India has a growing market for Ayurvedic, Unani, Siddha, Homoeopathic and other traditional healthcare products. However, businesses planning to manufacture medicinal products must meet specific regulatory requirements before starting operations. Obtaining an AYUSH License is an important step towards ensuring legal manufacturing, product quality and consumer safety.

The licensing process involves eligibility verification, document preparation, manufacturing infrastructure, quality control arrangements and regulatory inspections. Business owners must also identify the appropriate licence category and comply with applicable government regulations.

This information explains the licensing requirements, application procedures, government fees and essential compliance responsibilities for AYUSH medicine manufacturers in India.

What Is an AYUSH License in India?

An AYUSH License commonly refers to the regulatory authorisation required for manufacturing medicines belonging to recognised Indian and traditional systems of medicine.

AYUSH represents Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy. The wider regulatory framework also recognises Sowa-Rigpa medicines.

The Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, regulate manufacturing activities involving these medicinal products.

The relevant State or Union Territory Licensing Authority grants manufacturing licences after assessing the applicant’s eligibility, premises, technical staff, product information and manufacturing arrangements.

An important distinction: The Ministry of Ayush establishes and administers central regulatory policies, but State and Union Territory Licensing Authorities issue manufacturing licences.

Additionally, there is no single manufacturing licence covering every AYUSH activity. The required authorisation depends on the medicinal system, business model and product classification.

Who Needs an AYUSH License in India?

Businesses manufacturing regulated AYUSH medicines for sale must obtain the appropriate manufacturing authorisation.

The licensing requirements generally apply to:

• Ayurvedic medicine manufacturers: Businesses producing Ayurvedic tablets, oils, powders, syrups and other medicinal formulations.
• Unani medicine manufacturers: Companies manufacturing traditional Unani medicinal preparations.
• Siddha medicine manufacturers: Businesses producing Siddha medicines under applicable regulatory standards.
• Homoeopathic medicine manufacturers: Companies manufacturing Homoeopathic preparations, including mother tinctures and other regulated products.
• Sowa-Rigpa medicine manufacturers: Establishments producing medicines recognised under the relevant regulatory provisions.
• Third-party manufacturing businesses: Companies seeking production through another manufacturer’s facilities, where a loan licence or other applicable arrangement is required.
• Herbal medicine businesses: Enterprises marketing products that legally qualify as AYUSH medicines.

Retailers, distributors, wellness centres and online sellers may face different requirements. Manufacturing authorisation should not be confused with permissions for operating a clinic or selling medicinal products.

Types of AYUSH Licences Available in India

Applicants must identify the correct licence category before submitting their applications.

1. Ayurvedic, Siddha and Unani Manufacturing Licence

Businesses establishing their own manufacturing facilities generally apply using Form 24-D.

The competent authority issues the manufacturing licence in Form 25-D after verifying compliance with applicable requirements.

This category applies to eligible manufacturers operating their own production premises.

2. AYUSH Loan Manufacturing Licence

A loan licence allows an eligible applicant to use the manufacturing facilities of another appropriately licensed manufacturer.

For Ayurvedic, Siddha and Unani medicines, applicants generally use Form 24-E, while authorities issue the corresponding licence in Form 25-E.

This arrangement can help businesses avoid establishing an independent manufacturing unit.

3. Homoeopathic Manufacturing Licence

Homoeopathic medicine manufacturing follows separate regulatory provisions.

Applicants generally use Form 24C for manufacturing licence applications, with licences issued in Form 25C.

The applicable framework also provides for Homoeopathic loan licence applications through Form 24C1, with corresponding licences issued in Form 25C1.

4. GMP Certification

Good Manufacturing Practices certification demonstrates compliance with prescribed manufacturing quality standards.

AYUSH medicine manufacturers must meet the relevant GMP requirements. Certification and manufacturing licensing remain distinct regulatory matters.

Eligibility Criteria for Obtaining an AYUSH License

Applicants must fulfil the eligibility conditions applicable to their manufacturing activities.

1. Legally Established Business

The applicant should operate through an appropriate business structure, such as:

• Sole proprietorship
• Partnership firm
• Limited Liability Partnership
• Private limited company
• Other legally recognised entity

The applicant must provide relevant business registration and ownership documents.

2. Suitable Manufacturing Premises

Manufacturing premises must meet the applicable requirements concerning space, sanitation, ventilation, equipment and production activities.

The facility should support safe manufacturing and proper handling of raw materials.

3. Qualified Technical Personnel

Manufacturers must appoint competent technical personnel with qualifications and experience recognised under the applicable rules.

The precise qualifications depend on the medicinal system and manufacturing activities.

4. Quality Control Arrangements

Applicants must establish suitable arrangements for testing raw materials, intermediate products and finished medicines.

Where permitted, manufacturers may use approved external testing laboratories.

5. Regulatory Compliance

The applicant must comply with relevant manufacturing, safety, product documentation, labelling and quality requirements.

Meeting these conditions helps reduce objections during regulatory verification.

Documents Required for an AYUSH License in India

Documentation plays an important role in the licensing process. Incomplete records can delay verification or result in additional queries.

Business Registration Documents

Applicants may need:

• Certificate of incorporation or business registration
• Partnership deed or LLP agreement, where applicable
• PAN details of the applicant entity
• Identity and address proof of authorised persons
• Authorisation letter or board resolution
• Relevant statutory registrations, where applicable

Manufacturing Premises Documents

The authorities may request:

• Ownership documents or registered lease agreement
• Building layout and manufacturing site plan
• Details of manufacturing and storage areas
• Equipment and machinery specifications
• Proof of lawful possession of premises
• Relevant local permissions and no-objection certificates, where applicable

Technical Staff Documents

Applicants should prepare:

• Educational qualification certificates
• Professional experience records
• Appointment letters
• Identity documents
• Details of manufacturing and quality control responsibilities

Product-Related Documents

Depending on the product category, documentation may include:

• Proposed product names
• Complete formulations
• Ingredient details and quantities
• Manufacturing procedures
• Draft labels and packaging information
• Product specifications
• Testing procedures and supporting reports
• Safety and effectiveness information, where required

Additional Supporting Documents

Authorities may also seek declarations, affidavits, non-conviction information, standard operating procedures and relevant arrangements with approved testing facilities.

Important: Document checklists differ according to the State Licensing Authority, medicine category and application type.

Applicants should confirm the applicable checklist before submission.

GMP Requirements for AYUSH Manufacturing Units

Good Manufacturing Practices help manufacturers maintain consistent product quality and hygienic production conditions.

For Ayurvedic, Siddha, Sowa-Rigpa and Unani medicines, the applicable GMP requirements generally fall under Schedule T of the Drugs Rules, 1945.

Homoeopathic manufacturing units follow the relevant requirements under Schedule M-I.

Important GMP considerations include:

Premises and hygiene: Manufacturing areas should maintain appropriate cleanliness, sanitation and environmental conditions.

Equipment maintenance: Machinery must remain suitable for its intended use, with appropriate cleaning and maintenance records.

Raw material control: Manufacturers should establish systems for identifying, inspecting and storing ingredients.

Manufacturing records: Proper documentation should support production consistency and traceability.

Quality assurance: Manufacturers must maintain appropriate procedures for testing, releasing and handling medicinal products.

Personnel training: Employees should receive suitable instructions concerning hygiene, manufacturing procedures and safety responsibilities.

GMP compliance remains an ongoing obligation rather than a one-time requirement.

Step-by-Step AYUSH License Application Process in India

The licensing procedure involves several stages, from selecting the appropriate authorisation to obtaining regulatory approval.

Step 1: Identify the Required Licence

First, determine whether the business requires an independent manufacturing licence or a loan manufacturing licence.

Applicants should also identify the relevant medicinal system and classification of the proposed products.

Step 2: Establish the Business Entity

Complete the necessary business registrations and appoint an authorised representative to manage regulatory applications.

Ensure consistency across business names, addresses and supporting documents.

Step 3: Prepare Manufacturing Infrastructure

For independent manufacturing, establish suitable premises, equipment, storage areas and quality control arrangements.

The facilities must meet the applicable regulatory standards before inspection.

Step 4: Appoint Qualified Technical Staff

Recruit competent manufacturing and quality control personnel.

Collect their educational certificates, experience records and appointment documents.

Step 5: Prepare Product Information

Compile formulation details, ingredient specifications, proposed labels and supporting technical documents.

Separate classical formulations from patent or proprietary medicines wherever the regulatory requirements differ.

Step 6: Register on the e-AUSHADHI Portal

The Ministry of Ayush’s e-AUSHADHI platform supports digital licensing activities.

Applicants must create the required account and select the appropriate licensing service.

The portal supports applications concerning Ayurveda, Siddha, Sowa-Rigpa and Unani medicines, with applicable services extending to other regulated categories.

Step 7: Submit the Application

Complete the prescribed application form and upload the necessary documents.

Review all entries carefully before final submission.

Incorrect business details, incomplete formulations or missing attachments may create processing delays.

Step 8: Pay Applicable Government Fees

Pay the prescribed amount through the available payment mechanism.

Government charges depend on the application category, product details and applicable fee schedule.

Step 9: Complete Regulatory Verification

The licensing authority examines the submitted information.

For manufacturing units, the process can involve premises inspection and verification of GMP compliance.

Authorities may request corrections or additional documents.

Step 10: Receive the Licence

After satisfactory verification and approval, the competent authority issues the appropriate licence.

Applicants should check the authorised activities, products, premises and conditions before commencing regulated manufacturing operations.

AYUSH License Fees in India

The cost of obtaining an AYUSH manufacturing licence depends on the applicable government fee schedule and business requirements.

There is no single fixed fee covering every AYUSH licence category throughout India.

Government Licensing Fees

For an illustration of published State-level charges, Kerala lists the following fees for specified Ayurvedic manufacturing applications:

• Classical medicine manufacturing licence: ₹2,000
• Patent or proprietary medicine applications: ₹3,000 for up to ten products, with additional charges for further products
• Fresh GMP certificate: ₹5,000

These figures are examples of published charges for specified categories, not nationwide rates.

Homoeopathic applications follow separate fee provisions, including product-based charges in relevant cases.

Applicants must verify the latest applicable charges before making payments.

Other Business Expenses

The total investment may also include:

• Manufacturing premises and infrastructure
• Machinery and production equipment
• Laboratory testing expenses
• Technical personnel salaries
• Documentation preparation
• Product development and packaging
• Professional compliance assistance

Manufacturing infrastructure generally creates a greater financial commitment than licensing fees alone.

How Long Does AYUSH License Approval Take?

The approval period depends on the medicinal category, application completeness and regulatory verification requirements.

Applicable rules provide prescribed processing periods for certain licensing categories. However, applicants should not treat these periods as unconditional approval guarantees.

Factors influencing processing time include:

• Accuracy of submitted documents
• Availability of qualified technical personnel
• Readiness of manufacturing premises
• Completion of required inspections
• Product formulation verification
• Responses to regulatory objections

Preparing complete records and maintaining inspection-ready premises can reduce avoidable delays.

AYUSH License Validity and Renewal Requirements

Licence validity depends on the relevant regulatory provisions.

Under the Drugs (Eleventh Amendment) Rules, 2026, manufacturing licences issued under the relevant provisions for Ayurvedic, Siddha and Unani medicines, including applicable loan licences, have perpetual validity.

Consequently, businesses should not assume that older annual retention or periodic renewal procedures continue to apply unchanged.

However, perpetual validity does not eliminate compliance responsibilities.

Manufacturers must continue satisfying licence conditions, product requirements and quality standards.

GMP certificates have separate validity and maintenance requirements. Manufacturers should monitor those obligations independently.

Authorities may also require updates when businesses modify licensed premises, technical personnel, ownership details or authorised manufacturing activities.

Labelling and Product Compliance Requirements

Manufacturing approval does not permit unrestricted product promotion.

Businesses must comply with applicable packaging, labelling and advertising regulations.

Product labels may require information such as:

• Product name
• Relevant ingredients
• Manufacturer’s name and address
• Manufacturing licence particulars
• Batch identification details
• Manufacturing and expiry information, where applicable
• Directions and statutory warnings

Certain regulated ingredients require specific cautionary statements.

Manufacturers must also avoid misleading therapeutic claims.

Advertisements claiming miraculous cures or promoting prohibited disease-treatment claims may violate applicable laws.

Product classifications require particular attention. A herbal cosmetic, food supplement and Ayurvedic medicine may fall under different regulatory frameworks.

Applicants should determine the correct product category before selecting a licence.

Common Reasons for AYUSH License Application Delays

Several avoidable mistakes can disrupt the approval process.

Incorrect Licence Category

Selecting the wrong category may require substantial corrections or a fresh application.

Incomplete Documentation

Missing premises records, technical staff certificates or product details can delay verification.

Unsuitable Manufacturing Facilities

Authorities may raise objections when manufacturing premises fail to satisfy prescribed requirements.

Formulation Discrepancies

Differences between proposed ingredients, product documentation and labels may create compliance concerns.

Inadequate Quality Control

Missing testing arrangements or incomplete manufacturing procedures can affect approval.

Delayed Responses

Applicants who fail to respond promptly to official queries may experience longer processing periods.

A systematic compliance review before submission helps prevent these problems.

Can You Start an AYUSH Business Without Your Own Factory?

Yes. Certain businesses can use an appropriately authorised manufacturer’s facilities through a legally permitted manufacturing arrangement.

A loan manufacturing licence may suit eligible entrepreneurs seeking to market medicines without establishing independent production infrastructure.

However, applicants must satisfy the relevant licensing requirements, and the arrangement does not automatically exempt them from regulatory responsibilities.

Before selecting a manufacturing partner, businesses should assess:

• Validity and scope of the manufacturer’s licence
• GMP compliance status
• Available manufacturing capacity
• Product testing arrangements
• Documentation and traceability systems
• Responsibilities for quality and regulatory compliance

A private-label or third-party manufacturing agreement alone does not replace statutory authorisation wherever a separate licence is required.

How esbigdesk Can Assist with AYUSH Licensing

Obtaining an AYUSH manufacturing licence requires careful coordination between business documentation, technical requirements and regulatory procedures.

esbigdesk assists businesses with licensing and compliance-related processes by helping applicants organise the documentation and procedural requirements associated with their applications.

Businesses may seek assistance with:

• Identifying the appropriate licensing category
• Reviewing eligibility requirements
• Preparing documentation checklists
• Organising application-related records
• Coordinating compliance documentation
• Addressing procedural queries
• Reviewing applicable licence conditions

Professional documentation support can help applicants avoid administrative mistakes and maintain a more organised application process.

The concerned government authority retains responsibility for inspecting facilities and granting regulatory approval.

Conclusion

Obtaining an AYUSH License is an essential regulatory requirement for businesses manufacturing covered traditional medicines in India. Successful applications depend on appropriate licensing categories, qualified personnel, compliant premises, accurate documentation and suitable quality control systems.

Applicants must also consider government fees, product classifications, GMP obligations and continuing compliance requirements.

Businesses planning Ayurvedic, Unani, Siddha, Sowa-Rigpa or Homoeopathic medicine manufacturing can approach esbigdesk for assistance with documentation preparation and licensing procedures.

10 AEO & GEO-Based FAQs on AYUSH License in India

1. What is an AYUSH License in India?

An AYUSH License commonly refers to the legal authorisation required to manufacture regulated medicines associated with recognised traditional systems of medicine. State or Union Territory Licensing Authorities issue manufacturing licences under the applicable Drugs and Cosmetics legislation. The specific authorisation depends on the medicinal category and manufacturing arrangement.

2. Who is eligible to apply for an AYUSH License?

Individuals, proprietorships, partnerships, LLPs and companies may apply when they satisfy the relevant licensing requirements. Applicants must have appropriate business documentation, qualified technical personnel, suitable manufacturing arrangements and prescribed quality control systems. Eligibility depends on the particular medicine category and licence type.

3. What documents are required for an AYUSH License?

Common requirements include business registration records, identity documents, manufacturing premises details, site plans, machinery information, technical personnel qualifications, product formulations, proposed labels and relevant declarations. Authorities may request additional documents depending on the application type and State-specific requirements.

4. How much does an AYUSH License cost in India?

AYUSH licence costs vary according to the licensing category, product classification and applicable fee schedule. Government charges represent only one part of the overall investment. Businesses should also consider GMP certification, manufacturing infrastructure, testing arrangements and documentation expenses. Applicants should verify the current official fees before applying.

5. How can I apply for an AYUSH License online?

Applicants should identify the correct licensing category, prepare the required documents and register through the applicable e-AUSHADHI licensing service. They must complete the application, submit supporting records, pay prescribed fees and respond to verification queries. Approval follows the competent authority’s regulatory assessment.

6. Is GMP certification mandatory for AYUSH medicine manufacturing?

AYUSH medicine manufacturers must meet the applicable Good Manufacturing Practices requirements. Ayurvedic, Siddha, Sowa-Rigpa and Unani manufacturing units generally follow Schedule T, while Homoeopathic manufacturing units follow Schedule M-I. Manufacturers must also satisfy applicable GMP certification and continuing compliance obligations.

7. Can I manufacture Ayurvedic medicines without owning a factory?

Eligible applicants may use another licensed manufacturer’s facilities through an appropriate loan licensing arrangement. For Ayurvedic, Siddha and Unani medicines, Form 24-E generally supports the loan licence application process. The competent authority grants the corresponding authorisation after verifying the relevant requirements.

8. What is the validity of an AYUSH manufacturing licence?

Validity depends on the licence category and applicable rules. Following the 2026 amendments, relevant Ayurvedic, Siddha and Unani manufacturing and loan licences have perpetual validity. However, manufacturers must continue complying with regulatory conditions. GMP certification, product approvals and other obligations may require separate monitoring.

9. Is an AYUSH License required to sell herbal products online?

The requirement depends on how the product is legally classified and the seller’s activities. Manufacturers of regulated AYUSH medicines require appropriate authorisation. Retail sellers may face different rules, including specific Homoeopathic sales licensing provisions. Herbal foods, cosmetics and medicinal products should not automatically be treated as one regulatory category.

10. Can esbigdesk help with AYUSH License registration in India?

Businesses can approach esbigdesk for assistance with eligibility assessment, document preparation, application procedures and compliance-related requirements. Organised documentation helps applicants address regulatory queries and reduce avoidable submission errors. The relevant State or Union Territory Licensing Authority makes the final decision on licence approval.