AYUSH License

FSSAI License or FSSAI Registration in India is mandatory for starting a food or related business. The FSSAI License is issued by the Food Safety and Standards Authority Act,2006. The Food Safety and Standard Authority of India and therefore the State Food Authorities are jointly liable for implementing the FSAI rules. The FSSAI is liable for registering and licensing the Food business operators and also lays the principles and regulation for running any food or related business in India

Manufacturer who is handling the Ayurvedic or Herbal products in India is required to get the license from AYUSH regulated by the Ministry of AYUSH. The Ministry of AYUSH was formed on 9th November 2014, earlier it had been referred to as the Department of Indian System of drugs and Homeopathy (ISM&H) which was created in March 1995.

Types of AYUSH Licenses

Following are the manufacturing licenses that are issued by AYUSH:

  • Ayush Manufacturing License.
  • Ayush Loan License.
  • Contract Manufacturing / Third party manufacturing / White label Manufacturing / Product to Product manufacturing.
  • A. Complete Manufacturing License

    It is obtained within the cases when the applicant is desirous of obtaining the license has planned for manufacturing and marketing, both of the products. during this case, the manufacturer has got to found out his own manufacturing unit.

    The state requirement for such manufacturing found out varies from state to state. One has got to suits all the wants stated by the state authority of AYUSH.

      Prerequisite of AYUSH Manufacturing license to be obtained under AYUSH Act:

    • The manufacturing unit should be an industrial area.
    • The minimum size of 1200 sqft. Should be there, for one category of the drug only.
    • In case quite one drug is required, and add more categories, you would like to feature more room.
    • The manufacturing unit is mandatorily required to be GMP certified.
    • 2 Ayurvedic experts and a couple of Pharmacies must form the part of your team.
    • All the manufacturing and packaging machinery should be available with you.
    • Regular inspection of the premise shall be done by the Drug Inspectors.

    B. Ayush Loan License

    In this quite found out the manufacturing unit isn't owned by the applicant. The products are manufactured by the third party manufacturers. Such Loan license is to use with a GMP certified manufacturer and thereafter it'll be issued to the applicant company. Thereafter the merchandise approval is required to be obtained from the authorities.

      Prerequisite of AYUSH Loan license to be obtained under AYUSH Act:

    • The manufacturing unit should be an industrial area.
    • The premise should have minimum three rooms consistent with the outline as given below:
    • One room for the storage of raw material;
    • One for finished material storage and;
    • One for the office.
    • Renewal of Loan License should be done regularly
    • Visit of Drug inspectors on regular basis for inspection of premises may be a must.
    • No Ayurvedic experts and Pharmacist are required.
    • The company registration and therefore the manufacturing found out should be an equivalent .

    C. Ayush Contract / Third-Party Manufacturing License

    In such arrangements neither the person has the license nor has the manufacturing set of his own, only the marketing part is completed by the contract / third – hand manufacturing, therein 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 need to get approval for your product from the concerned authorities.

    However, you'll provide the raw materials and packaging material or manufacturer can arrange it from his own sources.

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