Natural products are not automatically licence-free.

A product may be obtained directly from nature, undergo only crushing and screening, and still require regulatory permission if it is packaged, labelled or advertised for medicinal use.

A common query is:

“I want to sell a natural mineral as a medical remedy. The mineral will not undergo any major processing except crushing, screening to the required size and packing. Do I need any licence or registration?”

The practical answer is:

Yes, a licence or regulatory approval may be required if the product is sold with claims that it treats, prevents, cures or manages a disease or affects the structure or function of the human body.

The exact licence depends on whether the product is classified as:

• A pharmaceutical drug
• An Ayurvedic, Siddha or Unani medicine
• A health supplement or nutraceutical
• An Ayurveda Aahara product
• A cosmetic or external-use product
• A general mineral or industrial product

You should determine the legal classification before printing the label or starting commercial sale.

“Natural” Does Not Mean Unregulated

The following statements do not automatically exempt a product from regulation:

• It is completely natural.
• It is found in the earth.
• It contains no synthetic chemical.
• It is traditionally used.
• It is only crushed and packed.
• It contains no pharmaceutical API.
• It is not manufactured in a factory.
• It has been used by local people for many years.

Regulators examine what the product is and how it is presented to consumers.

A naturally occurring substance can still contain:

• Heavy metals
• Arsenic
• Lead
• Mercury
• Cadmium
• Pathogenic microorganisms
• Pesticide residues
• Industrial contaminants
• Foreign matter
• Radioactive substances
• Variable mineral composition

Commercial sale therefore requires proper identification, specifications, testing and category-specific compliance.

The Product Claim Determines Regulatory Risk

A major deciding factor is the claim made on the:

• Label
• Carton
• Brochure
• Website
• Social media page
• Advertisement
• Distributor literature
• Verbal sales presentation
• Product name

Consider the following examples.

General Mineral Description

“Natural mineral powder, packed for industrial use.”

This may fall outside the medicine or food category, depending on its actual purpose.

Nutritional Description

“Provides calcium as a dietary mineral.”

This may fall within the food-supplement framework only when the mineral source, form, dosage and use are permitted under applicable FSSAI standards.

Medicinal Description

“Treats arthritis, kidney stones, acidity or diabetes.”

This creates a clear medicinal or disease-treatment claim and may bring the product within drug regulation.

Ayurvedic Description

“Classical Ayurvedic mineral remedy for a stated disease.”

This may require classification and manufacturing permission as an Ayurvedic medicine, along with compliance with authoritative textual references and applicable processing standards.

Changing only the wording on the front label does not necessarily change the category if the website or advertisements continue making therapeutic claims.

Does Crushing, Screening and Packing Count as Manufacturing?

A common assumption is that no manufacturing licence is required because the mineral is not chemically processed.

That assumption is unsafe.

Activities such as:

• Crushing
• Grinding
• Sieving
• Screening
• Blending
• Standardising
• Filling
• Repacking
• Labelling
• Sealing
• Preparing the product for sale

may be treated as manufacturing or processing activities under the applicable regulatory framework.

Therefore, a person should not purchase raw mineral, crush it at an ordinary premises, pack it in bottles and sell it as medicine without regulatory review.

Possible Regulatory Categories

1. Modern Pharmaceutical Drug

The product may be treated as a drug when it is intended for:

• Diagnosis
• Treatment
• Mitigation
• Prevention of disease
• Therapeutic alteration of a body function

In this situation, the business may require:

• Appropriate drug-manufacturing permission
• Product approval or permission
• Licensed manufacturing premises
• Qualified technical staff
• Quality-control arrangements
• Compliant labelling
• Applicable sale licence

A naturally occurring mineral does not become an approved pharmaceutical drug simply because published articles or traditional users describe medical benefits.

2. Ayurvedic, Siddha or Unani Medicine

Minerals are used in certain traditional formulations, but these products usually involve more than simple crushing.

Traditional mineral preparations may require processes such as:

• Purification
• Detoxification
• Shodhana
• Marana
• Bhavana
• Incineration
• Controlled heating
• Specific classical processing

The exact process depends on the recognized traditional formulation.

A raw mineral should not be labelled as a bhasma, pishti or other processed Ayurvedic medicine unless it has actually been prepared according to the appropriate recognized method and specifications.

Classical Ayurvedic Medicine

A classical product is generally based on an exact formulation appearing in an authoritative Ayurvedic text recognized under applicable law.

The manufacturer may need to document:

• Authoritative book
• Chapter or formulation reference
• Ingredient identity
• Mineral purification process
• Manufacturing method
• Dose
• Indication
• Quality specifications

Patent or Proprietary Ayurvedic Medicine

If the product is not an exact classical formulation, it may need evaluation as a patent or proprietary Ayurvedic medicine.

The authority may examine:

• Whether its ingredients are recognized
• Safety of the mineral
• Intended use
• Formula
• Manufacturing process
• Evidence and textual support
• Testing specifications
• Label claims

An old household remedy or family tradition does not automatically qualify for commercial Ayurvedic licensing.

3. Health Supplement or Nutraceutical

The FSSAI route may be possible only when the product genuinely qualifies as food or a regulated health supplement.

You must verify:

• Whether the mineral is permitted
• Permitted chemical form
• Permitted source
• Daily usage level
• Purity standards
• Contaminant limits
• Target consumer
• Required warnings
• Labelling category
• Whether prior approval is required

For example, calcium, iron, magnesium and zinc may be used in regulated supplement products only in suitable permitted forms and quantities.

A naturally mined stone or powdered earth does not automatically become a permitted mineral supplement.

4. Non-Specified Food or Ingredient

If a proposed mineral or its source is not covered by existing food standards, the business may need to examine whether it requires approval as a non-specified food or ingredient.

You should not commercially launch an unlisted mineral and wait for an inspector to decide its category later.

5. Ayurveda Aahara

Ayurveda Aahara is a separate food-regulatory category.

It should not be confused with an Ayurvedic medicine.

A product sold under the Ayurveda Aahara framework must satisfy the applicable food regulations and cannot simply use disease-treatment claims that make it a medicine.

6. Cosmetic or External-Use Product

A natural mineral may be intended for external use.

Examples may include products used for:

• Cleansing
• Beautifying
• Skin appearance
• Hair appearance
• Body-care applications

In that situation, it may fall within cosmetic regulation.

However, medicinal claims can change the position.

For example:

Cosmetic-style claim:
“Helps cleanse oily skin.”

Drug-style claim:
“Treats fungal infection and eczema.”

The second claim may place the product within a drug category rather than an ordinary cosmetic category.

7. General Mineral or Industrial Product

When a mineral is sold only for:

• Industrial use
• Laboratory use
• Agricultural use
• Construction
• Craft work
• General raw-material supply

and no human-consumption or medicinal claims are made, drug or FSSAI licensing may not apply.

Other requirements may still apply, including:

• Mining and mineral sourcing laws
• Pollution-control requirements
• Legal Metrology
• Packaged commodity declarations
• GST
• Local trade licence
• Transport requirements
• Hazard communication
• Consumer-protection law

Why You Cannot Simply Call It a Dietary Supplement

A food supplement should not be used as an alternative route merely to avoid drug licensing.

The following conditions should be checked:

1. Is the mineral permitted for human consumption?
2. Is its chemical form permitted?
3. Is the source food-grade?
4. Is the daily dose within permitted limits?
5. Is it safe for repeated oral consumption?
6. Are contaminants within acceptable limits?
7. Are the proposed claims permitted?
8. Is the product category available through FoSCoS?
9. Does the ingredient require separate approval?

If these questions cannot be answered, the FSSAI route should not be assumed.

Example Classifications

Example 1: Rock Salt

Rock salt intended for cooking may fall under the food category and applicable salt standards.

If the same pack claims to cure hypertension or kidney disease, the medicinal claim creates additional legal risk.

Example 2: Calcium Carbonate Supplement

A properly formulated calcium supplement may fall under food or drug regulation depending on:

• Strength
• Dosage form
• Claims
• Product category
• Permitted source

Raw limestone powder should not automatically be marketed as a calcium supplement.

Example 3: Ayurvedic Mineral Bhasma

A bhasma generally requires recognized Ayurvedic processing, appropriate manufacturing permission and quality testing.

Plain crushed metal or mineral is not automatically a legally compliant bhasma.

Example 4: Multani Mitti

Multani mitti sold for cosmetic face-pack use may be regulated differently from a product claiming to treat psoriasis or skin infection.

Example 5: Shilajit-Type Substance

A natural exudate or mineral-rich substance may fall under different categories depending on:

• Purification
• Source
• Composition
• Dosage form
• Claims
• Regulatory pathway

It should not be sold merely on the basis of its natural origin.

Basic Testing Required

The testing programme depends on the mineral and product category.

Common considerations may include:

• Identity
• Mineral composition
• Assay
• Particle size
• Moisture
• Foreign matter
• Heavy metals
• Arsenic
• Lead
• Mercury
• Cadmium
• Microbial limits
• Pesticide residues
• Aflatoxins, where relevant
• Stability
• Packaging compatibility
• Radioactivity assessment, where relevant to the source

A generic laboratory report saying “sample is natural” is not sufficient.

Testing should be linked to:

• Batch number
• Specification
• Method
• Acceptance limits
• Authorized laboratory report

Documents You May Need

Depending on classification, documents may include:

Business Documents

• Proprietorship, partnership, LLP or company registration
• PAN
• GST registration, where applicable
• Premises proof
• Local trade registration

Product Documents

• Exact mineral name
• Chemical composition
• Geological or botanical source
• Source and supplier details
• Intended use
• Manufacturing process
• Particle-size specification
• Proposed dosage
• Proposed label
• Product-category justification

Quality Documents

• Raw-material specification
• Finished-product specification
• Certificate of Analysis
• Heavy-metal report
• Microbial report
• Stability information
• Packaging specification
• Batch records

Regulatory Documents

Depending on category:

• Drug-manufacturing licence
• Ayurvedic manufacturing licence
• Product permission
• FSSAI registration or licence
• Non-specified food approval
• Cosmetic manufacturing licence
• Wholesale or retail sale licence
• Legal Metrology declarations

Third-Party Manufacturing Is Often Safer

A startup does not necessarily need to build its own mineral-processing facility.

After classification, it may be safer to work with a licensed third-party manufacturer that already has:

• Suitable premises
• Required licence
• Qualified staff
• Quality-control laboratory
• Relevant product experience
• Packaging facilities
• Documentation system

However, the marketer should still verify:

• Licence
• Product permission
• Testing
• Quality agreement
• Batch-wise COA
• Complaint and recall procedure

Label Information

The final label depends on product category.

It may need information such as:

• Product name
• Legal product category
• Complete composition
• Quantity
• Directions for use
• Batch number
• Manufacturing date
• Expiry or best-before date
• Manufacturer details
• Marketer details
• Licence number
• Storage conditions
• Warnings
• MRP
• Net quantity
• Customer-care information

Do not print labels before the category and claims have been reviewed.

Product Name Can Also Create a Medical Claim

Even without an explicit sentence, a product name may imply treatment.

Names containing words such as:

• Cure
• Stone remover
• Anti-diabetic
• Arthritis relief
• Cancer remedy
• Kidney treatment
• Infertility cure

may create a medicinal impression.

Choose a neutral brand name until the regulatory classification and approved claims are clear.

Recommended Step-by-Step Process

Step 1: Identify the Mineral Precisely

Do not use only a local or traditional name.

Determine:

• Common name
• Chemical name
• Mineralogical identity
• Source
• Composition
• Potential contaminants

Step 2: Decide the Intended Use

Will it be sold for:

• Oral consumption
• External use
• Industrial use
• Ayurvedic therapeutic use
• Nutritional supplementation

Step 3: Prepare Proposed Claims

Write every claim you want to use on:

• Label
• Website
• Brochure
• Advertisements

Classification cannot be completed without considering the claims.

Step 4: Obtain Laboratory Analysis

Test identity, composition and safety parameters through a competent laboratory.

Step 5: Seek Written Classification Advice

Approach the appropriate authority:

• State Drug Control Department
• State AYUSH Drug Licensing Authority
• FSSAI or state food authority
• Cosmetic licensing authority

Provide the exact composition, process and label.

Step 6: Select the Regulatory Route

Choose the route based on written technical and legal review—not on which licence is easiest or cheapest.

Step 7: Select a Licensed Manufacturer

Use an appropriate third-party manufacturer if your own facility is unavailable.

Step 8: Complete Product and Label Approval

Finalize:

• Product category
• Composition
• Claims
• Dosage
• Packaging
• Warnings

Step 9: Manufacture and Test Commercial Batches

Maintain:

• Batch records
• COA
• Source traceability
• Packing records
• Retention samples

Step 10: Sell Through the Correct Channel

Use the appropriate food, drug, cosmetic or general trade distribution system.

Common Mistakes to Avoid

Avoid:

• Assuming natural products need no licence
• Calling an unapproved mineral a dietary supplement
• Selling raw mineral powder as medicine
• Making disease-cure claims under FSSAI
• Using an Ayurvedic name without classical support
• Calling crushed mineral a bhasma
• Skipping heavy-metal testing
• Using a non-food-grade source for oral consumption
• Printing the label before classification
• Relying only on supplier statements
• Selling without batch traceability
• Hiding medicinal claims only on social media
• Using customer testimonials to make prohibited claims

Practical Answer to the Query

If you crush, screen and pack a natural mineral and sell it as a medical remedy, you should assume that regulatory permission will be required until the competent authority confirms otherwise.

The possible routes are:

• Drug licence if sold as a modern medicinal product
• AYUSH manufacturing licence if it qualifies as an Ayurvedic, Siddha or Unani medicine
• FSSAI licence only if it is a permitted food or supplement ingredient with compliant claims
• Cosmetic licence if intended for cosmetic external use
• General trade compliance if sold only as a non-medicinal mineral

Do not simply change the description to “dietary supplement” without confirming that the mineral, source, dosage and claims are permitted under FSSAI regulations.

Frequently Asked Questions

1. Does a completely natural product require a licence?

Yes, it may. Natural origin does not provide an automatic exemption from drug, food or cosmetic regulation.

2. Is crushing and packing considered manufacturing?

It may be treated as manufacturing or processing depending on the applicable law and product category.

3. Can every natural mineral be sold under FSSAI?

No. The mineral, source, chemical form, daily quantity and intended use must be permitted under the applicable food standards.

4. Can I sell it as a dietary supplement instead of medicine?

Only if it genuinely qualifies as a food supplement and all ingredients, doses, labels and claims comply with FSSAI requirements.

5. Can a food supplement claim to cure a disease?

Ordinary food supplements should not be marketed with medicinal disease-treatment or cure claims.

6. Can I sell raw mineral as Ayurvedic medicine?

Not automatically. Ayurvedic mineral medicines may require recognized ingredients, processing, textual references, product permission and licensed manufacturing.

7. Is a laboratory report enough to sell the product?

No. Testing is important but does not replace the required licence or product approval.

8. Do I need a manufacturing licence if I only pack the mineral?

Repacking and labelling may still be regulated. Confirm the requirement with the applicable licensing authority.

9. Can I get it manufactured by another company?

Yes, after determining the correct category, you can work with a licensed third-party manufacturer authorized for that product type.

10. Which authority should I contact first?

Contact the State Drug Control or State AYUSH Licensing Authority if medicinal claims are proposed. Contact the food authority when the product is genuinely intended as a permitted food or health supplement.

Final Thoughts

The legal category of a natural mineral product is decided by more than its origin or manufacturing process.

The correct sequence is:

Identify the mineral → Test its composition and safety → Decide its intended use → Review the claims → Confirm the regulatory category → Obtain the required licence → Manufacture and market

The statement “It is natural and only crushed, so no licence is required” is not a safe basis for launching a product.

Similarly, the statement “We will call it a dietary supplement and take FSSAI” is not correct unless the mineral is actually permitted as a food ingredient or supplement.

Obtain written classification advice before investing in packaging, advertising or commercial stock.

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