Manufacturers who are involved in producing Ayurvedic or Herbal products in India need to acquire an AYUSH License controlled by the Ministry ofAYUSH. 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.
Who can get AYUSH License?
Ayurvedic Products
Herbal products
Drug Products
Cosmetics
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 AYUSH 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.
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.