What is a drug license in India?

A drug license is a legal authorisation under the Drugs and Cosmetics Act, 1940 permitting manufacture, sale, stocking, or distribution of pharmaceutical products. Issued by the State Drug Licensing Authority (retail/wholesale) or CDSCO (manufacturing/imports). Different forms apply: Form 20/21 retail, Form 20B/21B wholesale. Operating without one is a criminal offence under Section 27.

What are the types of drug license?

Main types: (1) Retail - Form 20 (general) + Form 21 (Schedule C/C1), (2) Wholesale - Form 20B + Form 21B, (3) Manufacturing - CDSCO, (4) Import License, (5) Schedule X - Form 20F retail and Form 20G wholesale for narcotic/psychotropic substances, (6) Homeopathic - Form 20C retail and Form 20D wholesale.

How much does a drug license cost?

Government fees vary by state. Retail Form 20/21: Rs 1,500-3,000. Wholesale Form 20B/21B: Rs 3,000-6,000. Homeopathic Form 20C: Rs 250-500. Schedule X: Rs 600-2,400 additional. Manufacturing: Rs 5,000-25,000+. Professional fees from Patron Accounting start at Rs 4,999.

Drug license kaise banaye?

Drug license banane ke liye: (1) Business type decide karein (retail/wholesale/manufacturing), (2) Premises arrange karein (min 10 sq.m retail, 15 sq.m wholesale), (3) Registered pharmacist ya competent person appoint karein, (4) State Drug Control Department ke portal par Form 19 submit karein, (5) Drug Inspector inspection karega, (6) License milega Form 20/21/20B/21B mein. License perpetual hai - har 5 saal retention fee deni hoti hai. Patron Accounting - +91 945 945 6700.

What is the validity of a drug license?

Under amended Rule 63 (G.S.R. 1337(E)), drug licences are now perpetual - valid unless suspended or cancelled. A retention fee equal to the original grant fee must be paid every 5 years from the date of issue. Compliance is assessed through inspections not less than once in 3 years or based on a risk-based approach.

What is the difference between Form 20 and Form 20B?

Form 20 is the retail drug licence for sale of general allopathic drugs directly to consumers through a pharmacy. A registered pharmacist must be present. Form 20B is the wholesale licence for distribution to retailers, hospitals, and stockists. A competent person with pharmacy qualifications is required. Both are applied for using Form 19.

Dawa ki dukan ka license kaise le?

Dawa ki dukan (medical store) ke liye Form 20 aur Form 21 chahiye. Minimum 10 sq.m area honi chahiye. Registered pharmacist appoint karo. State Drug Control Department ke portal par Form 19 submit karo. Drug Inspector premises check karega. Fees Rs 1,500 se Rs 3,000 tak hoti hai. License perpetual hai par 5 saal mein retention fee deni padti hai. Patron Accounting poora process handle karta hai.

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Drug License in India

Q: Is a pharmacist mandatory?

For retail: a registered pharmacist must be present during all business hours - this is non-negotiable. For wholesale: a competent person is required (pharmacy graduate with 1 year experience, or pharmacy undergraduate with 4 years experience). Manufacturing requires approved technical staff with GMP compliance. Quick Answers Q: Can I sell medicines without a drug license? A: No. Section 18 prohibits it. Penalty under Section 27: up to 3 years imprisonment + Rs 1 lakh fine. Q: Separate licences for retail and wholesale? A: Yes. Form 20/21 (retail) and Form 20B/21B (wholesale) are separate licences with separate fees. Q: Can I sell ayurvedic with allopathic licence? A: No. AYUSH drugs require separate licences under the AYUSH department. Q: Is inspection mandatory? A: Yes. Drug Inspector inspects before licence grant and periodically (at least once in 3 years).

Reviewed by CA and CS Team, Patron Accounting LLP ICAI & ICSI Registered| 15+ Years Experience| Last Updated: 10 March 2026 Verify Credentials →

Coverage: Retail (Form 20/21), Wholesale (Form 20B/21B), and Manufacturing drug licenses under the Drugs & Cosmetics Act, 1940.

Government Fees: From Rs 1,500 (Retail) to Rs 6,000+ (Wholesale/Manufacturing). Varies by state and licence type.

Validity: Perpetual under amended Rule 63 - subject to licence retention fee every 5 years. No more 5-year expiry.

Authorities: State Drug Licensing Authority (retail/wholesale) + CDSCO (manufacturing/imports). Dual regulatory system.

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“

Got our retail drug license (Form 20 + Form 21) for our pharmacy in Pune within 25 days. Patron Accounting advised on premises layout, helped us find a registered pharmacist, and prepared us for the Drug Inspector visit. Zero issues at inspection.

Sandeep Kulkarni

Pharmacy Owner, Pune

★★★★★

“

We needed both wholesale (Form 20B/21B) and retail licences for our pharma distribution business across Maharashtra. Patron Accounting filed both simultaneously and managed the separate inspections efficiently. Their knowledge of state portal specifics was invaluable.

Rajesh Menon

Pharma Distributor, Mumbai

★★★★★

“

Our hospital pharmacy needed a drug license including Schedule C/C1 for vaccines and insulin. Patron Accounting handled the cold chain documentation, arranged the refrigerator compliance proof, and managed the entire Form 21 process. Extremely knowledgeable about pharma regulations.

Dr. Priya Gupta

Hospital Administrator, Delhi

★★★★★

“

Starting a medical store chain with 4 outlets. Patron Accounting handled all 4 drug license applications across different localities, ensuring each met the 10 sq.m requirement and had registered pharmacists. All licences received within 35 days. Now managing our 5-year retention tracking too.

Anil Kumar

Medical Store Chain, Gurugram

★★★★★

“

Our e-pharmacy needed a valid drug license for state compliance and marketplace verification. Patron Accounting guided us through the state portal requirements and ensured our digital operations were fully compliant. They also handled our GST registration alongside the drug license.

Neha Sharma

E-Pharmacy Founder, Bangalore

★★★★★

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Overview What Is Who Needs Our Services 7-Step Process Documents Challenges Fees Timeline Benefits Retail vs Wholesale vs Mfg FAQs

Drug License in India - Complete Guide for 2026

📌 TL;DR - Drug License Services at a Glance

A drug license is mandatory for any person or entity manufacturing, selling, stocking, or distributing drugs in India. Governed by the Drugs and Cosmetics Act, 1940 and Rules, 1945, licences are issued by the State Drug Licensing Authority for retail (Form 20/21) and wholesale (Form 20B/21B), and by CDSCO for manufacturing and imports. Licences are now perpetual (Rule 63 amended), subject to a retention fee every 5 years.

Drug licensing regulates every stage of the pharmaceutical supply chain - manufacturing, wholesale distribution, and retail sale. The 2018 amendment to Rule 63 made drug licences perpetual. Compliance is assessed through inspections not less than once in 3 years. Patron Accounting provides end-to-end drug licence services for retail pharmacies, wholesale distributors, and manufacturers.

Parameter	Details
Governing Law	Drugs and Cosmetics Act, 1940 + Rules, 1945 (as amended by G.S.R. 1337(E))
Retail Licence	Form 20 (general) + Form 21 (Schedule C/C1 drugs). Application: Form 19
Wholesale Licence	Form 20B (general) + Form 21B (Schedule C/C1). Application: Form 19
Validity	Perpetual - retention fee every 5 years (Rule 63). Inspections every 3 years
Key Prerequisite	Registered Pharmacist (retail) or Competent Person (wholesale). Min area: 10/15 sq.m
Issuing Authority	SDLA for retail/wholesale; CDSCO for manufacturing/imports
Penalty (No Licence)	Section 27: Up to 3 years imprisonment + Rs 1 lakh fine

Content is reviewed quarterly for accuracy.

What Is a Drug License?

A drug license is a legal authorisation issued under the Drugs and Cosmetics Act, 1940 that permits an individual or entity to manufacture, sell, stock, or distribute pharmaceutical products in India. The Act defines 'drug' broadly to include all medicines, diagnostic substances, medical devices (as notified), and cosmetics.

Drug licensing operates at two levels. The Central Drugs Standard Control Organisation (CDSCO), headed by the DCGI, handles manufacturing licences, new drug approvals, and import licences. State Drug Licensing Authorities (SDLAs) handle retail and wholesale licences.

Without a valid drug license, any activity related to sale or manufacture of drugs is illegal and attracts criminal penalties including imprisonment up to 3 years and fine up to Rs 1 lakh (Section 27). The SUGAM Portal handles CDSCO applications while state portals handle retail/wholesale.

Key Terms for Drug License:

CDSCO: Central Drugs Standard Control Organisation - the national regulatory authority under Ministry of Health & Family Welfare. Approves new drugs, clinical trials, and manufacturing licences.

SDLA / State Drug Controller: Issues retail and wholesale drug licences at the state level through Drug Inspectors.

Schedule C and C1: Lists of biologicals, sera, vaccines, toxins, antigens, insulin, and antibiotics requiring separate Form 21/21B licensing and cold-chain storage.

Schedule M: Good Manufacturing Practices (GMP) requirements for drug manufacturing facilities.

Rule 63 (amended): Drug licences are now perpetual - valid unless suspended/cancelled. Retention fee (equal to grant fee) payable every 5 years. Inspections not less than once in 3 years.

D&C Act, 1940 Retail + Wholesale + Manufacturing

Who Needs a Drug License?

Retail Pharmacies and Medical Stores: Any shop selling medicines to consumers. Requires Form 20 (general) + Form 21 (Schedule C/C1). Registered pharmacist must be present during business hours.
Wholesale Drug Distributors: Selling drugs in bulk to retailers, hospitals, and stockists. Requires Form 20B + Form 21B. Competent person required.
Pharmaceutical Manufacturers: Manufacturing formulations, bulk drugs, or repackaging. Manufacturing licence from CDSCO with Schedule M (GMP) compliance.
Hospital Pharmacies: In-house pharmacies dispensing medicines to patients. Require retail drug licence.
Online Pharmacies and E-Pharmacies: Digital platforms selling medicines online. Must hold a valid drug licence in the state of operation.
Ayurvedic, Unani, Siddha, and Homeopathic Drug Sellers: Separate licence forms under AYUSH department (Form 20C/20D for homeopathic).

6 Drug License Services by Patron Accounting

Service	What We Do
Licence Type Assessment	Assessment of your business model (retail, wholesale, manufacturing, or combination) and determination of exact forms and authorities required.
Application Preparation and Filing	Complete Form 19/19A/19B preparation, document compilation, and online submission to the State Drug Control Department or CDSCO SUGAM portal.
Premises Compliance Advisory	Advice on minimum area (10 sq.m retail, 15 sq.m wholesale), cold storage setup, ventilation, and hygienic conditions to pass Drug Inspector inspection.
Pharmacist/Competent Person Coordination	Assistance identifying and onboarding a registered pharmacist (retail) or competent person (wholesale) with qualification documentation.
Drug Inspector Inspection Support	Pre-inspection preparation, document organisation, and representation during the Drug Inspector premises visit.
Licence Retention and Compliance	5-year retention fee management (Rule 63), compliance assessment preparation, stock register advisory, and additional category endorsement.

Our Process

7-Step Drug License Application Process

Patron Accounting handles the complete process - from licence type assessment to Drug Inspector inspection support and ongoing compliance management.

Step 1

Determine Licence Type

Identify which forms you need: Form 20/21 (retail), Form 20B/21B (wholesale), Form 20C/20D (homeopathic), Form 20F/20G (Schedule X), or manufacturing licence from CDSCO.

Correct type identified Forms determined

Type Selected01

Step 2

Arrange Prerequisites

Secure premises meeting minimum area (10 sq.m retail, 15 sq.m wholesale). Appoint registered pharmacist (retail) or competent person (wholesale). Register the business entity.

Premises ready Pharmacist appointed

Prerequisites Met02

Step 3

Prepare Documents

Compile identity proof, premises proof (rent/ownership), pharmacist certificates, appointment letter, affidavit of non-conviction, site plan/layout, and cold storage proof for Schedule C/C1.

All docs ready Cross-verified

Docs Ready03

Step 4

File Application Online

Submit Form 19 (or 19A/19B as applicable) on the State Drug Control portal with all documents and prescribed fee. Each state has its own portal.

Form 19 filed Fee paid

Filed04

Step 5

Drug Inspector Inspection

Inspector visits premises to verify: minimum area, hygiene, ventilation, storage, refrigerator/cold chain (Schedule C/C1), pharmacist presence, and correctness of declared facts.

Inspection passed Premises approved

Inspection Done05

Step 6

Licence Grant

Drug Controller issues the licence in prescribed form (Form 20/21/20B/21B etc.). The licence must be prominently displayed at the business premises.

Licence issued Displayed at premises

Licence Issued06

Step 7

Post-Grant Compliance

Maintain stock registers, sales records, expiry tracking, and purchase bills. Pay licence retention fee every 5 years (Rule 63). Cooperate with inspections (at least once in 3 years).

Retention fee tracked Compliance ongoing

Compliant07

Documents Required for Drug License

Application Form: Form 19 (retail/wholesale allopathic), Form 19A (restricted drugs), Form 19B (homeopathic)
Identity Proof: PAN/Aadhaar/Passport of proprietor/partners/directors
Business Constitution: Partnership deed / MOA & AOA / LLP Agreement / Proprietorship declaration
Premises Proof: Registered rent agreement or sale deed + electricity bill/property tax receipt
Site Plan: Layout showing premises area, storage area, dispensing area, and refrigerator location
Pharmacist/Competent Person: Pharmacy Council registration, degree/diploma, mark sheets, appointment letter, bio-data
Affidavit: Non-conviction declaration under the Drugs & Cosmetics Act, 1940
Cold Storage Proof: Refrigerator/cold chain documentation for Schedule C/C1 drugs

4 Common Drug License Challenges and Solutions

Challenge	Impact	How Patron Accounting Solves It
Premises Area Below Minimum	Drug Inspector rejects if premises below 10 sq.m (retail) or 15 sq.m (wholesale)	We advise on premises selection before application, ensuring compliance from day one with area and layout requirements.
Pharmacist Not Available Full-Time	Registered pharmacist must be present during all business hours for retail licences	We help structure pharmacist employment contracts and shifts to ensure full compliance during operating hours.
State Portal Technical Issues	Each state has a different online system with varying interfaces and requirements	Our team has experience across multiple state portals (Maharashtra, Delhi, Karnataka, Gujarat) and handles all submissions.
Schedule C/C1 Cold Chain Issues	Vaccines, sera, and insulin require temperature-controlled storage for inspection clearance	We provide cold chain setup advisory and documentation for Drug Inspector satisfaction before the premises visit.

Drug License Fees in 2026

Fee Component	Amount
Retail - Form 20 & 21 (Allopathic)	Rs 1,500 - Rs 3,000 (varies by state)
Wholesale - Form 20B & 21B (Allopathic)	Rs 3,000 - Rs 6,000 (varies by state)
Retail - Homeopathic (Form 20C)	Rs 250 - Rs 500
Schedule X - Retail (Form 20F)	Rs 600 - Rs 1,200 (additional to Form 20)
Schedule X - Wholesale (Form 20G)	Rs 1,200 - Rs 2,400 (additional to Form 20B)
Licence Retention Fee (every 5 years)	Equal to original grant fee (Rule 63)
Patron Accounting Professional Fees	Starting from INR 4,999 (Exl GST and Govt. Charges)

All fees and charges listed are indicative only and do not constitute a binding offer. Final amounts may vary depending on the volume of work and the complexity involved.

Professional service charges for drafting, filing, and representation are separate from the statutory fees. The exact fee depends on the complexity of the case, disputed amount, and number of hearings required. Contact us for a detailed quote.

Get a free Drug License consultation - Call +91 945 945 6700 or WhatsApp us. No-obligation assessment.

How Long Does Drug License Registration Take?

Stage	Estimated Timeline
Document Preparation	3-7 days
Application Filing	1-2 days
Drug Inspector Inspection	7-30 days after filing
Total: Maharashtra	~30 days
Total: Delhi	15-30 days
Overall Range	15-45 days (varies by state)

Important: Timeline varies significantly by state. Maharashtra typically takes 30 days; Delhi 15-30 days. The Drug Inspector inspection is the key variable. Patron Accounting's pre-inspection preparation ensures smooth first-visit clearance, avoiding delays from repeat inspections.

Key Benefits

5 Benefits of Professional Drug License Services

Licence Type Clarity

We identify the exact forms needed for your business model - retail, wholesale, manufacturing, or combination - avoiding wrong applications and re-filings.

Premises Compliance

Pre-application premises assessment ensures you pass the Drug Inspector's inspection on the first visit - area, ventilation, storage, and cold chain requirements.

Multi-State Experience

We handle drug licence applications across Maharashtra, Delhi, Karnataka, Gujarat, Tamil Nadu, and other states with their varying portals and procedures.

Pharmacist Network

We assist in connecting businesses with qualified registered pharmacists for retail licence compliance, including employment contract structuring.

Lifecycle Management

5-year retention fee tracking (Rule 63), compliance inspection preparation, additional category endorsements, and modification handling throughout the licence lifecycle.

Legal Compliance

Section 27 prescribes up to 3 years imprisonment and Rs 1 lakh fine. Section 27A: spurious drugs causing death attract minimum 10 years. Professional filing ensures full compliance.

Why 10,000+ Businesses Trust Patron Accounting

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Retail vs Wholesale vs Manufacturing Drug License

Parameter	Retail	Wholesale	Manufacturing
Licence Forms	Form 20 (general) + Form 21 (Sch C/C1)	Form 20B (general) + Form 21B (Sch C/C1)	Form 25/28 (varies by drug type)
Application Form	Form 19	Form 19	Form 24/27 (varies)
Authority	State Drug Controller	State Drug Controller	CDSCO + State
Personnel Required	Registered Pharmacist (during business hours)	Competent Person (grad + 1yr or undergrad + 4yr)	Approved Technical Staff + GMP
Minimum Area	10 sq.m	15 sq.m	As per Schedule M
Fee Range	Rs 1,500-3,000	Rs 3,000-6,000	Rs 5,000-25,000+

Related Business Registration Services

GST Registration - Mandatory for pharmacies and drug businesses above Rs 40 lakh turnover.
Private Limited Company Registration - For incorporating your pharmaceutical business.
Trademark Registration - Brand protection for your pharmacy or drug brand name.
Startup Registration - DPIIT recognition for pharma and healthtech startups.
GST Returns - Monthly/quarterly GST compliance for drug businesses.

Legal Framework for Drug Licensing in India

Primary Legislation: Drugs and Cosmetics Act, 1940 + Drugs and Cosmetics Rules, 1945 (as amended).

Key Provisions:

Section 18: Prohibits manufacture/sale without licence.
Section 27: Penalty - up to 3 years imprisonment + Rs 1 lakh fine. Repeat offence: up to 5 years.
Section 27A: Adulterated/spurious drugs - 3-5 years + Rs 1-3 lakh. Spurious causing death: minimum 10 years.
Rule 63 (G.S.R. 1337(E)): Licences now perpetual. Retention fee every 5 years. Inspections every 3 years.

Schedules: C/C1 (biologicals, cold storage), M (GMP manufacturing), X (narcotics/psychotropics).

Regulatory: CDSCO (national) + SDLAs (state). SUGAM Portal: cdscoonline.gov.in. ONDLS: statedrugs.gov.in.

Frequently Asked Questions - Drug License

Answers about drug license types, fees, validity, Form 20 vs Form 20B, pharmacist requirements, and application process.

Quick Answers

Q: Can I sell medicines without a drug license? A: No. Section 18 prohibits it. Penalty under Section 27: up to 3 years imprisonment + Rs 1 lakh fine.

Q: Separate licences for retail and wholesale? A: Yes. Form 20/21 (retail) and Form 20B/21B (wholesale) are separate licences with separate fees.

Q: Can I sell ayurvedic with allopathic licence? A: No. AYUSH drugs require separate licences under the AYUSH department.

Q: Is inspection mandatory? A: Yes. Drug Inspector inspects before licence grant and periodically (at least once in 3 years).

Operating Without a Drug License is a Criminal Offence

Section 27 of the Drugs & Cosmetics Act prescribes imprisonment up to 3 years and fine up to Rs 1 lakh for selling drugs without a licence. For spurious or adulterated drugs, penalties escalate to minimum 10 years imprisonment. The Drug Inspector can seal premises, seize stock, and initiate prosecution at any time.

E-pharmacy platforms now verify drug licence status digitally. Get your licence before commencing operations.

Action: Call +91 945 945 6700 or WhatsApp us for a free consultation.

Get Your Drug License with Expert CA Support

Drug licensing is a mandatory regulatory requirement for every entity in the pharmaceutical supply chain. Governed by the Drugs and Cosmetics Act, 1940, licences are now perpetual under amended Rule 63, subject to a 5-year retention fee.

Patron Accounting provides end-to-end services - licence type assessment, application preparation, premises advisory, pharmacist coordination, Drug Inspector inspection support, and lifecycle management.

15+ years of practice. 10,000+ businesses served. Offices in Pune, Mumbai, Delhi, and Gurugram. Starting from Rs 4,999. Contact us for a free consultation.

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Drug License Services Across India

Expert drug license registration for pharmacies, wholesale distributors, and manufacturers with local CA support.

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Content Created: 10 March 2026 | Last Updated: 10 March 2026 | Next Review: 10 September 2026 | Reviewed By: CA & CS Team, Patron Accounting LLP

This page is reviewed every 6 months. Content aligned with the Drugs & Cosmetics Act, 1940, Rules 1945 (amended), CDSCO guidelines, and state Drug Control procedures. Next review: September 2026.

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