A Homeopathic medicines business can be started in India through several models. You can:

• Open a retail Homeopathic pharmacy
• Start wholesale distribution
• Launch your own marketing brand through a licensed manufacturer
• Obtain a loan licence
• Establish your own Homeopathic medicine manufacturing unit

Each model has different licensing, investment, staffing and GMP requirements.

Quick Answer

Business Activity	Main Application	Licence/Approval
Homeopathic retail shop	Form 19-B	Form 20-C
Homeopathic wholesale	Form 19-B	Form 20-D
Own manufacturing unit	Form 24-C	Form 25-C
Loan licence manufacturing	Form 24-C-1	Form 25-C-1
GMP certification	Form 24-C-2	Form 26-C-1
New Homeopathic medicine	Prior regulatory approval/NOC as applicable	Before manufacturing

The retail and wholesale licensing route is also reflected in the current Online National Drugs Licensing System and State Drugs Control systems.

---

What Is a Homoeopathic Medicine?

Under the Drugs Rules, the legal definition covers medicines recorded in Homoeopathic provings or recognised through the specified authoritative Homoeopathic literature and prepared according to Homoeopathic pharmacy techniques. It also covers combinations of Homeopathic ingredients and excludes medicines administered by the parenteral route.

Homeopathic source materials can therefore include materials of:

• Plant origin
• Mineral or chemical origin
• Animal origin
• Other recognised sources

A product’s legal status depends on the applicable pharmacopoeia, literature, formulation and regulatory requirements—not simply on whether it contains a herb.

---

Who Regulates Homeopathic Medicines in India?

Homeopathic medicines are regulated under the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945, with the Ministry of AYUSH and the Central/State drug regulatory structure having respective functions.

Retail, wholesale and ordinary manufacturing licences are generally processed through the State Licensing Authority, while Central involvement becomes particularly important for matters such as new Homoeopathic medicines. CDSCO currently maintains a dedicated AYUSH section and, in May 2026, published a specific notice for submission of applications seeking an NOC to manufacture a new Homoeopathy medicine.

---

Four Ways to Start a Homeopathic Medicine Company

1. Homeopathic Retail Pharmacy

If you want to sell Homeopathic medicines directly to customers from a shop, the applicable licence is:

Form 20-C

Application:

Form 19-B

Current rules introduced through the 2024 amendment provide for applications to be processed through the e-AUSHADHI system, subject to the notified implementation arrangements.

2. Homeopathic Wholesale Business

If you want to supply medicines to:

• Homeopathic pharmacies
• Retailers
• Clinics
• Distributors
• Other authorised purchasers

the wholesale licence is:

Form 20-D

through:

Form 19-B.

3. Homeopathic Marketing Company

A marketing company develops its own:

• Company identity
• Product range
• Brands
• Packaging
• Sales network

and obtains products from a licensed Homeopathic manufacturer.

If the marketing company itself stocks, sells or distributes Homeopathic medicines, the appropriate Form 20-C/20-D licensing requirements should also be examined according to the actual activity.

4. Homeopathic Manufacturing Company

If you establish your own factory, the main manufacturing licence is:

Form 25-C

Application:

Form 24-C

The unit must comply with Rule 85E and Schedule M-I GMP requirements.

---

Homeopathic Retail Licence – Form 20-C

A Form 20-C licence permits retail sale, stocking and distribution of Homeopathic medicines from the approved premises.

The 2024 amendment made Form 20-C and 20-D licences perpetual, unless suspended or cancelled. The licensee must periodically submit the prescribed self-declaration of continuing compliance; failure to do so can lead to cancellation.

Who Can Supervise a Homeopathic Retail Shop?

Rule 67F recognises qualifications including:

• Degree in Homoeopathy from a recognised university
• Degree in Pharmacy from a recognised university
• Bachelor’s degree plus one year of specified experience dealing in Homeopathic medicines
• Diploma in Homeopathic Pharmacy
• Diploma in Homeopathy Medicine and Surgery

subject to the Rule and approval of the Licensing Authority.

---

Homeopathic Wholesale Licence – Form 20-D

Form 20-D is used for wholesale operations.

The wholesaler should maintain appropriate:

• Purchase records
• Sales records
• Supplier details
• Product records
• Alcohol-containing medicine records where applicable

Rule 67G specifically contains additional recordkeeping requirements for Homeopathic medicines containing alcohol.

A separate licence is generally required for each premises from which Homeopathic medicines are sold or stocked for sale.

---

Current Licence Fee for Retail and Wholesale Homeopathy

The Drugs (Fifth Amendment) Rules, 2024 revised the Form 19-B framework and prescribed a fee of ₹2,000 for the Homeopathic sale-licence application.

State portals, professional fees and other local charges may be additional, so applicants should check the applicable State Licensing Authority at the time of filing.

---

How to Start a Homeopathic Marketing Company

For many startups, manufacturing through an existing licensed company is considerably easier than constructing a factory.

A practical process is:

1. Register your business.
2. Select your product categories.
3. Search and protect your proposed trademarks.
4. Select a licensed Form 25-C manufacturer.
5. Verify the manufacturer’s GMP certificate.
6. Check whether the proposed products are already approved.
7. Finalise formulation, potency and pack size.
8. Prepare compliant artwork.
9. Sign a manufacturing/marketing agreement.
10. Obtain batch-wise COA and quality documents.
11. Obtain Form 20-C/20-D where your own sale/distribution activity requires it.
12. Start marketing only after regulatory and artwork approval.

Do not assume that having your name printed as “Marketed by” automatically permits manufacturing or wholesale operations.

---

Third-Party Manufacturing vs Loan Licence

The 2024 amendment introduced a specific loan-licence system for Homeopathic medicines.

Third-Party Manufacturing

An existing manufacturer manufactures products under its own manufacturing licence for your marketing company.

This is suitable for a startup that primarily wants to focus on:

• Branding
• Promotion
• Distribution
• Sales

Loan Licence

A company that does not own a manufacturing facility can apply to use the manufacturing facilities of an existing eligible manufacturer under a formal loan-licence arrangement.

Application:

Form 24-C-1

Licence:

Form 25-C-1.

The loan licence gives the applicant a more direct regulatory position than a simple marketing arrangement.

---

How to Establish Your Own Homeopathic Manufacturing Unit

Step 1: Finalise the Product Range

Decide whether you want to manufacture:

• Mother tinctures
• Mother solutions
• Dilutions
• Potencies
• Triturations
• Tablets
• Pills/globules
• Syrups
• Oral liquids
• Ointments
• Lotions
• Ophthalmic preparations

Do not design one factory for every dosage form unless your business plan actually requires all of them.

Step 2: Prepare a Project Report

Include:

• Proposed products
• Batch sizes
• Manufacturing sections
• Required machinery
• Premises
• Utilities
• Technical staff
• QC/QA
• Investment
• Working capital
• Distribution strategy

Step 3: Select Industrial Premises

Homeopathic manufacturing premises should be distinct from residential premises and should comply with the applicable GMP and local requirements. Government drug-control guidance also requires industrial manufacturing premises to meet the specific schedule applicable to the requested licence.

Step 4: Design According to Schedule M-I

The Ministry of AYUSH notified G.S.R. 657(E) on July 24, 2026, substantially amending Schedule M-I for Homeopathic drugs. Existing stakeholders have until July 31, 2029 to comply with those amendments.

For a factory being designed now, it is commercially sensible to design according to the new 2026 Schedule M-I requirements immediately, rather than construct to an older standard and retrofit the plant later.

---

Important New Schedule M-I Requirements

The amended Schedule M-I strengthens requirements relating to:

• Controlled manufacturing environment
• Air filtration
• Cross-contamination prevention
• Personnel and material movement
• Cleaning and sanitation
• Equipment qualification and validation
• Pest control
• Material status identification
• QA-controlled dispensing
• Independent QA and QC
• SOPs
• Training
• Documentation
• Packaging and labelling
• Stability
• Record retention

For example, the amended rules call for logical/unidirectional production flow where possible, equipment positioning designed to avoid mix-ups and contamination, controlled material handling, validated systems, documented SOPs and separate QA/QC functions.

The new Schedule also specifies that amendments made in 2026 must be complied with no later than July 31, 2029.

---

Manufacturing Licence – Form 25-C

The main Homeopathic manufacturing application is:

Form 24-C

and the manufacturing licence is:

Form 25-C.

The 2024 amendment also changed the manufacturing licensing framework.

Current statutory fees include:

• ₹2,000 for any number of single-ingredient Homeopathic medicines
• ₹200 per product for combination Homeopathic medicines

All potencies of a single-ingredient Homeopathic medicine are treated as one product for this licensing-fee purpose.

State-specific filing charges or professional expenses may be additional.

---

GMP Certificate for Homeopathic Manufacturers

The 2024 rules introduced a dedicated GMP application and certificate system:

Application: Form 24-C-2
GMP Certificate: Form 26-C-1

The prescribed application fee is ₹5,000.

The manufacturing licence in Form 25-C/25-C-1 is now designed to remain valid perpetually unless suspended or cancelled, but the facility must maintain its GMP status. The GMP certificate is subject to the applicable retention requirements.

---

Technical Staff Qualification

Manufacturing must be carried out under a qualified whole-time technical person.

Following the 2024 amendment, Rule 85E recognises at least one whole-time person falling under specified qualification/experience routes, including:

Option 1

Graduate in Science with:

• Chemistry, or
• Botany, or
• Zoology

as a subject, along with three years’ experience in manufacture of Homeopathic medicines.

Option 2

Graduate in Pharmacy with:

18 months’ experience in manufacture of Homeopathic medicines.

Option 3

A qualification covered by the schedules of the National Commission for Homoeopathy Act, 2020, along with:

18 months’ Homeopathic manufacturing experience.

---

Quality Assurance and Quality Control

The amended 2026 Schedule M-I places greater emphasis on having proper QA/QC arrangements.

QA and QC should have defined, separate responsibilities, and production personnel should not simultaneously function as independent QC testing personnel.

The facility should establish specifications and testing arrangements for:

• Raw materials
• Mother tinctures
• Potencies
• Excipients
• Packaging materials
• In-process products
• Finished products
• Water
• Microbiological parameters where applicable

The Ministry/CDSCO also maintains information about approved/private testing laboratories for Homeopathic drugs.

---

Typical QC Equipment

Depending on the products manufactured, the laboratory may require equipment such as:

• Microscope
• Dissecting microscope
• TLC apparatus
• UV viewing system
• Analytical balance
• Hot-air oven
• Distillation apparatus
• Water bath
• Polarimeter
• Refractometer
• Melting-point apparatus
• pH meter
• Magnetic stirrer
• Centrifuge
• Muffle furnace
• Moisture-determination apparatus
• UV spectrophotometer
• Tablet-disintegration apparatus

The final equipment list should be based on your actual product scope, pharmacopoeial tests and the amended Schedule M-I, rather than copying an old generic machinery list.

---

Machinery for Mother Tinctures and Mother Solutions

Typical equipment may include:

• Cutting/chopping facilities
• Disintegrator
• Sifter
• Balances and measures
• Macerators
• Percolators
• Filtration equipment
• Stainless-steel mixing vessels
• Storage vessels
• Portable stirrers
• Water purification system
• Filling and sealing machinery

Where mother tinctures are manufactured, the manufacturer must also have suitable arrangements for identifying and testing raw materials and finished preparations.

---

Potentisation Section

The amended Schedule M-I continues to specify dedicated requirements for potentisation.

Typical facilities include:

• Stainless-steel workbenches
• Controlled storage for potencies and back-potencies
• Measuring and dispensing devices
• Potentisation phials
• Potentiser with counter, where used

The 2026 Schedule M-I retains a 20 square metre area for basic installations in the potentisation section and states that mechanical potentisers are not mandatory; manual potentisation can be used with proper SOPs. Where a potentiser is used, it must be appropriately validated/calibrated.

---

Trituration, Tablets, Pills and Globules

Depending on the approved manufacturing scope, equipment may include:

• Triturating machine
• Sifter
• Mixer
• Granulator
• Dryer
• Oven
• Tablet-compression machine
• Coating pan
• Tablet counter
• Filling equipment
• Balances

The equipment should be suitable for batch size and capable of being appropriately cleaned and controlled.

---

Syrups and Oral Liquids

Typical equipment may include:

• Stainless-steel manufacturing vessel
• Storage vessel
• Stirrer
• Homogeniser where applicable
• Filtration equipment
• Filling machine
• Sealing/capping machine
• pH meter

Alcohol-containing formulations require additional attention to storage, fire safety, excise requirements and current Drugs Rules.

---

Ointments and Lotions

Typical machinery can include:

• Stainless-steel manufacturing vessels
• Heated kettle
• Planetary mixer
• Homogeniser
• Colloid/ointment mill
• Filling machine
• Crimping equipment
• Filtration system
• Balances

---

Ophthalmic Homeopathic Preparations

Ophthalmic products require more stringent manufacturing controls.

Depending on the exact formulation and process, facilities may include:

• Controlled production area
• Appropriate air handling
• HEPA filtration
• Laminar-air-flow facilities
• Sterilisation equipment
• Autoclave
• Washing/drying equipment
• Controlled filling
• Inspection facilities

The final design should follow the amended Schedule M-I

---

Packing and Labelling Area

The 2026 Schedule M-I specifies a minimum 50 square metre area for packing and labelling, requires labels to be approved by Quality Control before use, and calls for appropriate storage conditions for labels.

Packaging materials should be controlled through:

• Receipt
• Quarantine
• Approval
• Issue
• Reconciliation
• Destruction of obsolete material

---

Homeopathic Medicine Labelling

A Homeopathic medicine label must comply with the specific provisions of the Drugs Rules.

Depending on the product, the label may need information such as:

• “Homoeopathic medicine”
• Name of the medicine
• Potency
• Ingredients and potencies in combinations
• Manufacturer name and address
• Batch number where applicable
• Manufacturing licence number
• Alcohol content where applicable
• Net quantity
• Other prescribed declarations

Single-ingredient Homeopathic medicines are also subject to specific rules regarding proprietary names.

The artwork should therefore be reviewed by the manufacturer’s QA/regulatory team before printing.

---

Alcohol-Containing Homeopathic Medicines

This area now requires extra care.

Homeopathic mother tinctures and many dilutions may contain alcohol. Existing Homeopathy-specific rules contain alcohol labelling, packing and recordkeeping provisions, and CDSCO also issued further amendments concerning restrictions on alcohol-containing drug products in July 2026.

For a new unit using alcohol, check:

• Drug-rule requirements
• State Excise requirements
• Alcohol procurement/storage permission
• Fire-safety requirements
• Flame-proof electrical requirements
• Pack-size restrictions
• Label declarations

Government drug-control guidance also specifically identifies fire-safety/NOC concerns for manufacturing operations involving alcohol and other inflammable substances.

---

What Is a “New Homeopathic Medicine”?

Not every proposed new combination can simply be added to a Form 25-C licence.

The 2024 amendment updated the definition and regulatory pathway for New Homoeopathic Medicines, including certain:

• Unrecognised medicines
• New combinations
• Combinations involving unrecognised ingredients
• New ratios
• New claims in circumstances covered by the rule

and introduced a formal approval framework.

In addition, CDSCO published a specific notice on May 4, 2026 concerning submission of applications for NOC to manufacture new Homoeopathy medicines.

Therefore:

Do not commercially manufacture a genuinely new Homeopathic combination merely because every individual ingredient already exists.

Its “new medicine” status should first be checked.

---

Documents Generally Required for Form 25-C

Exact State checklists vary, but commonly required documents include:

• Form 24-C application
• Prescribed fee receipt
• Site plan
• Key plan
• Proof of premises
• Ownership/rent documents
• Firm constitution documents
• Authorisation/power of attorney
• List of machinery
• Machinery capacity/details
• Technical staff qualification
• Technical staff experience certificates
• Appointment/joining documents
• Quality-control equipment list
• Proposed product list
• Detailed formulations
• Raw-material specifications
• Packaging details
• Non-conviction declarations
• Applicable Pollution Control approval
• Fire-safety documents where relevant
• GMP-related documentation

A current State Drug Control checklist confirms that manufacturing applications commonly require site/key plans, constitution documents, machinery details, technical-staff qualifications, QC equipment and detailed product formulae.

---

Documentation Required Inside the Factory

A modern Homeopathic manufacturing unit should maintain controlled records such as:

• SOPs
• Master Formula Records
• Batch Manufacturing Records
• Batch Packaging Records
• Material specifications
• Raw-material receipt records
• Testing records
• Equipment logs
• Calibration records
• Cleaning records
• Training records
• Market complaints
• Deviations
• CAPA
• Recall records
• Distribution records
• Personnel medical records
• Stability records

The 2026 Schedule M-I expressly strengthens these documentation requirements and requires records generally to be maintained for one year after batch expiry or three years, whichever is later.

---

Step-by-Step Procedure to Start a Homeopathic Manufacturing Company

Step 1 — Decide the Business Model

Choose:

• Third-party marketing
• Loan licence
• Own manufacturing

For a startup, evaluate third-party manufacturing before investing in a factory.

Step 2 — Finalise Product Range

Decide exactly which dosage forms you will manufacture.

Step 3 — Prepare a Regulatory Product List

Separate:

• Existing recognised single-ingredient medicines
• Combination products
• New Homeopathic medicines

Step 4 — Select Premises

Choose suitable industrial premises capable of meeting Schedule M-I.

Step 5 — Prepare GMP Layout

Design:

• Raw-material receipt
• Quarantine
• Approved stores
• Production rooms
• Potentisation
• Packing
• Finished-goods store
• QA/QC
• Change rooms
• Utilities
• Alcohol storage where applicable

Step 6 — Install Machinery

Purchase only machinery required for your actual product scope.

Step 7 — Establish QA/QC

Create separate and independent quality functions in accordance with the updated Schedule M-I requirements.

Step 8 — Appoint Technical Staff

Ensure Rule 85E qualification and experience requirements are met.

Step 9 — Prepare Documentation

Develop SOPs, MFRs, BMRs, specifications and quality procedures.

Step 10 — Apply for GMP and Manufacturing Licence

Use the applicable:

• Form 24-C
• Form 24-C-2
• Form 25-C
• Form 26-C-1

under the current licensing process.

Step 11 — Regulatory Inspection

The Licensing Authority will assess:

• Premises
• Equipment
• Technical staff
• QA/QC
• Documentation
• GMP compliance

Step 12 — Obtain Product Permissions

Ensure every proposed medicine is covered under the appropriate approval.

Step 13 — Approve Packaging

Verify labelling and claims before printing.

Step 14 — Conduct Validation and Qualification

Validate/qualify important:

• Equipment
• Water systems
• Processes
• Cleaning
• Analytical procedures
• Controlled environments

The revised Schedule M-I expressly requires equipment and system performance to be appropriately validated.

Step 15 — Begin Commercial Manufacturing

Manufacture only approved products after required licences and GMP arrangements are in place.

---

Own Manufacturing vs Loan Licence vs Third-Party Manufacturing

Factor	Own Manufacturing	Loan Licence	Third-Party Marketing
Own factory	Yes	No	No
Manufacturing licence	Form 25-C	Form 25-C-1	Manufacturer holds Form 25-C
Capital requirement	Highest	Medium	Lowest
GMP responsibility	High	Significant	Primarily manufacturer, with marketer responsibilities
Machinery	Required	Host facility	Not required
Control	Highest	High	Moderate
Startup suitability	After scale develops	Intermediate option	Often easiest

---

Common Mistakes to Avoid

Do not:

• Describe Homeopathic medicines as only herbal products
• Use the obsolete 1973 Act qualification reference without considering the 2024 update
• Build a factory solely according to an old Schedule M-I layout
• Ignore the July 2026 Schedule M-I amendment
• Start production without GMP certification
• Manufacture a new combination without checking new-medicine approval requirements
• Assume third-party manufacturing and loan licensing are the same
• Use a Form 20-C retail licence as a general manufacturing licence
• Mix Homeopathic and other-system manufacturing without checking segregation requirements
• Ignore alcohol/excise/fire requirements
• Print labels before regulatory approval
• Depend on old five-year licence-renewal advice
• Copy old fixed machinery/area lists without checking the current Schedule M-I

---

Frequently Asked Questions

1. Which licence is required to manufacture Homeopathic medicines?

The main manufacturing licence is Form 25-C, applied for through Form 24-C.

2. Which licence is required for a Homeopathic retail shop?

Form 20-C, normally applied for through Form 19-B.

3. Which licence is required for wholesale?

Form 20-D through Form 19-B.

4. Is there a Homeopathic loan licence?

Yes. The 2024 amendment introduced Form 25-C-1, with application in Form 24-C-1.

5. Is GMP compulsory?

A Homeopathic manufacturing facility must comply with applicable Schedule M-I GMP requirements and the 2024 framework provides for a dedicated GMP certificate in Form 26-C-1.

6. What is new in Schedule M-I in 2026?

G.S.R. 657(E), dated July 24, 2026, extensively revised requirements relating to premises, equipment, personnel, material movement, QA/QC, documentation, packaging, validation and other GMP controls. Compliance with those amendments is required by July 31, 2029.

7. Is a B.Pharm graduate eligible as manufacturing technical staff?

Rule 85E recognises a Pharmacy graduate with the prescribed 18 months’ experience in Homeopathic manufacturing.

8. Can a science graduate supervise manufacturing?

A Science graduate with Chemistry, Botany or Zoology can qualify subject to the prescribed three years’ manufacturing experience.

9. Does every Homeopathic company need its own factory?

No. A company can use third-party manufacturing or the formal loan-licence route.

10. Is a manufacturing licence renewable every five years?

The 2024 amendment moved Homeopathic manufacturing licences toward perpetual validity, subject to continuing GMP and other compliance requirements.

11. Are Form 20-C and Form 20-D also perpetual?

Yes, under the revised framework they remain valid perpetually unless suspended/cancelled, subject to the prescribed periodic compliance declaration.

12. Can I manufacture a new Homeopathic combination immediately?

Not necessarily. A product falling within the definition of a new Homeopathic medicine requires prior regulatory approval. CDSCO also issued a specific NOC application notice in May 2026.

13. Can I start only as a marketing company?

Yes. You can develop brands and obtain products from an appropriately licensed manufacturer. If you will independently stock, wholesale or retail the medicines, assess the corresponding Form 20-C/20-D requirements.

14. Do all old machinery-area requirements still apply?

The 2026 Schedule M-I substantially revised the GMP framework; some specified areas remain, while the overall plant must now satisfy stronger layout, contamination-control, QA/QC and validation requirements.

Final Thoughts

For a new entrepreneur, there are three practical routes:

Third-party manufacturing → lowest initial infrastructure

Loan licence → more regulatory control without constructing your own plant

Own Form 25-C factory → highest control, investment and GMP responsibility

If the market has not yet been tested, launching a focused product range through an established Form 25-C manufacturer may be more practical. An independent plant can be considered after achieving sufficient and predictable sales.

For anyone building a new factory in 2026, the most important change is to design the facility for the revised Schedule M-I notified on July 24, 2026, rather than relying on layouts prepared under older rules.

Looking for Ayurvedic Franchise or Distribution Opportunities?

Looking to start an Ayurvedic franchise, become a distributor, or launch your own herbal product range?

Elzac Herbal India offers:

• Ayurvedic & Herbal Product Range
• Franchise & Distribution Opportunities
• Third-Party Manufacturing
• Product Development Support
• Marketing Guidance
• PAN India Business Opportunities

Whether you are an entrepreneur, retailer, distributor, or healthcare professional, our team can help you explore the right business opportunity in the growing Ayurvedic sector.

Contact us today to discuss ayurvedic franchise, distribution, or third-party manufacturing opportunities.