Before launching a pharmaceutical or Ayurvedic product in India, a company should understand that there are usually two separate regulatory questions:

1. Is the formulation legally permitted to be manufactured and marketed?
2. Who owns or protects the brand name under which the product will be sold?

These are not the same process.

For example:

• A drug-manufacturing authority may permit a manufacturer to manufacture a particular formulation.
• The Trade Marks Registry deals separately with ownership and registration of the brand name.

Therefore, obtaining manufacturing approval does not automatically provide trademark rights over the product name.

Quick Answer

If your products are being manufactured in India by a third-party manufacturer:

For Pharmaceutical Products

The manufacturer must hold:

• A valid manufacturing licence
• Permission or endorsement for the relevant formulation
• Additional Central approval where the product falls under the definition of a new drug

The marketing company normally does not separately “register” every already-approved pharmaceutical formulation merely because its brand name will appear on the pack.

For Ayurvedic Products

The Ayurvedic manufacturer must hold an appropriate Ayurvedic manufacturing licence and the required product permissions under the applicable Drugs Rules.

For a patent or proprietary Ayurvedic product, the formulation and ingredients must satisfy the applicable Ayurvedic licensing requirements.

For Brand Name

Trademark registration is a separate process.

The person or company that intends to own the brand should normally:

• Conduct a trademark search
• File the trademark application
• Maintain ownership of the mark
• Handle objections or opposition, if any

Two Different Registrations You Should Understand

1. Regulatory Product Approval or Manufacturing Permission

This relates to:

• Composition
• Strength
• Dosage form
• Product category
• Manufacturing licence
• Safety and efficacy requirements
• Manufacturing site

The application is handled through the applicable drug regulatory authority.

2. Trademark or Brand-Name Registration

This relates to ownership and protection of names such as:

• ABC Tablets
• XYZ Syrup
• ABC Pharma
• XYZ Ayurveda

Trademark registration is handled by the Office of the Controller General of Patents, Designs and Trade Marks.

A drug licence does not give exclusive trademark ownership.

Pharmaceutical Product Registration in India

For an ordinary pharmaceutical formulation manufactured in India, the regulatory responsibility lies primarily with the licensed manufacturer.

The manufacturer must hold the applicable manufacturing licence for:

• Tablets
• Capsules
• Syrups
• Injections
• Ointments
• Creams
• Other dosage forms

The approved manufacturing site must also comply with applicable GMP requirements.

Is Every Pharmaceutical Brand Registered Separately With CDSCO?

Not necessarily.

There is an important difference between:

• Approval of the drug/formulation, and
• Commercial use of a brand name.

Manufacturing licences for ordinary formulations are primarily linked to the proper or generic name, composition and strength of the drug.

However, where a manufacturer intends to market a product under a brand or trade name, the licensing process may require declarations or undertakings regarding that proposed brand.

This regulatory declaration should not be confused with trademark registration.

What Happens If the Formulation Is Already Approved?

Suppose a third-party manufacturer already has permission to manufacture:

Paracetamol Tablets IP 500 mg

If your marketing company wants the same approved formulation under its own brand, it may not require a completely new central drug approval simply because the brand is different.

However, the manufacturer must ensure that:

• Its licence covers the formulation.
• The approved strength and dosage form are correct.
• The label complies with the Drugs Rules.
• Brand-name requirements of the licensing authority are fulfilled.
• The marketing-company details are correctly included.
• The product does not fall under a special regulatory category requiring additional approval.

The manufacturer’s regulatory or QA team should confirm this before commercial production.

What If It Is a New Drug or New Combination?

This is different.

If the proposed pharmaceutical product qualifies as a new drug under the New Drugs and Clinical Trials Rules, 2019, prior permission from the Central Licensing Authority may be required.

Examples can include:

• New chemical entities
• Certain new fixed-dose combinations
• New indications
• New routes of administration
• New dosage forms in circumstances covered by the rules
• Certain new strengths or combinations

The application may require data relating to:

• Pharmaceutical development
• Quality
• Stability
• Safety
• Efficacy
• Bioavailability or bioequivalence
• Clinical trials, where applicable

Therefore, a manufacturer cannot simply manufacture every new combination after paying a small “product approval fee.”

Who Applies for Pharmaceutical Product Approval?

Existing Approved Formulation

The licensed manufacturer normally handles manufacturing-related permissions.

If you are only the marketing company using third-party manufacturing, you generally coordinate with the manufacturer.

New Drug

The applicant seeking permission for the new drug must proceed under the New Drugs and Clinical Trials Rules and obtain the necessary Central Licensing Authority permission before commercial manufacture.

The exact applicant may depend on the commercial and licensing structure.

Loan Licence

Where the marketing company itself operates under a loan-licence structure, its regulatory responsibilities may be different from a simple “marketed by” arrangement.

Do not treat third-party manufacturing and loan licensing as automatically identical.

Can a Marketing Company Launch a Product Without Checking Manufacturer Approval?

No.

Before placing an order, request:

• Manufacturing licence
• Product permission or endorsement
• GMP certificate
• Manufacturer details
• Approved composition
• Product specification
• COA or testing arrangements
• Approved artwork confirmation

A quotation from the manufacturer is not proof that the product is legally authorised.

Ayurvedic Product Registration in India

Ayurvedic, Siddha and Unani medicines are governed under separate provisions of the Drugs and Cosmetics Act and Drugs Rules.

The State Government appoints the licensing authority for the manufacture of Ayurvedic, Siddha and Unani medicines.

Manufacturing applications are processed under the applicable Ayurvedic drug-licensing provisions.

Main Categories of Ayurvedic Medicines

It is important to distinguish between:

1. Classical Ayurvedic Medicines

These are formulations manufactured according to formulae described in the authoritative books recognised under the Drugs and Cosmetics Act.

Examples may include traditional formulations such as:

• Ashokarishta
• Dashmularishta
• Triphala Churna
• Chandraprabha Vati
• Classical Taila
• Classical Ghrita preparations

The formulation should correspond with the authoritative reference.

The manufacturer cannot arbitrarily modify the classical composition while continuing to present it as the same classical medicine.

2. Patent or Proprietary Ayurvedic Medicines

These are formulations composed of permitted ingredients from authoritative Ayurvedic texts but formulated as proprietary combinations according to the applicable rules.

The manufacturer must provide the necessary details and supporting information required by the licensing authority.

These may include:

• Ingredient names
• Botanical names
• Parts used
• Quantities
• Authoritative references
• Intended indication
• Dosage form
• Safety information where applicable
• Evidence requirements where applicable

Ayurvedic Manufacturing Licence

An application to manufacture Ayurvedic, Siddha or Unani drugs is generally made to the State Licensing Authority.

The manufacturing licence is issued in Form 25D, subject to applicable requirements.

A manufacturer without its own facilities may also operate under an approved loan-licence arrangement using the facilities of an eligible licensed manufacturer.

Who Applies for Ayurvedic Product Permission?

In a normal third-party manufacturing arrangement, the licensed Ayurvedic manufacturer generally deals with the product licensing and manufacturing permission.

However, the situation may differ if the marketing company:

• Holds a loan licence
• Is itself the licence applicant
• Owns the formulation dossier
• Uses a special contractual manufacturing structure

The regulatory structure should therefore be decided before manufacturing begins.

Does a Marketing Company Need Its Own Ayurvedic Manufacturing Licence?

Not merely because its name is printed as:

“Marketed by”

on a product manufactured by another properly licensed manufacturer.

However, the marketing company may require other registrations depending on:

• Its business model
• Storage activity
• Wholesale activity
• Product category
• State
• Online selling
• Export activity

If the marketing company wants to act as a loan-licensee or manufacture in its own name under the relevant licensing arrangement, separate licensing requirements apply.

Classical Ayurvedic Product Approval

Even though a classical medicine follows an authoritative formulation, the manufacturer still needs appropriate licensing documentation and must identify the authoritative reference.

The product should match:

• Classical name
• Ingredients
• Preparation method
• Dosage form
• Applicable authoritative text

Where changes are made to dosage form, indication or other important aspects, additional regulatory requirements may apply.

Patent and Proprietary Ayurvedic Product Approval

For a patent or proprietary Ayurvedic medicine, the regulatory authority may review:

• Formula
• Ingredients
• Authoritative-book references
• Safety requirements
• Evidence of effectiveness
• Product category
• Indications

The requirements differ depending on whether the formulation uses:

• Known classical ingredients
• Changed dosage form
• New indication
• New combination
• Other permitted proprietary approaches

Do not assume that any combination of herbal ingredients can automatically receive an Ayurvedic drug licence.

Ayurvedic Product Approval Fees

Under the current Drugs Rules, an application for an Ayurvedic, Siddha or Unani manufacturing licence has prescribed fees.

Broadly:

Classical medicines under Section 3(a)

The prescribed application fee is: Vary state to state

Patent or Proprietary medicines under the relevant Section 3(h) category

The prescribed fee is: vary state to state

These are regulatory fees prescribed for the licensing application.

They should not be confused with the amount that a third-party manufacturer may charge its customer.

A manufacturer may separately charge for:

• Documentation
• Regulatory consultancy
• Product development
• Samples
• Testing
• Stability work
• Artwork
• Administrative expenses

Therefore, the manufacturer’s commercial “product approval charge” may differ from the government fee.

How Much Time Does Ayurvedic Approval Take?

The Drugs Rules provide for issuance of the Form 25D manufacturing licence within two months from receipt of the application or from the date on which any shortcomings identified by the licensing authority have been complied with.

In practice, the actual total project time can be longer if:

• Documents are incomplete.
• The authority raises queries.
• Formulation clarification is required.
• Testing is pending.
• Manufacturing facilities require correction.
• Product-category questions arise.

Therefore, do not fix a commercial product-launch date until the manufacturer confirms approval in writing.

Brand Name Registration Is a Separate Process

A product licence does not mean that you own the brand.

For example, a manufacturer may be authorised to manufacture:

Brahmi Capsules

but this does not automatically give you exclusive rights to use:

BRAHMITEC

or any other proposed brand.

Trademark protection is dealt with separately under the Trade Marks Act and Rules.

Who Should Register the Brand Name?

Normally, the company that wants to own the brand should file the trademark application.

For a third-party marketed product, this is commonly the:

Marketing company

rather than the contract manufacturer.

This is important because the brand is a valuable business asset.

The manufacturing agreement should clearly confirm that:

• The marketing company owns the trademark.
• The manufacturer is only authorised to use it for manufacturing.
• The manufacturer does not acquire ownership rights.
• Packaging containing the trademark is controlled appropriately.

Is Trademark Registration Compulsory Before Launch?

Trademark registration is generally not the same as regulatory permission to sell the medicine.

However, filing for trademark protection before investing heavily in:

• Packaging
• Advertising
• Product launch
• Distributor appointments
• Website development

is strongly advisable.

Before selecting a brand name, conduct a proper trademark search.

Pharmaceutical Trademark Class

Pharmaceutical, medicinal and many veterinary preparations generally fall under Class 5 of the trademark classification system.

However, your business may require additional classes depending on what you want to protect.

For example:

• Medicine brand
• Company trading services
• Retail services
• Cosmetics
• Food supplements

A trademark professional should determine the appropriate class or classes.

Current Trademark Filing Fee

For a standard TM-A application filed electronically, the official fee is currently:

Individual / Startup / Small Enterprise

₹4,500 per mark per class

Other applicants

₹9,000 per mark per class

Professional fees of a trademark attorney or agent are additional.

If you file the same brand in multiple classes, separate class fees apply.

How Long Does Trademark Registration Take?

There is no fixed period that guarantees registration.

The process normally involves:

1. Filing
2. Formality check
3. Examination
4. Response to objections, if any
5. Hearing, where necessary
6. Acceptance
7. Publication in the Trade Marks Journal
8. Opposition period
9. Registration

After publication, there is a four-month opposition period.

If there is:

• No objection
• No opposition
• No hearing delay

registration can move considerably faster than a contested application.

If objections or opposition arise, the process may take much longer.

Check: In detail how to apply for trademark registration in India

Product Approval vs Trademark: Simple Example

Suppose your company wants to launch:

CARDIOZAC Tablets

containing an approved formulation.

Product Side

The manufacturer must be legally authorised to manufacture the composition.

Brand Side

You should check whether “CARDIOZAC” or a confusingly similar trademark already exists and consider filing your own trademark application.

These two procedures are independent.

The drug authority does not guarantee trademark ownership.

The Trade Marks Registry does not approve the medicine’s formulation.

Important Form 51 Brand-Name Requirement for Pharmaceutical Manufacturers

Current CDSCO manufacturing-licence guidance provides that where a manufacturer proposes to market a drug under a brand or trade name, an undertaking in Form 51 is furnished to the licensing authority.

The manufacturer declares, to the best of its knowledge, that:

• The proposed or similar drug brand does not already exist.
• The proposed name will not create confusion or deception.

This is a regulatory undertaking.

It is not a substitute for a trademark search or trademark registration.

Step-by-Step Procedure Before Launching a Pharmaceutical Product

Step 1: Finalise the Product

Confirm:

• Composition
• Strength
• Dosage form
• Pack
• Intended market
• Proposed brand

Step 2: Select the Manufacturer

Verify:

• Manufacturing licence
• GMP status
• Dosage-form capability
• Product approval
• Testing facilities

Step 3: Determine Whether the Formulation Is Already Approved

Ask the manufacturer for documentary evidence.

Step 4: Determine Whether It Is a New Drug

If applicable, obtain advice on requirements under the New Drugs and Clinical Trials Rules.

Step 5: Search the Proposed Trademark

Search:

• Exact name
• Similar spelling
• Similar pronunciation
• Similar pharmaceutical marks

Step 6: File the Trademark

File the application in the appropriate class or classes.

Step 7: Prepare Artwork

Include:

• Approved composition
• Manufacturer details
• Manufacturing licence number
• Marketed-by details
• Batch and expiry fields
• MRP
• Storage
• Schedule warnings
• Other mandatory declarations

Step 8: Obtain Manufacturer Approval of Artwork

Do not print packaging before the manufacturer’s QA/regulatory approval.

Step 9: Manufacture the Batch

Commercial manufacture should start only when the applicable regulatory requirements are complete.

Step 10: Maintain Documentation

Keep:

• Manufacturing licence
• Product permission
• GMP certificate
• Purchase order
• Manufacturing agreement
• Approved artwork
• Trademark application
• COA
• Batch documents
• Invoice

Step-by-Step Procedure Before Launching an Ayurvedic Product

Step 1: Decide the Product Category

Determine whether it is:

• Classical Ayurvedic medicine
• Patent/proprietary Ayurvedic medicine
• Food supplement
• Cosmetic

Do not assume every herbal product is an Ayurvedic medicine.

Step 2: Finalise the Formula

Mention:

• Ingredient
• Botanical name
• Part used
• Quantity
• Extract strength
• Authoritative reference
• Dosage form

Step 3: Select a Licensed Ayurvedic Manufacturer

Verify:

• Form 25D licence
• GMP certificate
• Approved product categories
• Manufacturing capability

Step 4: Confirm Product Licensing Status

Ask whether:

• The formulation already appears under the manufacturer’s approved scope.
• A new product application is required.
• Additional safety or evidence documents are required.

Step 5: Select and Search the Brand

Do a trademark search before packaging investment.

Step 6: File the Trademark

File the application in the appropriate class or classes.

Step 7: Submit the Required Product Application

The manufacturer or loan-license applicant should complete the applicable regulatory process.

Step 8: Finalise Artwork

Check:

• Product category
• Ingredients
• Classical reference where applicable
• Manufacturer
• Licence number
• Dosage
• Indication
• Warnings
• Batch details
• Marketed-by details

Step 9: Start Manufacturing Only After Approval

Do not launch the product while approval is still “under process.”

Documents a Marketing Company Should Obtain From the Manufacturer

Before launching a third-party manufactured product, maintain copies of:

• Manufacturing licence
• GMP certificate
• Product permission
• Product composition
• Manufacturer GST details
• Manufacturing agreement
• COA
• Test reports
• Approved artwork
• Invoice
• Batch number
• Expiry details

For Ayurvedic products, also request:

• Relevant Form 25D details
• Product approval/listing
• Classical reference where applicable
• Authoritative ingredient references for proprietary products

Approximate Responsibility Matrix

Activity	Manufacturer	Marketing Company
Manufacturing licence	Yes	No, unless own/loan licence
Product manufacturing permission	Primarily yes	Coordinate
New drug approval	Applicant/manufacturer as applicable	May be involved
Manufacturing quality	Yes	Must verify
Product testing	Yes	May independently verify
Brand selection	Joint review	Primarily
Trademark search	Should check	Yes
Trademark application	Not necessarily	Normally brand owner
Artwork technical approval	Yes	Yes
Marketing claims	Shared responsibility	Yes
Product promotion	Support	Primarily
Brand infringement risk	Both should check	Brand owner bears major commercial risk

Common Mistakes to Avoid

• Assuming manufacturer quotation means product approval
• Confusing drug approval with trademark registration
• Printing packaging before trademark search
• Believing a drug authority owns or protects the brand
• Assuming all Ayurvedic products follow one approval route
• Calling a health supplement an Ayurvedic medicine
• Launching a new pharmaceutical combination without checking NDCTR requirements
• Relying only on verbal approval from the manufacturer
• Using another company’s similar brand name
• Paying a “product approval fee” without asking what it covers
• Manufacturing before written approval
• Filing trademark only after the product becomes successful

Answer to the Original Questions

1. Is registration required before launching pharmaceutical or Ayurvedic products?

Yes, the formulation must be legally authorised for manufacture under the applicable regulatory framework.

However, this does not necessarily mean that the marketing company has to independently register every existing formulation.

The manufacturer must have the appropriate licence and product permission.

Trademark registration is a separate and strongly recommended process.

2. Who applies: manufacturer or marketing company?

Regulatory Manufacturing Approval

Usually the licensed manufacturer or applicable licence holder.

Trademark

Normally the person or company that intends to own the brand.

3. What are the approximate time and fees?

There is no single fee or timeline for every pharmaceutical and ayurvedic product.

Trademark e-filing currently costs:

• ₹4,500 per class per mark for individual/startup/small enterprise applicants
• ₹9,000 per class per mark for other applicants

Trademark completion time varies according to examination, objections and opposition.

Frequently Asked Questions

1. Does every pharmaceutical brand require a separate CDSCO registration?

Not simply because the brand name changes. The manufacturer must hold the appropriate licence and product authorisation for the formulation. New drugs require additional Central permission.

2. Does drug approval protect my brand name?

No. Trademark protection is separate.

3. Can I start manufacturing immediately after filing a trademark?

Trademark filing does not grant permission to manufacture a medicine. Drug regulatory requirements must be completed separately.

4. Who owns the brand in third-party manufacturing?

Normally the person or company that owns or applies for the trademark, subject to contractual arrangements.

5. Can a manufacturer use my brand for another customer?

Your manufacturing agreement and trademark rights should prohibit unauthorised use.

6. Does a classical Ayurvedic medicine require approval?

The manufacturer still requires the appropriate Ayurvedic manufacturing licence and the product must comply with the authorised classical formulation and reference.

7. Can I change the ingredients of a classical medicine?

Not arbitrarily while continuing to represent it as the same classical formulation.

8. Who grants Ayurvedic manufacturing licences?

The applicable State Licensing Authority grants Ayurvedic, Siddha and Unani manufacturing licences.

9. What is Form 25D?

Form 25D is the manufacturing licence for sale of Ayurvedic, Siddha or Unani drugs under the applicable Drugs Rules.

10. What is a loan licence?

A loan licence allows an eligible applicant without its own manufacturing facilities to use the manufacturing facilities of an approved licensed manufacturer under the applicable regulatory framework.

11. Should I register the trademark before ordering packaging?

Preferably conduct the trademark search and file the application before making substantial investment in printed packaging.

12. Can two pharmaceutical products have similar brand names?

Similar marks can create regulatory, commercial and trademark disputes. A comprehensive search should be conducted before adoption.

Final Thoughts

Before launching a pharmaceutical or Ayurvedic product, remember the following formula:

Product permission + licensed manufacturer + compliant packaging + trademark due diligence + quality documentation = safer product launch

Never treat product approval and brand registration as the same thing.

The manufacturer is primarily responsible for ensuring that the product is legally permitted to be manufactured.

The brand owner should protect the commercial identity of the product through proper trademark due diligence and registration.

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