INTERNALTIONAL EXPANSION PROCEDURE AND

DOCUMENTATION

Dawakhana Tibbiya College

Manufacturer Of Unani Medicines

Submitted By:

PURU YASHARTH
Student, MBA-International Business, F.M.S.R, AMU

Under the supervision of:

Prof. SALMA AHMAD

Member In Charge, Dawakhana Tibbiya College, AMU
Dean, Faculty of Management Studies and Research, AMU
 ACKNOWLEDGEMENT

The satiation and euphoria that accompany the successful completion of the project
would be incomplete without the mention of the people who made it possible.

I would like to take the opportunity to thank and express my deep sense of gratitude
to my mentor Prof. Salma Ahmad Dean of the Faculty of business administration,
AMU who is also the Member In Charge (MIC) of Dawakhana Tibbiya College. I am
greatly indebted to her for providing the valuable guidance at all stages of the study,
her advice, constructive suggestions, positive and supportive attitude and continuous
encouragement, without which it would have not been possible to complete the
project.

I would also like to thank Mr. Mohd. Shariq Azam General Manager, Dawakhana
Tibbiya College, AMU who in spite of busy schedule has co-operated with me
continuously & providedon ground support that has been important for the study and
indeed, his valuable contribution and guidance have been certainly indispensable for
my project work.

I owe my wholehearted thanks and appreciation to the entire staff of the company
and the factory for their cooperation and assistance during the course of my project.

I hope that I can build upon the experience and knowledge that I have gained and
make a valuable contribution towards more projects of DTC in coming future.

Puru Yasharth
Student, MBA-International Business, F.M.S.R, AMU

2
 PREFACE

The objective of the project is to compile “INTERNALTIONAL EXPANSION

PROCEDURES AND DOCUMENTATIONS” for Dawakhana Tibbiya College, AMU for
that I have to understand the Process, pricing (cost), terms, certifications, constraints,
response, emotions, strategies and beliefs regarding the steps involved in the process
of expansion of DTC. The purpose of this study is to analyze the procedures as DTC
plans to expand the business outside India, this project report contains the
documents and process to be followed for expansion in USA, Canada and Middle
East (UAE).

This report represents the culmination of diligent research, analysis, and

collaboration. It is with great enthusiasm that we present this document, aiming to
provide valuable insights into [briefly mention the subject or purpose of the report].

Throughout the process of compiling this report, we have strived to maintain a

comprehensive and objective perspective, ensuring the accuracy and reliability of the
information presented. Our team has dedicated significant time and effort to gather
data, review relevant literature, and apply critical thinking to address the core
objectives of this report.

3
 INDEX
Title Page
Acknowledgments
Preface

1. CHAPTER 1: Introduction.......................................................................5-6
i. Overview of the Company..........................................................6
ii. Vision..........................................................................................6
iii. Mission........................................................................................6
iv. Manufacturing Plant....................................................................6

2. CHAPTER 2: Goal, Objective and Scope of Study.............................7-12

i. International Expansion............................................................8
ii. Objective of the Study..............................................................9
iii. Scope of Study..........................................................................10
iv. Overview about Nutraceuticals.................................................10

3. CHAPTER 3: Target Study...................................................................13-21

i. Regulatory Compliances..........................................................14
ii. Import-Export (IE) Number.....................................................15
iii. Mode of Payment.....................................................................17
iv. Letter Of Credit (LC’s)............................................................18
v. Quality Certifications...............................................................20

4. CHAPTER 4: Findings & Suggestions.................................................22-27

i. Export Procedure in India.........................................................23
ii. Import procedures in USA........................................................27
iii. Import procedures Canada........................................................33
iv. Import procedures UAE............................................................33
v. Suggestions...............................................................................33

5. CHAPTER 5: Appendices......................................................................34-36
i. Annexures.................................................................................35
ii. Bibliography..............................................................................36
6.

4
CHAPTER 1
Introduction
 Overview of the Company
 Vision
 Mission
 Manufacturing Plant

5
OVERVIEW OF THE COMPANY

Dawakhana Tibbiya College, Aligarh Muslim University was established in 1950 and
transformed into a center of excellence in providing quality Unani Medicine as per the
ideals and objectives laid down by then Vice-Chancellor and former President of India Late
Janab Dr. Zakir Husain Saheb.
A blend of old and new techniques is utilized here to produce more than 500 high-quality
medicines for various diseases. Strict high standards of hygiene and quality are maintained
with special care in selecting pure ingredients for the products.
The Unani System of medicine and products of Dawakhana is suitable for the Indian
climate, lifestyle, and economic conditions, and millions of people of all classes are
benefited from its medicines.

VISION
To promote health and immunity of citizens of the nation and beyond in a naturalway.

MISSION
To establish Dawakhana Tibbiya College as a herbal based company dedicated to
manufacturing and supplying herbal products and solutions by adopting a unique business
model reach its customers through dealers, retailers and online services. Its aim to fulfill the
diverse needs to its customers to cater to heal and care for their health as well as personal
maintenance .It also targets to satisfy all stakeholders –the channel partners, employees
and customers.

MANUFACTURING PLANT

ADDRESS: Qila Rd, Masud Nagar, Qila, Aligarh, Uttar Pradesh 202001, INDIA

6
CHAPTER 2
Goal, Objective and Scope of Study
 International Expansion
 Objective of the Study
 Scope of Study
 Overview about Nutraceuticals

7
GOAL: INTERNATIONAL EXPANSION
International expansion refers to the process of a company extending its operations beyond
its domestic market and entering foreign markets. It involves establishing a presence in new
countries or regions to increase market share, access new customers, and capitalize on
growth opportunities abroad.
There are several approaches to international expansion that a company can consider:
1. Exporting: This is the simplest and least risky method, where a company sells its
products or services to customers in foreign markets without establishing a physical
presence there. Exporting can be done directly or through intermediaries like
distributors or agents. This report primarily centers on the expansion strategy
involving exports, where Dawakhana Tibbiya College intends to ship Indian-produced
goods to international markets.

2. Licensing and Franchising: Companies can grant licenses to foreign firms to produce
or sell their products or use their brand name. Franchising works similarly, where a
company grants the right to a foreign entity to operate under its established business
model and brand.

3. Joint Ventures and Strategic Alliances: Companies can form partnerships with local
firms in the target market through joint ventures or strategic alliances. This allows
them to leverage the local partner's knowledge, resources, and distribution networks
while sharing risks and rewards.

4. Foreign Direct Investment (FDI): FDI involves establishing a physical presence in a

foreign market by setting up subsidiaries, branches, or production facilities. This
approach gives the company greater control but involves higher risks and costs.

Factors to consider when planning international expansion include:

1. Market Research: Evaluate the target market's size, growth potential, competition,
cultural factors, regulatory environment, and customer preferences to determine its
attractiveness and suitability for your products or services.

2. Legal and Regulatory Considerations: Understand the legal, tax, and regulatory
requirements of the target market, including any restrictions or barriers to entry for
foreign businesses.

8
 3. Operational Challenges: Consider logistical factors, supply chain management,
cultural differences, language barriers, and talent acquisition to ensure smooth
operations in the new market.

4. Financial Considerations: Assess the financial implications of expansion, including

upfront costs, ongoing operational expenses, currency exchange rates, and
potential return on investment.

5. Competitive Advantage: Determine how the company's competitive advantage can

be leveraged in the target market and how it compares to local and international
competitors.

6. Risk Assessment: Identify and evaluate the risks associated with international
expansion, such as political instability, economic volatility, intellectual property
protection, and changes in market conditions.

Successful international expansion requires careful planning, adaptability, and a deep

understanding of the target market. Companies often engage in thorough market research,
feasibility studies, and consult with legal and financial experts to ensure a smooth and
successful expansion process.

OBJECTIVE OF THE STUDY

The objective of this report is to find out the procedures, documentations, Regulatory
Compliances, Import-Export (IE) Number, Mode of Payment, Letter Of Credit (LC’s) &
Quality Certifications involved for the expansion of Indian Company in overseas market,
the report basically focuses on expansion in USA, UAE and Canada.
Since DTC is prominant as a manufacturer of Unani and Ayurvedic medicines, it cannot sell
its products as drugs, Therefore the products will have to be sold as nutraceuticals in forign
market.

SCOPE OF STUDY
After successful completion of the study we will learn about the procedure &
documentation policies for business expansion in USA, UAE and Canada. We will also know
how Unani and Ayurvedic medicines can be exported as nutraceuticals outside India.

9
OVERVIEW ABOUT NUTRACEUTICALS
Nutraceuticals are a broad category of products that combine elements of nutrition and
pharmaceuticals. They are essentially bioactive compounds or substances that are
extracted from natural sources, such as plants, and are believed to have health benefits
beyond basic nutritional value. Nutraceuticals are often taken as dietary supplements to
support various aspects of health and well-being.
Some examples of nutraceuticals include:
1. Vitamins and Minerals: Many vitamins and minerals are taken as supplements to
address deficiencies or to support specific health goals. For instance, vitamin D for
bone health or vitamin C for immune support.
2. Herbal Supplements: These are derived from various parts of plants (roots, leaves,
flowers) and are often used to promote specific health effects. Examples include
echinacea for immune support or ginkgo biloba for cognitive function.
3. Omega-3 Fatty Acids: These are essential fats found in certain fish and plant sources.
They are often taken for heart health and cognitive function.
4. Probiotics and Prebiotics: Probiotics are live bacteria that are believed to have a
positive impact on gut health and digestion, while prebiotics are fibers that feed
these beneficial bacteria.
5. Amino Acids: These are the building blocks of proteins and are sometimes taken as
supplements to support muscle growth and recovery.
6. Antioxidants: These substances help protect cells from damage caused by free
radicals, potentially reducing the risk of chronic diseases.
7. Fiber Supplements: Fiber is important for digestive health, and some people take
fiber supplements to ensure they're meeting their daily intake.
8. 4Plant Extracts: Various extracts from plants, such as turmeric (containing curcumin)
and green tea (containing catechins), are taken for their potential anti-inflammatory
and antioxidant properties.

WHY TO EXPORT DRUGS AS NUTRACEUTICALS?

Unani and Ayurvedic drugs have their origins in traditional systems of medicine that have
been practiced for centuries, particularly in India and other regions. These systems use
natural ingredients, including herbs, minerals, and other substances, to formulate
remedies for various health conditions. Naturopathy drugs company can start exporting
Unani and Ayurvedic drugs as nutraceuticals for several reasons:
10
 1. Natural and Traditional: Unani and Ayurvedic systems of medicine emphasize the
use of natural ingredients and traditional knowledge. Many of the substances used in
these systems have historical and cultural significance.
2. Global Interest in Traditional Medicine: As interest in natural and holistic
approaches to health and wellness has increased globally, traditional systems of
medicine like Unani and Ayurveda have gained attention for their potential health
benefits.
3. Dietary Supplements and Nutraceuticals: Many Unani and Ayurvedic formulations
align with the concept of nutraceuticals — products derived from natural sources
that provide health benefits beyond basic nutrition.
4. Potential Health Benefits: Some ingredients used in Unani and Ayurvedic
formulations have been studied for their potential health-promoting properties, such
as anti-inflammatory, antioxidant, and immune-boosting effects.
5. Cultural and Heritage Value: Unani and Ayurvedic systems have deep cultural and
historical roots, and some countries might value the opportunity to export products
that reflect their traditional knowledge and heritage.
6. Economic Opportunities: Exporting Unani and Ayurvedic drugs as nutraceuticals can
create economic opportunities for countries with a strong tradition in these systems.
It can also support local communities involved in herbal cultivation and traditional
medicine production.
7. International Demand: There is a growing demand for natural and herbal products,
especially those with historical significance and perceived health benefits, in various
international markets.

However, it's important to note that the export of Unani and Ayurvedic drugs as
nutraceuticals involves various challenges and considerations. These include regulatory
compliance, quality control, standardization of formulations, safety and efficacy
evaluations, cultural sensitivities, and the need to align with the regulations of the
importing countries.

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12
 CHAPTER 3
Target Study
 Regulatory Compliances
 Import-Export (IE) Number
 Mode of Payment
 Letter Of Credit (LC’s)
 Quality Certifications

REGULATORY COMPLIANCES
Exporting goods from one country to another involves various regulatory compliance requirements to
ensure that the trade is conducted legally and in accordance with the laws and regulations of both the
exporting and importing countries. While the specific requirements can vary depending on the nature of
the goods, the countries involved, and the applicable trade agreements, here are some common regulatory
compliance considerations for a company to export:

13
1. Export Licenses and Permits: Depending on the type of product, its destination, and its intended use,
seller may need an export license or permit. These are typically issued by the government (Exporting
Country) and are used to control the export of specific goods, technologies, or services. Different countries
have different export control regimes, so it's essential to determine if you need a license for your particular
export.

2. Trade Sanctions and Embargoes: Ensure that your export activities do not violate any international
trade sanctions or embargoes imposed by your country or the destination country. These restrictions can
limit or prohibit trade with specific countries, entities, or individuals.

3. Customs Documentation: Prepare accurate and complete customs documentation, including invoices,
packing lists, bills of loading, and certificates of origin. Compliance with customs regulations is crucial to
ensure smooth clearance at the border.

4. Tariff Classification: Determine the correct tariff classification code (Harmonized System or HS code) for
your products. This code helps customs authorities assess applicable import duties and taxes.

5. Denied Party Screening: Check whether your trading partners (buyers, freight forwarders, etc.) are on
any denied party lists maintained by government agencies. Doing business with denied parties can lead to
serious legal consequences.

6. Export Documentation and Record-Keeping: Maintain accurate records of all export transactions,
including contracts, shipping documents, and communications. Retaining records is crucial for compliance
and can be requested during audits.

7. Environmental and Health Regulations: Ensure that your products comply with environmental and
health regulations in both the exporting and importing countries. Certain goods may require special
permits or certifications.

8. Export Insurance and Risk Management: Consider export credit insurance and risk management
strategies to protect your company from financial losses related to export transactions.

9. Incoterms: Understand and use appropriate Incoterms (international commercial terms) to define the
responsibilities and obligations of the buyer and seller regarding shipping, insurance, and customs
clearance.

10. Packaging and Labeling Requirements: Comply with packaging and labeling requirements of the
destination country, including language, safety, and product information standards.

14
11. Quality and Safety Standards: Ensure that your products meet the quality and safety standards of the
destination country, including product testing and certification when necessary.

12. Tax and Duty Considerations: Understand the tax and duty implications of your exports, including
value-added tax (VAT), GST, and import duties that may be imposed by the importing country.

It's essential to consult with legal experts, trade consultants, and government agencies specializing in
international trade to navigate the specific export compliance requirements for your company's products
and target markets, as these requirements can be highly complex and subject to change.

IMPORTER-EXPORTER (IE) NUMBER

An IE Number, often referred to as an Importer Exporter Code (IEC) in some countries, is a unique
identification number issued by the government to individuals or businesses engaged in import and export
activities. This number is used to facilitate international trade and is mandatory in many countries to
conduct import or export operations legally. Here are some key points about an IE Number:

1. Issuing Authority: The IE Number is typically issued by the government's customs department or a
related regulatory authority responsible for overseeing international trade.

2. Uniqueness: Each IE Number is unique and identifies the specific importer or exporter. It helps
government authorities track and monitor international trade transactions.

3. Mandatory Requirement: In many countries, having an IE Number is a legal requirement for anyone
involved in importing or exporting goods or services. Without it, you may not be allowed to engage in
international trade activities.

4. Application Process: To obtain an IE Number, individuals or businesses must apply to the relevant
government authority. The application process may involve providing specific documents, such as identity
proof, business registration details, and bank information.

5. Validity: IE Numbers are typically valid for a specific period, and they may need to be renewed or
updated as required by the issuing authority.

6. Usage: An IE Number is used in various aspects of international trade, including customs clearance,
documentation, and financial transactions related to imports and exports.
15
7. Exemptions: Some countries may exempt certain categories of businesses or individuals from the IE
Number requirement, especially for small-scale or occasional importers or exporters. However, this varies
from one country to another.

8. Confidential Information: While IE Numbers are publicly verifiable to ensure their authenticity, they
usually do not contain sensitive or private information about the holder.

It's essential for businesses or individuals engaged in international trade to check with their country's
customs or trade authorities to understand the specific requirements and procedures for obtaining an IE
Number, as the rules and regulations surrounding international trade can vary significantly from one
country to another. Failure to comply with these requirements can lead to legal issues and disruptions in
trade operations.
The issuance of an Importer-Exporter (IE) Number or Importer Exporter Code (IEC) is typically the
responsibility of the government of the country where the individual or business is located and intends to
engage in import and export activities. Each country has its own government agency or department
responsible for overseeing international trade and customs, and it is usually this agency that issues the IE
Number.

Here are a few examples of the relevant government agencies or departments responsible for issuing IE
Numbers in some countries:

1. United States: In the United States, the IE Number is known as an Employer Identification Number (EIN)
or a Federal Tax Identification Number (TIN). The U.S. Internal Revenue Service (IRS) is responsible for
issuing these numbers. However, there are also specific regulations related to importing and exporting
goods, which are overseen by the U.S. Customs and Border Protection (CBP).

2. India: In India, the Importer Exporter Code (IEC) is issued by the Directorate General of Foreign Trade
(DGFT), which operates under the Ministry of Commerce and Industry.

3. United Kingdom: In the United Kingdom, an Economic Operator Registration and Identification (EORI)
number serves a similar purpose. It is issued by HM Revenue and Customs (HMRC).

4. Canada: In Canada, businesses and individuals involved in importing and exporting can obtain a Business
Number (BN) from the Canada Revenue Agency (CRA), which serves as an identifier for various
government programs, including customs and trade-related activities.

16
5. Australia: In Australia, an Australian Business Number (ABN) is often used for trade-related purposes.
The Australian Business Register (ABR), maintained by the Australian Taxation Office (ATO), issues ABNs.

It's important to note that the specific name of the identifier and the government agency responsible for
its issuance can vary from one country to another.

MODE OF PAYMENT
Payment methods in international trade, whether for export or import transactions, play a crucial role in
ensuring that both the buyer and seller are satisfied and that the transaction is conducted smoothly. The
choice of payment method depends on various factors, including the level of trust between the parties, the
nature of the goods or services, the creditworthiness of the parties, and the specific trade terms
(Incoterms) agreed upon. Here are some common modes of payment in export and import:

1. Cash in Advance: In this method, the buyer pays the seller in full before the goods are shipped. It
provides the seller with the most security but may be less attractive to the buyer due to the risk of non-
delivery. It is commonly used in smaller transactions and when there is limited trust between the parties.

2. Letter of Credit (LC): A Letter of Credit is a financial instrument issued by a bank on behalf of the buyer
to guarantee payment to the seller upon presentation of specified documents, typically including shipping
documents. It provides a high level of security for both parties and is widely used in international trade.

3. Open Account: Under open account terms, the seller ships the goods and then invoices the buyer, who
agrees to pay at a later date. This method is common when there is a strong level of trust between the
parties. However, it can pose a risk to the seller if the buyer does not make timely payments.

4. Documentary Collections: Documentary collections involve the use of banks to facilitate the exchange
of shipping documents for payment. There are two types: Documentary Sight Collection (payment upon
presentation of documents) and Documentary Time Collection (payment at a later date, such as upon
acceptance of a draft).

5. Consignment: In a consignment arrangement, the seller sends the goods to the buyer, but ownership
remains with the seller until the goods are sold by the buyer. The seller is paid a commission when the
goods are sold.

6. Cash Against Documents (CAD): In a CAD transaction, the buyer receives shipping documents from the
seller's bank upon payment or acceptance of a draft. The buyer can then obtain possession of the goods
from the carrier.

17
7. Open Account with Credit Insurance: To mitigate the risk of non-payment in open account transactions,
sellers can purchase credit insurance to protect against potential losses.

8. Advance Payment with Performance Bonds or Guarantees: In cases where the seller requires an
advance payment but the buyer wants to assure performance, performance bonds or bank guarantees can
be used to provide financial security to the seller.

9. Factoring and Forfaiting: These are financial services that involve selling accounts receivable or trade
invoices to financial institutions at a discount, thereby providing the seller with immediate cash flow.

LETTER OF CREDIT (LC’S)

A Letter of Credit (LC), often abbreviated as L/C, is a widely used financial instrument in international trade
transactions. It is a formal and legally binding document issued by a bank (the issuing bank) at the request
of a buyer (the applicant) in favour of a seller (the beneficiary). The LC serves as a payment guarantee to
ensure that the seller will receive payment if they meet the specified conditions and provide the required
documents as outlined in the LC. Here are the key components and features of a Letter of Credit:

1. Parties Involved:

 Applicant (Buyer): The party that initiates the LC by requesting their bank to issue it. The
buyer is the one who will make the payment when the conditions of the LC are met.
 Beneficiary (Seller): The party to whom the LC is issued. The seller will receive payment if
they fulfill the LC's terms and conditions.
 Issuing Bank: The buyer's bank that issues the LC on behalf of the applicant.
 Advising Bank: An intermediary bank located in the beneficiary's country, responsible for
notifying the beneficiary about the LC's existence and terms. In some cases, the advising
bank may also confirm the LC, providing an additional payment guarantee to the
beneficiary.
 Confirming Bank (optional): If the LC is confirmed, the confirming bank adds its own
payment guarantee to the LC, enhancing the beneficiary's assurance of payment.

2. Types of LCs:

 Revocable LC: Can be modified or canceled by the buyer without the consent of the
beneficiary. Rarely used in international trade due to its lack of security.
 Irrevocable LC: Cannot be altered or canceled without the agreement of all parties involved,
providing a higher level of security for both buyer and seller.

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3. LC Conditions: The LC sets out specific conditions that must be met for payment to occur. These
conditions often include details about the shipment, product quality, shipping documents, and the
timeline for presentation.

4. Documents: The LC typically requires the beneficiary to present specific documents, such as invoices,
bills of lading, certificates of origin, and inspection certificates. These documents must comply with the
LC's terms.

5. Payment Terms: The LC may specify the payment terms, such as whether it is at sight (payment upon
presentation of compliant documents) or deferred (payment at a later date after acceptance).

6. Validity Period: The LC has a specified period during which the beneficiary must present the required
documents to the bank for payment. If documents are not presented within this period, the LC becomes
void.

7. Types of LCs: Depending on the transaction and requirements, various types of LCs can be used,
including:

 Standby LC: Used as a backup payment method if the buyer fails to fulfill their obligations.
 Transferable LC: Allows the beneficiary to transfer all or part of the LC proceeds to another
party.
 Back-to-Back LC: Involves two separate LCs, one from the buyer to an intermediary and
another from the intermediary to the seller.

8. Benefits: LCs offer security to both parties. Sellers are assured of payment if they meet the conditions,
while buyers can be confident that they will receive compliant goods and documents.

9. Risks: LCs can be complex, and discrepancies in documents can lead to delays or non-payment. Buyers
may also incur fees related to LC issuance and management.

10. Uniform Customs and Practice for Documentary Credits (UCP): The International Chamber of
Commerce (ICC) publishes the UCP, a set of rules that govern the use of LCs. The latest version is UCP 600,
which provides standardized guidelines for LC issuance and administration.

Letter of Credit is a valuable tool for international trade, providing a secure method of payment and
mitigating risks for both buyers and sellers when used correctly and in accordance with the agreed-upon
terms and conditions.

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QUALITY CERTIFICATIONS
Quality certifications play a significant role in international business by ensuring that products and services
meet certain standards and requirements. These certifications can help businesses build trust with
customers, enter new markets, and comply with regulations. Here are some important quality
certifications relevant in this study of international business expansion:

1. ISO 9001: Quality Management System (QMS) Certification: ISO 9001 is a globally recognized
certification for quality management systems. It sets out criteria for a systematic approach to managing
processes and ensuring customer satisfaction. Organizations that achieve ISO 9001 certification
demonstrate their commitment to delivering consistent, high-quality products or services.

2. ISO 14001: Environmental Management System (EMS) Certification: ISO 14001 certification is awarded
to organizations that have implemented an effective environmental management system. It signifies a
commitment to environmental sustainability, pollution prevention, and compliance with environmental
regulations.

3. ISO 4500: Occupational Health and Safety Management System (OHSMS) Certification: ISO 45001 is a
certification related to occupational health and safety management. It demonstrates that an organization
is committed to providing a safe and healthy workplace for its employees and stakeholders.

4. ISO 27001 Information Security Management System (ISMS) Certification: ISO 27001 is a certification
for information security management systems. It focuses on protecting sensitive information and ensuring
data security. Organizations that hold ISO 27001 certification are often trusted with handling confidential
data.

5. FDA Approval: The U.S. Food and Drug Administration (FDA) approves and regulates various products,
including pharmaceuticals, medical devices, and food items. FDA approval ensures that a product is safe
and effective.

6. GMP (Good Manufacturing Practices): GMP certifications are essential for pharmaceutical,
biotechnology, and food industries. They ensure that manufacturing processes and facilities adhere to
strict quality and safety standards.

7. Fair Trade Certification: Fair Trade certification is awarded to products that adhere to social,
environmental, and economic standards that prioritize fair wages and ethical production practices,
particularly in the agricultural and farming sectors.

20
8. Organic Certification: Organic certification ensures that agricultural products are produced using organic
farming methods, free from synthetic pesticides, herbicides, and genetically modified organisms (GMOs).

21
CHAPTER 4
Findings & Suggestions
 Export Procedure in India
 Import procedures in USA
 Import procedures Canada
 Import procedures UAE
 Suggestions

22
 EXPORT PROCEDURE IN INDIA

Regulatory Compliances

Import-Export (IE) Number

Mode of Payment

Letter Of Credit (LC’s)

Quality Certifications

Exporting nutraceuticals from India involves several regulatory requirements to ensure compliance with domestic
and international standards. The export requirements for nutraceuticals from India typically include the following
steps:

 Import-Export Code (IEC): Obtain an Import-Export Code (IEC) from the Directorate General of Foreign
Trade (DGFT). This code is essential for all businesses engaged in import and export activities.

 FSSAI Registration: Obtain registration or licensing from the Food Safety and Standards Authority of India
(FSSAI) as per the Food Safety and Standards Act, 2006. Nutraceuticals are considered food products, and
compliance with FSSAI regulations is mandatory.

 Labeling and Packaging: Ensure that product labels meet the mandatory requirements of the Food Safety
and Standards (Packaging and Labeling) Regulations, 2011. Labels should include essential information such
as ingredients, nutritional information, shelf life, and FSSAI license number.

 Export Documentation: Prepare the necessary export documents, including the commercial invoice, bill of
loading, certificate of origin, packing list, and any other documents required by the importing country.

 Export Licensing: Check if your product requires any specific licenses or permits for export. Some
nutraceuticals may require additional approvals or licenses, depending on their ingredients or intended use.

 Customs Clearance: Comply with customs regulations for export, including filing export declarations and
providing required documentation to customs authorities.

 Sanitary and Phytosanitary (SPS) Requirements: Be aware of the SPS requirements of the importing
country, which may include regulations related to product safety, quality, and hygiene.

 Intellectual Property: Ensure that the products do not infringe on any intellectual property rights, such as
patents or trademarks.

23
  Export Inspection Council (EIC): If required, get the products inspected and certified by the Export
Inspection Council (EIC) of India. This is often necessary for certain food products.

 Export Promotion Councils: Consider joining relevant Export Promotion Councils or trade associations to
access resources and support for exporting your nutraceutical products.

 Shipping and Logistics: Choose reliable shipping and logistics partners to ensure the safe and timely delivery
of your products to the destination country.

 Import Regulations of the Destination Country: Research and comply with the import regulations and
requirements of the destination country, which may include product registration, labeling, and import
permits.

Let's delve into the specific regulatory compliances and considerations for exporting nutraceuticals from
India in terms of Import-Export (IE) Number, mode of payment, Letter of Credit (LCs), and quality
certifications:

1. Import-Export (IE) Number:

 Requirement: An Import-Export Code (IEC) is mandatory for exporting nutraceuticals from

India. It's obtained from the Directorate General of Foreign Trade (DGFT).
 Process: We can apply for an IEC online or through the regional DGFT office. The application
typically requires providing business details, bank information, and relevant documents.
(https://www.dgft.gov.in/CP/)
 Validity: An IEC is valid for the lifetime of the entity and does not need renewal.

2. Mode of Payment:

 Common Modes: Exporters in India often use common payment methods like telegraphic
transfer (TT), letter of credit (LC), and open account transactions.
 Risk Management: Consider the risk associated with the chosen payment method. LCs are
often preferred for international trade as they provide a level of security for both parties.

3. Letter of Credit (LC’s):

 Use: LCs are a widely used payment method for international trade. They offer a guarantee
of payment to the exporter, provided they meet the terms and conditions specified in the
LC.
 Negotiation: Ensure that the LC terms are clear and favorable to your business. It's essential
to review and negotiate the LC terms before agreeing to them.

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  Documentary Compliance: Strictly adhere to the LC's documentary requirements, including
shipping documents, quality certificates, and compliance certificates.

4. Quality Certifications:

 FSSAI: As mentioned earlier, obtain the necessary approvals and licenses from the Food
Safety and Standards Authority of India (FSSAI) for your nutraceutical products.
 GMP and Other Standards: Ensure compliance with Good Manufacturing Practices (GMP)
and any other relevant quality standards specific to nutraceuticals in India.
 ISO and International Standards: Depending on the target markets, you may need to obtain
ISO certifications or comply with international quality standards relevant to nutraceutical
products.

Procedure to Be Followed While Undergoing the IEC Online Application Process

An IEC is a 10-digit number awarded by the DGFT (Directorate General of Foreign Trade) to any Indian
business entity that seeks to make international trade from India. Para 2.05 of the FTP (2015-20) lays down
the procedure for IEC application in India. Here is the step-by-step process to be followed for IEC
application in India.

The process for obtaining an Importer Exporter Code (IEC) in India through the DGFT portal can be
summarized in the following steps:

1. Visit the DGFT online portal (https://www.dgft.gov.in/CP/).

2. Fill out the IEC online application form with personal details and receive an OTP on your registered
mobile number. Enter the OTP and submit.

3. Provide business-related details, including establishment date, PAN, and bank account information. Click
"Submit" to proceed.

4. Pay the required IEC application fee through electronic fund transfer.

5. Upload digital copies of all necessary documents.

6. Submit the completed IEC application form. Upon successful submission, you will receive an Ecom
reference number.

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7. Print a copy of the completed IEC application form as you'll need to submit it to the DGFT office in your
jurisdiction.

8. Your IEC will be issued within 3 to 7 days after the verification of your credentials.

This process allows individuals and businesses in India to obtain the necessary Importer Exporter Code for
engaging in international trade activities.

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 IMPORT PROCEDURES IN USA

Importing nutraceuticals into the United States involves several steps and regulatory
requirements to ensure compliance with U.S. laws and regulations. Here's a general
overview of the process:

1. Business Setup and Registration: Establish a legal entity or business in the United States
if you don't already have one. You may choose to operate as a sole proprietorship,
partnership, LLC, or corporation.

2. FDA Registration: Nutraceutical manufacturers and distributors must register their

facilities with the U.S. Food and Drug Administration (FDA). You can do this online through
the FDA's Unified Registration and Listing System (FURLS).

3. Labeling and Packaging Compliance: Ensure that your nutraceutical products comply
with FDA labeling requirements. Nutraceutical labels must include information such as
ingredient lists, nutrition facts, serving sizes, and health claims. The FDA provides
guidelines for labeling nutraceuticals on their website.

4. Ingredient and Product Compliance: Verify that the ingredients used in your
nutraceutical products are approved by the FDA. Certain ingredients may require pre-
market approval or notification to the FDA. Be aware of any new dietary ingredient
notifications (NDINs) or New Dietary Ingredient (NDI) requirements.

5. Good Manufacturing Practices (GMP): Implement Good Manufacturing Practices (GMP)

to ensure the quality, safety, and consistency to the nutraceutical products. GMP
regulations apply to dietary supplements and nutraceuticals.

6. Hiring a U.S. Agent: If your business is located outside the U.S., you may need to appoint
a U.S. Agent who will act as a liaison between your company and the FDA.

7. FDA Prior Notice: Submit prior notice to the FDA before importing nutraceuticals into the
U.S. This should be done electronically through the FDA's Prior Notice System.

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8. Customs and Import Documentation: Work with a customs broker to ensure compliance
with U.S. Customs and Border Protection (CBP) regulations. Prepare the necessary import
documentation, including a bill of loading, commercial invoice, and any required permits or
certificates.

9. FDA Inspections and Audits: Be prepared for possible FDA inspections and audits of your
facilities and records. The FDA conducts inspections to ensure compliance with regulatory
requirements.

10. Testing and Quality Control: Conduct quality control testing of nutraceutical products
to ensure they meet FDA standards. Keep records of these tests for compliance purposes.

11. Product Testing and Certification: Consider obtaining third-party testing and
certification for your nutraceutical products. Some certifications may help build trust with
consumers and retailers.

12. Distribution and Sales Channels: Establish distribution and sales channels in the U.S.
This may include working with distributors, wholesalers, and retailers to get the products to
market.

13. Stay Informed: Keep up-to-date with changes in FDA regulations and requirements
related to nutraceuticals. The regulatory landscape can evolve, and staying informed is
crucial to maintaining compliance.

14. Legal Consultation: Consider seeking legal advice from experts in FDA regulations and
import/export laws to ensure full compliance with U.S. regulations.

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All facilities that pack, process, manufacture, or store foods consumed in the United States
is register with the USFDA (US Food & Drug Administration). Facilities outside the US must
also obtain a USFDA registration through a registered agent and abide by USFDA guidelines
at all times.
Here's a compilation of the process for obtaining a US FDA registration for foreign
facilities involved in packing, processing, manufacturing, or storing foods consumed in the
United States:

1. Appoint a US FDA-Registered Agent: Foreign applicants must designate a US FDA-

registered agent to handle communications with the FDA, schedule inspections, and
respond to queries.
2. Submission of Information: Submit all relevant details and documents to your appointed
agent, including copies of necessary documents.
3. Submission via FURL: The agent submits the information to the FDA through the Unified
Registration and Listing System (FURL) (https://www.access.fda.gov/)
4. Fill out FDA Registration Application: Complete and authorize the FDA registration
application form, which is submitted via FURL.
5. Registration Confirmation: Upon successful registration, the FDA issues an 11-digit
registration number to the registered email ID of the business.
6. Review and Certificate Issuance: FDA officials review the submitted details and provide a
registration certificate to the agent, who then forwards it to the business.

Note: Renewal of FDA Registration: FDA registrations must be renewed every two years
for facilities involved in the processing, packing, manufacturing, storage, or distribution of
food products consumed in the United States.
7. Import and Customs Clearance:
 After booking a container for exporting food products, obtain a bill of loading.
 Submit relevant documents to the Indian Customs Office to facilitate
clearance.
 Customs will issue a Let Export certificate after verification.
8. Import Security Filing (ISF): File an Import Security Filing 48 hours before loading goods
for customs clearance in the United States.

29
Note: Failure to comply with FDA regulations or renew the registration can lead to exports
being held at US ports until the business renews its US FDA registration. Additionally,
registration renewal is required every two years to maintain compliance with FDA
guidelines.

Labelling and packaging standards to import in USA:

Importing products into the United States requires compliance with specific labeling and packaging
standards, which may vary depending on the type of product. However, there are some general guidelines
and regulations that apply to most imported products. Here are key aspects of labeling and packaging
standards for imports in the USA:

1. FDA Regulations: The U.S. Food and Drug Administration (FDA) regulates the labeling and packaging of
many food, dietary supplement, pharmaceutical, and cosmetic products. Ensure that your product
complies with FDA regulations, which include:

 Accurate Ingredient List: Include a complete and accurate list of ingredients, with
each ingredient listed by its common name.
 Nutrition Facts: For food products, provide a Nutrition Facts panel with information
on calories, nutrients, serving size, and daily values.
 Allergen Information: Clearly identify any major food allergens present in the
product.
2. Country of Origin Labeling (COOL): Products imported into the U.S. must be labeled with their country
of origin. This labeling requirement helps consumers make informed choices.
3. Metric System: Use the metric system (e.g., grams, milliliters) for measurements on labels and
packaging, except for specific industries where customary units are allowed.
4. Language: All labeling, including product names, instructions, and warnings, should be in English. If you
wish to provide additional languages, you can do so, but the English version must be prominent and easily
readable.
5. Labeling Claims and Claims Substantiation: Be cautious with health claims and advertising statements.
Claims about a product's health benefits must be supported by scientific evidence and comply with FDA
regulations.
6. Child-Resistant Packaging: Certain products, such as medications, chemicals, and hazardous materials,
may require child-resistant packaging to prevent accidental ingestion.
7. Barcodes and UPCs: Consider adding barcodes or Universal Product Codes (UPCs) for retail purposes.
8. FDA Registration: Depending on the product category, your facility or product may require FDA
registration and listing. Ensure compliance with FDA regulations for your specific product type.
9. Warning Labels: If your product poses any hazards or risks, it should include appropriate warning labels.
For example, hazardous chemicals must be labeled according to the Hazard Communication Standard
(HCS) requirements set by the Occupational Safety and Health Administration (OSHA).

30
10. Packaging Material Safety: Ensure that packaging materials are safe and do not contaminate the
product. Some materials, such as plastics used in food packaging, may have specific FDA regulations.

11. Environmental Packaging: Consider eco-friendly and sustainable packaging options, as there is growing
consumer demand for environmentally responsible packaging.

12. Compliance with Industry-Specific Regulations: Some products have industry-specific labeling and
packaging regulations, such as alcoholic beverages, tobacco, and medical devices. Consult the relevant
regulatory authorities for specific guidelines.

Can we import it into the United States in secondary packaging for the purpose of repackaging and not in
final packaging?
Yes, it is possible to import products into the USA in secondary packaging with the intention of repackaging them in
the USA for various purposes, such as branding, marketing, or complying with specific labelling requirements.
However, there are some important considerations and regulatory requirements to keep in mind when doing so:

1. Customs Compliance: When importing products in secondary packaging, we must still comply with U.S. Customs
and Border Protection (CBP) regulations, including providing accurate and complete customs declarations. Ensure
that the secondary packaging meets CBP requirements.

2. FDA Regulations: Since the products fall under the jurisdiction of the U.S. Food and Drug Administration (FDA),
such as food, dietary supplements, cosmetics, or pharmaceuticals, must adhere to FDA labelling and packaging
regulations. The FDA has specific requirements for labelling and packaging, even if the final packaging is done in the
USA.

3. Labelling Compliance: Ensure that any labelling applied in the USA on the secondary packaging complies with U.S.
regulations. This includes providing accurate ingredient lists, nutrition facts (if applicable), country of origin
labelling, and any other required information.

4. Claims and Claims Substantiation: As the company make health claims or advertising statements on the
secondary packaging, ensure they comply with FDA regulations.

5. Recall and Traceability: Maintain records and traceability of products imported in secondary packaging to comply
with recall procedures, if necessary.

6. Packaging Material Safety: Ensure that the secondary packaging materials are safe and do not contaminate the
products.

31
7. Environmental Considerations: Be mindful of environmental regulations related to packaging materials and waste
disposal.

8. Product-Specific Regulations: Depending on the type of products being imported, there may be additional
regulations and requirements that apply. Consult with regulatory experts or relevant agencies for specific guidance.

9. Importer Responsibilities: As the importer, one is responsible for ensuring that the products and packaging meet
all applicable regulations and standards. Work with reliable suppliers and consider conducting quality control checks.

32
IMPORT PROCEDURES CANADA
IMPORT PROCEDURES UAE
SUGGESTIONS

TO BE WORKED UPON

33
CHAPTER 5
Appendices
 Annexures
 Bibliography

34
 ANNEXURES

IMPORT EXPORT AGENTS CONTACT INFORMATION:

 https://adcodes.in/

 https://www.kireeticonsultants.com/

ALIGARH
 Global EXIM Trade (GET)
Address: Niranjanpuri Gaushala Near Pathwari Mandir, Nagla Masani Khair Road, Aligarh,
Uttar Pradesh 202001

Phone: +1 971-999-9122

 Shri Krishna Enterprises

Address: Pratibha Colony phase 1, near shiv temple of colony, Nagla Masani, Aligarh, Uttar
Pradesh 202001

Phone: 086306 34244

 Awadh Buying Agency India

Address: C-6, Prag Mill Compound, Ramghat Rd, Aligarh, Uttar Pradesh 202001

Phone: 093590 67064

IMPORT EXPORT ADVISORS CONTACT INFORMATION:

 https://www.eximbankindia.in/export-advisory-services

 https://www.kireeticonsultants.com/

 https://www.indiamart.com/foreign-trade-development/

 https://www.grandmarkca.com/services-offered-by-grandmark/business-consulting-outsourcing-
services/import-export-advisory/

 https://www.bhatiaexport.in/export-import-consultancy-services/

Mobile: +91 7878045651

Email: info@bhatiaexport.in

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 BIBLIOGRAPHY

Reference Books

The World that Trade Created by Kenneth Pomeranz, First Edition

International Trade and Port Logistics by I.C.J. Verhaart

Website References

 www.dgft.gov.in

 www.indiantradeportal.in

 www.forbes.com

 www.statista.com

 en.wikipedia.org

 www.globaldata.com

 www.tofler.com

 www.chat.openai.com

 www.fda.gov/drugs

 www.commerce.gov.in/trade-statistics/export-import-data-bank-monthly

Other Website Used

 www.canva.com

 www.quillbot.com

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