Ayush Premium Mark License
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.
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.
- Application File
- Inspection by the department if required
- Liaison department
- License issued
- Yearly compliance if applicable
- Renewal when due
Who can issue the Ayush Premium Mark?
FAQ
Ayush relates to manufacturing of herds and other products which are utilized for Industrial purposes.
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.