GENERIC DRUGS VERSUS BRANDED PRODUCTS

FOCUS ROW GEOGRAPHY: LATIN AMERICAN

COUNTRIES AND CARIBBEAN ISLANDS

SUMMER INTERNSHIP PROJECT REPORT

POST GRADUATE DIPLOMA IN MANAGEMENT

(PHARMACEUTICAL MANAGEMENT)

MARKETING SHEENA SELWYN CHETTIVILAKAM

2018-2020 Roll No.07

SIES COLLEGE OF MANAGEMENT STUDIES

NERUL, NAVI MUMBAI 400706

i
 GENERIC DRUGS VERSUS BRANDED PRODUCTS
FOCUS ROW GEOGRAPHY: LATIN AMERICAN
COUNTRIES AND CARIBBEAN ISLANDS

SUMMER INTERNSHIP PROJECT REPORT

SUBMITTED

AS A PARTIAL FULFILMENT OF THE CURRICULUM FOR THE DIPLOMA

POST GRADUATE DIPLOMA IN MANAGEMENT

(PHARMACEUTICAL MANAGEMENT)

SUBMITTED BY

SHEENA SELWYN CHETTIVILAKAM

ROLL NO. 07

SPECIALIZATION- MARKETING

PGDM – PM (2018-20)

ii
 Declaration

I, Ms. Sheena Selwyn Chettivilakam, studying in the second year of Post Graduate
Diploma in Management (Pharmaceutical Management) program at SIES College of
Management Studies, Nerul, Navi Mumbai, hereby declare that I have completed the
Summer Internship Project titled “Generic drugs versus Branded products. Focus
ROW geography: Latin American countries and Caribbean islands” as a part of the
curriculum requirement for Post Graduate Diploma in Management (Pharmaceutical
Management).

I also declare that the work undertaken by me is original and has not been copied from
any source. I further declare that the information presented in this project report is true
and has not been submitted to SIESCOMS or any other Institute for any other
examination.

Signature of the Student Date:

Name of the Student: Sheena Selwyn Chettivilakam

Roll No.: 07

iii
Certificate by the Company Guide

iv
 Certificate by Faculty Guide

This is to certify that Ms. Sheena Selwyn Chettivilakam, studying in the second year of
PGDM (Pharmaceutical Management) program at SIES College of Management Studies,
Nerul, Navi Mumbai, has completed the Summer Internship Project titled “Generic
drugs versus Branded products. Focus ROW geography: Latin American countries
and Caribbean islands” as a part of the curriculum requirement for Post Graduate
Diploma in Management (Pharmaceutical Management).

Name: Dr. Suniel Deshpande

Date:

v
 Acknowledgement

It gives me a great pleasure to present the report of summer internship, which is an

important aspect of the PGDM curriculum. The summer internship project was a great
opportunity for me to prove myself and it was a great platform to elaborate the skills and
tactics in reality. First and foremost, I must acknowledge and thank God for blessing and
guiding me throughout this period. I could never have accomplished this without the faith
I have in him.

I am very grateful to be a student of SIESCOMS as this institute has given me a golden

opportunity to work with a great pharmaceutical company. It was an esteem feeling to be
summer intern at Umedica Laboratories Pvt. Ltd. I am very thankful to our
Chairperson, Dr.Chitra Ramanan and Prof. Jharna Lulla, for giving me the
opportunity to face the corporate world in the form of this internship program and also
my faculty guide Dr. Suniel Deshpande for his constant support and guidance all
throughout this project. I take this opportunity to express my deep sense of gratitude to
my project guide Mr. Sanjay Gupta, for his guidance and insights at each step. Also, I
would extend my gratitude towards all faculty members in SIESCOMS who imparted
knowledge at various levels during the internship tenure. I also want to thank my college
seniors in Umedica Laboratories Pvt. Ltd. with whom I worked and all my classmates
and close friends for their love and support.

Lastly and most importantly, I want to say that I am what I am today because of my Mom
and Dad. I am eternally indebted to both of you, and so grateful that I am your daughter.

I would like to end with a small message which always kept me motivated ―It’s going to
be hard, but hard does not mean impossible.

Sheena Selwyn Chettivilakam Date:

vi
 Executive Summary

Introduction
The project is about the market exploration study of business development in the ROW
market of the Latin American countries for Umedica Laboratories Pvt. Ltd. The project is
study is done to know about the generic and branded products market, government
policies for healthcare and the new market segments for business.
Research Methodology
For understanding, analysis and completion of project primary and secondary data was
utilized. The data obtained in primary and secondary research was of qualitative nature.
Secondary data was obtained using research articles, guidelines and report. Primary data
was obtained from a set of 20 respondents with the help of an open ended questionnaire
to understand their insights.
Literature review
In the literature review various research papers, articles and guidelines were referred.
The literature review covered topics such as information about kinds of market in
pharmaceutical trade, categories of regulatory regime, Indian pharmaceutical exports,
emerging markets and statistics of Lain America and the policies to promote the
efficiency in the pharmaceutical spending.
Data Analysis
Data analysis includes the analysis of primary data obtained from the respondents and
additional data obtained from various stakeholders. This data is used to understand the
types of pharmaceutical products registered and the trade in Latin America, key
therapeutic product portfolios to be considered by the disease prevalence status,
launching of a ‘branded generic’ product over an unbranded generic, dominance of
branded generics over unbranded generics, countries were the local companies are highly
successful and profitable, strategy that one should implement when the local government
only encourages trade with local companies, regions that should be targeted by a small
scale pharmaceutical manufacturing company for business and the SWOT analysis for
generics in Latin America.

vii
Once all the data was collected it was critically analyzed to arrive at a reasonable
conclusion and recommendations, which the company can use or refer to come out with
new strategies or approaches which will help them to grow effectively.
Recommendations
Based on the primary and secondary data, few points were recommended for the business
development of Umedica.

viii
 Table of contents

Serial no. Particulars/Title Page no.

Chapter 1 Introduction 1

1.1 Company Overview 1

1.2 Background of the Project 5

1.3 Objective & Scope 5

1.4 Significance & Limitations 6

Chapter 2 Review of Literature 7

2.1 Kinds of market in pharmaceutical trade 7

2.2 Categories of regulatory regime 7

2.3 Indian pharmaceutical exports 8

2.4 Emerging markets of Lain America 8

2.5 Statistics of the Latin American markets 9

2.6 Policies to promote the efficiency in the pharmaceutical 10

spending

Chapter 3 Methodology 11

3.1 Objective & Design 11

3.2 Sources of Data Collection 11

3.3 Sampling 12

Chapter 4 Data Analysis 13

4.1 Types of pharmaceutical products registered in Latin 13

America

4.2 Pharmaceutical trade in Latin America 14

4.3 The key therapeutic product portfolios to be considered by 15

the disease prevalence status

ix
 4.4 Launching a ‘branded generic’ product over an unbranded 16
generic is a success

4.5 Dominance of branded generics over unbranded generics 16

4.6 Latin American countries were the local companies are 17

highly successful and profitable

4.7 Strategy that one should implement when the local 18

government only encourages trade with local companies

4.8 Latin American regions that should be targeted by a small 19

scale pharmaceutical manufacturing company for business

4.9 SWOT analysis for generics in Latin America 20

Chapter 5 Conclusions 21

Chapter 6 Recommendations 23

Chapter 7 References 24

Chapter 8 Appendices 25

Chapter 9 Sample of questionnaire 27

x
 CHAPTER 1: INTRODUCTION

1.1 COMPANY OVERVIEW

Umedica Laboratories Pvt. Ltd. was founded in 1982 by late Mr. Umed Doshi, a dynamic
entrepreneur whose vision is being spurred further by the able leadership of his son, Mr.
Manish Doshi - a true technocrat and an aggressive marketer.

Umedica is a part of the Amoli Group of Companies, manufacturing and exporting a

wide range of formulations viz; Injectables, Tablets, Capsules, Suspensions, Dry Syrups,
etc. UMEDICA offers a diverse product portfolio comprising of antibiotics, non-steroidal
anti-inflammatory (NSAIDs), analgesics, antifungal, antiviral, anti-malarial, anti-
tuberculosis agents, anti-histaminic, psychotropic, anti-hypertensive, lipid-lowering
agents, drugs for sexual dysfunction, multivitamins etc.

Umedica has business operations in more than 51 countries, spanning Central & South
American countries, Africa, Asian & CIS countries. We are now expanding in Europe,
Middle East, Canada & Australia.

Umedica is a Government recognized Export House that has been awarded ‘Chemexcil’
Top Export Award for performance in exports.

1
VISION – To deliver internationally competitive products, at affordable prices.

MISSION - To protect and improve human health worldwide by providing superior

and innovative products for the prevention and treatment of disease.

FACILITIES:
 Manufacturing capabilities
Umedica has a US FDA, EU, TGA approved & WHO GMP approved manufacturing
facility located in Vapi, Gujarat. The facility is equipped with world class machines
capable of manufacturing a wide range of formulations - Injections, Tablets, Capsules,
Suspensions, Dry Syrups, etc. UMEDICA’s diverse product portfolio comprises of
antibiotics, non-steroidal anti-inflammatory (NSAIDs), analgesics, antifungal, antiviral,
anti-malarial, anti-tuberculosis agents, antihistamines, psychotropic, diuretics,
antihypertensive, lipid-lowering agents, drugs for sexual dysfunction and multivitamins
etc. UMEDICA has the expertise in manufacturing Sustained Release Formulations
(Tablets & Capsules). The facility has been audited and approved by Regulatory
authorities of various countries viz. USA, EU, Australia, UAE, Zimbabwe, Ethiopia,
Tanzania, Nigeria, Uganda, Kenya, Ghana, Ivory Coast, Malawi etc.

 Quality assurance & control

Umedica undertakes and ensures quality assurance at each stage, right from raw materials
receipt to finished products. Quality tests are carried out on all raw materials, excipients,
packing materials, etc. to ensure highest international quality standards. Umedica’s
facility is GLP (Good Laboratory Practices) compliant. Independent and well equipped
QA & QC departments establish and maintain an effective quality control check to ensure
that the final product is of a world-class standard. Umedica’s Quality Management Team
ensures that every product manufactured and distributed complies with all internationally
accepted good practices and standards of quality, purity, efficacy and safety.

2
  Research & Development
Umedica is supported by a full-fledged R & D center, located at Turbhe, Mumbai &
approved by the Ministry of Science & Technology, Government of India. The R&D
Center with a built-up area of 20,000 sq. ft is manned by a team of 90 well qualified and
experienced scientists. Regular R & D work is carried out, not only to improve on the
existing products, but also in keeping with the demand for new and improved
formulations.

ASSOCIATE COMPANIES:
 Amoli Organics Ltd.
 Chemphar

WEBSITE:
https://www.umedicalabs.com/

Figure 1: Products of Umedica Laboratories Pvt. Ltd.

3
UMEDICA’S BUSINESS UPDATE IN LATIN AMERICA:

Figure 2: Business update in Central America & Caribbean regions

Figure 3: Business update in South America

4
1.2 BACKGROUND OF THE PROJECT
Umedica is a manufacturer and exporter of pharmaceutical formulations. Since its
inception, Umedica has established itself as a company delivering products meeting
international quality standards. The project revolves around the market exploration study
of business development in the Latin American countries. Also it is important to
understand the competitors move to understand how they are doing things to sustain at
higher ranks in the ROW market.

 Duration of project: 2 months

 Methodology: Interview based discussion
 Type of research: Exploratory research
 Sample Size: 20
 Target respondents: Country managers and associates of various pharmaceutical
companies

1.3 OBJECTIVES AND SCOPE

Objectives

1. To study about the affordability of drugs in LATAM.

2. To study the penetration of generic and branded products market.
3. To analyze the government policies for healthcare products.
4. To know about the new market segments which are presently untouched

Scope

As the Indian Pharmaceutical Industry is growing rapidly than the overall global
pharmaceutical market and the competition is also increasing day by day, thus to keep up
with the growing pace of the market the company needs to identify their position in
market to strategize accordingly. This research can be taken a step further by framing a
conclusive type of research based on the responses obtained from this survey. To know
the top risks in doing business in Latin American regions

5
1.4 SIGNIFICANCE AND LIMITATIONS

Significance
The findings of these project is not only relevant to this particular company but can be
used for guidance to other companies in the same ROW segment as well. These findings
and recommendations may be applied to companies.

Limitations
1. Sample size was not representative of the population as it was collected from
confined companies only.
2. It was difficult to retrieve insights from the respondents from the competitor
pharmaceutical companies.
3. The study conducted is an exploratory research which focuses only on the
qualitative data obtained during primary research for completion of project.

6
CHAPTER 2: REVIEW OF LITERATURE

2.1 KINDS OF MARKET IN PHARMACEUTICAL TRADE

1. Regulated market: US, EU (UK, Germany, France, Ireland, Sweden), Japan, Canada,
Australia, New Zealand, South Africa

2. Semi regulated Market: (ROW Countries)

(a) Asia- (Sri Lanka, India, Bangladesh, ASEAN: 10 Countries cluster Philippines,
Vietnam, Singapore, Malaysia, Thailand, Indonesia, Laos, Cambodia, Brunei Darussalam,
Myanmar
(b) African countries- Algeria, Zambia, Ethiopia, Ghana, Kenya, Malawi, Mozambique,
Namibia, Nigeria, Sierra Leone, Tanzania, etc.
(c) Middle East countries - Gulf Co-operation Council countries i.e. Bahrain, Kuwait,
Oman, Qatar, Saudi Arabia, UAE
(d) Latin America - Mexico, Brazil, Panama, Peru, Guatemala, Argentina, Chile,
Dominican Republic
(e) CIS (common wealth of independent states) - Russia, Ukraine, Armenia, Azerbaijan,
Belarus, Georgia, Kazakhstan, Kirghizstan, Moldova, Tajikistan, Turkmenistan,
Uzbekistan

2.2 CATEGORIES OF REGULATORY REGIME IN LATIN

AMERICA (LATAM) COUNTRIES:
1. Countries with established regulations (Brazil, Chile, Mexico and Venezuela) to
demonstrate the efficacy, safety through clinical trials and therapeutic equivalence studies
with the proper drug approval systems.
2. The countries (Argentina, Columbia, Ecuador, Paraguay) that have the regulations to
register a new drug or generics however not as stringent as the first category.
3. The countries (Guatemala, Barbados, Bolivia, Nicaragua and Peru) that have amiss
shaped drug regulations for the approval of medication.

7
2.3 INDIAN PHARMA EXPORTS TO LATIN AMERICA

Figure 4: Pharmaceutical exports to Latin America (values in USD millions)

India beat China in export of prescription drugs to Latin America. India’s exports were
$651 million compared to China’s $404 million in 2016. In fact, within the last five
years, India has been exporting more drugs to Latin America than China.

2.4 EMERGING MARKETS OF LATIN AMERICA

The top six countries – Brazil, Mexico, Venezuela, Argentina, Colombia, and Chile –
account for 80 percent of the Latin American pharmaceuticals market, but differ widely
in their economic conditions.

8
 2.5 STATISTICS OF THE LATIN AMERICAN MARKETS
Table 1: Latin America’s statistics

Argentina Brazil Chile Colombia Cuba Mexico Peru Uruguay Venezuela

GDP per
capita (US$)
14,398 9,812 15,346 6,408 8,433 8,910 6,571 16,245 15,692
[The World
Bank, 2017]

Health
expenditure
(% of GDP) 6.8 8.9 8.1 6.2 11 5.9 5.3 9.2 3.2
[WHO,
2015]

Health
expenditure
742 990 949 472 607 514 269 989 663
per capita
(US$)

Life
76 72 77 74 79 76 72 76 73
expectancy
Poverty
(% of 30 26 12 46 - 18 35 21 38
population)
Urbanization

(% of 92 84 89 75 75 78 77 92 93
population)

Population
41.45 200.36 17.62 48.32 11.27 122.33 30.38 3.41 30.41
(millions)

9
2.6 POLICIES TO PROMOTE THE EFFICIENCY IN THE
PHARMACEUTICAL SPENDING

Table 2: Government policies in various Latin American countries

Policy

Mechanisms Governmental Incentives for

for database for production or
Price centralized price registration of
Countries regulation negotiation consultation generics
Chile No Yes Yes No
Colombia Yes Yes Yes Yes
Costa Rica No Yes No No
Dominican
Republic No Yes No No
Ecuador Yes Yes Yes Yes
El Salvador Yes Yes Yes Yes
Mexico Yes Yes Yes Yes
Mexico Yes Yes Yes No

10
CHAPTER 3: METHODOLOGY
3.1 OBJECTIVE AND DESIGN
Research objective:
 To study about the affordability of drugs in LATAM.
 To study the penetration of generic and branded products market.
 To analyze the government policies for health care products.
 To know about the new market segments which are presently untouched

Research design:
In order to achieve the objective of the study, a systematic research design was adopted.
Various attributes were measured and analyzed. An exploratory method of research
design was selected with the intention that it is flexible in its approach and mostly
involves a qualitative investigation. The information was collected through the survey
and then was complemented with the information obtained from government websites
and archival documents.

3.2 SOURCES OF DATA COLLECTION

Primary data: A simple 9-point questionnaire containing open ended questions and also
an in-depth interview with the respondents was done to collect information. After self-
introduction and informing the purpose of the study, consent from the respondents was
taken for participating in the study.

Secondary data: Secondary data was used to study the previous work done by other
researchers in similar field or on topics. It was obtained from literature available in the
form of journals, news articles, research papers and company database.

11
3.3 SAMPLING
Sampling design
Convenient sampling design was selected as it is used to obtained information quickly
and inexpensively.

Sample unit
A sample of 20 respondents including country managers and associates were taken from
various pharmaceutical companies.

Sample size
Survey was conducted among 20 respondents.

12
CHAPTER 4: DATA ANALYSIS

4.1 TYPES OF PHARMACEUTICAL PRODUCTS REGISTERED IN

LATIN AMERICA:

 In Brazil and Argentina the pharmaceutical products are classified in three

categories for its registration - Innovative drug, similar drug (copy) and generic
drug.
i. Innovative or original drug - a product sold by the originator or by a company
licensed or authorized by the originator.
ii. Generic drug - pharmaceutical products that have been proven to be
therapeutically equivalent to the original product.
iii. Similar (copy drug) – Pharmaceutical product that is off patent but there is no
proof of bio-equivalence.

 Wherein in the countries like Bolivia, Chile, Colombia, Costa Rica, Ecuador,
Nicaragua, Peru and Uruguay classify pharmaceuticals under two categories:
i. Branded pharmaceuticals: branded originals, branded generics and branded
similar drugs.
ii. Generics: original generics, generics manufactured by pharmaceutical companies
other than the originator and similar drugs.
 It has been estimated that generic medication made 61 percent of the total
medication spending in Latin America in the presented period.

13
4.2 PHARMACEUTICAL TRADE IN LATIN AMERICA

i. Tender business - refers to the process where the governments and/or financial
institutions invite bids in bulk quantities.
ii. Trade business - the commercial business done by marketing and selling of
pharmaceuticals to the customers.

Figure 5: The tender market business driven Latin American countries

 The product must be first registered for tender entry/qualification.

 The requirements for tender are – Technical, administrative and financial data
(not required in LATAM)
 Tenders are mainly won by L1 (1st lowest) bidders.
 In Peru, the government is encouraging localization. Thus the local manufacturers
win the bid in the government tender even when they have the L2 (second lowest)
quote.
 15% margin is given to the local manufacturers in tender business.

14
  Thus the MNC’s give marketing authorization to the local distributors to take part
in the tender bids.

4.3 THE KEY THERAPEUTIC PRODUCT PORTFOLIOS TO BE

CONSIDERED BY THE DISEASE PREVALENCE STATUS

Figure 6: Disease prevalence status

 The most resilient diseases such as AIDS, tuberculosis and malaria account for
less that 10% deaths in Latin America.
 Obesity rates are found to be the highest among Mexicans (64%) and Chileans
(63%).
 By 2030, obesity rates will reach 60% for women and more than 50% for men in
Latin America.

15
4.4 LAUNCHING A ‘BRANDED GENERIC’ PRODUCT OVER AN
UNBRANDED GENERIC IS A SUCCESS:

Figure 7: Success of a branded generic over an unbranded generic

 From a business perspective, launching a ‘branded generic’ product may be a

good choice in middle-income countries where the ‘brand’ provides some
perceived signal of assures quality.
 Branded generics are aggressively marketed as premium is charged on them.
 For Latin American countries, branded generics with bio-equivalent studies are
always be preferred.

4.5 DOMINANCE OF BRANDED GENERICS OVER UNBRANDED

GENERICS:
 This is observed in Brazil, Chile, Argentina and Colombia.
 For these LATAM countries, branded generics with bio-equivalence will be
always preferred.
 17% duty is imposed for branded generics.

16
4.6 LATIN AMERICAN COUNTRIES WERE THE LOCAL
COMPANIES ARE HIGHLY SUCCESSFUL AND PROFITABLE:

Figure 8: Percentage pie-chart of the successful countries for local manufacturers

 This depends on the regulatory policies of the country.

 In case of Venezuela, it is unattractive to the multinational companies due to its
currency devaluation, tenders favored by local manufacturers, government
resistance to pricing and under funding in health-care which leads to a low per
capita spending on medicines.
 In Brazil, the market is price driven towards the products manufactured in the
country.
 Argentina and Venezuela is viewed to be risky by the multinational companies
due to its protectionist policies and high levels of economic uncertainty.

17
4.7 STRATEGY THAT ONE SHOULD IMPLEMENT WHEN THE
LOCAL GOVERNMENT ONLY ENCOURAGES TRADE WITH
LOCAL COMPANIES:

Figure 9: Strategy to be implemented in Latin America

 The local government generally encourages the local manufacturers to flourish

rather than the global pharmaceutical players to earn profit in their region.
 Thus for a large scale multinational company setting up their own manufacturing
plants is the best option.

18
4.8 LATIN AMERICAN REGIONS THAT SHOULD BE TARGETED
BY A SMALL SCALE PHARMACEUTICAL MANUFACTURING
COMPANY FOR BUSINESS:

Table 3: Pharmaceutical import values of Central American countries

COUNTRY IMPORTS
Costa Rica $383 million

Guatemala $299 million

Panama $277 million

Honduras $239 million

Nicaragua $209 million

El Salvador $179 million

 Central American imports increased by 4% and reached $1.587 million in 2018

from $1.523 million in 2017.

 Central American regions especially like Guatemala, Honduras and El Salvador

are great options for a small scale formulation manufacturing company.

 The registration charges there are neither as high as Brazil and Mexico nor is the
registration period that extended.

 Along with the Central American region, the Caribbean islands are to be
considered.

19
4.9 SWOT ANALYSIS FOR GENERICS IN LATIN AMERICA

Strength:
 Generic substitution is encouraged
 Weak reimbursement systems for the branded products

Weakness:
 Drug portfolio of the prevalent diseases not being there in the list of marketed or
products submitted for registration
 Regulatory differences from country to country in Latin America so one must
have proper insight about each country’s regulations and needs

Opportunity:
 IP enforcement & FTA’s for harmonization
 Mandatory substitution due to the generic law and policy
 Promotion of generics

Threat:
 Local industry protection/ encouragement by the government
 Economies may not grow as expected
 Non-bioequivalent & copy drugs

20
CHAPTER 5: CONCLUSION

 The pharmaceutical products in different countries of Latin America have key

differences. Most countries require additional documentation that is not part of
module 2-5 of the CTD, and some of that might also be challenging to obtain.

 The antibiotics market is sort of dense because of the competition.

 The heterogeneity in regulatory landscape causes huge challenge in case of

generic drug development and filing, even when continuous process of
harmonization is taking place. Thus a lot of strategic planning is required before
development of any generic product in Latin America.

 Price controls aim to reduce expenditure and not usage.

 Generics are going to outperform in the LATAM market as a whole but they have
a threat by the ‘copycat drugs’.

 Obesity: By 2030 obesity rates in Latin America will reach 60% for women and
more than 50% for men. In addition, obesity rates are highest among Mexicans
(64%) and Chileans (63%).

 Senior population: In 2018 there were 71 million seniors in Latin America. This
figure will double by 2035. In addition, by 2055 seniors will be the largest age
group in Latin America: 43% more populous than the next-largest age group and
totaling 214 million.

 Since the world is divided in the drug approval procedures with

technical data as described above, it is important especially for the generic
manufacturers, to carefully judge the market need, development cost, target
regions, & regulatory requirements before the development of drugs. Hence it
is critical to plan and co-ordinate all the activities for successful launch of

21
 product in the market on time.

 Due to vast difference in regulatory requirements it is impractical to get global

marketing approval at same time and launch the product at once in all
regions. Hence, one should carefully study and understand to make the strategy
by looking at the target regions, different patent terms and its
extension, various application possibilities, data requirements, potential
timeline for marketing launch in different regions. This eliminates
unnecessary studies, minimizes the delay in drug approvals and subsequent
launch, and reduces overall cost of development.

22
CHAPTER 6: RECOMMENDATIONS
 Generic product registration should be thought-about for contraceptives,
hormonal, oncology and medical specialty medication. (Less range of competition)

 In Costa Rica, there’s prevalence of Wilson’s illness. It is treated by the niche

orphan drug – Trientine hydrochloride. Since the drug molecule is rare, no
registration is needed for its tender.

 If certain products are approved and registered in the Regulated markets of US,
UK, Australia then one must check for its SRA approval for entry access to Latin
American tenders, which can be done without registration.

 More of chronic non-communicable disease products must be registered because

the demographic shift is towards more of aging population with obesity issues
leading to cardiac ailments, stroke, diabetes, etc.

 Incentives are provided for the production or registration of generics is

implemented in the countries like Colombia, El Salvador, Ecuador and Mexico.
This is a great advantage for a small scale manufacturing company.

23
CHAPTER 7: REFERENCES

News article:
 The Wire - Why It's Important for India to Trade with Latin America
https://thewire.in/diplomacy/trade-india-latin-america

Article:

 Shweta Handoo, Vandana Arora, Deepak Khera, Prafulla Kumar

Nandi and Susanta Kumar Sahu (2012). A comprehensive study on regulatory
requirements for development and filing of generic drugs globally.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3555014/

 Jitendra Kumar Badjatya, Ramesh Bodla & Pankaj Musyuni (2013). Export
registration of pharmaceuticals in rest of world countries (ROW).
http://jddtonline.info/index.php/jddt/article/view/391/221
 Doug Long (2018). Global Generic and Biosimilars Trends and Insights - IQVIA
https://accessiblemeds.org/sites/default/files/2018-02/Doug%20Long.pdf
 J.J. Valverde, Latin American pharmaceutical overview
 Perspectives on healthcare in Latin America by McKinsey & Company
 Pharmexcil Annual Reports, Pharmaceutical Markets in Latin
https://pharmexcil.com/v1/docs/PharmamarketsinLatinAmerica.pdf

24
CHAPTER 8: APPENDICES

Appendix I- List of abbreviations

ASEAN Association of South East Asian Nations

CIS Commonwealth of Independent States
CTD Common Technical Document
GLP Good Laboratory Practices
GMP Good Manufacturing Practices
FDA Food and Drug Administration

FTA Free Trade Agreement

IP Intellectual Property
LATAM Latin American
L1 Lowest First Bidder
L2 Lowest Second Bidder
NSAID Non-Steroidal Anti-Inflammatory
QA Quality Assurance
QC Quality Control
ROW Rest of the World
SRA Stringent Regulatory Authorities
TGA Therapeutic Goods Administration

WHO World health organization

25
 Appendix II (a) - List of tables

Table 1: Latin America’s statistics

Table 2: Government policies in various Latin American countries
Table 3: Pharmaceutical import values of Central American countries

Appendix II (b) - List of figures

Figure 1: Products of Umedica Laboratories Pvt. Ltd.

Figure 2: Business update in Central America & Caribbean regions
Figure 3: Business update in South America
Figure 4: Pharmaceutical exports to Latin America (values in USD millions)
Figure 5: The tender market business driven Latin American countries
Figure 6: Disease prevalence status
Figure 7: Success of a branded generic over an unbranded generic
Figure 8: Percentage pie-chart of the successful countries for local manufacturers
Figure 9: Strategy to be implemented in Latin America

26
CHAPTER 9: SAMPLE OF QUESTIONNAIRE

1. What are the types of drugs registered in the country?

2. What according to you dominates the Latin American market in general? -

Branded drugs, biosimilars or copies, generic drugs

3. In which countries do we find the dominance of branded generics over unbranded

generics?

4. Are there an official generics’ policy or laws?

5. In which countries do the MNC’s struggle wherein the local companies are highly
successful?

6. Which are the key therapeutic product portfolios in LATAM considering the
disease prevalence status?

7. Which are the tender and private trades driven countries?

8. For a small scale manufacturing company which LATAM regions must be

targeted first?

9. What strategy should implement when the local government only encourages
trade with local companies?

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