How to get AYUSH Manufacturing License?

All such manufacturer who is dealing with the Ayurvedic or Herbal products
in India is required to obtain the license from AYUSH regulated by the
Ministry of AYUSH. The Ministry of AYUSH was formed on 9th November
2014, earlier it was known as the Department of Indian System of Medicine
and Homeopathy (ISM&H) which was created in March 1995.

Types of AYUSH Licenses required by manufacturers

Following are the manufacturing licenses that are issued by AYUSH:

 Ayush  Manufacturing License.

 Ayuhs Loan License.
 Contract Manufacturing / Third party manufacturing / White label
Manufacturing / Product to Product manufacturing.

Types of AYUSH Licenses

A. Complete Manufacturing License
 It is obtained in the cases when the applicant is desirous of obtaining the
license has planned for manufacturing and marketing, both of the products.
In this case, the manufacturer has to set up his own manufacturing unit.

The state requirement for such manufacturing set up varies from state to
state. One has to comply with all the requirements stated by the state
authority of AYUSH.

In case you wish to take AYUSH Manufacturing license following is

the requirement to be obtained under AYUSH Act:

 The manufacturing unit should be an industrial area.

 The minimum size of 1200 sqft. should be there, for one category of
the drug only.
 In case more than one drug is required, and add more categories,
you need to add more space.
 The manufacturing unit is mandatorily required to be GMP certified.
 2 Ayurvedic experts and 2 Pharmacies must form the part of your
team.
 All the manufacturing and packaging machinery should be available
with you.
 Regular inspection of the premise shall be done by the Drug
Inspectors.

B. Ayush Loan License

In this kind of set up the manufacturing unit is not owned by the applicant.
The products are manufactured by the third party manufacturers.  Such
Loan license is to apply with a GMP certified manufacturer and thereafter it
will be issued to the applicant company. Thereafter the product approval is
required to be obtained from the authorities.

How is the Loan License holder involved in it?

The Loan License holder can provide the raw materials and packaging
material or manufacturer can arrange it from own sources also. The
manufacturer converts such raw material into finished products and
thereafter provides the finished product.

What if the manufacturer so appointed is required to be changed?

The license holder is required to apply for a Loan license again with a new
GMP certified manufacturer.
 What are all charges charged by the manufacturer on the Loan license
holder?

Conversion charges are charged by the manufacturer i.e. the cost for
manufacturing the desired product in his manufacturing unit or premises. 

Will such a product display anything about the manufacturer?

No, the Product label will not display anything about the manufacturer,
rather it will display that the product is both manufactured and marketed by
the License holder company. It will not mention anything about the
manufacturer who has been seasoned with by the license holder.

In case you wish to take the above-stated license following is the

requirement to be obtained under AYUSH:

 The manufacturing unit should be an industrial area.

 The premise should have minimum three rooms according to the
description as given below:
 One room for the storage of raw material;
 One for finished material storage and;
 One for the office.
 Renewal of Loan License should be done  regularly
 Visit of Drug inspectors on regular basis for inspection of premises is
a must.
 No Ayurvedic experts and Pharmacist are required.
 The company registration and the manufacturing set up should be
the same.

C. Ayush Contract / Third-Party Manufacturing License

In such arrangements neither the person has the license nor has the
manufacturing set of his own, only the marketing part is done by the
contract / third – hand manufacturing, in that case, all compliance and
liaison work shall be taken care by the manufacturer.

The manufacturing license of the manufacturer shall be used; the

manufacturer will have to get approval for your product from the concerned
authorities.

However, you can provide the raw materials and packaging material or
manufacturer can arrange it from his own sources.
 What will the product display?

The Product shall display that the product is manufactured by the XYZ
manufacturer and marketed by you.

What are all charges charged by the manufacturer on the Loan license
holder?

 Conversion charges are charged by the manufacturer i.e. the cost for
manufacturing the desired product in his manufacturing unit or premises.
 The product approval fees are also charged to you by the
manufacturer.
 A legal document is required to be drafted between the manufacturer
and your details about the fact that you own the product. The Legal
document so drafted should be strong enough to safeguard your rights in
case of any dispute. It should include a clause that your company remains
the owner of the product.

The benefit of such Contract Manufacturing:

 The marketing company can operate in any state irrespective of the

location of a manufacturing company.
 Only the marketing portion is to be taken care rest all compliances is
to be to be done by the manufacturer.
 This modus oprandi is trending nowadays; many big companies are
doing this.

General Documents required

Documents required for making an Application for GMP certification &
issuance of COPP.
 Details about the applicant like Name, address, telephone, fax, e-mail
etc.
  Manufacturing License copy.
 List of products applied for issuance of COPP & their composition.
 Site Master file.
 Master manufacturing formula along with the manufacturing process.
 Method of Analysis and finished product specification.
 List of approved products.
 List of products for which the firm has already availed the CoPP.
 Stability study evaluation batch wise, along with the Date of
manufacturing, Date of Expiry, stability study condition, the name of Drug
etc
 Process validation report for 3 batches. (Applicable in case of herbal
products)
 Validation report of the analytical method.
 List of technical staff along with their qualification, experience 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 2 years,  wherever re-validation of  CoPP is 
applicable
 Product summary sheet.
 Actual labels of the products which are required to be applied for
WHO-CoPP.
 Proof of safety and effectiveness as per Rule 158B of Drugs &
Cosmetic Rules, 1945.
 Certificates of Analysis for three batches of each product. (Applicable
in case of herbal products), (Applicable in case of herbal products).
  Undertaking regarding 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 regarding compliance with the provisions of domestic
regulations inter-alia Drugs & Cosmetics Act, 1940 and Rules thereunder,
Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and
Rules there under, (Applicable in case of herbal products).

NOTE: However the list of documents may vary from state to state, one
needs to visit the individual sites of the required state and check the
required documents.
 GMP certification: Good manufacturing practice
Good manufacturing practice (GMP) is a system whereby it is ensured that
the products are consistently produced and controlled according to quality
standards as prescribed in line with the WHO. The intent behind such
certification is to minimize the risks involved in any pharmaceutical
production.

A good manufacturing practices certificate (GMP) indicates that the

pharmaceutical manufacturing company has cleared the inspection of the
pharmaceutical regulatory body of that country and is safe even to be
exported and it ensures that the product meets the standards of good
manufacturing practices as stated by the WHO.

COPP: Certificate of a Pharmaceutical Product (COPP)

The COPP is the legal document that certifies the manufacturing company
having this certificate is legally allowed to sell their pharmaceutical product
in the country they are producing. In cases where the pharmaceutical
product is to be registered under the overseas, the government body in
charge of approving the application will ask for COPP to ensure that the
product is being sold as a commercial finished product in the country that is
producing it.

The process of obtaining the AYUSH License

 Go to the individual state sites of AYUSH.
 Download the requisite form, attachments, list of documents which
may include affidavits and other certification such as GMP and CoPP as
the case may be.
 Apply for GMP and CoPP if applicable.
 Submit it before the Directorate of the AYUSH, falling under the
jurisdiction