INTRODUCTION

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for
Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical
industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH
guidelines. Since its inception in 1990, ICH has gradually evolved, to respond to increasingly
global developments in the pharmaceutical sector and these ICH guidelines are applied by a
growing number of regulatory authorities. ICH's mission is to achieve greater harmonization
worldwide to ensure that safe, effective and high quality medicines are developed, and registered
and maintained in the most resource efficient manner whilst meeting high standards. Since its
announcement of organizational changes in October 2015, ICH has grown as an organization and
now includes 20 Members and 36 Observers.

At the first ICH Steering Committee (SC) meeting of ICH the Terms of Reference were agreed
and it was decided that the Topics selected for harmonization would be divided into Safety,
Quality and Efficacy to reflect the three criteria which are the basis for approving and
authorizing new medicinal products. The birth of ICH took place at a meeting in April 1990,
hosted by EFPIA in Brussels. Representatives of the regulatory agencies and industry
associations of Europe, Japan and the US met, primarily, to plan an International Conference and
terms of reference of ICH. First decade saw significant progress in the development of Tripartite
ICH Guidelines on Safety, Quality and Efficacy topics. Work was also undertaken on a number
of important multidisciplinary topics, which included MedDRA (Medical Dictionary for
Regulatory Activities) and the CTD (Common Technical Document). For two decades the ICH
process has achieved much success. This success is attributed not only to a process of scientific
consensus developed between industry and regulatory experts, but also to the commitment of the
regulatory parties to implement the ICH Tripartite Harmonized Guidelines and
recommendations. Throughout the second decade the development of ICH Guidelines continued,
but with more attention given to the need to maintain already existing Guidelines as science and
technology continued to evolve. Entering into its third decade of activity, ICH's attention is
directed towards extending the benefits of harmonization beyond the ICH regions.
 1. Dhirubhai Ambani

Organizations founded: Reliance Industries Limited, DA-IICT, Reliance Group, Reliance

Capital, Reliance Power

Dhirubhai Ambani (1932–2002) is an Indian businessman who started

out humbly by selling traditional snacks to religious pilgrims. His
business soon grew, and he expanded and diversified into industries
including telecommunications, power generation, information
technology, consumer goods, and logistics .
Today, Reliance Industries is India's largest private company and is listed on
the Fortune 500. Ambani's son now runs Reliance and is one of India's
wealthiest people; Mukesh Ambani, 65, is worth $92.5 billion, according to
Forbes.

Dhirubhai Ambani faced many risks like leaving his country for
employment, risking his job to start a business, changing the
direction of his business from spices to yarn, entering into new
businesses like petrochemicals, etc. He achieved grand success
because of his risk taking ability.

Dhirubhai Ambani, Indian industrialist, was the founder of Reliance

Industries, a giant petrochemicals, communications, power, and textiles
conglomerate that was the biggest exporter in India and the first
privately owned Indian company in the Fortune 500.

2. Azim Premji

Azim Premji, Indian business entrepreneur, served as chairman of Wipro

Limited, guiding the company through four decades of diversification and
growth to emerge as a world leader in the software industry. By the early 21st
century, Premji had become one of the world’s wealthiest people.
Premji, who over the course of a 40-year career helped transform
Wipro from a family-owned vegetable oil business (Western India
Vegetable Products Ltd.) into one of the largest outsourcing
companies in the world, said failure is a critical ingredient in
innovation. He added that innovation is what enabled young startups
to upset the existing balance of power.

To that end, companies must deliberately design a culture of

innovation to actively seek feedback from customers, celebrate all
kinds of diversity in their workforces, and also foster an environment in
which workers feel safe taking risks, even when they fail.
 Indian entrepreneur Azim Premji turned a small, family-owned cooking-
oil company into Wipro Limited, a multinational conglomerate focused
on providing technology outsourcing services.
 In 1980, Premji seized the opportunity to transform Wipro into an IT
company when IBM withdrew its business from India.
 Premji successfully diversified the company, steering its growth toward
developing custom software solutions for customers in the United
States.
 Premji has pledged to donate the majority of his wealth to charity and
has already given away $21 billion, much of it to improve primary
education in India.

3. Jehangir Ratanji Dadabhoy Tata

Jehangir Ratanji Dadabhoy Tata or JRD Tata (1904–1993) was born in Paris
to Indian and French parents. He was trained as an aviator in Europe and
later became India's first commercial airline pilot. Working for the family
business, TATA group, he set out on his own and built TATA Airlines, which
ultimately became the modern Air India.
Failures faced by Ratan Tata are hereby mentioned with the
following list of points:
1. Ratan Tata was bound to close an assignment of nurturing a
loss-making unit – Empress Mill during the year 1977 due to not
sanctioning 50 lakhs rupees of fund from the core management.
The unit was dreamed to be revolutionary but it got
unfortunately closed making Ratan feel depressed.
"Take the stones people throw at you. And use them to
build a monument."

2. Ratan Tata faced several public criticisms after being

declared the next successor of Tata Group of Industries by JRD
Tata in the year 1981. Public along with the Tata Groups
employees, investors, and shareholders as well believed him to
be a fresher for handling the sole responsibility of such a big
group of companies.
"If you want to walk fast, walk alone. But if you want to
walk far, walk together"

3. Ratan Tata decided to come up in the car market during the

year 1998 and launched his first car model with the name Tata
Indica which failed completely as people never shown their
interest in buying the car.
"Ups and downs in life are very important to keep us going
because a straight line even in an ECG means we are not
alive."

JRD's contributions to the development of India go far beyond establishing and

nurturing the country's aviation industry, or guiding India's leading business
conglomerate for 50 years. In fact, it was clear that his destiny and India's would
be intertwined, as early as 1926.

4. Nagavara Ramarao Narayana Murthy

Nagavara Ramarao Narayana Murthy, age 75, is an Indian entrepreneur
who co-founded IT giant Infosys (INFY) with an initial investment of
10,000 rupees, or just a few hundred dollars in today's terms .
With a net worth of $3.6 billion, he is often referred to as the father of the
Indian IT industry, serving as CEO of Infosys from 1981 until 2002, and then
its chair until 2011.As of March 2022, Infosys has a market capitalization of
around $104.7 billion.

As the 67-year-old Murthy completes one year of his second innings at

Infosys this week, the magnitude of the challenges facing the former
information technology (IT) industry bellwether at a time when it is
hunting for its first non-founder chief executive officer (CEO) appear
daunting, a fact underscored in Sunday’s mail.

His biggest challenges include putting in place a succession plan,

addressing the exodus of middle managers in the past 12 months and
retaining the company’s biggest clients as a result of these exits.

Murthy has been listed among the 12 greatest entrepreneurs of our time
by Fortune magazine. He has been described as the "father of the Indian
IT sector" by Time magazine and CNBC for his contribution
to outsourcing in India. In 2005, he co-chaired the World Economic
Forum in Davos, Switzerland.

5. Shiv Nadar
Shiv Nadar, 76, founded HCL Infosystems in 1976 with an investment
of a few thousand dollars, selling calculators and microcomputers. HCL
soon expanded to Singapore and the Far East, generating over 1 million
rupees in sales not long after its expansion. HCL has continued to grow,
making Nadar a billionaire worth over $24.5 billion.

Working as an employee made him realise that this was not what he was
meant to do. He, along with a few of his colleagues who shared similar
opinions on the passionless job, decided to quit and start their own
company.

The first venture Nadar and his partners established was MicroComp
Limited. This company was involved in manufacturing and selling
teledigital calculators. But the group harboured a greater goal.
Nonetheless, MicroComp was considered as a first step toward
achieving the bigger goal.

By India Today Web Desk: With an annual donation of Rs 1,161

crore, Software giant HCL's founder, Shiv Nadar, has bagged the title of
'India's Most Generous', as per the EdelGive Hurun India Philanthropy
List 2022.

6. Lakshmi Niwas Mittal

Lakshmi Niwas Mittal, 71, is an Indian entrepreneur who began his
career working for his father's steel business. He later set out on his
own, due to family infighting and created what is now one of the largest
steelmakers in the world, ArcelorMittal (MT). As of May 18, 2022,
ArcelorMittal has a market capitalization of $25.79 billion. Mittal
himself is worth about $16.8 billion.

"The biggest crisis or challenge I faced I believe is when I left India. I

did not have any exposure to the global market global situation and I
landed up in a country (Indonesia) I never knew about. That was the
biggest challenge," Mittal, chairman and CEO of steel behemoth
ArcelorMittal, told private broadcaster CNBC TV18.

Lakshmi Mittal, in full Lakshmi Narayan Mittal, (born June 15, 1950,
Sadulpur, Rajasthan, India), Indian businessman who was CEO (2006–
21) of ArcelorMittal, the world's largest steelmaking company. In
the 1960s Mittal's family moved to Calcutta (Kolkata), where his father
operated a steel mill.

7. Ghanshyam Das Birla

Ghanshyam Das Birla (1894-1983) is a well-known Indian businessman
who started his first company in the early 1900s operating a cotton
and textile mill. By 1919, Birla's businesses also included significant
paper and sugar production. By the time he died, Birla Group was a
multi-sector global conglomerate.

His great-grandson Kumar Mangalam Birla, 54, now runs the company
and commands a net worth of $14.3 billion.

GD had to scale a number of obstacles as the British and Scottish

merchants tried to shut his business through unethical and
monopolistic means, but he was able to persevere. When World War I
resulted in supply problems throughout the British Empire, Birla's
business skyrocketed

One of the institutions he founded was the prestigious Birla Institute of

Technology and Sciences (BITS), Pilani. A Padma Vibhushan awardee,
he also played an instrumental role in setting up several temples,
planetariums and hospitals across India

8. Dilip Shanghvi
Dilip Shanghvi, 66, started Sun Pharmaceutical in 1982 with a meager 10,000
rupee investment, or approximately $200. As the son of a pharmaceutical
distributor, Shanghvi knew what he was doing. Today, through gradual
development and a series of acquisitions, that investment has grown revenue
in 2021 to $4.31 billion, making Sun Pharma India's largest pharmaceutical
company. Today, Shanghvi has a net worth of around $15 billion.

Sun Pharma is celebrated as a great crisis manager after it has created a

track record of buying drug firms in distress and then turning them
around. It had acquired US-based Caraco Pharma and Israeli drugmaker
Taro Pharma at attractive valuations before turning them into success
stories. This time around, the price Sun has agreed to pay for its rival
Ranbaxy is not too steep either, but it’s nowhere near what can be
dubbed cheap, experts say.

In 1982, the 27-year-old Shanghvi finally opened his first

manufacturing unit with a capital of INR 10,000. He named his
venture Sun Pharmaceutical Industries. The unit, located in Vapi in his
native state of Gujarat, a short drive away from Mumbai, produced
exactly one psychiatry drug.

9. Karsanbhai Patel
Karsanbhai Khodidas Patel (born 1945, Ruppur, Patan, Gujarat) is an Indian
billionaire businessman, industrialist and founder of the Nirma group a company
with major business interests in cements, detergents, soaps and cosmetics. As of
2021 Forbes has listed his net worth at US$4.9 billion.[1] He has interests in
education, and founded leading pharmacy college (Nirma Institute of
Pharmacy)and a leading engineering college/ university .

Karsanbhai Patel started out mixing detergents, manufactured and packaged in the
10x12ft room of his house and selling handmade detergent powder door-to-door
on his bicycle while going to his workplace, which was 17km from his home.

At that time detergent powder and cake market was limited only to the premium
segment and was dominated by Multinational corporations (MNC) like Procter &
Gamble, Hindustan Lever

Karsanbhai Patel is one such example from Gujarat. He quit his full-time
government job to follow his dream. He is said to have gone door-to-door selling
detergent on his bicycle thereby turning the company into a formidable group.
Today, he is one of the richest businessmen from Gujarat with a net worth of $4.1
billion, according to Forbes.
 10. Ardeshir Godrej

Ardeshir Godrej (1868-1936) co-founded the Godrej Group, a

diversified conglomerate with interests in real estate, consumer
products, security, household appliances, and industrial tools. The
company had modest beginnings—Ardeshir and his brother
succeeded at locksmithing after failed ventures into hand-fashioned
medical devices.

The Godrej Group’s innovation journey began in 1897, when Ardeshir

Godrej patented a high-precision padlock that wouldn’t rust in India’s
humid weather. In 1918, Godrej manufactured the world’s first soap
made from vegetable oil instead of animal fat. A century later, the
company introduced Magic, a 20-cent powder-to-liquid handwash that
helped to democratize sanitation during the pandemic.

Born in 1868, this Parsi-Zoroastrian boy laid the foundation of one of

the biggest Indian consumer goods companies, in pre-independent
India. No one could have guessed that Ardeshir Godrej would
revolutionize the Indian economy as he did.