Ayush Standard Mark License
What is Ayush Standard Mark?
Quality Council of India has been engaged for voluntary certification of the 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 with 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 Standard Mark License
Ayurvedic Products
Herbal products
Drug Products
Cosmetics
Document Required for Ayush Standard 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 Standard 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:
- 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
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
Who can issue the Ayush Standard 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.