documents and samples of ayurvEdic product export to USA

1. CRITICAL EVALUATION & PRESENTATION OF
DOCUMENTS REQUIRED FOR EXPORT OF
AYURVEDIC PRODUCT TO USA
Submitted By:
Jitendra Kalambe
Nikhil Sarkate
Nitish Karhale
Payal Patle
Kajal Bhulaiwale
Guided by:
Dr. Ajay G. Pise
(Department of regulatory
affairs)

2. INTRODUCTION
 Ayurvedic medicine is the world’s oldest method of holistic healing methods, and it
was developed in India more than 3,000 years ago. Ayurveda focuses on wellness
and health, and it depends on a balance between the mind, body, and spirit.
 The main goal of Ayurveda treatments is to fight diseases by strengthening the
immune system while promoting good health.
 To export Ayurvedic products from India, a few documents and licenses need to be
obtained.
 While the documents depend on the product type, destination country and shipping
mode, here are a few key requirements.

3. IEC
Product approval from AYUSH (in case
of manufacturer)
Free Sale Certificate (in case of exporting
Ayurvedic supplements and medicines)
FSSAI license (in case of exporting
consumables)
FDA registration and product labelling
requirements
NPOP (National Program for Organic
Production) certification (in case of
exporting organic
Depending on the Ayurvedic product
being exported, for instance – Ayurvedic
medicines, other certificates will also be
required
Certificate of Analysis (COA)
GMP Certification
Importer of Record (IOR)
Export Documentation
Trademark and Patent Registration
Product Liability Insurance
Bill of Lading
Certificate of Origin

4. 1.What is an Import Export Code?
 An Import Export Code is a 10-digit number issued by the Directorate General of
Foreign Trade (DGFT), Ministry of Commerce and Industry, Government of India.
 It is a unique identification number that is required by importers and exporters to
run a seamless business in international trade.

5. What is the need for an IEC?
 Obtaining an IEC is one of the most essential steps before starting an import-export
business.
 Following are some of its benefits:
 Makes the business registration process easy
 Both registered and non-registered businesses must apply for an IEC on the DGFT
website. If all the documents submitted are verified, an IEC is issued within 10
working days. If your business is registered for GST, then your GSTIN can be used
in place of IEC as a unique identifier.

6. How to register for IEC?
 It is important to register for Import Export Code for all types of businesses such as
sole proprietorship, partnership, private limited or charitable organizations.
 Documents required for IEC registration
 Some of the documents required for IEC registration are:
 Aadhar card (as address proof)
 A canceled cheque from the bank
 Business proof (GST registraion or incorporation certificate)

7. 1.Log on to DGFT website
2.Enter PAN details
3.Fill the application
4.Upload documents
5.Preview and submit

8. 2.What is AYUSH Licence?
 Manufacturers who are involved in producing Ayurvedic or Herbal products in
India need to acquire an AYUSH License controlled by the Ministry of AYUSH.
 The Ministry of AYUSH was framed on 9th November 2014.

9. Types of AYUSH Licenses

10. Documents required to obtain an AYUSH License
 Applicant’s details such as Name, Address, E-mail, Contact Number
 A copy of the Manufacturing License,
 Complete product list applied for issuance of COPP and their composition,
 Site Master file/ Manufacturing Plant Layout,
 Submit the manufacturing formula along with the manufacturing process,
 Method of analysis and finished product specification Report,

11. 3.What is FSSAI license?
 FSSAI license is a certification given to food businesses in India to ensure safety of
food products and consumables.
 Mandated by the FSS Act 2006, FSSAI is administered by the Ministry of Health &
Family Welfare, Government of India1.
 To be a common ground for all food and safety-related matters, FSSAI performs the
following functions:

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 Lays down the procedure and guidelines for quality testing laboratories and
stores information about the accredited laboratories
 Provides scientific advice to Central and state government for policies and
rules related to food safety
 Collects and arranges data about food consumption, contamination in food,
potential biological risks and risk management systems
Establishes a network of information across the country to deliver reliable
information about food safety and issues of concern
 Provides training programs to businesses and sellers in the sector
 Promotes general awareness about food safety and quality standards

13. How to obtain FSSAI license to export from India?
 An online food safety platform, Food Safety and Compliance System (FoSCoS),
is a centralized point for all the FBOs (Food Business Operators) to complete
transactions related to license and registration.
Below are the steps to apply for the food registration certificate2:
 Open the official website of FoSCoS, FSSAI. Click on “Apply for Registration
Certificate”.
 Enter your mobile number and other required details. You will receive an OTP on
the given mobile number. Enter the code and submit.

14. Enter your state in the following box and then select the appropriate type of
business and click ‘Proceed’.
Fill all the details in the registration form that appears. You will require the
following documents here:
• Photo of the business owner
• Government issued identity proof such as Aadhar or PAN or Voter ID.
Proof of Address of Businesses activity (if address is other than as
mentioned in ID Card).
• Fill the form and pay the required fee.
• A receipt will be generated with a 17-digit reference number that can be
used for future reference.
• The registration will be completed and license will be generated within 30
days.

16. 4.What is a Free Sale and Commerce Certificate? - An Overview
 A Free Sale and Commerce Certificate provide assurance to the importing country
about the status and quality of imported goods.
 It is issued in the Exporting country by a national regulatory authority of the country.
In India, it is issued by DGFT and is also known as a certificate of export or
Certificate to Foreign Governments.
 A Free Sale and Commerce certificate certifies that the export goods listed in the
certificate are freely sold and consumed in their country of origin and approved for
export.

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 It is issued to the export of items that are not covered under the Drugs & Cosmetics
Act, 1940, have usage in Nursing homes, clinics, and hospitals for medical and
surgical purposes, and are not prohibited for export.
 There are two categories under which Certificate is issued –
 Certificate for the products related to Medical Devices/Instruments
 Certificate for the products not related to Medical Devices/Instruments

18. Purpose to obtain a Free Sale and Commerce Certificate
 For verification of Manufacturer
 For the verification of products
 To Verify Good Manufacturing Practice (GMP) Compliance
 Validity and Government fee to obtain the Certificate?
 Documents Required to obtain Free Sale and Commerce Certificate

19. Documents Required to obtain Free Sale and Commerce
Certificate
 A valid copy of the IEC copy and RCMC copy.
 Valid manufacturing licenses.
 The product permission letters of the requested products for the issue of the Free
Sale Certificate.
 List of export products for which Free Sale Certificate are required.
 Letter of the concerned authority-demanding certificate.
 Copy of the power of attorney/authorization letter.

20. How to apply for a Free Sale Certificate online in India?
 The exporter is required to access the DGFT Website, select the Certificate
management from the services list.

21. Free Sale and Commerce certificate
The export firms are advised to send
their applications for grant of Free
Sale and Commerce Certificate at the
official email ID of the concerned
RA as per the format given in ANF
2H due to RAs are working with
skeletal staff leading to delays in the
issuance of the certificate.

22. Role of the FDA in exporting to the USA
• FDA regulates compliances to prevent the entry of violative products, giving
guidance to exporters and the industry with education materials and certification
programs.
• Following are the key roles of FDA:
• FDA develops rules regarding clinical test to be done on new medication before
being marketed to individuals.
• It oversees divisions involving food, drugs, cosmetics, animal food, dietary
supplements, biological goods and medical devices.
• FDA aims to protect public health by inspecting and reviewing food and drugs.
• It has the power to inspect products in the market for safety or other reasons.

23. • Receipt of applications
• Providing standards and operational
documents
• Agreement
• Demand for Fee
• Document audit
• Physical field inspection
• Risk assessment
• Compliance verification
• Reporting by inspector
• Review by reviewer
• Certification decision
Process of Certification by Accredited agency

24. • Visits of facilities, fields, etc.
• Review of records and accounts.
• Calculation of input/output norms,
production estimates etc.
• Assessment of production system
• Interview with responsible persons
• Risk assessment
• Part Conversion and Parallel Production
• Inspection for Use of Genetically
Engineered Products
• Use of off-farm inputs
• Analysis for residue testing (if required)
National Program for Organic Product

25. Certificate of origin
A certificate of origin (CO) is a document
declaring in which country a commodity or good
was manufactured. The certificate of origin
contains information regarding the product, its
destination, and the country of export. For
example, a good may be marked "Made in the
USA" or "Made in China".
Required by many treaty agreements for cross-
border trade, the CO is an important form
because it can help determine whether certain
goods are eligible for import, or whether goods
are subject to duties.

26. What Is a Bill of Lading?
• A bill of lading (BL or BoL) is a legal document issued by a carrier
(transportation company) to a shipper that details the type, quantity, and
destination of the goods being carried.
• A bill of lading also serves as a shipment receipt when the carrier delivers
the goods at a predetermined destination.
• This document must accompany the shipped products, no matter the form
of transportation, and must be signed by an authorized representative from
the carrier, shipper, and receiver.

28. What is AD Code ?
An Authorized Dealer Code
(AD Code) is a 14-digit numerical
code provided by a bank with
which your business has a current
account.
You will need to register an AD
Code at every port from where
your goods are cleared by
customs.
 At the time of customs
clearance, your Customs House
Agent (CHA) will ask you to
provide the AD Code for that
particular port.

29. Importance of AD Code in Exports
A registered AD Code for export is essential for customs clearance. If you do not
have one, you will not be able to generate your shipping bill number, which is
compulsory for customs clearance. If you are eligible for government benefits, an AD
Code registration with the customs enables you to get the same directly credited into
your current account.
How to apply for AD Code?
To obtain an AD Code, you will have to write a letter to the bank requesting it to
issue the same against your business’s account. You will have to address this request
to the branch manager in the prescribed format. The bank will then issue a 14-digit
AD Code on its letterhead in the format prescribed by the Directorate General of
Foreign Trade (DGFT).

30. The procedure to apply for an AD
Code is as follows:
AD code letter format

31. Commercial documents:
1.
• Sales contract /purchase order
2.
• Commercial invoice
3.
• Packing list
4.
• Certificate of analysis

32. A sales contract is a legally binding document between a buyer and seller. The document
includes the details of the exchange, the terms of sale, clear product or service descriptions
and more. A good sales contract should leave no doubt in either party’s mind about their
rights and obligations during a transaction.
What is a sales contract ?
What to include in a sales contract
1. Details of parties
involved
2. Description of goods
or service
3. Prices and payment
terms
4. Delivery or supply
instructions
8. Breach of contract
terms
7. Confidentiality
clauses
6. Inspection period
5. Warranty
information

34. Commercial invoice
A commercial invoice is a legal document used for processing agreements in international
trade. As it is legally legitimate and holds no standard format, the seller (exporter) can
issue the document to the buyer (importer) once the goods are shipped.
Commercial Invoice Requirements:
• Any commercial invoice for shipping & export should contain following essential
details:
• Exporter’s company name, address, and contact number
• Importer’s company name, address, and contact details
• Buyer’s details if they are not essentially a consignee
• Mode of dispatch (whether by road, rail, air, or sea)

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• Type of shipment (FCL, LCL, breakbulk, etc)
• Types of Containers (Refer Container, TEU containers, Insulated Containers, etc)
• Vessel name and voyage number
• Names of the loading port, discharge port, and destination
• Invoice number and date
• Name of country of origin of the goods
• Destination of the goods
• Terms/method of payment (optional)

37. Importer of record
 The Importer of Record (IOR) is officially noted by many governments as the owner
or purchaser of the products being imported into a destination country. The IOR can, in
fact, be the owner, purchaser, or a customs broker with the proper authorization.
 In most cases, a power of attorney (POA) provides the authorization to do clearance
for an importer. The IOR must ensure all goods are appropriately documented and
valued. Furthermore, the Importer of Record is the responsible party for the payment
of duties, tariffs, and fees of the imported goods.

38. Import data list of Himalaya wellness company

39.  There are approximately 2 billion Muslims
across the globe, with almost 4 million residing is
the US. This market segment has experienced a
rapid growth rate over the past several years and
is currently valued at approximately $2 trillion
USD.
 According to CNBC, the cosmetic, personal
care, healthcare and pharmaceutical industries
will see the largest growth in Halal products as
the demand is growing at a rapid rate.
Why is it important to be Halal
Certified?

40. In order to complete the Halal Certification process, companies must complete a three
step process with an advisory group. This process includes
•Evaluation -- explanation of company and the need for receiving Halal Certification
•Inspection -- onsite inspection of plant and process
•Certification -- once the evaluation and inspection are complete, if passed, the
organization will be granted certification.
Halal Certification Process

41.  To get the protection of trademark rights one has
to register the trademark. It is important to register
your trademark because it prevents others from
copying your mark and misrepresenting other
products with your mark.
 Trademarks help the customers to recognize the
brand and the brand value in one look such as the
logo of a tick sign for Nike or a jumping wildcat
for Puma etc.
 Where a patent expires in 20 years a trademark
registration expires after 10 years of its
registration, but unlike patents, a trademark can be
renewed again for another 10 years.
Why trademark certificate is
important?

42. Dossier preparation

43. References
• Cited from
https://www.yumpu.com/en/document/read/4092295/application-form-for-
ayush-product-foodcert-india cited on 25/3/2023 1:12 pm
• Cited from https://www.foodlicenses.co.in/sample-certificates/cited on
25/3/2023 2:18 pm
• Cited from https://www.indiamart.com/proddetail/organic-npop-nop-
certification-24152699055.html 25/3/2023 12:56 pm
• Cited from https://sell.amazon.in/grow-your-business/amazon-global-
selling/blogs/export-ayurvedic
products#:~:text=i)%20inspection%20certificate%20for%20ensuring,revie
w%20submitted%20by%20the%20manufacturer. Cited on 24/3/2023 2:45
pm