Updated: Apr 3
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 Aysuh License
Ayush Manufacturing LicenseIt 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 Fulfil 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 1200sqft. 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 LicenseUnani 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 LicenseThe 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 endeavour 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.
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.
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 LicenseIn 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.
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).
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.