Ayurveda, Unani and Siddha provide several business opportunities, including:

• Medicine manufacturing
• Third-party product marketing
• PCD or franchise distribution
• Wholesale supply
• Retail medicine shops
• Online selling
• Clinics
• Therapy and day-care centres
• Panchakarma centres
• Business consultancy
• Direct selling
• Product export

These businesses do not require the same qualifications, licences or infrastructure.

The correct legal structure depends on whether the entrepreneur intends to:

• Manufacture medicines
• Own medicine brands
• Store and distribute medicines
• Sell products to consumers
• Diagnose and treat patients
• Provide therapeutic procedures
• Sell food supplements or cosmetics
• Export products

The practical rule is:

Select the exact business model first, identify whether each product is a medicine, food, cosmetic or device, and then obtain the licences applicable to that activity.

Ayurveda, Unani and Siddha: Important Difference

Ayurveda, Unani and Siddha are recognized systems of Indian medicine, but they are not interchangeable.

Ayurveda

Ayurveda is practised by appropriately qualified and registered Ayurvedic practitioners, commonly holding recognized qualifications such as BAMS.

Panchakarma is a specialized Ayurvedic therapeutic discipline.

Unani

Unani medicine is practised by appropriately qualified and registered Unani practitioners, commonly holding recognized qualifications such as BUMS.

Unani centres should describe their therapies according to the Unani system rather than calling every treatment Panchakarma.

Siddha

Siddha medicine is practised by appropriately qualified and registered Siddha practitioners, commonly holding recognized qualifications such as BSMS.

Siddha centres should offer and describe treatments within the practitioner’s recognized training and registration.

Clinical standards require practitioners to be registered with the relevant State or National Commission and to provide services in accordance with their qualification, training and registration.

Main Business Options

Business model	Principal requirement
Own ASU manufacturing unit	Form 25-D manufacturing licence and Schedule T GMP
Loan-licence manufacturing	Form 25-E loan licence
Third-party marketing company	Licensed manufacturer, product approval, agreement and business registrations
Wholesale or distribution	No separate central ASU sale licence ordinarily; verify state rules
Retail medicine shop	No separate central ASU sale licence ordinarily; verify state and local rules
Online medicine shop	Offline requirements plus e-commerce and Schedule E(1) controls
Ayurveda clinic	Qualified and registered Ayurvedic practitioner
Unani clinic	Qualified and registered Unani practitioner
Siddha clinic	Qualified and registered Siddha practitioner
Panchakarma centre	Registered Ayurvedic practitioner and therapy-centre compliance
Nutraceutical business	Applicable FSSAI licence
Cosmetic business	Applicable Cosmetics Rules compliance
Direct-selling company	Consumer Protection (Direct Selling) Rules
Export business	Domestic compliance, IEC and importing-country requirements

Product Classification Comes First

Before registering the business, determine whether each product is legally classified as:

• Ayurvedic medicine
• Siddha medicine
• Unani medicine
• Food supplement
• Nutraceutical
• Cosmetic
• Medical device
• General wellness product

The same dosage form can fall under different laws.

For example, a capsule may be:

• An Ayurvedic medicine
• A nutraceutical
• A conventional drug
• A food supplement

A syrup may be:

• An Ayurvedic proprietary medicine
• A classical Ayurvedic formulation
• A food beverage
• A nutraceutical
• A conventional medicine

The category depends on:

• Formula
• Ingredients
• Classical reference
• Intended use
• Product claims
• Regulatory permission
• Labelling

Ayurvedic, Siddha and Unani drugs are regulated under specific provisions of the Drugs and Cosmetics Act and Drugs Rules. The relevant Rules cover manufacture, labelling, packing, testing and enforcement.

Business Model 1: Ayurvedic, Siddha or Unani Manufacturing Unit

Manufacturing requires the highest level of investment and regulatory responsibility.

A licensed manufacturer is responsible for:

• Raw-material authenticity
• Formula compliance
• Manufacturing processes
• Product testing
• Batch records
• Labelling
• Shelf life
• Product complaints
• Recalls
• Quality and safety

Manufacturing-Licence Forms

Own Manufacturing Licence

An application is generally submitted in:

Form 24-D

The manufacturing licence is granted in:

Form 25-D

Loan Licence

An application is generally submitted in:

Form 24-E

The loan licence is granted in:

Form 25-E

A loan licence allows an applicant without its own complete manufacturing arrangements to use the approved facilities of another Form 25-D manufacturer under the regulatory arrangement.

Form 25-D and Form 25-E are the current licensing routes identified by State ASU drug-control authorities.

Who Grants the Manufacturing Licence?

Manufacturing licences are granted by the concerned State Licensing Authority or State Drug Controller.

They are not ordinarily issued directly by the central Ministry of Ayush.

The e-AUSHADHI system provides online services for licensing and management of Ayurveda, Siddha, Unani and homoeopathic manufacturing establishments and testing laboratories.

Schedule T GMP

Manufacturing premises must comply with Good Manufacturing Practices under Schedule T.

Schedule T compliance covers areas such as:

• Location and surroundings
• Factory building
• Hygiene
• Water
• Waste disposal
• Raw-material control
• Manufacturing procedures
• Equipment
• Quality control
• Documentation
• Storage
• Complaints
• Product recall

Compliance with Schedule T, applicable pharmacopoeial standards and evidence requirements is mandatory for manufacturers.

Manufacturing-Premises Area

Many state checklists use approximately 1,200 square feet of compliant built-up premises as a baseline for an initial ASU manufacturing setup.

However, it should not be treated as a guaranteed nationwide area for every project.

Additional space may be necessary for:

• Multiple dosage forms
• Raw herbs
• Separate Unani or Siddha processes
• Minerals and metals
• Furnace operations
• Fermentation
• Quality-control laboratory
• Packing
• Quarantine
• Finished-goods storage
• Rejected materials
• Utilities

Kerala’s current official guidance uses 1,200 square feet as a baseline and also specifies manufacturing, quality-control and storage infrastructure.

Manufacturing Sections

A plant may establish one or more sections.

Powder or Churna Section

May require:

• Herb-cleaning area
• Dryer
• Pulverizer
• Sifter
• Blender
• Dust extractor
• Filling machine
• Sealing machine

Tablet and Vati Section

May require:

• Pulverizer
• Sifter
• Mass mixer
• Granulator
• Dryer
• Blender
• Tablet press
• Coating equipment
• Blister or bottle-packing line

Capsule Section

May require:

• Grinder
• Sifter
• Blender
• Capsule-filling machine
• Capsule polisher
• Packing equipment

Liquid Section

May manufacture:

• Syrups
• Kwatha
• Liquid extracts
• Drops
• Certain Unani preparations

Possible equipment includes:

• Water-treatment system
• Manufacturing vessel
• Storage vessel
• Homogenizer
• Filtration unit
• Filling machine
• Capping and labelling equipment

Oil and Ghrita Section

May require:

• Heating vessel
• Steam-jacketed kettle
• Mixing vessel
• Filtration unit
• Storage vessel
• Filling equipment

Avaleha and Semi-Solid Section

Possible equipment includes:

• Heating vessels
• Mixing equipment
• Concentration system
• Controlled filling
• Cooling arrangements

Asava and Arishta Section

Requires controlled fermentation, including:

• Suitable fermentation vessels
• Batch monitoring
• Maturation
• Alcohol-content testing
• Cleaning controls

Mineral, Metal or Rasaushadhi Section

May require:

• Separate processing areas
• Furnaces
• Heating arrangements
• Occupational-safety controls
• Environmental approvals
• Specialized testing
• Appropriate technical expertise

Technical Staff for Manufacturing

Technical-staff requirements depend on the system, products and state checklist.

A current state example requires:

• BAMS, BSMS or BUMS-qualified manufacturing supervision
• Qualified chemist for quality control
• Botanist or pharmacognosy support for herbal-material identification

The final technical-staff requirement must be confirmed with the State Licensing Authority.

Quality-Control Requirements

The manufacturer must establish suitable quality-control arrangements.

Testing may include:

• Botanical identification
• Foreign matter
• Moisture
• Ash values
• Extractive values
• pH
• Alcohol content
• Microbial limits
• Heavy metals
• Pesticide residues
• Aflatoxins
• Finished-product specifications
• Stability

Approved ASU testing laboratories are regulated under Rules 160-A to 160-J. Manufacturers remain responsible for product quality even where certain tests are outsourced.

Product Approval

A manufacturing licence does not automatically authorize every medicine.

Each product may require submission of:

• Product name
• Dosage form
• Complete formula
• Quantity of ingredients
• Botanical name
• Part used
• Classical reference
• Manufacturing method
• Finished-product specification
• Test method
• Dose
• Indications
• Cautions
• Proposed label
• Safety and effectiveness evidence

Rule 158-B prescribes the licensing framework for classical and patent or proprietary ASU medicines, including applicable evidence requirements.

Classical and Proprietary Medicines

Classical Medicine

A classical medicine follows a formula described in an authoritative book recognized under the Act.

The application should contain the exact:

• Book name
• Chapter
• Formula
• Ingredient
• Manufacturing method

Patent or Proprietary Medicine

A patent or proprietary ASU medicine is a formulation made from ingredients recognized in the authoritative books but is not itself the exact classical formula.

The term “patent or proprietary” does not mean that the product has received a patent.

Manufacturing Documents

Common documents include:

• Form 24-D or Form 24-E
• Fee receipt
• Entity documents
• Ownership or lease documents
• Owner’s NOC
• Layout plan
• Site plan
• Machinery list
• Laboratory-equipment list
• Technical-staff documents
• Product applications
• Schedule T documents
• Water-analysis report
• Pollution-control documents
• Fire and factory approvals
• Site Master File
• SOP list
• Quality-control arrangements

State-specific checklists and fees must be confirmed before submission.

Investment for Manufacturing

There is no fixed statutory investment amount.

Broad planning ranges may be:

Manufacturing project	Illustrative investment
Small leased single-category unit	₹40 lakh–₹1.25 crore
Multi-section ASU manufacturing facility	₹1.25–₹5 crore or more
Large automated or export-oriented plant	₹5 crore to several crores

The estimate depends on:

• Premises
• Dosage forms
• Machinery
• Laboratory
• Raw materials
• Packing
• Staff
• Utilities
• Working capital

Business Model 2: Ayurvedic, Unani or Siddha Marketing Company

A marketing company develops and promotes products but gets them manufactured by a licensed third-party manufacturer.

The marketing company may:

• Select products
• Select brands
• Develop packaging
• Appoint distributors
• Offer PCD franchise
• Conduct promotion
• Manage product positioning
• Sell products online or offline

Does a Marketing Company Need a Manufacturing Licence?

A pure marketing company using a properly licensed third-party manufacturer does not ordinarily require its own Form 25-D manufacturing licence.

The actual manufacturer must hold:

• Form 25-D or applicable loan licence
• Schedule T GMP compliance
• Product permission
• Suitable manufacturing sections

The marketing company should maintain a written agreement covering:

• Formula
• Product approval
• Quality
• Testing
• Packaging
• Complaints
• Recall
• Liability
• Intellectual property
• Payment
• Expiry policy

Registrations for a Marketing Company

Common registrations may include:

• Proprietorship, partnership, LLP or company
• PAN
• GST registration
• Current bank account
• Trademark application
• Shop and Establishment registration
• Municipal trade licence
• Udyam registration
• FSSAI licence for food-category products
• Cosmetic or device-related compliance where applicable

FSSAI Relabeller Requirement

Where the business gets nutraceuticals or food supplements manufactured through a third-party food manufacturer, FoSCoS directs the brand owner to apply under the Relabeller Kind of Business.

The earlier new-application categories of “Supplier” and “Marketer” have been disabled.

Qualification for Marketing Company

No BAMS, BUMS, BSMS, B.Pharm or D.Pharm qualification is ordinarily required merely to own an ASU marketing company.

However:

• Medical consultation requires a qualified practitioner.
• Product development should involve qualified technical experts.
• Medicinal claims must remain within approved product permissions.
• Marketing employees should not diagnose or prescribe.

Marketing-Company Investment

Broad illustrative ranges are:

Marketing model	Planning range
Small PCD or third-party launch	₹4–12 lakh
Structured 10–25 product company	₹12–30 lakh
Regional marketing company	₹30 lakh–₹1 crore or more

The main investment heads are:

• Initial products
• MOQ
• Packaging
• Artwork
• Trademark
• Marketing material
• Staff
• Distributor credit
• Reorder funding

Business Model 3: Wholesale and Distribution

An ASU distributor purchases products and supplies:

• Retail shops
• Clinics
• Hospitals
• Other distributors
• Wellness centres
• Institutions

Is a Drug-Sale Licence Required?

The Ministry of Ayush has stated that a separate sale licence is not required for Ayurvedic medicines under the central framework. Kerala’s current official guidance similarly says Ayurvedic, Siddha and Unani medicines do not require a special licence for sale, provided the products come from approved manufacturers.

However, the statement:

“No licence is required anywhere in India”

is unsafe.

Karnataka currently provides an online state service for licensing an establishment that sells or stores Ayurvedic, Siddha, Unani and homoeopathic medicines.

Therefore, verify the position with the:

• State AYUSH Department
• State Licensing Authority
• District AYUSH Officer
• Municipal authority

Distribution Registrations

A distributor may require:

• Entity registration
• PAN
• GST
• Shop and Establishment registration
• Trade licence
• State AYUSH establishment registration
• FSSAI licence
• Medical-device registration
• Other product-category licences

Storage Controls

Maintain:

• Clean racks
• Dry premises
• Pest control
• Batch-wise records
• Expiry control
• Returned-goods segregation
• Damaged-stock segregation
• Schedule E(1) identification
• Recall records

Business Model 4: Ayurvedic, Unani or Siddha Medicine Shop

A medicine shop sells properly licensed packaged medicines to consumers.

Central Sale-Licence Position

A separate central sale licence is ordinarily not prescribed merely for selling licensed Ayurvedic, Siddha or Unani medicines.

Nevertheless, local or state registrations can apply.

Qualification for Shop Owner

No system-specific medical degree is ordinarily required merely to own or operate an ASU medicine shop.

The shopkeeper may sell packaged products but should not:

• Diagnose disease
• Prescribe treatment
• Advise patients to stop medical treatment
• Claim to be a Vaidya, Hakim or Siddha doctor
• Conduct therapeutic procedures without qualification
• Guarantee a cure

Mixed-Product Shop

Separate requirements arise where the shop also sells:

Allopathic Medicines

Requires applicable retail drug licences and a registered pharmacist.

Homoeopathic Medicines

Requires the applicable homoeopathic retail licence.

Food Supplements

Requires FSSAI registration or licensing.

Medical Devices

May require premises registration under the Medical Devices Rules.

Cosmetics

Must comply with applicable cosmetic and packaging requirements.

Shop Investment

Broad planning ranges:

Shop model	Illustrative investment
Small local ASU shop	₹3–7 lakh
Well-stocked shop	₹7–15 lakh
Large franchise or wellness outlet	₹15–40 lakh or more

Business Model 5: Online Ayurvedic, Unani or Siddha Store

Online sales do not eliminate offline regulatory requirements.

The business should comply with:

• Business registration
• GST
• E-commerce rules
• Consumer-protection requirements
• Product-category licences
• Packaging declarations
• Return and refund policies
• Advertising restrictions
• Data and prescription controls

Schedule E(1) Products

Medicines containing Schedule E(1) ingredients must carry:

“Caution: To be taken under medical supervision”

in English and Hindi.

The CCPA has advised e-commerce platforms to permit sale of Schedule E(1) ASU medicines only after the consumer uploads a valid prescription from a registered practitioner of the relevant system.

The online system should:

• Flag Schedule E(1) products
• Require prescription upload
• Prevent automatic unrestricted checkout
• Maintain records
• Display warnings
• Verify practitioner details where possible

Product-Quality Responsibility

Government authorities inspect and sample ASU medicines from manufacturers and retail shops. Where products fail standards, authorities may stop sales and initiate legal action.

Online sellers should therefore verify:

• Manufacturer’s licence
• Product approval
• Batch
• Expiry
• Ingredients
• Label
• Supplier invoice
• Schedule E(1) warning

Business Model 6: Ayurveda, Unani or Siddha Clinic

A clinic provides:

• Consultation
• Examination
• Diagnosis
• Prescription
• Follow-up
• Health advice
• Dispensing, where permitted

Qualification Required

The practitioner should possess a recognized qualification in the relevant system and be registered with the appropriate State or National register.

Clinical standards define an AYUSH clinic as an establishment in which registered practitioners provide consultation, examination and prescriptions.

Generally:

• Ayurveda clinic: registered Ayurvedic practitioner
• Unani clinic: registered Unani practitioner
• Siddha clinic: registered Siddha practitioner

The practitioner’s name, qualification and registration number should be displayed.

Clinical-Establishment Registration

Clinic registration depends on:

• Clinical Establishments Act applicability
• State clinical-establishment law
• Nursing-home law
• Municipal rules
• State AYUSH requirements

The central Clinical Establishments Act currently applies in adopting states and union territories and covers recognized systems of medicine, including single-doctor clinics.

Minimum Clinic Standards

The national minimum standards for an AYUSH consultation clinic specify:

• Registered practitioner
• Safe and hygienic environment
• Ventilation and lighting
• Registration signage
• Fee display
• Patient records
• Infection control
• Biomedical-waste management
• First-aid arrangements
• Emergency contact details

The published standard uses 100 square feet as the normal consultation-clinic baseline, with a limited 75-square-foot relaxation for space-constrained cities. State requirements may be higher.

Clinic Documents

Common documents may include:

• Degree certificate
• Internship completion
• State or national registration
• Identity proof
• Premises documents
• Clinical-establishment registration
• Trade licence
• Biomedical-waste agreement
• Fire documents where applicable
• Staff documents
• Professional indemnity insurance
• Patient-record formats

Clinic Records

Maintain:

• Patient registration
• History
• Examination
• Diagnosis
• Prescription
• Treatment
• Consent
• Follow-up
• Referrals
• Adverse reactions
• Bills and receipts

Business Model 7: Panchakarma Centre

Panchakarma belongs specifically to the Ayurvedic system.

A Panchakarma centre should ordinarily operate under the clinical supervision of a registered Ayurvedic practitioner trained in the procedures being offered.

A massage or spa establishment should not present itself as a medical Panchakarma centre unless it meets clinical requirements.

Panchakarma-Centre Classification

Depending on services, the centre may be treated as:

• Ayurveda clinic with procedures
• AYUSH therapy centre
• Day-care centre
• Clinical establishment
• Hospital, where inpatient beds are provided

The national Clinical Establishments framework separately publishes minimum standards for:

• Consultation clinics
• Dispensaries
• Therapy or day-care centres
• AYUSH hospitals

Panchakarma Infrastructure

Depending on services, the centre may require:

• Doctor’s consultation room
• Waiting area
• Male therapy room
• Female therapy room
• Changing space
• Attached or nearby washroom
• Handwashing
• Therapy tables
• Shirodhara equipment
• Steam chamber
• Oil-heating arrangements
• Medicine storage
• Laundry arrangements
• Waste segregation
• Emergency equipment
• Privacy controls

Panchakarma Staff

A centre may require:

• Registered Ayurvedic doctor
• Trained Panchakarma therapists
• Male and female therapists
• Nursing or support staff
• Reception and housekeeping personnel

Therapists should work under documented clinical instructions and should not independently diagnose or prescribe.

Panchakarma Safety

Before treatment, maintain:

• Medical assessment
• Patient history
• Contraindication review
• Written treatment plan
• Informed consent
• Therapy record
• Emergency referral plan
• Hygiene and infection controls

Certain procedures require careful patient selection and should not be offered as general spa packages.

Panchakarma Claims

Avoid statements such as:

• Guaranteed detoxification
• Permanent cure
• Removes every toxin
• Cures diabetes in seven days
• Reverses all chronic disease
• Safe for every person

Claims should be consistent with:

• Practitioner competence
• Accepted clinical practice
• Available evidence
• Advertising law
• Patient-specific assessment

Panchakarma-Centre Investment

Centre type	Broad planning range
Small consultation and therapy centre	₹8–20 lakh
Structured Panchakarma day-care centre	₹20–50 lakh
Premium multi-room centre	₹50 lakh–₹2 crore or more

The estimate depends on:

• Location
• Interiors
• Therapy rooms
• Equipment
• Staffing
• Laundry
• Heating and ventilation
• Clinical-establishment requirements

Siddha and Unani Therapy Centres

A Siddha or Unani practitioner may establish a therapy centre according to:

• Recognized system-specific treatments
• Professional qualification
• State registration
• Clinical-establishment standards
• Practitioner competence

Such centres should not use “Panchakarma” as a general term where the procedures are not Ayurvedic Panchakarma.

Business Model 8: Consultancy

Consultancy may include:

• Product-development consulting
• Manufacturing-project planning
• Quality-control advice
• Distribution planning
• Packaging and branding
• Regulatory documentation
• Clinic-management consulting

No medical qualification is necessarily required for general business consultancy.

However, clinical consultation, diagnosis and prescription require a qualified and registered practitioner.

A business consultant should not present themselves as a medical practitioner.

Business Model 9: PCD and Franchise

Franchise opportunities include:

• Product-distribution franchise
• Retail outlet franchise
• Clinic brand franchise
• Panchakarma-centre franchise
• Third-party product franchise

Product Franchise

The franchise partner may:

• Purchase products
• Promote brands
• Supply shops
• Develop a territory
• Appoint distributors

Required registrations depend on:

• Product categories
• Stock model
• State sale requirements
• GST
• FSSAI
• Local business laws

Clinic or Panchakarma Franchise

A franchise agreement does not permit an unqualified person to practise medicine.

Every clinical outlet must independently comply with:

• Practitioner registration
• Clinical-establishment registration
• Staffing
• Patient records
• Biomedical waste
• Local requirements

Franchise Agreement

A written agreement should cover:

• Territory
• Products or services
• Brand use
• Investment
• Purchase terms
• Royalty
• Training
• Quality standards
• Advertising
• Patient safety
• Complaints
• Termination
• Closing stock
• Intellectual property

Business Model 10: Direct Selling or MLM

Direct selling of legally compliant ASU products is possible, but the business must comply with the Consumer Protection (Direct Selling) Rules, 2021.

The Rules apply to direct-selling entities and sellers and prohibit:

• Pyramid schemes
• Recruitment-based disguised schemes
• Money-circulation schemes

They also require written seller contracts, consumer disclosures, grievance systems and product-law compliance.

Warning Signs of an Illegal Scheme

Be cautious where:

• Earnings depend mainly on recruitment.
• Large joining fees are charged.
• Members must purchase excessive stock.
• Products have little genuine retail demand.
• No return or buy-back process exists.
• Unrealistic income is promised.

A product should not be used merely as a cover for a pyramid scheme.

Business Model 11: Export

Export may involve:

• Ayurvedic medicines
• Unani medicines
• Siddha medicines
• Herbal cosmetics
• Food supplements
• Raw herbs
• Wellness services

Export Requirements

Possible requirements include:

• Valid domestic product and manufacturing licences
• IEC
• GST
• Export invoices
• Product dossier
• Free Sale Certificate
• Certificate of Pharmaceutical Product
• GMP or WHO-GMP documentation
• Country-specific product registration
• Certificate of analysis
• Heavy-metal testing
• Microbial testing
• Stability data
• Country-specific label
• Importer authorization

Domestic approval does not automatically authorize sale in another country.

CDSCO publishes details of Ayurvedic products for which CoPP has been granted under the WHO-GMP certification scheme.

GST on ASU Medicines

From 22 September 2025, drugs and medicines generally attract 5% GST except items specifically placed under the nil-rate category.

However, this rate should not automatically be used for:

• Food supplements
• Herbal drinks
• Cosmetics
• Personal-care products
• Devices

GST classification should be confirmed product-wise.

Advertising and Product Claims

Manufacturers, marketers, shops, online sellers, clinics and franchisees should avoid misleading claims.

Do not advertise:

• No side effects
• Guaranteed cure
• Permanent cure
• Government-approved cure
• Works within a fixed number of days
• Safe for everybody
• Replaces surgery
• Replaces prescribed medical treatment

The Government’s AYUSH quality and pharmacovigilance framework includes monitoring of suspected adverse reactions and objectionable or misleading advertisements through Ayush Suraksha.

Important Business Registrations

Depending on the model, registrations may include:

• Proprietorship, partnership, LLP or company
• PAN
• GST
• Current account
• Shop and Establishment registration
• Trade licence
• Udyam
• Trademark
• FSSAI
• Clinical-establishment registration
• Biomedical-waste authorization
• Fire NOC
• Pollution Control Board consent
• Factory licence
• IEC

No single registration covers every ASU business activity.

Documents Generally Required

Business Documents

• PAN
• Aadhaar or identity proof
• Address proof
• Entity documents
• Partnership deed
• Incorporation documents
• Bank details
• Authorization

Premises Documents

• Ownership proof
• Rent or lease agreement
• Owner’s NOC
• Utility bill
• Site plan
• Commercial or industrial-use proof

Technical Documents

• Degree certificates
• Practitioner registration
• Technical-staff appointment
• Experience records
• Manufacturing or laboratory qualifications

Product Documents

• Formula
• Classical reference
• Product permission
• Label
• Manufacturer’s licence
• GMP certificate
• Certificate of analysis
• Marketing agreement

Step-by-Step Business-Selection Guide

Choose Manufacturing When:

• You have substantial capital.
• You have technical experience.
• You have regular demand.
• You intend to manufacture for other brands.
• You can manage daily GMP compliance.

Choose Third-Party Marketing When:

• You want to build brands.
• Capital is limited.
• You want multiple dosage forms.
• You do not want to operate a factory.
• Faster market entry is needed.

Choose Distribution When:

• You know local retailers and clinics.
• You can manage stock and credit.
• You have delivery capability.
• You prefer trading over product promotion.

Choose a Shop When:

• You have a suitable retail location.
• Local consumer demand exists.
• You can maintain a proper product range.
• You understand mixed-product licences.

Choose a Clinic When:

• You possess the recognized system-specific qualification.
• Your professional registration is active.
• You can meet clinical-establishment requirements.

Choose a Panchakarma Centre When:

• A qualified Ayurvedic doctor will supervise it.
• Trained therapists are available.
• Clinical safety and hygiene systems can be maintained.
• The business is not merely a spa using a medical name.

Common Mistakes

Avoid:

• Treating Ayurveda, Unani and Siddha as identical systems
• Describing every therapy centre as Panchakarma
• Claiming that no licence is required for any ASU business
• Ignoring state-specific shop registration
• Manufacturing products without Form 25-D
• Marketing products from an unlicensed manufacturer
• Treating food supplements as medicines
• Allowing an unqualified owner to practise medicine
• Opening a clinic without practitioner registration
• Opening a therapy centre without clinical-establishment review
• Making no-side-effect claims
• Selling Schedule E(1) products online without prescription controls
• Operating an MLM based primarily on recruitment
• Exporting without importing-country registration
• Launching too many products without working capital

Frequently Asked Questions

1. Which licence is required for ASU manufacturing?

An application is generally made in Form 24-D, and the manufacturing licence is issued in Form 25-D.

2. What is a loan licence?

An application is made in Form 24-E, and the loan licence is granted in Form 25-E to use another approved manufacturer’s facilities.

3. Is Schedule T GMP compulsory?

Yes. Schedule T compliance is mandatory for licensed Ayurvedic, Siddha and Unani manufacturing.

4. Is a licence required to sell Ayurvedic medicines?

A separate central ASU sale licence is ordinarily not prescribed, but state-specific shop or establishment registration may apply.

5. Is a licence required for Unani and Siddha medicine shops?

The central position is similar, but the concerned state’s AYUSH rules and local registrations should be checked.

6. Is any qualification required to own an ASU shop?

No system-specific degree is ordinarily required merely to own a shop. Medical practice requires a recognized degree and registration.

7. Can a BAMS doctor open a Unani clinic?

A practitioner should practise according to their recognized system, qualification and registration. A BAMS qualification does not automatically authorize independent practice as a Unani physician.

8. Can a BUMS practitioner run a Panchakarma centre?

Panchakarma is an Ayurvedic discipline. The centre should be clinically supervised by a suitably qualified and registered Ayurvedic practitioner.

9. Who can open a Siddha clinic?

A suitably qualified and registered Siddha practitioner may provide Siddha clinical services according to applicable state requirements.

10. Is FSSAI required?

FSSAI registration or licensing is required for nutraceuticals, food supplements and other food-category products.

11. Can Schedule E(1) medicines be sold online?

E-commerce platforms have been advised to sell such medicines only after upload of a valid prescription from a registered practitioner.

12. Can ASU products be sold through MLM?

Yes, provided the products comply with applicable laws and the business complies with the Direct Selling Rules. Pyramid and money-circulation schemes are prohibited.

13. Is GST applicable?

Drugs and medicines generally attract 5% GST from 22 September 2025, except specifically nil-rated products. Other product categories may have different rates.

14. Can products be exported with only an Indian manufacturing licence?

No. Importing-country product registration and additional export documentation may be required.

15. Which business requires the lowest investment?

A small PCD, distribution or third-party marketing model normally requires less investment than establishing a manufacturing plant or full Panchakarma facility.

Final Conclusion

The correct process for starting an Ayurvedic, Unani or Siddha business is:

Select the exact business activity
→ Confirm the product category
→ Check central and state requirements
→ Register the entity
→ Arrange qualified staff where required
→ Obtain activity-specific licences
→ Purchase or manufacture only approved products
→ Maintain quality, safety and records
→ Use responsible advertising
→ Expand only after achieving stable demand

The major distinction is:

• Manufacturing requires a manufacturing licence and Schedule T GMP.
• Selling ASU medicines generally does not require a separate central sale licence, but state and local requirements may apply.
• Clinical diagnosis and treatment require a qualified and registered practitioner.
• Panchakarma should operate as a clinically supervised Ayurvedic service—not merely as a wellness massage business.

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 Services
• 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.