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AYUSH Manufacturing License Registration

We specialize in AYUSH Manufacturing License Registration services to help your Ayurvedic, Unani, Siddha, and Homoeopathy manufacturing business meet compliance requirements. Our services include the following:

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Overview

AYUSH Manufacturing License Registration in India

Ayurveda, which translates as "The Science of Life," is one of the oldest medical sciences in history, having been practiced for at least 5000 years. Ayurveda may be traced back to the ancient Vedic civilization and serves as the foundation for many popular natural treatment methods in the West, such as Polarity Therapy and Homeopathy. An AYUSH License should be obtained by any company involved in the production, distribution, retail, wholesale, or other commercial activity involving Ayurvedic or herbal products. The Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy) is responsible for issuing the AYUSH Manufacturing License. The growth, teaching, research, and development of India's alternative medicine system are under the purview of the Ministry of AYUSH.

AYUSH Manufacturing License Services in Chennai
Who Needs This Service

Is an AYUSH Manufacturing License the right fit for you?

An AYUSH Manufacturing License is mandatory for any business involved in the manufacturing of Ayurvedic, Unani, Siddha, or Homoeopathy products in India.

  • Manufacturers of Ayurvedic, Unani, Siddha, and Homoeopathy medicines
  • Herbal product manufacturers and exporters
  • Companies looking to start an AYUSH manufacturing unit
  • Existing pharmaceutical companies expanding into AYUSH products
  • Contract manufacturers of AYUSH products
  • Ayurvedic medicine producers and distributors
Eligibility Requirements

Qualification Required for AYUSH Manufacturing License

To obtain an AYUSH Manufacturing License, the following qualifications are required:

  • A diploma from a recognised university or institution in Siddha or Unani systems of medicine, Ayurveda, or Ayurvedic pharmacy
  • A diploma in Siddha or Unani systems of medicine, Ayurveda, or Ayurvedic Pharmacy from a recognised institution or college
  • A recognised university graduate in pharmacy, chemistry, or botany having at least two years' expertise in the production of ayurvedic pharmaceuticals
  • A Vaid or Hakim with at least four years of experience producing ayurvedic pharmaceuticals who is included in a state register of practitioners of medicine
  • A degree in pharmacy from an accredited institution and at least eight years of experience working in the Ayurvedic (including Siddha) or Unani systems of medicine
Business Entity Eligibility
  • Sole proprietorship
  • Partnership firm
  • Limited Liability Partnership (LLP)
  • Private Limited Company
  • One Person Company (OPC)
  • Public Limited Company
Manufacturing Facility Requirements
  • Manufacturing unit area should not be less than 1285 sq. ft
  • Compliance with DMR Act (Drugs and Magic Remedies Act, 1954)
  • GMP (Good Manufacturing Practices) compliance
  • Technical specialist (BMS doctor or BSC with Bio.) required
Documents Required

Documents Required for AYUSH Manufacturing License

Documents are grouped the way the Ministry of AYUSH reviews them — business documents, premises, product information, and personnel qualifications.

Business Documents
  • Incorporation / Proprietorship / Partnership Certificate
  • GST Registration Certificate
  • PAN Card of the entity
  • TAN Number (if applicable)
  • MSME / Udyam Registration
  • Shop & Establishment Registration
Personnel Documents
  • Aadhaar Card of Authorized Person
  • PAN Card of Authorized Person
  • Educational qualification certificates
  • Experience certificates (if applicable)
  • Passport-size photographs
  • Technical specialist qualification (BMS doctor or BSC with Bio.)
Product & Manufacturing
  • Product specifications (products to be manufactured)
  • Product form (tablets, liquid, powder, etc.)
  • GMP (Good Manufacturing Practices) Certificate
  • DMR Act compliance documentation
  • Manufacturing process details
  • Quality control measures documentation
Premises Related
  • Layout Plan of manufacturing unit
  • Area proof (minimum 1285 sq. ft required)
  • Lease / Rental Agreement
  • Latest Utility Bill
  • Property Tax Receipt
  • Premises photographs (interior & exterior)
Step-by-Step Procedure

AYUSH Manufacturing License Registration Steps

Each stage is a real, sequential step through the Ministry of AYUSH.

01
1–2 working days

Connect with First Auditor Team

Get in touch with our experts to discuss your AYUSH manufacturing license requirements and scope of operations.

02
2–3 working days

Submit Required Documents

Provide all necessary documents for AYUSH manufacturing license application. Our team verifies and completes the documentation.

03
2–3 working days

Draft Affidavit & Application

We draft the required affidavit and prepare the complete application for submission to the Ministry of AYUSH.

04
1–2 working days

Fee Payment

Pay the prescribed government fees for processing the AYUSH manufacturing license application.

05
20–45 working days

Application Processing & Inspection

The Ministry of AYUSH processes the application, including verification of documents and premises inspection by state authorities.

06
5–10 working days

Follow-ups & Query Resolution

Our team handles all follow-ups with the Ministry of AYUSH and resolves any queries that may arise during processing.

07
1–3 working days

License Issuance

Upon approval, we receive the AYUSH Manufacturing License certificate and send a copy to you via email or courier.

Authority, Timeline & Fees

Where the application goes, and what it costs

Government Authority

Ministry of AYUSH, Government of India, through the respective state licensing authorities.

Estimated Processing Period

Typically 30–60 working days from complete document submission, depending on verification and inspection.

License Issued

AYUSH Manufacturing License issued for the specified products and premises with a validity of up to 5 years.

Fee Structure

Government fee varies by state and product category. Professional fee quoted upfront by First Auditor.

ComponentPaid ToNature of charge
Government application fee Ministry of AYUSH / State Authority Varies by state and product category
Inspection fee State Licensing Authority As prescribed by the authority
Professional fee First Auditor Quoted upfront, one-time

Government fees are prescribed by the Ministry of AYUSH and respective state authorities. Our team quotes both components separately before you proceed, with nothing added later.

Validity & Renewal

How long is the AYUSH Manufacturing License valid?

An AYUSH Manufacturing License is typically valid for a period of 5 years from the date of issue. To maintain the license, manufacturers must:

  • Apply for license renewal at least 90 days before expiry
  • Maintain proper manufacturing and quality control records
  • Comply with GMP (Good Manufacturing Practices) standards
  • File annual returns with the licensing authority
  • Report any changes in manufacturing premises or product lines
  • Ensure compliance with DMR Act and other relevant regulations
  • Maintain technical personnel qualifications as required
Common Reasons for Rejection

What causes the Ministry of AYUSH to reject an application

  • Incomplete or incorrect application form submission
  • Manufacturing area less than the prescribed minimum of 1285 sq. ft
  • Lack of qualified technical personnel (Vaid, Hakim, or pharmacist)
  • Missing GMP (Good Manufacturing Practices) Certificate
  • Non-compliance with DMR Act (Drugs and Magic Remedies Act, 1954)
  • Inadequate quality control measures or documentation
  • Invalid or expired premises documents
  • Mismatch between PAN, Aadhaar, and other identity documents
  • Failure to provide product formulation details
  • Directors without experience in the herbal domain
How First Auditor Assists

One team, from qualification check to license issuance

We manage every step, document, and follow-up with the Ministry of AYUSH so you can focus on your manufacturing operations.

Eligibility & Qualification Check

We verify your eligibility and recommend the right qualifications for AYUSH manufacturing.

Document Preparation

Complete document checklist, drafting, and verification to ensure error-free submission.

Product & Process Support

Guidance on product formulation, manufacturing process, and quality control documentation.

Premises Guidance

Support with layout plans, area requirements, and premises documentation for compliance.

Application Filing

Complete AYUSH manufacturing license application filing with the Ministry of AYUSH.

Query Handling

We respond to all queries from the Ministry on your behalf.

Compliance Calendar

A full compliance schedule including renewal reminders and annual return filing.

Dedicated Support

A single point of contact for questions throughout the entire process.

Frequently Asked Questions

FAQ

The AYUSH Manufacturing License is a regulatory requirement for manufacturers of Ayurvedic, Siddha, Unani, and Homeopathic products in India. It ensures that products meet safety, quality, and efficacy standards set by the government.

Eligible applicants include individuals, partnership firms, limited liability partnerships, and private limited companies engaged in manufacturing Ayurvedic and traditional medicine products. The manufacturing facility must comply with regulatory standards.

Necessary documents typically include application forms, details of the manufacturing process, quality control measures, ID and address proof of the applicant, and the layout plan of the manufacturing facility.

The processing time may vary depending on the state authority, but it generally takes 2 to 6 months, depending on the completeness of the application and the authority's workload.

The AYUSH Manufacturing License is usually valid for five years from the date of issuance. However, it is essential to renew the license before it expires.

Renewal applications should be submitted at least 90 days before the expiration of the license to ensure uninterrupted operations.

No, a separate AYUSH Manufacturing License is required for each state where you intend to operate. Each state has its own licensing process and requirements.

Operating without a valid license can lead to penalties, including fines, product seizure, and legal action against the manufacturer. It is essential to comply with the regulations to avoid such consequences.

While not mandatory, it is highly recommended to undergo training on good manufacturing practices (GMP) and regulatory compliance to ensure adherence to quality standards.

The minimum area required for an AYUSH manufacturing unit is 1285 sq. ft. This includes manufacturing, storage, and quality control areas as per GMP guidelines.
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Disclaimer: This page is provided for general informational purposes only and does not constitute legal, tax, or professional advice. Government fees, processing timelines, and documentation requirements are prescribed by the Ministry of AYUSH and respective state authorities, and are subject to change without notice. First Auditor is an independent professional services firm and is not affiliated with, or an agent of, any government department. Please consult our team or a qualified professional for advice specific to your situation before making any registration decision.
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