Overview of AYUSH License
All the Manufacturers who want to start manufacturing Ayurvedic or Herbal products in India require to obtain AYUSH License from the Ministry of AYUSH.
Further, the Ministry of AYUSH was introduced on 09.11.2014, and before that it was known as the “Department of Indian System of Medicine and Homeopathy” (ISM&H), which was established in the year March 1995.
Different Types of Ayush License
The different types of Ayush License are as follows:
Ayush Manufacturing License
The term Ayush Manufacturing License denotes a license which is acquired by the candidate who want to start a plan of manufacturing as well as marketing of products.
Further, it shall be pertinent to mention that every state has its own set of prescribed requirements for starting such manufacturing units. Also, it is compulsory for everyone to agree to all the necessities and requirements prescribed by the state authority of AYUSH.
Unani Manufacturing License
The term “Unani Medicine” is termed as the science and art of healing. Further, it is regarded as a respectable profession of healing the continuing of mankind.
Also, it shall be relevant to mention that Unani framework is a popular format amongst people due to its one of a kinds styles by which it prevents and cures diseases.
Moreover, Unani framework has got mass recognition as one of the resembling medical systems.
Siddha Manufacturing License
The term Siddha means a treatment that is done to uphold a balance between the mind-body and spirit system. Further, Siddha treatment gives equal weightage to the spirit, mind, and body, and attempts to maintain a complete harmony between different physiological and psychological functions of the body.
Also, it shall be relevant to state that in the treatment Ayurveda, “yoga” plays a significant role, together with meditation, diet and lifestyle.
Moreover, siddha treatment provides more focus on preventing disease rather than curing them. Therefore, the remedies followed under Siddha framework have been duly verified by scientific research.
Siddha Treatment helps in treating diseases, such as
Ayush Loan License
In this type of set up the applicant does not own the manufacturing unit. All the products are manufactured by the third party manufacturers. Further, such a Loan License is to be apply with a “GMP certified manufacturer” and after that the same will be given to the applicant company. Thereafter it is necessary to obtain product approval from the authorities.
White Label Manufacturing/ Contract Manufacturing/ Third Party Manufacturing/ Product to Product Manufacturing
In such a type of arrangements, neither the applicant has the loan license nor has the any manufacturing set of his own, also, the marketing part is undertaken by way of contract or third – hand manufacturing, then, in that case, all the compliance and liaison work will be taken care by the manufacturer.
Further, the manufacturing license or permit of the manufacturer will be used; and the manufacturer will need to get approval for his/ her product from the concerned authorities.
Requirements for obtaining Ayush Manufacturing License
As per the Ayush Act, the set of basic requirements for obtaining Ayush Manufacturing License are as follows:
- The manufacturing unit must be located in an industrial area;
- For one category of Drug, a minimum size of 1200 sq. ft. must be there;
- In case of more than one drug, the applicant can add more categories, but he/ she will then require to add more space;
- The manufacturing unit must be GMP certified;
- There must be at least 2 Ayurvedic experts and 2 Pharmacies, who are forming a part of the applicant’s team;
- The applicant must be fully equipped with all the required manufacturing and packaging machinery;
- Drug Inspectors will conduct regular inspection of the premise being used for manufacturing purpose;
Requirements for obtaining Ayush Loan License
As per the Ayush Act, the set of basic requirements for obtaining Ayush Loan License are as follows:
- The manufacturing unit must be located in an industrial area;
- The premise of the building should have minimum three rooms as per the description given below:
- One room for office;
- One room for storing all the raw material;
- One room for storing all the finished product;
- Must ensure to renew the ayush loan license;
- Inspection of the premise being used by the drug inspector on regular basis;
- No need of any Ayurvedic expert and Pharmacist;
- Both the company registration and manufacturing structure should be the same;
Documents Required for obtaining Ayush License
The documents required for obtaining Ayush License in India are as follows:
- Details of the applicant, such as Name, address, email id, telephone, fax, etc.;
- A copy of Manufacturing License;
- A complete list of all the products applied for the issuance of COPP and their composition;
- Site Master Plan;
- Master manufacturing formula, together with the process of manufacturing;
- Method of Analysis and specification of finished product;
- List of all the approved products;
- A complete list of the products for which the company has already availed the CoPP;
- Batch wise stability study evaluation, together with the stability study condition, date of manufacturing, date of expiry, and the name of the drug etc;
- Process validation report for three batches (Applicable only in the case of herbal products);
- Validation report of the analytical method;
- A completed list of the technical staff, together with their experience, qualification, and approval status;
- List of all the equipment, instruments, and machinery used or to be used;
- Layout for Manufacturing Plant layout;
- Diagram form Water System;
- Diagram from HVAC System;
- Export data for the previous two years, where re-validation of CoPP is applicable;
- Product summary sheet;
- Actual label of the product that is needed to be applied for WHO-CoPP;
- Proof of safety & effectiveness in accordance with the Rule 158B of the Drugs and Cosmetic Rules 1945;
- Analysis Certificates for the three batches of each product;
- Undertaking concerning the absence of any non-herbal, such as metals or minerals, etc.;
- Undertaking concerning compliance with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder;
- Undertaking concerning the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and Rules made there under;
Procedure for Obtaining Ayush License
The steps involved in the process for obtaining Ayush License are as follows:
- Firstly, visit the respective state website of AYUSH;
- Download the requisite application form, attachments, complete list of documents, which may include certifications, affidavits and other permits, such as GMP and CoPP as the case may be;
- Now, apply for GMP and CoPP Certifications, if in case applicable;
- Submit the application form before the Directorate of AYUSH, under whose jurisdiction the respective office falls;
Concept of GMP Certification
The term GMP or Goods Manufacturing Practice Certification is a mechanism whereby the goods are consistently manufactured and controlled accordingly to meet the quality standards specified by the WHO (World Health Organisation).
Further, a GMP Certificate denotes that a particular pharmaceutical manufacturing company has successfully cleared the process of inspection of the pharma regulatory body of the country, and is harmless and safe even for export.
Concept of COPP Certification
The term COPP or Certificate of Pharmaceutical Product is a legal document that certifies that a manufacturing company having this particular certification is legally permitted to sell their pharma product in the country, where they are producing.
However, if in case the pharmaceutical product is registered somewhere overseas, then the government body in-charge, who has the authority to approve the application form, will ask for COPP to confirm that the said product is being sold as a “commercial finished product” in the country that is manufacturing it.
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Frequently Asked Questions
The term “Ayush License” denotes a permit that is required for manufacturing herbal and ayurvedic products in India.
There are 5 different types of Ayush License prevalent in India.