Drug License

AYUSH License

Dealing in Ayurveda, Siddha or Unani products in India?

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AYUSH License

Gateway for your Herbal Products

AYUSH is an abbreviation for Ayurveda, Yoga, Unani, Siddha, and Homeopathy.

Ayurvedic, Siddha or Unani (ASU) drug includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicine, specified in the First Schedule. ASU drugs and herbal cosmetics is regulated by Drugs and Cosmetics Acts and Rules.

Manufacturers dealing in Ayurvedic or Herbal products in India are required to obtain license from AYUSH regulated by the Ministry of AYUSH. Manufacturing licenses under AYUSH is obtained from the respective State.

Types of AYUSH license:

[1] Manufacturing license;
[2] Loan License;
[3] Contract Manufacturing/ Third Party manufacturing

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AYUSH Manufacturing License

• Manufacturing license is obtained when the applicant desires to obtain the license for manufacturing as well as marketing the products. The manufacturer has to set up his own manufacturing unit in this case.
• The 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.
• As per Drugs & Cosmetics Act, 1940, it is mandatory to apply for GMP along with manufacturing license.
• If Ayurvedic (including Siddha) or Unani drugs are manufactured on more than one premises – a separate application is to be made and separate license shall be obtained in respect of each premises.

Certificates required for AYUSH Manufacturing License: GMP & COPP (if applicable)

• GMP Certification: Good manufacturing practice (GMP) is a system whereby it is ensured that the products are consistently produced and controlled according to quality standards as prescribed in line with the WHO. The intent behind such certification is to minimize the risks involved in any pharmaceutical production.

A good manufacturing practices certificate (GMP) indicates that the pharmaceutical manufacturing company has cleared the inspection of the pharmaceutical regulatory body of that country and is safe even to be exported and it ensures that the product meets the standards of good manufacturing practices as stated by the WHO.

• CoPP: Certificate of a Pharmaceutical Product (CoPP): The CoPP is the legal document that certifies that the manufacturing company having this certificate is legally allowed to sell their pharmaceutical product in the country they are producing.

Duration of License:
Manufacturing License is valid for 5 years from the date of its issue.


AYUSH Loan License

• • Under this kind of set up, the manufacturing unit is not owned by the applicant. The products are manufactured by third-party manufacturers.
  • Loan license should be applied with a GMP certified manufacturer. Thereafter loan license will be issued to the Applicant Company and products will have to be authorized by Authority.
  • The loan license holder may supply raw material or packaging material to the manufacturer as per the contract and the manufacturer will convert this raw material to finished goods or manufacturer can arrange the raw materials or packaging material from own sources also.
  • 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.
  • Changing the Manufacturer- On change of manufacturer, the loan license holder is required to apply for a Loan license again with a new GMP certified manufacturer.
  • Product Label Display- 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 It will not mention anything about the manufacturer who has been seasoned with by the license holder.

 
Duration of License:
Loan License is valid for 5 years from the date of its issue.


AYUSH Contract/ Third Party Manufacturing License

• • • In Contract manufacturing, one neither has the manufacturing/loan license nor the manufacturing set up of his own.
    • You only have to market the product. The manufacturer will get all the necessary approvals for your product from the concerned authorities.
    • You only have to provide the raw materials, packaging materials but if you fail to do so then the manufacturer will arrange all those items and you will receive the final product from the manufacturer.
    • Charges charged by the manufacturer- Conversion charges are charged by the manufacturer i.e., the cost for manufacturing the desired product in his manufacturing unit or premises. The product approval fees are also charged to you by the manufacturer.
    • Product Label Display- the Product label will display that the product is manufactured by the Third-Party Manufacturer and Marketed by you.

    Benefits of Contract/Third Party Manufacturing:

    • The marketeer company can function in any state irrespective of the location of the manufacturing company.
    • It only looks after the marketing part of the product and all the compliances for the product is taken care by the manufacturing company.
    • This form of manufacturing is in trend these days.

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This information is in summary form and is therefore intended for general guidance only. It is not intended to be a substitute for detailed research or the exercise of professional judgment. Mind Sync does not accept any responsibility for loss occasioned to any person acting or refraining from action as a result of any information provided herein. On any specific matter, reference should be made to the appropriate advisor.