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.
Why this License is Required?
To conduct a medicine business under the purview of the Drug & Cosmetic act 1940 all forms of drug business like allopathic, homeopathic, ayurvedic, herbal, or Unani drugs are protected. An individual must obtain a license from the Ministry of AYUSH to start the manufacturing of Ayurvedic medicines.
Who can get a Ayush Premium Mark License
Ayurvedic Products
Herbal products
Drug Products
Cosmetics
Document Required for Ayush Premium Mark License
Personal hygiene records
Premises Approved Plan from FDA
FDA License copy
Quality Control Record
Material Purchase record
Packaging Material record
Finished Product Record
Rejected, recovered, reprocessed and reworked materials record
Recalled products |record
Reference samples and standards record
Labels
Batch Processing records
Batch packaging records
Standard operating procedures (SOPs) and records
GMP certificate for Standard mark
WHO GMP certificate for Standard mark
Test requirements - In-process control
Test requirements - Finished products
Stability studies
Training Records
Role of Shamkris and Process of Ayush Premium Mark License
Shamkris adopts a results-oriented approach to compliance with mandatory licence requirements in the organization. A simple and guidance methodology help organisation to achieve licence in a timely manner and cost-effective. Shamkris support 100% in advisory, Guidance, Compliance with respect to license requirements to obtain approval.
The License process described below:
Advisory for the document required
Preparation of documents as per application & list of documents.
Application File
Inspection by the department if required
Liason department
License issued
Yearly Compliance if Applicable
Renewal when due
Advertising for the document required
Preparation of documents as per application & list of documents.
The government department regulates the manufacturing of Ayush. The ministry of Ayush carries of the regulation of Ayush in India. This ministry was considered as the Department of Indian System of Medicine and Homeopathy.
The ayush manufacturing license is utilised for manufacturing of medicines and products which come under the purview of Ayush category. However, the manufacturer has to set up his own plant for the process of manufacturing.