AYUSH MARK Certificate & Consultants in India

Harmonizing Health: Premier AYUSH MARK Consultants and Certification Providers in India

Ayush Mark is voluntary product certification scheme for AYUSH products to enhance consumer confidence, managed by QCI and owned by Department of Ayush. In the vibrant landscape of traditional healthcare and wellness products, AYUSH MARK certification stands as a testament to quality, authenticity, and adherence to time-honored practices. We proudly stand as the foremost AYUSH MARK consultants and certification providers in India, committed to guiding businesses in the AYUSH sector towards excellence in quality and compliance.

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AYUSH MARK CERTIFICATION!

HIGHLIGHTS

Ayush Products

Products of ayurveda, unani, siddha and homeopathy systems of medicine that are covered under the Drugs and Cosmetics Act.

Scope

Standard prescribes the product requirements, good manufacturing practices, requirements for competence of personnel and testing of Ayush Products included in the API.

Levels

Scheme has two levels, Standard Mark based on compliance to the domestic regulatory requirements and Premium Mark based on compliance to the international regulatory requirements and WHO GMP.

Acceptance Criteria

Numerical limits, ranges, or other suitable measures for acceptance of the herbal substance, should be within the permissible limits.

Time Period

Ayush Standard Mark Certification will take 45-60 days for 20-30 Products and duration of the Premium Mark may be bit longer.

Validity

The Certificate shall be awarded for fixed time tenure of 3 years, during which operations and the products will be subjected to surveillance evaluations and testing.

OVERVIEW FOR AYUSH MARK

The Ayush products are regulated under the Drugs and Cosmetics Act, 1940 by the Drugs Controller General of India through the State Governments. AYUSH Certification is Voluntary Product Certification Scheme for selected AYUSH products to enhance consumer confidence. Department of AYUSH being the Scheme owner and QCI being responsible for managing the Scheme.

The Scheme will be overseen by a Multi stakeholder Steering Committee (MSC) chaired by the Secretary (AYUSH) with secretariat in QCI. The MSC will be supported by a Technical Committee and a Certification Committee constituted by QCI. Ayush License is mandory before applying for Ayush Standard/ Premium Mark.

LEVELS OF CERTIFICATION FOR AYUSH MARK

The Scheme is based on a criteria for certification. It has two levels:

Ayush Standard Mark which is based on compliance to the domestic regulatory requirements.
Ayush Premium Mark which is based on GMP requirements based on WHO Guidelines and product requirements with flexibility to certify against any overseas regulation provided these are stricter than the former criteria.

REGISTRATION PROCESS FOR AYUSH MARK

1. Identify

Identify the Level Wish to Apply

2. Preparation

Set up the Plant and Product as Per Standard

3. Registration

Registration of Application

4. Initial Evaluation

Evaluation by Competent Team,

5. Certificate

Grant of Certificate

INTERNAL QUALITY ASSURANCE PROTOCOL FOR AYUSH MARK

Inspection and Testing Plan Defining the Controls.
Define the Batch based on fixed quantity or fixed time interval.
Testing of Products and Compliance relevant API/UPI /SPI/HPI.
Calibration of Test Equipment from NABL accredited lab.
Entire Production shall be subject to Controls defined in Inspection & Testing Plan.
Conformity Decision based on tests & analysis results and batch processing & dispatch records.
Apply the Certification Mark after satisfactory test results and corrective actions.
Finished Products should be held in quarantine until their final release.

Incoming Material shall be Checked for Compliance.
Batch of Non-Conforming Products should be rejected.
Hygienic Practices to be maintained during processing, storage and distribution.
Rejected Materials should be clearly marked and stored separately.
Permit the drawl of samples for evaluation of the product quality.
Defective Goods are replaced free of cost by the licensee.
Finished Ayush Products shall be marked legibly on the label of the package.
Manufacturing Unit can Suspend the Certification Voluntarily in case of difficulty to maintain the conformity.

Choose 3M Management Consultants for Unrivaled AYUSH MARK Expertise

By choosing us as your AYUSH MARK consultants and certification providers in India, you’re not just ensuring compliance; you’re harmonizing health and wellness with traditional authenticity. Trust us to guide you towards a future where your commitment to AYUSH excellence is recognized nationally. Contact us today to initiate a journey towards excellence in AYUSH MARK certification.

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FREQUENTLY ASKED QUESTIONS

1. What is Ayush Certification?

AYUSH MARK. Quality Council of India has been engaged for voluntary certificationof quality of Ayurveda Siddha Unani (ASU)products. AYUSH Standard and AYUSH Premium Marks are awarded for products moving in domestic and international market respectively.

2. Who Owned this Scheme?

It is a scheme launched by Ministry of AYUSH, Government of India and managed by QCI.

3. What are the Prerequisite for Ayush Certification?

1. Obtain the relevant applicable legal documents based on selected certification criteria e.g. Domestic Regulations under the Drugs and Cosmetics Act, GMP Requirements based on WHO Guidelines, Levels of Contaminants, and Regulations of the importing country etc

2. Assess and prepare yourself so as to ensure that the processes and the Ayush product being manufactured would comply with the requirements of the relevant Certification Criteria.

3. Install inhouse testing facilities if seeking certification for Ayush Premium Mark.

4. Confirm that your production facility has been in production for at least one year.

5. Verify that five commercial batches of the products of dosage form for which certification is being planned to be sought, have been manufactured during the current licensed period.

4. Who Can Conduct the Audit for Ayush Certification?

Only Product Certification Bodies that are accredited by NABCB/recommended by QCI can certify for Ayush Product certification. In selecting a certification body, consider the range of products covered under the scope of accreditation of the Product Certification Body