AYUSH LICENSE IN INDIA

AYUSH LICENSE IN INDIA

This License is basically granted to those manufacturers who deal with ayurvedic or herbal products in India.


INTRODUCTION

Ayush License is regulated by the Ministry of Ayush. Commissioner of Ayush Department approves the application of Ayush License.

Previously the Ayush Department was known as the Department of Indian System of Medicine & Homeopathy (ISM & H) which was formed in 1995. Later, on 9th November 2014, the name of the department was changed to the Ministry of Ayush.

After taking the prior consent from the Ministry of Ayush, ayurvedic medicines can be manufactured in India. For getting the Ayush License, one needs to file an application along with all the required documents to the Ministry of Ayush.
 

TYPES OF LICENSES 

Ministry of Ayush issues various types of licenses to manufacture ayurvedic or herbal products in India and they are as follows:-


 

Retail license – This License is required in the case of selling the ayurvedic or herbal products as a retailer. 

Wholesale license – The wholesale License is required to be obtained in case of selling the ayurvedic or herbal products as a wholesaler.

Manufacturing license – If anyone wants to manufacture ayurvedic drugs and medicines, then in this case they have to obtain an Ayush License for manufacturing the medicines. For the purpose of manufacturing the ayurvedic medicines, they also have to set up their own manufacturing unit for the same.

The applicant who wants to apply for Ayush manufacturing license has to comply with all the requirements issued by the specific Ayush state authority as every state has its own set of requirements to issue this license.

To obtain the manufacturing license, the following documents are required:

  • The manufacturing unit has to be there in an industrial area.
  • The area of the manufacturing unit should be of a minimum of 1200 sq.ft for each category of drug.
  • In case when the category of drug increases, then in such situation the area of the manufacturing unit should also increase
  • GMP certification is mandatory for the manufacturing unit.
  • 2 ayurvedic experts and 2 pharmacists should be there in a team.
  • Availability of manufacturing and packaging machinery.
  • The drug inspector should inspect the premise regularly.
     


 

Ayush loan license  – This license is required when the ayurvedic or herbal medicines or products are being manufactured by the third party. The Applicant in this case is not responsible for manufacturing the medicines, the manufacturing work is done somebody else i.e the third party.

This License needs to apply with a GMP certified manufacturer and then later on issued to the applicant.

The following documents are required to obtain the Ayush loan license:

  • The location of the manufacturing unit should be there in an industrial area.
  • Minimum three rooms should be there in a premise and the room should be for-
  • one room for storing the raw material
  • one room for storing the finished material
  • a room for office
  • Drug Inspector must regularly inspect the premise.
  • Regular renewal of Loan license
  • No requirement of any ayurvedic experts and pharmacists
  • Company registration and manufacturing unit have to be the same.
     

Ayush contract/ third party manufacturing licenses: In this case, one uses the manufacturing license of a third-party manufacturer to manufacture the product. The applicant only has to market the product. Further, in the applicant part, it is not necessary that they should own a manufacturing unit.

All the necessary requirements and formalities with the ministry will be done by the manufacturer itself. The manufacturer will get all the necessary approval for your product from the concerned authorities. Here, the applicant uses the manufacturing license of the manufacturer.

The applicant only has to provide the raw materials, packaging materials but if they fail to do so then the manufacturer will arrange all those items. The applicant receives the final product from the manufacturer. On the product, the labeling will display the name of the company that has manufactured and marketed the product.
 

There are certain benefits one can have if they obtain Ayush contract/third party manufacturing license and they are-

a.  The applicant can function in any state irrespective of the location of the manufacturing company.

b.  The applicant only looks after the marketing part of the product, rest all the compliance as required for the product is being taken care of by the manufacturing company.

c.  There are a number of big firms that follow this form of work.
 

TYPES OF CERTIFICATIONS
 

GMP (GOOD MANUFACTURING PRACTICE) CERTIFICATION

GMP (Good manufacturing practice) certification provides the assurance that the products are consistently produced and controlled as per prescribed WHO quality standards. The GMP certification is given to minimize the risk involved in any pharmaceutical production.

GMP indicates good manufacturing practice certification which shows that the pharmaceutical manufacturing company has come out clean after the inspection of the pharmaceutical regulatory body of the country, and it meets the values of good manufacturing practices as prescribed by WHO. GMP certification also indicates that the product is safe to be exported in any part of the country.
 

COPP (CERTIFICATE OF PHARMACEUTICAL PRODUCT)

If any manufacturing company have a COPP certificate, then they have legal permission to sell the products in any part of the country. If any pharmaceutical product is registered overseas, then the in charge of the government authority will ask COPP to make sure that the product is being sold as a commercial finished product in the country.
 

DOCUMENTS REQUIRED FOR GMP AND COPP CERTIFICATION
 

The documents required for GMP and COPP certification are –

  • Address, name, contact, etc. of the applicant
  • Manufacturing license
  • Details of products along with their composition for which COPP is being applied for.
  • Manufacturing site’s master plan
  • The 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.
  • The 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).
     

REQUIREMENT OF DOCUMENTS TO OBTAIN AYUSH LICENSE 

Both retailer and the wholesaler are required to have the following documents in order to obtain Ayush License and the documents are as follows:-

  • Memorandum of Association and Article of Association of the Company.
  • Premise Address proof such as rent agreement etc.
  • Identity Proof of the proprietor/Director/Partner of the Company (as the case may be).
  • Photograph of the proprietor/ Director/partner of the company (as the case may be).
  • Refrigerator details, (if any).
  • The affidavit required for the compliance of MPD 2021.
  • Proof of Qualification
  • Registration of Delhi Ayush Council. (In case applying for the license in Delhi state)
  • Letter of Appointment and Biodata of the director of the company. 
     

Steps to obtain the Ayush License

The steps involved in obtaining the Ayush License is as follows- 

STEP 1 – One has to visit the state website for Ayush as per there requirement because every state has a different website for Ayush.

STEP 2 –The process involved in the second step is to download the application form, attachment, list of required documents which includes affidavits & other certifications such as GMP and COPP (one has to apply for GMP & COPP if it is applicable to them)

STEP 3 – For the third step, one has to fill the application form and have to send the same for review along with the necessary documents to the commissioner of the Ayush department.

STEP 4 – After receiving the documents, the commissioner will review the application. If everything falls in the place and the commissioner of the Ayush department gets satisfied after reviewing the application, then the application will be processed within 15 days.

STEP 5 - At last the Ayush License will be granted to the company after processing of the application.
 

FREQUENTLY ASKED QUESTIONS (FAQ’s)
 

What is Ayush License?

Ayush License is regulated by the Ministry of Ayush. This License is basically granted to those manufacturers who deal with ayurvedic or herbal products in India. Commissioner of Ayush Department approves the application of Ayush License.
 

What is the previous name of the Ministry of Ayush?

Previously the Ayush Department was known as the Department of Indian System of Medicine & Homeopathy (ISM & H) which was formed in 1995.
 

In which year the name of the Department of Indian System of Medicine & Homeopathy (ISM & H) changed to the Ministry of Ayush?

On 9th November 2014, the name of the Department of Indian System of Medicine & Homeopathy (ISM & H) was changed to the Ministry of Ayush.
 

What are the types of Ayush License?

The Types of Ayush License are as follows-

  • Retail License
  • Wholesale License
  • Manufacturing License
  • Ayush Loan License
  • Ayush contract/ third party manufacturing licenses
     
Can anyone sell the Ayurvedic or herbal products without the Ayush license in India?

No, it is not possible to sell the Ayurvedic or herbal products in India without obtaining the Ayush license.
 

What are the types of Certification?

There are two types of Certification and they are-

a.  GMP (Good manufacturing practice) certification

b.  COPP (Certificate of pharmaceutical product)
 

What are the documents required for Ayush License?

The documents required for obtaining Ayush License are-

•    Memorandum of Association and Article of Association of the Company.
•    Premise Address proof such as rent agreement etc.
•    Identity Proof of the proprietor/Director/Partner of the Company (as the case may be).
•    Photograph of the proprietor/ Director/partner of the company (as the case may be).
•    Refrigerator details, (if any).
•    Affidavit required for the compliance of MPD 2021.
•    Proof of Qualification
•    Registration of Delhi Ayush Council. (In case applying for the license in Delhi state)
•    Letter of Appointment and Biodata of the director of the company. 
 

What are the criteria to get the Ayush License for both retailers and wholesalers?

The criteria to get the Ayush License for both retailer and wholesaler are:

For retailer- The area of the premise of the shop should be 10 square meters and the height of the premises should be as per the National Building Code 2005.

For wholesaler - The minimum area of the premises should be around 15 meters and the height of the premises should be as per the National Building Code 2005.
 

What is GMP certification?

GMP (Good manufacturing practice) certification provides the assurance that the products are consistently produced and controlled as per prescribed WHO quality standards. The GMP certification is given to minimize the risk involved in any pharmaceutical production.

GMP indicates good manufacturing practice certification which shows that the pharmaceutical manufacturing company has come out clean after the inspection of the pharmaceutical regulatory body of the country, and it meets the values of good manufacturing practices as prescribed by WHO.GMP certification also indicates that the product is safe to be exported in any part of the country.
 

What is the COPP certification?

If any manufacturing company have COPP certificate, then they have legal permission to sell the products in any part of the country. If any pharmaceutical product is registered overseas, then the in charge of the government authority will ask COPP to make sure that the product is being sold as a commercial finished product in the country.
 

Conclusion

It is suggested that the entities who want to sell the ayurvedic or herbal products in the country should obtain a license from the Ministry of Ayush. As the license will give them the legal rights to sell their products in any part of the country. Due to the license, their product will be considered as more trustworthy in the eye of the customer.
 

Edited by Minu Mishra

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