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Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) Systems of Medicine have age old acceptance among various communities in India. They are time tested and validated by thousands of years of use during which they have played role in the prevention and mitigation of diseases. AYUSH System of Medicine have important role in the prevention and mitigation of many life style related chronic ailments where modern medicines are not so successful. With the increase in number of life style disorders, there has been a resurgence of interest in the AYUSH Systems of medicine both globally and within the country.
It is obtained in the cases when the applicant is desirous of obtaining the license has planned for manufacturing and marketing, both of the products. In this case, the manufacturer has to set up his own manufacturing unit. The state requirement for such manufacturing set up varies from state to state. One has to comply with all the requirements stated by the state authority of AYUSH.
In case you wish to take AYUSH Manufacturing license following is the requirement to be obtained under AYUSH Act:
In this kind of set up the manufacturing unit is not owned by the applicant. The products are manufactured by the third party manufacturers. Such Loan license is to apply with a GMP certified manufacturer and thereafter it will be issued to the applicant company. Thereafter the product approval is required to be obtained from the authorities. How is the Loan License holder involved in it? The Loan License holder can provide the raw materials and packaging material or manufacturer can arrange it from own sources also. The manufacturer converts such raw material into finished products and thereafter provides the finished product. What if the manufacturer so appointed is required to be changed? The license holder is required to apply for a Loan license again with a new GMP certified manufacturer. What are all charges charged by the manufacturer on the Loan license holder? Conversion charges are charged by the manufacturer i.e. the cost for manufacturing the desired product in his manufacturing unit or premises. Will such a product display anything about the manufacturer? No, the Product label will not display anything about the manufacturer, rather it will display that the product is both manufactured and marketed by the License holder company. It will not mention anything about the manufacturer who has been seasoned with by the license holder. In case you wish to take the above-stated license following is the requirement to be obtained under AYUSH:
In such arrangements neither the person has the license nor has the manufacturing set of his own, only the marketing part is done by the contract / third – hand manufacturing, in that case, all compliance and liaison work shall be taken care by the manufacturer.The manufacturing license of the manufacturer shall be used; the manufacturer will have to get approval for your product from the concerned authorities. However, you can provide the raw materials and packaging material or manufacturer can arrange it from his own sources. What will the product display? The Product shall display that the product is manufactured by the XYZ manufacturer and marketed by you.What are all charges charged by the manufacturer on the Loan license holder?
The benefit of such Contract Manufacturing:
Documents required for making an Application for GMP certification* & issuance of COPP*.
NOTE: However the list of documents may vary from state to state, one needs to visit the individual sites of the required state and check the required documents.
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