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Hisho & Kanri
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We provide accounting, compliance,
and advisory services.

Drug License

Sell, stock, or manufacture medicines legally, from day one.

A Drug License is the statutory authorization issued by the Central and State Drug Control Authorities that permits a business to sell, stock, distribute, or manufacture drugs and pharmaceutical products. It's what separates a pharmacy, wholesaler, or drug manufacturing unit from an unauthorised operation — and it's mandatory under the Drugs and Cosmetics Act, 1940, before any medicine changes hands commercially.

Held correctly, it opens the door to retail counters, wholesale distribution, hospital supply contracts, and manufacturing units alike. Operating without one — or letting an existing one lapse — invites heavy penalties, seizure of stock, and even criminal liability, which is why most applicants prefer to have a licensing specialist manage the premises inspection, documentation, and approval process end to end.

Talk to a Licensing Expert Compare License Types
0Licenses Facilitated
0States & UTs Covered
0Avg. Turnaround
0Inspection Pass Rate
Verified
Drug License
Retail & Wholesale Pharmacy Authorization
License FormForm 20 / 21
Issuing AuthorityState Drug Control
StatusActive
Apply Inspect Approve Issue
License Categories

Which drug license does your business need?

The right license depends on whether you sell, distribute, store, manufacture, or import pharmaceutical products. Here's the full lineup we help applicants secure, at a glance.

Retail Drug License

Required to operate a pharmacy or medical store selling medicines directly to consumers, issued under Form 20 and 21.

Most Popular

Wholesale Drug License

Permits bulk sale and distribution of drugs to retailers, hospitals, and other wholesalers, issued under Form 20B and 21B.

Manufacturing License

Authorizes production of allopathic, ayurvedic, or cosmetic formulations at a registered manufacturing facility meeting GMP standards.

Loan License

Lets a business manufacture drugs using another licensed manufacturer's facility and approved premises, without owning a plant.

Restricted Drug License

Covers Schedule H, H1, and X substances requiring extra storage, record-keeping, and dispensing controls due to higher regulatory risk.

Import Drug License

Authorizes import of drugs and medical devices into the country, issued by the Central Licensing Authority under Form 10.

Repacking & Loan License

Covers businesses that repack or relabel bulk drugs into smaller retail-ready packaging under an approved license.

Multi-State & Chain License

For pharmacy chains and distributors operating across multiple states, each outlet requiring its own state-specific approval.

The Process

From application to approval, in eight steps

Here's exactly what happens between deciding to apply and holding an active Drug License in hand.

1

Choose License Category

We help you determine whether you need a retail, wholesale, manufacturing, or restricted-drug license based on your business activity.

2

Premises Assessment

We verify your storage area, cold-chain setup, and layout meet the minimum space and refrigeration norms set by the drug control authority.

3

Document Collection

Pharmacist credentials, premises proof, and identity documents are gathered and verified from the applicant ahead of filing.

4

Registered Pharmacist Appointment

A qualified pharmacist or competent technical staff member is appointed and registered against the premises, as mandated by law.

5

Application Filing

The complete Form 19/20/21 application, fee, and supporting documents are filed electronically with the State or Central Drug Control Authority.

6

Drug Inspector Site Visit

A drug inspector visits the premises to verify storage conditions, staffing, and compliance with the Drugs and Cosmetics Rules.

7

License Approval & Issuance

Once the inspection is cleared, the authority issues your Drug License certificate — the legal proof you can now trade or manufacture.

8

Renewal Tracking Setup

We set up renewal reminders and record-keeping systems so your license stays valid well ahead of its expiry date.

Eligibility

Who can apply for a Drug License?

Requirements vary slightly by license type and state, but most applications share the same baseline criteria set out under the Drugs and Cosmetics Rules.

Registered Pharmacist on Record

A qualified pharmacist or competent person registered with the State Pharmacy Council must be attached to the premises.

Minimum Premises Area

A dedicated retail or wholesale area of at least 10–15 sq. m., separate from residential or unrelated commercial use.

Cold Storage Facility

A working refrigerator or cold-chain unit for temperature-sensitive drugs, vaccines, and biologicals.

Valid Identity & Address Proof

Government-issued ID and address proof for the applicant and every partner or director involved in the business.

No Prior Disqualification

Applicants must have no history of license cancellation, drug-law conviction, or pending regulatory action.

Lawful Business Premises

The proposed premises must be legally occupied — owned or rented — with clear site and key plans submitted.

Paperwork

Documents you'll need to keep handy

Gathering these upfront is the single biggest thing you can do to speed up your license approval and pass the inspection on the first visit.

Pharmacist Certificate

Registration proof of the qualified pharmacist

Identity Proof

Aadhaar, PAN, or voter ID of the applicant

Premises Proof

Ownership deed or registered rent agreement

Site & Key Plan

Layout diagram of the storage premises

Cold Storage Proof

Refrigerator purchase bill or photograph

Constitution Documents

Partnership deed, MOA/AOA, or proprietorship proof

Affidavit

Declaration of compliance with drug rules

NOC

From property owner, if applicable

Why It's Worth It

What a Drug License actually buys you

Beyond the legal formality, licensing changes what your pharmacy or pharma business can do and how protected it is while doing it.

Legal Authorization

Sell, stock, or manufacture drugs without risk of seizure

Business Credibility

Patients and doctors trust a licensed pharmacy faster

Access to Govt. Tenders

Eligible to bid for hospital and institutional supply contracts

Multi-Outlet Expansion

Open additional branches and chains under one compliant framework

Consumer Trust

A visible license builds confidence in product authenticity

Penalty Protection

Avoid fines, prosecution, or closure under drug law violations

Import/Export Eligibility

Unlocks pathways to trade pharmaceutical products globally

Brand Reputation

A licensed, compliant operation builds long-term recognition

After Licensing

Staying compliant, year after year

Getting the license is the start, not the finish — here's what keeps it in good standing afterward.

Timely License Renewal

Renewal application filed before expiry to avoid lapse, penalties, or forced closure.

Storage Condition Compliance

Cold-chain temperatures and storage layout maintained as approved during inspection.

Statutory Register Maintenance

Purchase, sale, and Schedule H/X registers kept accurate and audit-ready at all times.

Pharmacist Availability

A registered pharmacist present during business hours as mandated by the license conditions.

Periodic Inspections

Cooperation with routine and surprise inspections by drug control officials.

Adverse Event Reporting

Timely reporting of expired stock, recalls, or adverse drug reactions where applicable.

Why Hisho & Kanri

Licensing handled by people who do this daily

We've guided enough pharmacies, distributors, and manufacturers through drug licensing across India to know exactly where inspections usually go wrong — and how to avoid it.

Regulatory Specialists

Consultants who track drug control requirements and file applications every week.

Fast Processing

Documents reviewed and filed without the back-and-forth delays.

Affordable Pricing

Transparent packages with no hidden government-fee surprises.

Inspection Readiness

We prep your premises and paperwork so the drug inspector's visit goes smoothly.

Dedicated Support

One point of contact from your first call through license issuance and renewal.

Secure Documentation

Your identity and business documents handled under strict confidentiality.

FAQ

Common questions about Drug License

Can't find your question here? Use the form alongside this page and we'll answer it directly.

It's a statutory permit issued under the Drugs and Cosmetics Act, 1940, that authorizes a business to sell, stock, distribute, or manufacture drugs legally.

It depends on your business activity — retail, wholesale, manufacturing, or import — our experts assess this with you before recommending a category.

Yes, a retail or wholesale license requires a qualified, registered pharmacist or competent person to be attached to the premises at all times.

Typically around 15 working days once documents and premises are in order, though it can vary by state and inspection scheduling.

Pharmacist certificate, premises proof, identity proof, and site plan are the core set — see the Documents section above for the full list.

Yes, a drug inspector visits the premises to verify storage conditions, staffing, and layout before any license is approved.

No, each premises needs its own license — chains and multi-city operators must apply separately for every outlet or warehouse.

Most drug licenses remain valid indefinitely once granted, subject to periodic fee payment and continued compliance — we can confirm your state's rule.

It can lead to stock seizure, heavy fines, and prosecution under the Drugs and Cosmetics Act — see the Compliance section above for ongoing obligations.

Because we handle licensing daily across multiple states, keep you informed at every filing stage, and stay on for compliance long after approval is done.