required to register their shop or establishment and acquire a trade licence.
  • The government of India regulates the quality of medications sold in the country. The Medicines and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945 accomplish this.
  • From the time manufacturers make and sell medicines, the government controls them. The control lasts until a pharmacist sells the drugs. This can happen in a retail pharmacy, hospital, or dispensary.
  • The government can oversee issues related to importing and exporting medications. It also regulates the sale of drugs to minors.
  • Additionally, it monitors the use of drugs listed in Schedule H and X. These matters require careful planning and attention. In accordance with the Drugs and Cosmetics Act of 1940, the drug governing authority grants the pharmaceutical licence..
DRUG LICENSING

Types of Drug Licenses

Different pharmaceutical activities require different drug licenses in India. Choose the right license based on whether your business involves retail, wholesale, manufacturing, loan manufacturing, or importing medicines.

01

Retail Drug License

A Retail Drug License is required for businesses that sell medicines directly to the final customer. Retailers may supply medicines to medical, educational, research, dispensary, and other permitted institutions.

Under the Drugs and Cosmetics framework, a chemist or drug retailer must obtain the applicable shop license from the State Drug Controller Authority before starting retail drug sales.

Selling drugs without the required license can result in imprisonment and monetary penalties under applicable law.
Get Retail Drug License Assistance
02

Wholesale Drug License

A Wholesale Drug License is required for businesses involved in the wholesale distribution or supply of medicines. This may include pharmaceutical distributors, wholesalers, and eligible agents representing manufacturers in India.

Businesses engaged in wholesale drug distribution must obtain the applicable license from the competent drug regulatory authority and comply with the prescribed storage, documentation, and distribution requirements.

Apply for Wholesale Drug License
03

Drug Manufacturing License

A Drug Manufacturing License is required for businesses involved in manufacturing medicines. Manufacturing can include processes used to make, alter, pack, label, or otherwise handle drugs intended for sale or distribution.

Manufacturers must meet applicable premises, technical staff, equipment, quality, storage, and regulatory requirements before manufacturing drugs for commercial distribution.

Get Manufacturing License Support
04

Loan License

A Loan License allows eligible applicants to manufacture drugs using the manufacturing facilities and premises of another licensed manufacturer, subject to the applicable regulatory requirements.

The manufacturing facility used for production must have the required drug license and adequate manufacturing capacity for the products covered under the arrangement.

Explore Loan License Assistance
05

Drug Import License

Businesses importing medicines into India must comply with the applicable drug import requirements. Drug import licensing and regulatory processes are handled under the central drug regulatory framework.

The Central Drugs Standard Control Organisation (CDSCO) plays a key role in regulating the import of drugs and related products into India.

Get CDSCO Import Assistance
Need Help Choosing the Right License?

Tell us about your pharmaceutical business and get assistance in identifying the applicable drug license and completing the required documentation and filing process.

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Note- If your business involves stocking or selling medical devices, ensure you also apply for an MD-42 License.

Drug License Issuing Authority by State

State / UTDrug Licensing Authority (State FDA / Drug Control Department)Office Type / Jurisdiction
DelhiDrug Control Department, GNCTDState Licensing Authority
MaharashtraFDA MaharashtraState Drug Controller Office
Uttar PradeshUP Drug Control AdministrationState Licensing Authority
GujaratFDCA GujaratState Drug Controller Office
RajasthanRajasthan Drug Control OrganisationState Licensing Authority
Tamil NaduTN Drugs Control DepartmentState FDA Authority
KarnatakaKarnataka State Drug Control DepartmentState Licensing Authority
KeralaKerala Drugs Control DepartmentState FDA Authority
West BengalWest Bengal Drug ControlState Licensing Authority
Madhya PradeshMP Food & Drug AdministrationState FDA Authority
HaryanaHaryana State Drug Control DepartmentState Licensing Authority
PunjabPunjab Drugs Control DepartmentState FDA Authority
BiharBihar Drug Control & Licensing AuthorityState Licensing Authority
TelanganaTelangana Drug Control AdministrationState FDA Authority
Andhra PradeshAndhra Pradesh Drug Control DepartmentState Licensing Authority
OdishaOdisha Drug Control OrganisationState FDA Authority
ChhattisgarhChhattisgarh FDA / Drug ControlState Licensing Authority
Himachal PradeshHP Drug Control AdministrationState FDA Authority
UttarakhandUttarakhand Drug Control DepartmentState Licensing Authority
AssamAssam Drugs Control AdministrationState FDA Authority

Documents Required for Drug License Application

The documents required to obtain a pharmaceutical licence:

  • The company's rules include the partnership deed, articles of association (AOA), memorandum of association (MOA), and LLP agreement.
  • Identification of the director, partner, or proprietor.
  • Records about the property include several important documents. These are a copy of the ownership papers and the rental agreement. If necessary, there is also the NOC (No Objection Certificate) from the property owner.
  • The premises' site plan and key plan.
  • A copy of the board resolution authorizing licence acquisition.
  • Evidence of the availability of cold storage, refrigerators, and other storage spaces.
  • Challan copy as evidence of paid deposit.
  • Affidavit of non-conviction of the firm, its proprietor, partner, or director.
  • A cover letter from a qualified individual or certified pharmacist.
  • Cover letter with applicant's name and title Declaration form in the manner required by law.
  • The education certificate of the applicant
  • Proof of Education, local Pharmacy Council registration, and letter of appointment of the wholesaler or retailer.
PSR Compliance Drug License Video
YouTube
WATCH & LEARN

Drug License Registration Guide

Watch this quick video to understand drug licensing and regulatory requirements in India.

ELIGIBILITY & COMPLIANCE

What Are the Requirements for Getting a Pharmaceutical Certification?

The following are the main prerequisites for getting a Pharmaceutical certification in Delhi, India:

01
PREMISES

Area of Premises

At least 10 square meters of space is required. This is necessary for anyone who wants to open a retail pharmacy or medical store.

Crucial to note is that a retail or wholesale drug business must have a minimum of 15 square meters.

10 m² Retail pharmacy / medical store
15 m² Retail or wholesale drug business
02
STORAGE

Storage Space

To store medications, you need to have the right storage options. This includes a refrigerator or a cold storage area.

Refrigerator Suitable storage for medications requiring controlled temperature.
Cold Storage Required where applicable for temperature-sensitive medicines.
03
PERSONNEL

Staff

Having knowledgeable and skilled staff is essential for a retail pharmacy. Their proficiency in the field is crucial. Moreover, the pharmacist must fulfill the necessary criteria to qualify for a medicines license.

WHOLESALE Qualified Person
A
Undergraduate Four years of relevant experience
OR
B
Graduate One year of relevant experience
04
VERIFICATION

Property Examination

A Drug Inspector can visit the site to inspect it before issuing a Pharmaceutical certification.

01
Site Visit Drug Inspector visits the premises.
02
Measurement Property area and details are checked.
03
Verification Information and qualified person are verified.
Before applying, check all four requirements

Premises, storage arrangements, qualified staff and property inspection can all form part of the licensing requirements.

List of Application Forms for Drug License

Form No.PurposeApplicable License TypeAuthority
Form 8Application to import drugs not specified in Schedule XImport LicenseCDSCO
Form 8AApplication to import drugs specified in Schedule XImport LicenseCDSCO
Form 9Manufacturer's undertaking submitted along with import license applicationImport LicenseCDSCO
Form 10Import license granted for drugs/medical devices (issued after Form 8/8A + Form 9)Import LicenseCDSCO
Form 19Application for retail/wholesale license for drugs other than Schedule XRetail/Wholesale LicenseState FDA
Form 19AApplication for restricted retail license for dealers not engaging a registered pharmacistRestricted Retail LicenseState FDA
Form 19BApplication for retail license to sell Homoeopathic medicinesRetail License (Homoeopathy)State FDA
Form 19CApplication for retail/wholesale license for drugs specified in Schedule XRetail/Wholesale License (Schedule X)State FDA
Form 20License to sell drugs by retail (other than Schedules C, C(1), X)Retail LicenseState FDA
Form 20BLicense to sell drugs by wholesale (other than Schedules C, C(1), X)Wholesale LicenseState FDA
Form 20CLicense to sell Homoeopathic medicines by retailRetail License (Homoeopathy)State FDA
Form 21License to sell drugs by retail specified in Schedules C & C(1)Retail LicenseState FDA
Form 21BLicense to sell drugs by wholesale specified in Schedules C & C(1)Wholesale LicenseState FDA
Form 24Application to manufacture for sale drugs other than Schedules C, C(1), and XManufacturing LicenseState FDA
Form 24AApplication for loan license to manufacture drugs other than Schedules C, C(1), and X (using another's facility)Loan LicenseState FDA
Form 24CApplication to manufacture Homoeopathic medicinesManufacturing License (Homoeopathy)State FDA
Form 24DApplication to manufacture Ayurvedic/Siddha/Unani drugsManufacturing License (ASU)State FDA
Form 24FApplication to manufacture drugs specified in Schedule X (excluding C & C(1))Manufacturing LicenseState FDA (CDSCO for select special categories)
PHARMACEUTICAL LICENCE

What is the Process of Pharmaceutical Licence Registration?

The process of Pharmaceutical licence in Delhi registration involves online application, document verification, inspection and approval by the Drug Licensing Authority.

01
STEP 01

Register on the Drug Licensing Portal

Start by registering on your state's Pharmaceutical Licensing Portal. Each state has a Drug Regulatory Authority.

This authority manages an online Pharmaceutical Licensing Portal. Users utilize the portal to register for drug-related licenses. You can apply for the Pharmaceutical License Certificate by logging into the portal if you have the right credentials.

✓ Online registration through the applicable Drug Licensing Portal
02
STEP 02

Submission of an Application

You must input the pharmacist's and competent individuals' details after registering on the website. Next, enter the name and parties related to the Pharmacist Council Registration.

After that, you can submit your application using the form that matches your application type.

Form 19 Form 19A Form 19B Form 19C

You can use Forms 19, 19A, 19B, or 19C to apply for a certificate of Medication permit in Delhi registration according to your needs. After you enter the necessary information, check it one last time. You cannot change it later. Then, submit the online Medication permit Application Form.

✓ Review all application details carefully before final submission
03
STEP 03

Procedure for Inspection

The Drug Licensing Authority (DLA) will inspect your property after they get your completed Medication permit Application Form. They will set a time for the inspection.

To register for a Medication permit in Delhi, a drug inspector comes to the location on the prescribed date.

✓

Premises and required conditions are inspected

✓

Original documents are verified by the Drug Inspector

✓

Inspection report is submitted to the Drug Licensing Authority

The Drug Inspector (DI) checks the conditions needed to issue a Medication permit. The DI also verifies the applicant's original documents. After this, the DI sends the report to the Drug Licensing Authority.

04
STEP 04

Issuance of a Medication Permit in Delhi, India

The Drug Licensing Authority reviews the report forwarded by the Drug inspector. The authority verifies if the application is in compliance with the Drug Rules.

If the application is accurate, the relevant authority grants the applicant a Medication permit. The Drug Inspector's report forms the basis of this decision.

Licence Issued Approval is granted after the application and inspection report meet the applicable requirements.

Drug License Fees Across India (Retail, Wholesale, Manufacture)

License Type Application / Grant Fee Retention Fee
(Every 5 Years)		 Validity
Retail Drug License Form 20, 21 ₹3,000 Combined government fee Equal to original grant fee Perpetual
Subject to timely retention fee
Wholesale Drug License Form 20B, 21B ₹3,000 Combined government fee Equal to original grant fee Perpetual
Subject to timely retention fee
Manufacturing License Form 24, 25 ₹5,000 – ₹30,000+ Varies by state and product category Equal to original grant fee Perpetual
Subject to timely retention fee
Loan License Form 24A / 25A ₹5,000 – ₹25,000 Varies by state Equal to original grant fee Perpetual
Subject to timely retention fee
Import License Form 8/8A + Form 10 ₹5,000 – ₹50,000 Varies by product class N/A — separate renewal process via CDSCO 5 Years
Import licenses under Form 10 remain time-bound
!

Fee Note: The ₹3,000 fee shown for Retail and Wholesale Drug Licences represents the combined government fee for the applicable forms. Additional charges may apply depending on the state, premises, licence category and other regulatory requirements.

Processing Time by License Type

License TypeTypical Processing TimeBasis
Retail Drug License (Form 20/21)15–30 working days after premises inspectionPost-inspection turnaround cited by multiple state-licensing consultants
Wholesale Drug License (Form 20B/21B)15–30 working days after premises inspectionSame as retail — inspection is the main bottleneck
Full application to grant (documents + SUGAM/state portal + inspection)30–60 working daysCommonly cited end-to-end estimate across states
Manufacturing License (Form 24/25)60–90 working daysIncludes mandatory Schedule M (GMP) compliance audit
Import License (Form 8/8A → Form 10)Varies by product class; typically longer than sale licensesInvolves CDSCO-level review, not just state SLA

Drug License Validity: Perpetual, Not Fixed-Term

Under the Drugs and Cosmetics (Tenth Amendment) Rules, 2017 (amending Rule 63), a Retail, Wholesale, Manufacturing, or Loan drug license does not expire on a fixed cycle. It remains valid indefinitely, provided the licensee pays a retention fee before the end of every 5-year period from the date of issue.

  • Retention fee amount: equal to the original license grant fee
  • Due: before the 5-year anniversary of the license issue date
  • Late payment (within 6 months of due date): retention fee + a late fee of 2% of the license fee per month or part thereof
  • Beyond 6 months unpaid: the license is deemed to have expired — you must file a fresh application to reinstate it

Exception: Import Licenses (Form 10) do not follow this retention-fee model. They remain valid for a fixed 5-year term and require an actual renewal application before expiry, not a retention payment.

Penalties for Operating Without a License

This is worth getting right because the number that's commonly repeated across competitor sites (and possibly your own blog) — "1–3 years imprisonment, fine up to ₹1 lakh" — understates the actual current penalty. I pulled the actual statutory text.

Penalty for Selling or Distributing Drugs Without a Valid License

Under Section 27(b)(ii) of the Drugs and Cosmetics Act, 1940, manufacturing, selling, stocking, exhibiting, or distributing drugs without a valid license (as required under Section 18(c)) is punishable with:

  • Imprisonment: minimum 3 years, extendable up to 5 years
  • Fine: minimum ₹1,00,000, or three times the value of the drugs confiscated — whichever is higher

The court may, for special and adequately recorded reasons, impose a lesser sentence or fine. Separately, drugs found to be adulterated or spurious under Section 27(a) carry far harsher penalties — minimum 10 years' imprisonment, extendable to life, with a minimum fine of ₹10,00,000.

How PSR Compliance Can Help You Apply

Whether you need a new wholesale drug license or require assistance with the renewal of your wholesale drug license, PSR Compliance provides expert guidance to ensure a hassle-free process.

This applies whether you are a manufacturer, distributor, or retailer of medicines and cosmetics in India or other places. PSR Compliance ensures that your license issues on time. This will improve the credibility of your drugs or medicines. We provide a comprehensive solution to help medicine manufacturers in India secure licenses and testing facilities.

Written by

Advocate Rajkumar

Advocate Rajkumar

Indian Taxation ( GST and Income Tax)

10+ Years Experience

Advocate Rajkumar has over 10 years of experience in Indian taxation, with a focus on tax-related matters and regulatory compliance.

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8796104190 support@psrcompliance.com
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Frequently Asked Questions

Once obtained, a drug license is valid for five years, until the Drug Department suspends or cancels it.

The applicant's store must have at least 10 square meters of space. The person in charge, called the Competent Person, must be a Registered Pharmacist.

This person should have completed high school or its equivalent. They must also have four years of experience handling drugs. Confirmation, they can hold a degree from an accredited university and have one year of experience handling drugs.

The Drugs & Cosmetics Act of 1940 and the rules enacted thereunder contain several sections pertaining to drug licensing. You can also contact the drug inspector of your area to obtain information about drug licenses. Moreover, to get any information, you can contact the expert of PSR Compliance and ask your questions.

Yes, selling drugs using motor vehicles does require a special license. Applicants must choose to take it at the time of making an application.

If the applicant's address changes, they must return the drug license for the old location. They will need to apply for a new one.

You can check drug license status, visit the regulatory authority's website: https://www.statedrugs.gov.in/, enter the license number, and review the status. Ensure the site is official and secure to obtain accurate information.

To get a drug license in Uttar Pradesh, you need several documents. First, you need a cover letter. Second, you must fill out an application form. You also need a key plan and site plan of your location.

Additionally, provide proof of ownership or lease for the premises. You also need an Registration certificate.

You must show proof of the applicant's Education. An appointment letter for the registered pharmacist or qualified person is necessary too. Finally, include an affidavit stating that the applicant has no criminal convictions.

The fee for a drug license in Uttar Pradesh depends on the type and scale of medicines operations. Costs differ for manufacturing, sales, and distribution licenses. For the latest fee information, check with the Food Safety and Drug Administration. This location exists in Uttar Pradesh.

A Drug License generally stays valid for five years, and you must renew it to maintain legal operations.

To check your drug license online in India, follow these steps. First, visit the official website of the Central Drugs Standard Control Organization (CDSCO).

Confirmation, you can go to your local State Drug Control department's website. Go to the Drug License section. Enter your application or license number to check the status and details of your license.

PSR Compliance is a leading consultancy firm offering expert assistance in drug license registration for wholesalers, retailers, and manufacturers across India.

To apply for a drug license in Gurugram, you need to submit the required documents and comply with government regulations. Our team at PSR Compliance provides expert drug license services in Gurugram to ensure a smooth and hassle-free approval process.

To start a new pharmacy, obtaining a drug license for a new pharmacy is mandatory as per regulatory requirements. The process involves submitting the necessary documents, meeting compliance standards, and applying to the appropriate drug authority. At PSR Compliance, we assist in every step to ensure a smooth and hassle-free approval.

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