Build trust and credibility with AYUSH certification for your products. Ensure quality, authenticity, and regulatory compliance to unlock global markets and drive sustainable growth.
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:
Ayush Standard Mark: Confirms compliance with Indian regulatory requirements under the Drugs and Cosmetics Act, ensuring product quality and safety.
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.
CERTIFICATION ROADMAP FOR AYUSH
PRODUCTS
Obtaining and Maintaining AYUSH Product Certification
Select certification type: Choose either the Ayush Standard Mark or Ayush Premium Mark based on your target market.
Review eligibility criteria: Understand requirements outlined by the Department of AYUSH and the Quality Council of India (QCI).
Meet pre-certification needs: Complete all required documentation, process improvements, and compliance activities before submitting your application.
Using the Ayush Premium Mark(s)
The AYUSH Certification Mark may be displayed only on certified
products and packaging to confirm compliance with quality and safety
standards
The mark is owned by the Department of AYUSH and licensed
exclusively to certified organizations.
Certified units may use it across communication materials,
including packaging, marketing, advertisements, exhibition displays, vehicles, and
digital platforms.
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
Mandatory Requirements for AYUSH
Certification
Responsibilities of Certified AYUSH Organizations
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:
Compliance with Certification Requirements
The client shall always comply with all certification requirements, including product
standards and any changes communicated by IRQS.
Responsibility for Certified Products
The client is fully responsible for ensuring that certified products consistently meet
all AYUSH certification requirements.
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.
Claims Within Approved Scope
The client shall make claims regarding certification only within the scope for which
certification has been granted by IRQS.
Proper Use of Certification
The client shall not use its certification in any way that could mislead others or bring
IRQS into disrepute.
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.
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.
Accurate Use of Certification Documents
The client shall ensure that no certificate, report, or part thereof is used in a
misleading manner.
Reproduction of Certification Documents
If copies of certification documents are shared, they must be reproduced in full and
without alteration.
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.
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.
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.
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.
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.
Use of Certification in Communications
The client shall comply with IRQS requirements when referencing certification in
marketing materials, brochures, or advertising.
Use of Certification Mark
The certification mark shall be used only on products verified to meet all certification
requirements and within the approved scope.
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.
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).
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.
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.
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.
Providing Access and Information to IRQS
The client shall provide IRQS with all documents, information, facility access, and
updates necessary to deliver certification services.
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.
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.
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.
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.
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.
Multi-Site Audits
The client organization shall ensure that audits cover all certified sites within the
approved certification scope to maintain compliance and validity.
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CERTIFICATE PDF
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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.
Let's get you certified-Start your journey today!
Connect with our experts for a seamless and hassle-free certification process.
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