What is Ayush Premium Mark?

The Ayush Premium Mark is part of a new, voluntary quality certification scheme to ensure the efficacy of herbal products. Issued by the department of Ayush under the health ministry, this scheme is designed to ensure the efficacy of herbal products based on the Indian systems of healthcare including Ayurveda, Unani, Siddha as well as homeopathy. The Ayush Premium Mark is intended for companies who export their products and are in compliance with high manufacturing practice standards such as those set by WHO, European Commission, USA, and other countries.

The Scheme is based on criteria for certification. It has two levels:
a. Ayush Standard Mark which is based on compliance to the domestic regulatory requirements
b. Ayush Premium Mark which is based on GMP requirements based on WHO Guidelines and product requirements with the flexibility to certify against any overseas regulation provided these are stricter than the former criteria.

Benefits of Ayush Premium Mark

Ensure Product Safety


Access to new business

Improved efficiency

Customer satisfaction

Helps you stand out from your competitors

Certified Ayush Premium Mark Certification Video

Who can be certified Ayush Premium Mark?

Pharmaceutical Industry

Drug Industry







Document required for Ayush Premium Mark

  • Technical File, Product Master File (TCF)
  • Product Testing
  • System Manual
  • System Procedure
  • Policy
  • Objectives
  • Mission & Vision
  • Plant Master File
  • Standard Operating Procedure (SOP)
  • Checklist
  • Forms
  • Formats
  • Records

The extent of Documented Information differs as per:

  • Product and it's uses
  • Testing requirement of products
  • Directive in which product classified
  • Self Certification or Compliance Certification
  • Notify body Certificate

Role of Shamkris and Process of Ayush Premium Mark

Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives.

The implementation process is described below:

Day 1

Scope defined, BIS Registration, Procedure, Selection, Cost Estimates

• Finding Ayush Standard Mark standard applicable to the product
• Selecting the appropriate certification scheme
• Based on the scope of the product and certification scheme

Week 1

Developing Documents

• Technical file, Plant Master file and Test Protocol
• Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
• Review of Standard Operating Procedures (SOP)

Week 4

Implementing Product Management System

• Ayush Standard Mark/GOST R Awareness training to QC manager and Production Manager
• Implementing a well-documented manual throughout the life cycle of the product

Week 8

Internal Audit, MRM, CAPA

• Internal audits identifying nonconformities related to Ayush Standard Mark requirements
• Management Review Meetings
• Corrective and Preventive Action plan for nonconformities

Week 10

Ayush Standard Mark, Audit, N-C Closing

• Shamkris acts on your behalf and assists you in the third-party audit
• Closing of any nonconformities identified by the Ayush Standard Mark where applicable

Week 12

Ayush Standard Mark

• Ayush Standard Mark/GOST R certificates issued for 5 years (or each project)
• Surveillance Audits yearly where aaplicable

Year on Year

Yearly Compliance

• Support of Yearly documentation for audit

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

This scheme aims to provide grant-in-aid to Government / Non-Government organizations for the roll out of only proven AYUSH interventions for improving health status of the population through AYUSH interventions, like distribution of medicines, organizing Health awareness camps etc.

AYUSH is an acronym for Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy and are the six Indian systems of medicine prevalent and practiced in India and some of the neighboring Asian countries with very few exceptions in some of the developed countries.