Overview

Manufacturers who are involved in making Ayurvedic or herbal products in India are required to obtain an AYUSH license controlled by the Ministry of AYUSH. The Ministry of AYUSH was framed on 9 November 2014, before it was known as the Department of Indian Medicine and Homeopathy (ISM & ampH) which was created in March 1995.

Type of License

Manufacturing licenses issued by Aayush are as follows:

• Aayush Manufacturing License

  This is achieved in situations when the candidate wishes to obtain a license and has come up with a plan for the manufacture and marketing of both products. In such a situation, the manufacturer is required to set up its own manufacturing unit.

  Each state has its own set of requirements for setting up such manufacturing units. All requirements expressed by the AYUSH State Authority are required to be agreed.

  Applicants desirous of obtaining AYUSH manufacturing license are required to fulfill all the requirements under the AYUSH Act:

  1. The manufacturing sector is required to be in the industrial sector.

  2. The minimum size of manufacturing land to produce a drug should be only 1200 sq ft.

  3. In case if you are planning to produce more than one drug adds more categories as you will need more space.

  4. Manufacturing unit must be certified by GMP

  5. Ensure on board 2 Ayurvedic experts and 2 pharmacies

  6. You have access to all manufacturing and packaging machinery

  7. The Drug Inspector will conduct regular inspection of your manufacturing unit

• Greek Manufacturing License

  Unani medicine is considered the science and craft of healing. It is a respectable profession of permanent treatment of mankind. The Unani Framework is popular among people, as it is a kind of approach through which it prevents and cures diseases. It has received widespread acceptance as one of the related medical systems.

• Proven Manufacturing License

  Treatment is done to maintain balance between mind-body and soul system. Siddha treatment gives equal importance to the body, mind and soul and seeks to restore a complete harmony to the various psychological and physical functions of the body. Treatment In Ayurveda, yoga plays an important role along with meditation, diet and lifestyle.

  Siddha treatment places more emphasis on preventing disease than curing them. The measures taken under Siddha have been verified through scientific research. It helps in curing disease such as:

• 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.

Charges levied by the manufacturer on the license holder of the loan

• Manufacturer may charge conversion charges ie, 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 should be prepared between the manufacturer and your insights concerning the way you own the item. If there is a dispute, the legal record should be able to adequately protect your privileges. It should have a clause that says that no matter your company remains the owner of the product.

Registration process

• Visit Aayush's personal state website
• Download the list of required forms, attachments, documents, which may also include affidavits and other certificates such as GMP and CoPP.
• If suitable for GMP and CoPP
• Submit all pre-determined documents to Directorate of AYUSH

Required Documents

• Applicant’s details such as Name, Address, E-mail, Contact Number
• A copy of the manufacturing license
• Entire product list implemented for the release of COPP and their structure
• Site Master File
• Submit formulas with manufacturing process
• Method of analysis and finished product specification
• List of accepted products
• Product List for which the firm has already taken advantage of CoPP
• Date of manufacture, date of expiry, status of stability study, stability study analysis based on batch with drug name,
• Process Verification Report for three batches
• Analytical method’s validation report
• Technical staff list along with the information like experience, qualification, and approval status
• List of devices and equipment used or used
• Manufacturing Plant Layout
• Water System Diagram
• HVAC System Diagram
• Export data for the last 2 years, where re-verification of CoPP is applicable
• Product Summary Sheet
• Actual label of products that must 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 / minerals etc. in the products WHO-CoPPs (applicable in the 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 under which it is guaranteed that the items are manufactured and controlled reliably according to the quality standards recommended by the WHO. The purpose behind such certification is to limit the dangers associated with any drug formulation.

The Certificate of Good Manufacturing Practices (GMP) shows that the Pharmaceutical Manufacturing Organization has gone through the examination and has been conducted by the regulatory body of that country and is also given shelter to trade and guarantees that Meets item guidelines Good manufacturing practices expressed by WHO

COPP: Pharmaceutical Product Certificate

The COPP is an official document that confirms the organization producing the certificate that they are legally allowed to sell their pharmaceutical items in the nation they are producing. In situations where the pharmaceutical item is to be registered abroad, the administrative body responsible for approving the application will request the COPP to ensure that the item is being sold as a commercial finished product in that nation Which is producing

How is the license holder involved in this?

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

• 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