Quality Council of India has been engaged for voluntary certification of quality of Ayurveda Siddha Unani (ASU) products. Through this scheme, drug manufacturers are awarded the quality seal to the products on the basis of the third-party evaluation of the quality, subject to fulfillment of the regulatory requirements.
AYUSH Standard and AYUSH Premium Marks are awarded for products moving in the domestic and international markets respectively. 146 ASU products are reported to have been awarded AYUSH Premium Mark and 97 products AYUSH Standard Mark.
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.
The extent of Documented Information differs as per:
• Finding EAC TRCU standard applicable to the product
• Selecting the appropriate certification scheme
• Based on the scope of the product and certification scheme
• Technical file, Plant Master file and Test Protocol
• Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
• Review of Standard Operating Procedures (SOP)
• Ayush Premium Awareness training to QC manager and Production Manager
• Implementing a well-documented manual throughout the life cycle of the product
• Verification of test report as per Ayush guidelines
• Internal audits identifying nonconformities related to EAC TRCU/GOST R requirements
• Management Review Meetings
• Corrective and Preventive Action plan for nonconformities
• Shamkris acts on your behalf and assists you in the third-party audit
• Closing of any nonconformities identified by the Certification Body
• Ayush Premium certificates issued for 3 years
• Surveillance Audits yearly
• 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.