Quick answer
A drug licence lets you sell, stock or make medicines under the Drugs and Cosmetics Act, 1940. Retail and wholesale licences are granted by the state drug control authority, and a registered pharmacist is needed for most retail sales. Imports and some cosmetics need CDSCO registration. Fees and processes differ by state.
Also searched as: pharmacy license · medical store license
Overview
What you need to know about Drug License & Cosmetic License in India
Drugs are regulated under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. Cosmetics are also governed by the Act, with licensing requirements primarily under the Cosmetics Rules, 2020.
Retail drug licences commonly include Forms 20 and 21, while corresponding wholesale categories commonly use Forms 20B and 21B. The required combination depends on the products; Schedule X and other specialised categories require separate consideration.
State drug licensing authorities generally handle retail, wholesale and many manufacturing licences. CDSCO handles central functions such as drug imports, new drug approvals and specified manufacturing categories; cosmetic imports follow the central registration route, while cosmetic manufacturing is generally state-licensed.
Is this for you?
Who needs this and when
Anyone who wants to run a pharmacy, a medical store or a wholesale drug business, or to manufacture medicines, needs a licence from the state licensing authority. A retail licence usually needs a qualified, registered pharmacist, suitable premises and storage facilities such as a refrigerator. Wholesale licences need a competent person and proper storage conditions.
Cosmetics are regulated too. Importing cosmetics needs registration with the Central Drugs Standard Control Organisation (CDSCO), and manufacturing cosmetics needs a licence from the state authority. Online sellers of medicines also face extra scrutiny. The rules for premises size, fees and forms differ across states, so check with your state drug controller before you sign a lease.
Benefits
What you get with LawLine
- Drug versus cosmetic regulatory classification
- Retail, wholesale and manufacturing route assessment
- Premises and storage requirement review
- Pharmacist or competent-person eligibility checks
- Application and inspection preparation
- Licence condition and retention-fee guidance
Process
Step-by-step: how it works
- 1Classify the ActivityDetermine product categories, business activity and the competent state or central authority.
- 2Review Premises and PersonnelCheck space, storage and pharmacist or technical-person eligibility.
- 3Prepare and SubmitCompile the applicable forms, supporting documents and statutory payments.
- 4Support Inspection and QueriesAssist with documentary responses and inspection preparation without guaranteeing approval.
- 5Explain Ongoing ConditionsReview the issued licence scope, staffing duties and applicable retention or renewal requirements.
Documents required
Clear scans or phone photos are enough to get started.
- Entity PAN and constitution documents
- Proprietor, partner or director identification
- Premises ownership or lease documents and layout
- Registered pharmacist credentials for retail pharmacy, as applicable
- Competent-person qualifications and experience for wholesale
- Storage, refrigeration and equipment details
- Product categories and proposed activity details
- Authorisations, declarations and technical documents required for the licence
Pricing
Cost breakdown
| Item | Amount | What it means |
|---|---|---|
| Government licence fee | Varies by state | It is set by the Drugs Rules and state notifications, and differs for retail, wholesale and manufacture. |
| LawLine retail or wholesale licence service | ₹7,999 onwards | Covers the application, document check and inspection follow-up. |
| Cosmetic manufacturing or import registration | ₹14,999 onwards | Government fees for CDSCO and state processes are charged separately. |
| Pharmacist, premises and equipment | Varies | The cost depends on salary, rent and the storage equipment required. |
| Retention fee or renewal | Varies by state | Licences are now generally valid until cancelled, subject to a periodic retention fee. Check your state. |
Statutory fees, inspection charges and testing costs depend on the licence category and competent authority and are separate from professional fees.
Timeline
How long it takes
Premises, pharmacist and document readiness
1–3 weeks
Application filing with the drug controller
1–3 days
Inspection by the drugs inspector
1–4 weeks
Query reply and approval
Varies by state
Licence issued
Often 3–8 weeks overall
Avoid delays
Common mistakes to avoid
- Taking premises that do not meet the minimum area or storage rules. An inspector can reject the application after you have already paid the rent.
- Using a pharmacist’s registration without their real involvement. The pharmacist must be present, and misuse can lead to suspension or cancellation of the licence.
- Starting sales before the licence is granted. Selling drugs without a licence is an offence under the Act.
- Not keeping records of purchase bills, batch numbers and expiry dates. Inspectors check these, and gaps may lead to action.
- Assuming a cosmetics business needs no licence. Manufacture and import of cosmetics are regulated, so check the rules before you launch.
State directory
State-specific rules
Food & Drug Administration (FDA) Maharashtra, Bandra Kurla Complex, Mumbai
Est. govt fee: ₹3,000 - ₹5,000 per application (Form 20 & 21)
Validity: Perpetual with 5-year retention fee payment
Drugs Control Department, Govt of NCT of Delhi, Karkardooma
Est. govt fee: ₹3,000 (Retail) / ₹3,000 (Wholesale)
Validity: Perpetual with periodic retention
Drugs Control Department, Palace Road, Bengaluru
Est. govt fee: ₹3,000 - ₹6,000
Validity: 5 Years with renewal
Next steps
After it’s done: staying compliant
Once the licence is issued, display it in the shop and keep the pharmacist’s registration certificate available. Buy only from licensed suppliers, keep every purchase and sales invoice, and maintain a prescription register where the rules require one. Store medicines properly and remove expired stock. Inspectors can visit without notice, so records must always be current.
Pay any retention fee on time and tell the authority when you change premises, partners or the pharmacist. Register for GST and, where relevant, other local licences. If you want to sell or make additional categories of products, check whether an amendment or new licence is needed.
FAQs
Frequently asked questions
Are Forms 20 and 21 wholesale licences?
No. They are commonly used for specified retail drug categories. Forms 20B and 21B are the corresponding common wholesale categories. The exact forms depend on the products and applicable rules.
Do I need a registered pharmacist?
A retail pharmacy ordinarily requires a registered pharmacist for prescription dispensing. Wholesale licensing uses prescribed competent-person requirements, which can include qualifying education and experience rather than pharmacist registration in every case.
Does CDSCO issue every manufacturing licence?
No. State licensing authorities issue many manufacturing licences. CDSCO has central responsibilities for imports, new drugs and specified products or approval categories, so the route must be assessed product by product.
Do cosmetics use the same licensing forms as retail medicines?
No. Cosmetics follow the Cosmetics Rules, 2020 and their prescribed forms. Domestic manufacturing and imports have different licensing or registration routes; retail drug sale forms should not be used as a substitute.
What commonly causes a refusal or delay?
Unsuitable premises, inadequate storage, missing technical staff credentials, incorrect product classification or incomplete documents can delay approval. Inspection deficiencies must be addressed before the authority decides the application.
Can I start selling before approval, and what does the fee cover?
Do not undertake an activity requiring a licence before obtaining it. Unlicensed drug activities can attract serious penalties. The indicative professional fee covers only the agreed application scope, not government fees, premises work, testing or technical staff costs.
Key takeaways
- Drug licences come from the state authority under the Drugs and Cosmetics Act, 1940.
- Retail sale generally needs a registered pharmacist and suitable premises.
- Cosmetic imports need CDSCO registration, and manufacture needs a state licence.
- Fees and procedures vary by state.
- Selling without a licence is a punishable offence.
Official sources & government portals
- CDSCO
- India Code – Drugs and Cosmetics Act
- National Single Window System
- FSSAI FoSCoS Portal
- Directorate General of Foreign Trade
This guide is general information, not legal advice for your situation. Laws and fees change; confirm with an expert before acting.
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