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AYUSH Certification for Trusted Brands

Build trust and credibility with AYUSH certification for your products. Ensure quality, authenticity, and regulatory compliance to unlock global markets and drive sustainable growth.

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OVERVIEW

AYUSH Certification
Building Quality and Global
Trust

AYUSH products in India are regulated under the Drugs and Cosmetics Act, 1940, by the Drugs Controller General and state authorities. To enhance product safety and consumer confidence, the Department of AYUSH, in collaboration with the Quality Council of India (QCI), introduced a voluntary certification scheme that allows manufacturers to demonstrate authenticity and quality.

The scheme offers two certification levels:

  1. Ayush Standard Mark: Confirms compliance with Indian regulatory requirements under the Drugs and Cosmetics Act, ensuring product quality and safety.
  2. Ayush Premium Mark: Aligns with WHO-GMP guidelines and international best practices. Certification is issued through NABCB-accredited bodies, and certified facilities are subject to regular surveillance audits.

By obtaining AYUSH certification, businesses increase credibility, improve transparency, and gain global recognition, strengthening the competitiveness of Indian AYUSH products in health and wellness markets.

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CERTIFICATION ROADMAP FOR AYUSH PRODUCTS

Obtaining and Maintaining
AYUSH Product Certification

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Planning for Product Certification

Effective preparation ensures successful AYUSH certification with minimal delays. Key steps include:

  • check icon Select certification type: Choose either the Ayush Standard Mark or Ayush Premium Mark based on your target market.
  • check icon Review eligibility criteria: Understand requirements outlined by the Department of AYUSH and the Quality Council of India (QCI).
  • check icon Meet pre-certification needs: Complete all required documentation, process improvements, and compliance activities before submitting your application.
team planning

Using the Ayush Premium Mark(s)

All Natural Badge
  • tick The AYUSH Certification Mark may be displayed only on certified products and packaging to confirm compliance with quality and safety standards
  • tick The mark is owned by the Department of AYUSH and licensed exclusively to certified organizations.
  • tick Certified units may use it across communication materials, including packaging, marketing, advertisements, exhibition displays, vehicles, and digital platforms.
  • tick Misuse can result in penalties such as suspension or cancellation of certification. Proper usage builds consumer trust, global credibility, and brand recognition.

Financial Support and Fee Structure

  • IRQS, a division of IRCLASS Systems and Solutions Pvt. Ltd., derives financial support from revenues generated through:
  • Certification activities for management systems, products, processes, and services. Additional services offered by IRQS.

Fee Structure

  • Fees are calculated based on the Voluntary AYUSH Product Certification Scheme, considering factors such as number of dosages, number of products, and number of employees.
  • Application and accreditation fees are charged separately.
  • Product sample testing charges are applied depending on the number of products and dosage forms submitted for certification.
  • Quotations are provided on request, with all applicable terms and conditions clearly outlined in the IRQS letter.
  • For agreements under tender documents, fees and terms of payment follow the tender conditions.
  • All charges are based on the assumption that the information provided by the organization is complete and accurate.
  • Financial Support
  • Fee Structure
  • Special Surveillance Visits
  • Travel and Incidental Expenses
  • Postponement – (Recovery of Administrative Costs)
  • Cancellation – (Recovery of Administrative Costs)
  • Statutory Taxes
  • Invoices
  • Payment Terms
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Mandatory Requirements for AYUSH Certification

Responsibilities of Certified
AYUSH Organizations

AYUSH Certification

Certified units under the AYUSH scheme must adhere to defined responsibilities to retain their certification. These obligations ensure consistent compliance with certification standards, uphold public trust, and maintain product quality and safety. Organizations are expected to follow guidelines related to certification usage, internal processes, product integrity, and communication protocols. Regular updates, cooperation during assessments, and transparent reporting are essential.

Below is a structured overview of the key responsibilities that certified AYUSH organizations must follow to ensure continued compliance and certification validity:

  1. Compliance with Certification Requirements The client shall always comply with all certification requirements, including product standards and any changes communicated by IRQS.
  2. Responsibility for Certified Products The client is fully responsible for ensuring that certified products consistently meet all AYUSH certification requirements.
  3. Access and Cooperation During Evaluation The client shall make all necessary arrangements for evaluation, including access to documentation, records, facilities, relevant areas, personnel, and any information needed for complaint investigations.
  4. Claims Within Approved Scope The client shall make claims regarding certification only within the scope for which certification has been granted by IRQS.
  5. Proper Use of Certification The client shall not use its certification in any way that could mislead others or bring IRQS into disrepute.
  6. Suspension or Withdrawal of Certification Upon suspension or withdrawal, the client shall: Stop using all promotional material referencing certification. Return all certification documents as required. Recall any non-conforming certified AYUSH products that caused the suspension. Submit recall status updates to IRQS every 15 days. IRQS will inform QCI of the recall status or affected product details as necessary.
  7. Suspension and Corrective Action Upon receiving suspension instructions, the certified unit shall immediately stop using the AYUSH Certification Mark and perform a root cause analysis to identify and implement corrective actions.
  8. Accurate Use of Certification Documents The client shall ensure that no certificate, report, or part thereof is used in a misleading manner.
  9. Reproduction of Certification Documents If copies of certification documents are shared, they must be reproduced in full and without alteration.
  10. Implementation of IQAP The client shall maintain and implement the agreed Internal Quality Assurance Protocol (IQAP) to ensure continuous compliance of products and processes with certification requirements.
  11. Renewal of Certification Renewals shall take effect from the expiry date of the previous certificate. The period between expiry and renewal will be treated as a suspension period during which certification marks cannot be used.
  12. Changes to Certification Requirements When new or revised requirements are introduced, IRQS will communicate these to all applicants and certified units. The client must implement the required changes within the specified time frame.
  13. Notification of Significant Changes The client shall inform IRQS (A Division of IRCLASS Systems & Solutions Pvt. Ltd.) within three working days of any significant change affecting compliance, including: Legal, commercial, or ownership changes Organizational or management changes Changes in name, address, or site details Scope of operations, dosage forms, or product range Any update that affects the certificate's accuracy The organization shall seek IRQS's guidance when unsure about the significance of a change.
  14. Reporting of Serious Events The client shall immediately inform IRQS of any incident that could affect product safety or certification integrity, including: Legal proceedings or prosecutions related to product legality or safety Public product safety events such as recalls or alerts IRQS will assess the situation and may conduct verification or additional audits, which may impact certification status.
  15. Use of Certification in Communications The client shall comply with IRQS requirements when referencing certification in marketing materials, brochures, or advertising.
  16. Use of Certification Mark The certification mark shall be used only on products verified to meet all certification requirements and within the approved scope.
  17. Placement of Certification Mark The mark may appear on certified products, packaging, or accompanying documentation, but never on uncertified products or prior to certification approval.
  18. Design and Format of Certification Mark The size, color, and usage of the certification mark must comply with guidelines from the Ministry of AYUSH and QCI. Accreditation marks are not to be used on products. For details, refer to Annexure A: Approval for Use of Certification Mark to Certified Units available on the IRQS website (www.irqs.co.in).
  19. Complaint Management The client shall maintain records of all complaints related to certification compliance and document actions taken. These records must be available to IRQS upon request.
  20. Information Sharing and Transparency The AYUSH-certified organization agrees to: Share relevant information with QCI, NABCB, and government authorities when required. Allow IRQS and QCI to display certification details, including organization name, scope, and location, on their official websites.
  21. Confidentiality of External Information Any information about the client obtained from sources other than the client (such as complaints or regulators) will be treated as confidential.
  22. Providing Access and Information to IRQS The client shall provide IRQS with all documents, information, facility access, and updates necessary to deliver certification services.
  23. Access for Accreditation Bodies The client shall provide IRQS's accreditation bodies with all necessary documents, information, and site access to verify audits conducted by IRQS.
  24. Staying Updated on Certification Scheme Clients must regularly visit the IRCLASS website (www.irclass.org) to stay informed about any updates or changes to the AYUSH Certification Scheme.
  25. Validation Visits by NABCB Based on assessments, feedback, or complaints, NABCB may conduct validation visits to certified organizations. IRQS will include provisions for such visits in client contracts. NABCB will share visit details with IRQS, including purpose, duration, and data to be collected. IRQS may accompany NABCB assessors if required. The cost of these visits will currently be borne by NABCB.
  26. Validation Visits by IRQS IRQS may conduct its own validation visits instead of standard witnessing activities. NABCB will inform IRQS in advance about the number of visits, duration, charges, and sample selection.
  27. Witness Assessments If the accreditation body or IRQS selects the organization for a witness assessment, the client must participate. Refusal to participate will result in immediate withdrawal of certification.
  28. Multi-Site Audits The client organization shall ensure that audits cover all certified sites within the approved certification scope to maintain compliance and validity.
@if($certifications->count() > 0)
@foreach($certifications as $index => $certification) @endforeach
Sr.No CLIENT ADDRESS CERTIFICATE NO DOSAGE AND PRODUCT TOTAL CERTIFICATE PDF
{{ $index + 1 }} {!! nl2br(e($certification->client_details)) !!} {{ $certification->address ?: 'N/A' }} {{ $certification->certificate_no ?: 'N/A' }} {!! nl2br(e($certification->dosage_and_product)) !!} {{ $certification->total }} @if($certification->certificate_pdf_url) Download PDF @else No PDF @endif
@endif @if($transparency && ($transparency->suspended_clients_pdf_url || $transparency->withdrawn_clients_pdf_url))
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Transparency in ISO Certification Services

Client Status & Certification Information

Updated records of clients with suspended or withdrawn certifications.

@if($transparency->suspended_clients_pdf_url) PDF icon
View List of Suspended Clients
→
 @endif @if($transparency->withdrawn_clients_pdf_url) PDF icon
List of Withdrawal Clients
→
 @endif
@endif
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Frequently Asked Questions

Your AYUSH
Certification Questions
—Answered

AYUSH stands for Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy. These are traditional Indian and South Asian medicine systems. The AYUSH Mark Certification Scheme, introduced in 2009, is governed by the Quality Council of India (QCI). AYUSH certification confirms that a product complies with the Drugs and Cosmetic Rules, 1945, ensuring it meets safety, quality, and regulatory requirements. For businesses trading in Ayurvedic, Unani, Siddha, or other traditional medicine products, an AYUSH certificate is mandatory to build consumer trust and access wider markets.

Getting AYUSH certification involves a clear ten-step process. It starts with planning your application, understanding the certification requirements, and reviewing the eligibility criteria. Next, you prepare by gathering regulatory documents, ensuring compliance with GMP standards, and aligning your processes. A self-assessment helps you identify gaps before selecting an accredited certification body recognized by QCI or NABCB. Once the application is submitted, your facility undergoes inspections and product evaluations. After meeting all requirements, the certification body issues the official AYUSH certificate.

Currently, 146 products have been awarded the AYUSH Premium Mark, and another 197 products hold the AYUSH Standard Mark. These certifications demonstrate compliance with rigorous domestic and international quality standards, building trust with consumers and global markets.

Yes, Ayurvedic medicines can be certified under the AYUSH scheme, provided they meet regulatory requirements. Certification applies not only to Ayurvedic drugs but also to herbal and traditional formulations that comply with the Drugs and Cosmetics Act, 1940. Oversight is provided by the Drugs Controller General of India (DCGI), supported by advisory boards such as ASUDTAB and ASUDCC. Certified Ayurvedic medicines also require a Certificate of Pharmaceutical Product (CoPP) from the DCGI, ensuring credibility in both domestic and international markets.

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