Drug & Cosmetics licensing, mapped before filing
Identify the product, activity, premises and competent authority before preparing a manufacture, sale or import application.
- Professional fee
- Written quote
- Working timeline
- Confirmed after product, activity, premises and authority mapping
- Government charges
- Shown before payment
Built for
Pharma, pharmacy and cosmetics businesses
Best when
Products and premises are defined
What will the business
do with the product?
Manufacture, wholesale, retail and import are separate regulatory activities.
Manufacture
Own-facility and loan-manufacture routes depend on product, plant, technical staff and quality controls.
Retail or wholesale
Sale licences depend on premises, storage and a pharmacist or competent person as applicable.
Import
Foreign manufacturer, Indian agent, site and product permissions can involve central review.
Cosmetics
Cosmetics manufacture and import follow distinct pathways rather than a generic pharmacy licence.
Drug & Cosmetics Licence
Right product. Right activity. Right authority.
A “drug licence” is not one universal approval.
Forms, authorities, technical people, premises and product evidence change by activity and category. Central and state permissions are not interchangeable.
What you receive,
ready to use.
We distinguish manufacture, loan manufacture, retail, wholesale and import pathways, then map the competent authority, technical people, facility and product evidence.
properly scoped.MAKE · SELL · IMPORT
Product and activity classification
Central versus state authority map
Premises, storage and technical-person readiness
Application and inspection evidence plan
Licence, retention, amendment and record calendar
What must be
in place.
An eligible applicant entity with a defined activity and premises.
Product classification and schedules identified under the current Drugs and Cosmetics framework.
Required pharmacist, competent person, technical staff or manufacturing experts for the selected licence.
Premises, equipment and storage—including refrigeration or cold chain where applicable—meeting the route's conditions.
Product permissions, test evidence and manufacturing or import records required for the category.
Premises and qualified-person readiness should be assessed before a lease, facility build or non-refundable filing cost is committed.
Choose by activity and product
The same product can require different permissions at different supply-chain stages.
| Decision | Manufacture | Sale | Import |
|---|---|---|---|
| Applicant | Manufacturer or loan licensee | Retailer or wholesaler | Indian importer or authorised agent |
| Core readiness | Plant, staff and quality controls | Premises, storage and qualified person | Foreign site and product evidence |
| Authority | State / central by category | Usually state authority | Central route for applicable products |
From product classification to
inspection-ready operations.
Product schedule, commercial role and premises determine the competent authority and application path.
Product and activity map
Step 1
We handle
Classify products and distinguish manufacture, sale, distribution, import or cosmetics activity.
You provide
Share labels, composition, dosage form, intended claims, supply chain and premises.
Authority and form
Step 2
We handle
Identify central, state or linked approvals and the applicable licence form.
You provide
Confirm state, sites, manufacturer or importer role and product ownership.
Readiness review
Category specific
We handle
Check premises, storage, equipment, technical staff and document gaps.
You provide
Appoint qualified people and complete necessary facility or cold-chain arrangements.
Filing and inspection
Authority controlled
We handle
Prepare the application and coordinate factual queries, product evidence and inspection readiness.
You provide
Authenticate, pay official charges and make premises, people and originals available.
Licensed operations
After grant
We handle
Map display, records, retention, changes and product-specific duties.
You provide
Operate only within approved products, activities and premises.
A checklist without
the back-and-forth.
We ask only for records or data relevant to your application, review, or audit scope.
- Constitution, PAN and tax records
- Ownership or lease and owner consent
- Site plan, area and storage layout
- Electricity, refrigeration and facility evidence where applicable
Before you begin
Use clear PDF, JPG, or PNG files.
Keep address records recent and readable.
Transparent fees,
before you commit.
Each registration carries its own government fee, and some are state-specific. We quote the exact combination for your business before any work begins.
Your written quote covers
- — Product and activity map
- — Authority and form
- — Readiness review
- — Filing and inspection
- — Licensed operations
Not included automatically
- — Central or state application, retention and product fees
- — Laboratory testing, sample, inspection and travel charges
- — Premises, equipment, HVAC, storage or cold-chain upgrades
- — Pharmacist, competent person, technical staff, import duty or foreign-site costs
Costs that can repeat
- — Licence retention or renewal action under the applicable route
- — Technical-person and premises continuity
- — Purchase, sale, batch, test and storage records
- — Prior approval or amendment for material product, premises or constitution changes
Licence effective,
quality duties continue.
Technical supervision, storage, records, product scope, complaints, recalls and material changes remain controlled.
Retention fee
Before each applicable five-year block ends
Many drug sale and manufacturing licences are perpetual subject to timely retention fee; other routes follow their own validity rules.
Technical person
Continuously
Report and regularise a change in pharmacist, competent person or manufacturing staff as required.
Product or site change
Before implementation
New products, facilities, constitution or premises can need endorsement or a fresh approval.
Records and storage
Ongoing
Maintain prescribed transaction, batch, test, temperature, complaint and recall records.
Got questions?
We’ve got answers.
Get clarity on product classification, central and state authorities, premises, technical people, inspections, records and retention.
Still deciding?
AI CA can compare structures around cost, risk, compliance, and funding.