AYUSH License

Manufacturers who are involved in producing Ayurvedic or Herbal products in India need to acquire AYUSH License controlled by the Ministry of AYUSH. The Ministry of AYUSH was framed on 9th November 2014, prior it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H) which was made in March 1995.

Types of Ayush License

Manufacturing Licenses That Are Issued By Ayush Are As Follows:

Let’s Discuss Types Of Ayush License In Depth.

• Ayush Manufacturing License
  

It is acquired in the situations when the candidate wishes of getting the license and has come out with the plan of manufacturing and marketing, both of the products. In a situation like this, the producer needs to set up his own manufacturing unit.

Every state has its own set of requirements for setting up such manufacturing units. One needs to agree to all the requirements expressed by the state authority of AYUSH.

Applicant Who Wants To Obtain Ayush Manufacturing License Needs To Fulfill All The Requirements Under Ayush Act:

1. It is necessary for the manufacturing unit to be in an industrial area.

2. Minimum size of the manufacturing land for producing one drug only should be 1200 sq ft.

3. In case if you are planning to produce more than one drug then adds more categories because you will require more space.

4. It is compulsory for the manufacturing unit to be certified by GMP

5. Make sure to have on board 2 Ayurvedic experts and 2 pharmacies

6. You have access to all the manufacturing and packaging machinery

7. Drug inspector will conduct regular inspection of your manufacturing unit

• Unani Manufacturing License
  

Unani Medicine is regarded as the science and craft of healing. It is a respectable profession of healing the enduring of mankind. Unani framework is popular amongst people because of its one of a kind approach through which it prevents and cures diseases. It has got mass acknowledgment as one of the corresponding medical systems.

• Siddha Manufacturing License
  

The treatment is done to maintain a balance between mind-body and spirit system. Siddha treatment gives equal importance to the body, mind, and spirit and endeavor to restore a complete harmony to different psychological and physiological functions of the body. In the treatment Ayurveda, yoga plays a crucial role along with meditation, diet and lifestyle.

Siddha treatment gives more emphasis on preventing disease than curing them. Remedies followed under Siddha have been verified through scientific research. It helps in treating disease like:

• Ayush Loan License
  

In this sort of set up the manufacturing unit isn't claimed by the candidate. Third party manufactures the product. Such Loan License is to apply with a GMP certified manufacturer and from there on it will be given to the applicant organization. Thereafter product approval is needed to be acquired from the authorities.

How is the Loan License holder involved in it?

The Loan License holder can give the crude materials and packaging material or producer can arrange it from own sources too. The manufacturer works to convert such raw material into finished product and hence gives the finished product.

The license holder can apply for a Loan License again with a new GMP certified manufacturer.

If You Wish To Obtain Ayush Loan License Following Is The Requirement One Has To Fulfil Under AYUSH Act:

• The manufacturing must be in an industrial area
  
• The premise of the building should have minimum three rooms as per the description given below:
  

1. One room for office

2. One room for storing the raw material

3. One room for storing the finished product

• Make sure to renew the loan license
  
• Inspection of premise by drug inspector on regular basis is must
  
• No need of Ayurvedic expert and Pharmacist
  
• The manufacturing structure and company registration should be the same
  

• Ayush Contract/Third Party Manufacturing License
  

In such courses of action neither the individual has the license nor has the manufacturing set of his own, only the advertising part is finished by the contract/third – hand manufacturing, all things considered, all compliance and contact work will be taken consideration by the producer.

The manufacturing license of the producer will be utilized; the manufacturer has to obtain the approval for your product from the responsible authorities.

Charges Imposed by the Manufacturer on Loan License Holder

• Manufacturer may charge conversion charges i.e., you may have to pay for manufacturing the desired item in the manufacturer’s premise.
  
• Manufacturer will also ask for the product approval fee.
  
• A legal report is required to be drafted between the maker and your insights concerning the way that you own the item. The Legal record so drafted ought to be sufficiently able to safeguard your privileges if there should be an occurrence of any dispute. It must have a clause in it that says no matter what your company remains the owner of the product.
  

Documents Required to Obtain Ayush License

• Applicant’s details such as Name, Address, E-mail, Contact Number
  
• A copy of Manufacturing License
  
• Complete product list applied for issuance of COPP and their composition
  
• Site Master file
  
• Submit the manufacturing formula along with manufacturing process
  
• Method of analysis and finished product specification
  
• Approved products list
  
• Product lists for which the firm has already availed the CoPP
  
• Stability study analysis on the basis of batch, along with the Date of manufacturing, Date of Expiry, stability study condition, the name of Drug
  
• Process validation report for three batches
  
• Analytical method’s validation report
  
• Technical staff list along with the information like experience, qualification, and approval status
  
• List of equipment and instruments used or to be used
  
• Manufacturing Plant Layout
  
• Water System Diagram
  
• HVAC System Diagram
  
• Export data for the last 2years, wherever re-validation of CoPP is applicable
  
• Product Summary Sheet
  
• Actual labels of the products which are required to be applied for WHO-CoPP
  
• A proof of safety and effectiveness as mentioned in the Rule 158B of Drugs & Cosmetic Rules, 1945.
  
• Analysis certificate for three batches of each product
  
• Undertaking related to the absence of any non-herbal such as metals/ or minerals etc in the products applied for WHO-CoPPs (Applicable in case of herbal products)
  
• Undertaking related to compliance with the provisions of domestic regulations inter-alia Drug and Cosmetics Act, 1940 and Rules there under, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and rules there under, (Applicable in case of herbal products).
  

AYUSH License Registration Process

• Visit the individual state website of AYUSH
  
• Download the necessary form, attachment, list of documents which also comprises of affidavits and other certification such as GMP and CoPP as the case maybe
  
• If appropriate apply for GMP and CoPP
  
• Submit all the prerequisite documents to the Directorate of the AYUSH
  

GMP Certification: Goods Manufacturing Practice

Good Manufacturing Practice (GMP) is a framework whereby it is guaranteed that the items are reliably produced and controlled as per the quality principles norm as recommended in accordance with the WHO. The aim behind such certification is to limit the dangers associated with any pharmaceutical creation.

Certificate of Good Manufacturing Practices (GMP) demonstrates that the pharmaceutical manufacturing organization has gone through the examination and passed it conducted by the regulatory body of that country and is sheltered even to be traded and it guarantees that the item fulfils the guidelines of good manufacturing practices as expressed by the WHO.

CoPP: Certificate of Pharmaceutical Product

The COPP is the authoritative document that confirms the manufacturing organization having this certificate is legitimately permitted to sell their pharmaceutical item in the nation they are creating. In situations where the pharmaceutical item is to be registered under the abroad, the administration body responsible for approving the application will request COPP to guarantee that the item is being sold as a commercial finished product in the nation that is producing it.

FAQs

Q. What is AYUSH License?

Manufacturers who are involved in producing Ayurvedic or Herbal products in India need to acquire AYUSH License controlled by the Ministry of AYUSH. The Ministry of AYUSH was framed on 9th November 2014.

Q. What is Unani Manufacturing License?

Unani framework is popular amongst people because of its one of a kind approach through which it prevents and cures diseases. It has got mass acknowledgment as one of the corresponding medical systems.

Q. Define GMP Certification?

Good Manufacturing Practice (GMP) is a framework whereby it is guaranteed that the items are reliably produced and controlled as per the quality principles norm as recommended in accordance with the WHO.

Q. What is Siddha Manufacturing License?

Siddha treatment gives equal importance to the body, mind, and spirit and endeavour to restore a complete harmony to different psychological and physiological functions of the body.

Q. Who can sell Ayurvedic medicines?

It is compulsory to have Ayush Retail license if you want to sell Ayurvedic /Unani / siddha medicines or any product related to ayurvedic in India. Without Ayush License, you may have to pay penalties for dealing in business of selling Ayurvedic/Unani products.

Q. What is CoPP?

The COPP is the authoritative document that confirms the manufacturing organization having this certificate is legitimately permitted to sell their pharmaceutical item in the nation they are creating.

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Posted by Pooja

​Team Taxaj