What is AYUSH License?
Manufacturers who are involved in producing Ayurvedic or Herbal products in India need to acquire an AYUSH License controlled by the Ministry of AYUSH. The Ministry of AYUSH was framed on 9th November 2014, before it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H) which was made in March 1995. Ayurveda is known as “The Science of Life” is one of the oldest relieving sciences to have ever survived be made in almost 5000 years or more. Consequently, there has been an uninterrupted growth in the number of Ayurvedic medicine manufacturing units established in India. Also, since these medicines produce no adverse effects, experts anticipate the demand for such Ayurvedic medicine to rise even greater.
- Any individual or entity cannot start or continue a drug or cosmetic business without obtaining an applicable license for running such an operation.
- 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.
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.
Check out the Ayush License Video
Who can get AYUSH License?
Ayurvedic Products
Herbal products
Cosmetics
Drug Products
Document Required for AYUSH 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 FDA 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
- Yearly Compliance if Applicable
- Renewal when due
Who can issue the FDA License?
Ayush relates to manufacturing of herds and other products which are utilized for Industrial purposes.
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.