News & Blog

Ministry of Ayush License

News & Blog

Ministry of Ayush License
Ministry of Ayush License

GET IN TOUCH

Ministry of Ayush License 

 

Background

The Ministry of AYUSH regulates AYUSH license which has to be obtained by all manufacturers dealing in herbal or Ayurveda products within India. Earlier this ministry was known as the Department of Indian System of Medicine and Homeopathy which was established in March 1995 and this was changed to the Ministry of AYUSH on 9th November 2014.

Licenses issued by the Ministry of AYUSH for manufacturing purpose:

 

  • License for
  • License for Loan.
  • Third-party manufacturing /Contract Manufacturing / Product to Product manufacturing/ White label Manufacturing.

 

AYUSH Licenses

a.      Complete manufacturing license

 

If the applicant plans to do the marketing as well as manufacturing of products then this license has to be obtained. The applicant must own a manufacturing unit to be eligible for this license.

Each state has its requirements for this license. The applicant has to abide with the requirements laid down by the respective state authorities of AYUSH.

 

Listed below are the detailed requirements for this license:

  • The manufacturing plant has to be located in an industrial location.
  • Each drug category should have a minimum of 1200 sqft of manufacturing area.
  • The area requirement increases with an increase in the category of drugs being manufactured.
  • GMP certificate is mandatory for the manufacturing plant.
  • The team should comprise of at least 2 Pharmacies and 2 Ayurveda experts.
  • The applicant must have all the machinery required for packaging and manufacturing.
  • The Drug Inspector shall carry out regular inspections.

 

b. AYUSH Loan License

 

The applicant does not need to be the owner of the manufacturing plant to obtain this license and a third party does the manufacturing of products. A manufacturer with GMP certificate can apply for this license which can be issued in the name of his company. Approval of authorities is required for sales of products.

Listed below are the detailed requirements for this license:

  • The manufacturing plant has to be located in an industrial location.
  • There should be at least three rooms in the manufacturing plant with the following specifications:

-Storage room for raw material.

-Storage room for finished goods.

-Office.

 

  • The license has to be renewed regularly.
  • The Drug Inspector shall carry out regular inspections.
  • It is not mandatory to have Pharmacist and Ayurveda experts in the team.
  • Manufacturing unit and company registration has to be the same.

 

c.   AYUSH Third Party/Contract Manufacturing License

 

The applicant only involves in the marketing of the business in this case and manufacturing is not under him. All the liaison work and compliances have to be seen by the manufacturer in this case. Manufacturer has to get approval from concerned authorities. The applicant can provide packaging material and raw material to the manufacturer or they can be sourced by the manufacturer himself.

 

Benefits of this License

  • The applicant can operate in any state irrespective of the state in which the products are being manufactured.
  • The manufacturer takes care of all the compliances and the applicant only needs to handle the marketing.
  • Many big companies have adopted this model of business in this sector.

The process to obtain AYUSH License

  • Visit the state website for AYUSH.
  • Download the application form, document list which consists of affidavits and other certificates like COPP and GMP as per the case and other attachments.
  • If applicable apply for COPP and GMP.
  • Submit the form to the concerned authorities of AYUSH for the state.

GMP or Good manufacturing practice

This is a system that assures that the products are being produced as per the guidelines laid down by the WHO. The main objective of this certificate is to reduce the risk involved in the production of pharmaceutical products.

GMP certificate states that the manufacturing company has obtained a green signal from the pharmaceutical regulatory body of the country and the products are safe for exports to other countries as the manufacturer is following the best practices as per WHO.

 

COPP or Certificate of a Pharmaceutical Product

This certifies authorizes the manufacturing company to do sales of pharmaceutical products in the country where production is taking place. In case the manufacturer wants to sell products overseas then the government bodies of another country ask for the COPP certificate to verify if the products are being sold in the country where they are being made.

 

Documents required for GMP and COPP certificates

  • Applicant’s details like address, name, contact, etc.
  • Copy of manufacturing license
  • Details of products along with their composition for which COPP is being applied for.
  • Master plan for the manufacturing site.
  • Detailed manufacturing process and formula.
  • Specification of finished products and the methods used for their analysis.
  • Approved products list
  • Details of products for which COPP has already been obtained.
  • Batch wise details of stability studies.
  • Validation report of the batches for at least 3 batches. ( For herbal products)
  • Analytical method’s validation report.
  • Details of technical employees along with the details of their experience, qualifications, and status of approval.
  • List of machines and types of equipment.
  • Layout of the unit
  • Diagram of the water system.
  • Diagram of the HVAC system.
  • In the case of revalidation of COPP, previous2 years export data is required.
  • Original packaging slips of the products which require the certifications.
  • Effectiveness and safety proof according to Rule 158B of Drugs and Cosmetics rule, 1945.
  • Undertaking if any non-herbal products are being used like minerals, metals etc. in products that need COPP certifications. (Mandatory for herbal goods).
  • Undertaking concerning conformity with the requirements of domestic regulations inter-alia Drugs & Cosmetics Act, 1940 and Rules thereunder, Drugs &Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder, (Applicable in case of herbal goods).

 

Frequently Asked Questions (FAQ)

How can the loan license holder be involved in the manufacturing of products?

 

Raw materials and packaging supplies can be provided bythe Loan License holder. The manufacturer can further use these raw materials to make finished goods which will be used for sale.

 

What happens if the manufacturer has to be changed in case of a Loan License?

The loan license holder has to apply for a new loan license by providing details of the new manufacturer who has GMP certification.

 

What charges are taken by the manufacturer from the loan license holder?

Manufacturers take the cost incurred on manufacturing products in his unit from the loan license holder. The loan license holder decides the MRP of the goods based on all the costs incurred by him.

 

Do products sold by the loan license holder display manufacturer’s details on labels?

The labels will not display any details regarding the manufacturer and only the loan license holder’s details will be mentioned under production and marketing.

 

Registrationseva.com can help in all kind of Registration in a very less time and at affordable price. You can reach to us at info@registrationseva.com or post your query here.

Leave a Reply

Your email address will not be published. Required fields are marked *

We take processes apart, rethink, rebuild, and deliver them back working smarter than ever before.