A drug licence is the permission issued by the State Drugs Controller under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945 to sell, stock or distribute drugs, whether as a retail chemist or as a wholesaler. You apply on Form 19 and receive a licence on Form 20, 21, 20B or 21B depending on the type of drugs and the kind of sale. This page explains the forms, premises and pharmacist requirements, the fee and retention structure, and how the process works in Delhi, Uttar Pradesh and Haryana.
What is a drug licence?
India regulates drugs at two levels. The Central Drugs Standard Control Organisation (CDSCO) handles imports, new drugs, clinical trials and certain categories, while the State licensing authorities license the manufacture for sale, the sale and the distribution of drugs within the State. For a pharmacy or a distributor, the licence that matters is the State sale licence.
The Drugs Rules distinguish licences by the nature of the drugs and the kind of sale. Forms 20 and 21 are retail licences, 20B and 21B are wholesale licences, and the 'B' forms cover distribution to other dealers, hospitals and institutions. Forms 20 and 20B cover drugs other than those in Schedules C, C(1) and X, and Forms 21 and 21B cover drugs in Schedules C and C(1), which include vaccines, sera and other biological products. Schedule X drugs, which are psychotropic substances with additional controls, need their own licence forms. Restricted licences on Forms 20A and 21A allow general stores in areas without a chemist to sell a limited range of drugs.
All of these are applied for on Form 19. Most pharmacies apply for a combined set of Forms 20 and 21 so that they can stock both ordinary medicines and the Schedule C and C(1) products such as insulin and vaccines. Many applicants also take a wholesale licence along with retail if they sell to other dealers.
A licence granted under the Rules does not have an expiry date. Renewal was abolished by a 2017 amendment to the Drugs Rules, and the licence remains in force provided a retention fee is paid every five years from the date of grant and the conditions of the licence are met. Missing the retention fee for too long leads to cancellation, after which you must apply afresh.
Who needs a drug licence?
Anyone who sells, stocks for sale or distributes drugs in India needs a licence from the State licensing authority for that premises. Typical applicants include:
- Retail chemists and medical shops selling allopathic medicines to the public
- Wholesale distributors and stockists supplying to retailers, hospitals and institutions
- Hospital and nursing home pharmacies selling to patients, where the law requires a licence
- Online pharmacy operators and aggregators who hold stock or whose partner chemists must be licensed, noting that India has no separate e-pharmacy licence regime in force yet
- General stores in areas where a restricted licence is permitted for a limited list of drugs
- Sellers of homoeopathic medicines, who need the forms for homoeopathic sale licences
- Businesses dealing in Schedule X drugs, who need the additional licence forms
Benefits of Drug Licence (Retail and Wholesale)
Lawful sale of medicines
Selling drugs without a licence is a criminal offence under the Act. A valid licence lets you operate openly with wholesalers, manufacturers and insurers.
Access to suppliers and distributors
Manufacturers, super-stockists and distributors will supply only to licensed dealers. They ask for a copy of your licence and your GST registration before opening your account.
Insurance and hospital empanelment
Health insurers, TPAs, hospitals and government schemes expect a licensed chemist for tie-ups and for reimbursement of medicine claims.
No annual renewal burden
Because renewal has been replaced by a five-yearly retention fee, the licence is administratively lighter than many other State licences.
Foundation for related approvals
A drug licence is the starting point for GST registration of a pharmacy, bank and lender relationships, and, where relevant, for Schedule X or additional business lines.
Eligibility, premises and qualified person
The rules focus on the premises and the technical person responsible for sale. These are checked at inspection, and most rejections relate to them.
- Premises of a minimum area under Rule 64: 10 square metres for retail only or for wholesale only, and 15 square metres where retail and wholesale are carried on together
- Premises that are independent, adequately lit and ventilated, with arrangements for storing drugs, including a refrigerator for temperature-sensitive products
- Delhi prescribes a minimum clear height and expects the premises to be in a permitted commercial use, with conversion charges paid for residential plots
- Retail licence: a registered pharmacist, registered with the State Pharmacy Council, who personally supervises the dispensing of drugs
- Wholesale licence: a competent person, such as a registered pharmacist, or a graduate or matriculate with the prescribed period of experience in dealing in drugs
- Constitution of the applicant clearly defined: proprietor, partnership, LLP or company, with a person responsible for the conduct of the business
- No conviction of the applicant under the Drugs and Cosmetics Act, to be affirmed by affidavit
Documents required
Applicant and constitution documents
- System-generated application on Form 19 with the fee receipt
- Photo identity and address proof of the proprietor, partners or directors
- Partnership deed, LLP agreement, or memorandum and articles with a board resolution for companies
- Affidavit of non-conviction under the Drugs and Cosmetics Act, 1940
- PAN of the business and GST registration, where available
Premises documents
- Sale deed, registered rent agreement or lease deed, with ownership proof of the landlord for rented premises
- Site plan and key plan showing area, dimensions and layout
- Electricity, water or property tax bill as address proof
- Proof of commercial use, such as conversion or mixed-use charge receipts where applicable
- Photographs, including geotagged photos where the State requires them
Pharmacist or competent person documents
- Educational qualification certificate of the registered pharmacist or competent person
- Registration certificate from the State Pharmacy Council for the pharmacist
- Appointment letter and bio-data of the technical person, and experience certificate for a competent person
- Affidavit or declaration from the pharmacist or competent person accepting the role
- Identity proof and photograph of the technical person
Step-by-step drug licence process
The sequence below reflects the common steps in the three States. Delhi's published guidelines require online submission and physical inspection with originals, and UP and Haryana have their own portals and payment methods.
Decide the licence type
Decide whether you need retail, wholesale or both, and whether you will deal in Schedule C, C(1) and Schedule X drugs, since this decides the forms and the premises area. Most medical shops apply for Forms 20 and 21 together.
Arrange premises and the technical person
Secure premises that meet the area rule and local land use, fit it out with racks, a refrigerator and signage, and appoint a registered pharmacist or competent person before applying, not after.
Register on the State portal
Create a login on the State drug licensing portal, such as the Delhi portal where you request a user ID and password with firm details, or the UP and Haryana portals. Use the proprietor's or authorised signatory's details.
Fill in Form 19 and upload documents
Complete the form exactly, upload documents in the specified size and format and pay the fee through the portal or the State treasury challan route. An incomplete or unsent application may not be received, and fees can be forfeited on rejection for incomplete information.
Submit and respond to queries
Submit the application and watch the portal and your email for queries from the licensing authority. Respond within the time allowed, with supporting documents.
Inspection of premises
A Drugs Control Officer or Drugs Inspector visits to check area, storage, refrigeration, the pharmacist's presence and the documents against the application. Keep originals, the pharmacist and the owner available.
Grant of licence
After a favourable report, the licensing authority grants the licence. In Delhi you receive a message and print the licence from the portal. Display it at the premises and note the date of grant for the five-year retention fee.
Set up compliance routines
Start purchase and sale records, prescription records for scheduled drugs and the register for Schedule H1 and X drugs, and diarise the retention fee date.
Government fees for a drug licence
Licence fees are fixed centrally in the Drugs Rules, while States add portal or service charges. The figures below are those reported for sale licences and should be checked against the current Rules and your State portal at the time of payment.
| Item | Amount | Note |
|---|---|---|
| Forms 20, 21, 20B and 21B (retail and wholesale licences) | ₹1,500 each | Statutory licence fee as reported; no inspection fee is charged for a sale licence |
| Restricted licences (Forms 20A, 21A) and Schedule X forms | ₹500 | Reported figure; confirm in the Rules |
| Duplicate licence | ₹150 | Reported figure |
| Retention fee | Equal to the licence fee, every five years | Delay is charged at 2% of the fee per month, with a grace limit of six months, after which the licence is cancelled |
| State portal or treasury charges | Varies by State | Added on top of the statutory fee, e.g. via treasury challan in Haryana |
Professional charges are quoted separately after reviewing your case. Government fees are paid directly to the authority. We re-check each fee against the current Drugs Rules and State notification before you pay.
How long does a drug licence take?
State citizen's charters provide for a decision in roughly 30 to 35 days from a complete application, with Delhi and Haryana publishing their own service periods. In practice, the actual time depends on the inspection date, queries on premises and the pharmacist's documents, and whether the premises is ready. Do not stock or sell before you hold the licence.
| Stage | Typical time |
|---|---|
| Premises ready and documents prepared | 1–2 weeks, depending on fit-out |
| Online application and fee payment | 1–2 working days |
| Scrutiny, queries and inspection | Around 2–4 weeks; not fixed |
| Grant of licence | Within the State's notified service period after a favourable inspection |
Validity, retention fee and changes
Since the amendment notified as G.S.R. 1337(E) on 27 October 2017, drug sale licences do not carry an expiry date. Instead, a retention fee equal to the grant fee is payable every five years from the date of grant. If you pay late, a fee of 2% per month applies, and the grace period is capped at six months, after which the licence is cancelled and a fresh Form 19 is needed. A change in the proprietor, partners or directors is treated as a change in constitution and generally needs a fresh licence or approval. A change of pharmacist, premises or the addition of a new category is handled through the corresponding application on the State portal.
Compliance after you get the licence
- Keep the registered pharmacist present whenever drugs are sold, and inform the authority if the pharmacist changes
- Display the licence at a conspicuous place in the premises
- Sell prescription drugs only against a valid prescription and maintain the prescription register as required for Schedule H, H1 and X drugs
- Maintain purchase and sale records with batch numbers and supplier invoices, and retain them for the period the Rules require
- Store drugs under the labelled temperature conditions, use a refrigerator for cold-chain products and keep expired stock separate
- Display the pharmacovigilance QR code as required by the CDSCO circular of November 2025, and follow any labelling or QR code requirements for scheduled drugs as they come into force
- Pay the retention fee every five years and report any change in constitution, premises or technical person to the authority
Retail vs wholesale drug licence
| Point | Retail (Forms 20 and 21) | Wholesale (Forms 20B and 21B) |
|---|---|---|
| Sells to | Patients and consumers on prescription or over the counter | Retailers, hospitals and other dealers |
| Technical person | Registered pharmacist who supervises sales | Competent person: pharmacist, or a graduate or matriculate with experience |
| Minimum area | 10 sq m (15 sq m if combined with wholesale) | 10 sq m (15 sq m if combined with retail) |
| Schedule C and C(1) drugs | Form 21 | Form 21B |
| Reported licence fee | ₹1,500 per form | ₹1,500 per form |
Common mistakes and rejection reasons
Pharmacist appointed on paper only
Inspectors check whether the pharmacist actually works there. A pharmacist registered in another State or already named in another licence is a frequent cause of rejection.
Premises below the minimum area or poorly laid out
The 10 or 15 square metre rule is checked against the site plan and the actual shop. Include only usable area and show the storage and refrigerator.
Residential premises without conversion
In Delhi, residential plots used commercially need conversion or mixed-use charges paid. UP is reported to have barred drug stores in residential buildings, so confirm the current rule.
Wrong forms for the drugs you plan to sell
Applying only for Form 20 and later wanting to stock insulin or vaccines means a second application for Form 21. Decide your range beforehand.
Incomplete or unsent online application
Delhi's guidance warns that an application that is not e-sent is not received, and fees are forfeited if it is rejected for incomplete information.
Missing the retention fee
Because there is no expiry date, owners forget the five-year fee. After the grace period, the licence is cancelled and you must apply again.
Change in partners or directors without approval
A change in constitution is treated as a fresh licence event. Continuing to trade on the old licence after such a change is a breach.
Penalties for non-compliance
The Drugs and Cosmetics Act treats sale without a valid licence as a serious offence. Section 27(b)(ii) of the Act provides imprisonment for a term that may extend to five years, with a minimum term, together with fine. Reports on the Jan Vishwas (Amendment of Provisions) Act, 2026 indicate that adjudication with show cause and appeal has been introduced for certain lesser provisions, but the penalties for sale without a licence were not decriminalised. Because the exact fine amounts and recent amendments need verification against the Act text, we do not list figures here.
| Default | Consequence | Provision |
|---|---|---|
| Sale or stocking of drugs without a valid licence | Imprisonment, with a minimum term as provided, and fine | Section 27(b)(ii), Drugs and Cosmetics Act, 1940 |
Practitioner tips
- Confirm the pharmacist's registration with the State Pharmacy Council before you sign the appointment. A lapsed or other-State registration is the single most common reason for a stalled application.
- Measure the shop yourself and mark the usable area on the site plan. An inspector who finds the area short of the rule rejects the file, regardless of how complete the papers are.
- Place the refrigerator and rack layout in the plan and photographs. Inspectors look for cold-chain storage for the Schedule C range and for separate storage of expired or returned stock.
- Apply for both Form 20 and Form 21 at the start if there is any chance you will stock insulin, vaccines or other biological drugs. Adding the second form later is another application cycle.
- Write the date of grant on your compliance calendar and set a reminder for the retention fee four and a half years later. Licences are cancelled when it is missed beyond the grace period.
How Lawgical Guru helps
Licence type and forms advice
We help you decide between retail, wholesale or both, and whether Schedule C, C(1) or X forms are needed for your product range.
Premises and pharmacist readiness check
We review your premises documents, area and layout, and the pharmacist's registration, so that the application matches what the inspector will see.
Portal filing
We prepare Form 19 and the document set, and file on the Delhi, UP or Haryana portal, with the fee payment route followed correctly.
Query and inspection support
We help you respond to queries from the drugs control office and prepare an inspection checklist.
Changes and retention
We handle change of pharmacist, premises or constitution applications and track the five-year retention fee.
Related approvals
We coordinate GST registration, trade licence, shop and establishment registration and, where relevant, a cosmetic licence or medical device registration.
Drug Licence (Retail and Wholesale): frequently asked questions
Which form is used to apply for a drug licence?
Applications for retail and wholesale sale licences are made on Form 19. The licence is then granted on Form 20 or 21 for retail, and Form 20B or 21B for wholesale, depending on whether the drugs are in Schedules C and C(1) or outside them. Restricted licences use Forms 20A and 21A.
Is a registered pharmacist compulsory for a medical shop?
Yes, for a retail licence the sale must be supervised by a registered pharmacist who is registered with the State Pharmacy Council and works at the premises. Wholesale licences require a competent person, which may be a pharmacist, or a graduate or matriculate with the prescribed experience.
What is the minimum area required for a drug licence?
Under the Drugs Rules, the premises should be at least 10 square metres for a retail-only or wholesale-only licence and 15 square metres if both retail and wholesale are carried on together. States add requirements, such as a minimum clear height in Delhi, and the premises must be independent and adequate.
What is the fee for a drug licence?
The statutory fee reported for Forms 20, 21, 20B and 21B is ₹1,500 each, with lower amounts for restricted and Schedule X forms, plus any State portal charges. A retention fee equal to the grant fee is due every five years. Please verify the current figure on the State portal before payment.
Does a drug licence have to be renewed every year?
No. Renewal was abolished by G.S.R. 1337(E) of 27 October 2017, and the licence has no expiry date. Instead, a retention fee equal to the grant fee is paid every five years from the date of grant. Late payment attracts 2% a month, and the licence is cancelled after the six month grace period.
How do I apply for a drug licence in Delhi?
Apply through the Delhi Department of Drugs Control's online system. Request a user ID with the firm's details, upload scanned documents, fill in the application and e-send it, pay the fee online and then present originals at inspection. Approved licences are printed from the portal, and the Delhi guidelines mention a timeline of about 35 days.
Can I run a medical store from a residential building?
It depends on the State and the local land use. In Delhi, the premises must be in permitted commercial use with conversion charges paid for residential plots. Uttar Pradesh is reported to have restricted drug stores in residential buildings from late 2025, so confirm the current rule with the State drugs authority before taking premises.
Do I need a separate licence for wholesale and retail?
Yes. Retail and wholesale are separate licences, though one premises can hold both if it meets the larger area and staffing conditions. Many businesses take Forms 20 and 21 for retail and Forms 20B and 21B for wholesale together, subject to the 15 square metre rule for combined activity.
What happens if I sell medicines without a licence?
Sale of drugs without a licence is an offence under section 27(b)(ii) of the Drugs and Cosmetics Act, 1940, punishable with imprisonment and fine, and the stock can be seized. Reports on the Jan Vishwas Act 2026 state this offence was not decriminalised. Apply before you stock or sell.
Can I change the pharmacist or shift my shop after getting the licence?
Yes, but only with the licensing authority's approval. A change of pharmacist or competent person, a change of premises or the addition of premises is handled through a specific application on the State portal with the new documents. A change in proprietor, partners or directors is treated as a change in constitution and may need a fresh licence.
Reviewed by Satyam Gupta, Company Secretary (CS) & Advocate
8+ years of industry experience. This page was last reviewed on 16 October 2026 against the official sources below. Rules and fees change — confirm on the official portal before you apply.