RESEARCH REPORT

ON

CHANGES IN PHARMACEUTICAL
INDUSTRY

AUTHORS:- ANKITA TIWARI

ARTI YADAV
 Content

1. Introduction

2. History

3. Size of the pharma industry

4. Investments and Recent Developments

5. Top Pharmaceutical Companies in India

6. Advantages of Pharmaceutical Industry in India

7. COVID-19 Impact on Indian Pharmaceutical Industry

8. Government measures

9. Challenges and Opportunities

10. Review of Literature

11. Objective

12. Conclusion
13. Reference

Introduction

As a leading producer of cost-effective and quality-controlled generic drugs, India supplies

around 20 percent of the global pharmaceuticals demand in terms of volume. In fact, the
Indian healthcare and pharmaceuticals sector was one of the fastest growing in the world and

was expected to grow by a whopping 754 percent between 2017 and 2060. Generic drugs

have traditionally been India’s stronghold and contributed over 70 percent to the overall

market revenue in 2018 alone.

The Indian pharmaceuticals market has several unique characteristics that have contributed to

its steady growth as well as recognition. Firstly, the country’s grip on the branded generics

market is its biggest strength. India has the highest number of United States FDA-approved

plants for generic drug manufacturing outside the north American country. Generic drugs are

the pharmacologically equivalent versions of branded drugs and have the same dosage,

intended use and other qualities as the original drug. In 2015, India earned over 21 billion

U.S. dollars through biosimilars in the prescribed drug market.

Secondly, the industry has many local players who have created their niche through early

investments and new formulation development capabilities. Six domestic firms, namely,

Aurobindo, Cipla, Desano, Emcure, Hetero Labs and Laurus Labs have UN-backed

Medicines Patent Pool to manufacture anti-AIDS medicine for over 112 countries in the

developing markets. Healthy competition in the market and generic productions have ensured

that the prices of drugs from Indian manufacturers are extremely low compared to global

prices. Even though India ranks tenth globally in terms of pharma production value, it comes

in third for production volumes.

In 2019, the country’s export value of drugs and pharmaceuticals amounted to over 1.3
trillion rupees. This impressive record has also lead to some major foreign investments in the

sector along with several key M&A deals. The government has also been keen on backing the

sector through various policy implementations. There are plans in place to regulate drug

prices and approvals through the “Pharma Vision 2020” program along with the Drug Price

Control Order initiated in 2013. Under this vision, there are several manufacturing plants

being set-up across the country, generating employment and further impetus to the sector.

This, combined with the Ayushman Bharat Yojana and an increased health expenditure,

along with rising cooperative agreements with global pharma companies have given domestic

companies a new boost.

However, the recent outbreak of the coronavirus (COVID-19) pandemic has exposed some

weak links in the Indian pharma sector. One of the biggest setbacks was the

country’s dependency on China for raw materials. Due to the global lockdown to curb the

spread of the virus, supply chains to and from China were disrupted making it harder for
Indian pharma companies to source essential drug molecules. As of March 2020, the Indian

government put in place a “China-plus-one” policy to fill in supply gaps and bolster

production of essential raw materials within India. Under this policy, 53 drug raw materials

and APIs were identified to be produced on priority by investing over 1.3 billion U.S. dollars

in domestic pharmaceutical companies and state-run manufacturers. New restrictions have

also been ordered on the export of several drug formulations to ensure enough supplies for

India.

At the same time, the coronavirus crisis has led to a surge in market caps of many Indian

companies like Cipla, Dr. Reddy's, and Zydus Cadila. The race for a vaccine for COVID-19

is underway and how India tackles the crisis will determine the country’s standing as a

potential pharma heavyweight in coming years.

 History

The history of Indian pharmaceutical market in 1970's was almost non-existent. Today, India

has gained immense importance and carved a niche for itself in the pharmaceutical domain.

In fact, it has emerged as a big mart for the pharmaceutical industry. In today's world, Indian

pharmaceutical industry ranks 4th in terms of volume and 13th in terms of value. For

example it might be anything like formulations, bulk drugs, generics, Novel Drug Delivery

Systems, New Chemical Entities, or Biotechnology, etc. Indian companies are dominating in

the marketplace which was traditionally manned by MNC's. In 1930, in Calcutta the first

pharmaceutical company called Bengal Chemicals and Pharmaceutical Works, which still is

today as one of 5 government-owned drug manufacturers was started.

Today in India, Pharma Industry rank's first of India's science-based industries with wide

ranges of capabilities in the complex field of drug manufacture and technology. The industry

is estimated to be worth $4.5 billion, which is growing at 8-9% annually. It is one of the best

and highly organized sectors. The sector specializes in term of technology, quality and range

of medicines manufactured. The product of the industry ranges from simple headache pills to

sophisticated antibiotics and also complex cardiac compounds.

 Size of the Pharma Industry

The Indian Pharmaceutical industry consists of more than 20,000 registered units which are

highly fragmented. It has been expanding in a tremendous manner in the last two decades and

includes 250 pharmaceutical companies which control 70% of the market.

The Indian Pharma Industry has around 70% of the country's demand for bulk drugs, drug

intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals and injectibles.

250 large units and about 8000 Small Scale Units, form the core of the pharmaceutical

industry in India. The units produced have the complete range of medicines which are ready

for consumption by patients.

In India the output of Indian Pharmaceutical industry increased to Rs260 billion in the

financial year 2002, which accounts for 1.3% of the global pharmaceutical sector. The bulk

drugs accounts for Rs 54 bn (21%), the remaining Rs 210 bn (79%) for formulations, imports

were Rs 20 bn while exports were Rs87 bn in year 2002. There is huge expansion of

Domestic Pharma sector which estimated US$ 11.72 billion (Rs 55454 crore) in 2008-09

from US$ 6.88 billion (Rs 32575 crore) in 2003-04. India exports its Pharma Products to

various countries around the globe including highly regulated markets of USA, Europe, Japan

and Australia.

• India ranks 3rd worldwide for pharmaceutical production by volume and 14th by

value. The country has an established domestic pharmaceutical industry, with a strong

network of 3,000 drug companies and ~10,500 manufacturing units.

 India's biotechnology industry comprising biopharmaceuticals, bio-services, bio-

agriculture, bio-industry, and bioinformatics. The Indian biotechnology industry was

valued at US$ 64 billion in 2019 and is expected to reach US$ 150 billion by 2025.

• India’s drugs and pharmaceuticals exports stood at US$ 17.57 billion in FY21 (From

December 2020 to April 2021).

 Investments and Recent Developments

The Union Cabinet has given its nod for the amendment of existing Foreign

Direct Investment (FDI) policy in the pharmaceutical sector in order to allow

FDI up to 100% under the automatic route for manufacturing of medical

devices subject to certain conditions.

The drugs and pharmaceuticals sector attracted cumulative FDI inflow worth

US$ 17.75 billion between April 2000 and December 2020 according to the

data released by Department for Promotion of Industry and Internal Trade

(DPIIT).

Some of the recent developments/investments in the Indian pharmaceutical

sector are as follows:

• In April 2021, National Pharmaceutical Pricing Authority (NPPA) fixed the

price of 81 medicines including off-patent anti-diabetic drugs allowing due

benefits of patent expiry to the patients.

• In February 2021, Aurobindo Pharma announced plans to procure solar

power from two open access projects of NVNR Power and Infra in Hyderabad.

The company will acquire 26% share capital in both companies with an US$

1.5 million investment. The acquisition is expected to be completed by the end

of March 2021.

• In February 2021, the Telangana government partnered with Cytiva to open a

‘Fast Trak’ lab to strengthen the biopharma industry of the state.

• In February 2021, Glenmark Pharmaceuticals Limited launched SUTIB, a

generic version of Sunitinib oral capsules, for the treatment of kidney cancer

in India.

• In February 2021, Natco Pharma launched Brivaracetam for the treatment of

epilepsy in India.

• In February 2021, the Russian Ministry of Health allowed Glenmark

Pharmaceuticals to market its novel fixed-dose combination nasal spray in

Russia.

• In January 2021, the Central government announced to set up three bulk drug

parks to make chemicals compounds or active pharmaceutical ingredients

(APIs) for medicines and reduce their imports from China.

TOP Pharmaceutical Companies in India

1. SUN Pharmaceutical Industries (1,60,372Cr Market Cap)

Sun Pharmaceutical Industries established in 1983 with five psychiatry products and a

two person marketing team. Sun Pharma is the fifth largest specialty generic

pharmaceutical company in the world. It provide high-quality, affordable medicines

trusted by healthcare professionals and patients in many countries worldwide. Sun

Pharma is also India’s largest and pharmaceutical company. Its global presence is

supported by several manufacturing facilities.

2.Divi’s Laboratories Limited (1,11,306 Crore)

It is a Company limited by shares, incorporated and domiciled in India. The Company

is engaged in the manufacture of Active Pharmaceutical ingredients (API’s),

Intermediates and Nutraceutical ingredients with predominance in exports. In addition

to generic business, the Company, through its custom synthesis business, supports

innovator pharma companies for their patented products business right from gram

scale requirements.

3.Dr. Reddys Laboratories Ltd.(87,906 Crore)

Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company located

in Hyderabad, Telangana, India. The company was founded by Anji Reddy. The

company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for

drug manufacture, diagnostic kits, critical care, and biotechnology products.

4.Cipla Ltd.(77,453 Crores)

Cipla Limited is an Indian multinational pharmaceutical company, headquartered in

Mumbai, India. Cipla primarily develops medicines to

treat respiratory, cardiovascular disease, arthritis, diabetes, weight

control and depression other medical conditions

 5.Cadila Healthcare Ltd.(63,493 Crores)

Cadila Pharmaceuticals is an Indian multinational pharmaceutical group based

in Ahmedabad, Gujarat, India. With more than 6 decades of experience, the company's

integrated operations focus on manufacturing products ranging from API's-

Intermediates, finished formulations, OTC-Food Supplements, Biotechnology Products

and pharmaceutical Machinery. Cadila Pharmaceuticals manufacturing facilities are

approved by International bodies such as WHO-GMP, UK-MHRA, USFDA-API, TGA-

Australia, and AIFA-Italy.

Advantages to Pharmaceutical Industry In India

• To achieve self-reliance and minimise import dependency in the country's

essential bulk drugs, the Department of Pharmaceuticals initiated a PLI

scheme to promote domestic manufacturing by setting up greenfield plants

with minimum domestic value addition in four separate ‘Target Segments’

with a cumulative outlay of Rs. 6,940 crore (US$ 951.27 million) from FY21

to FY30.

• Under Union Budget 2021-22, the Ministry of Health and Family Welfare has

been allocated Rs. 73,932 crore (US$ 10.35 billion) and the Department of

Health Research has been allocated Rs. 2,663 crore (US$ 365.68 billion).
 • The government allocated Rs. 37,130 crore (US$ 5.10 billion) to the 'National

Health Mission’. PM Aatmanirbhar Swasth Bharat Yojana was allocated Rs.

64,180 crore (US$ 8.80 billion) over six years. The Ministry of AYUSH was

allocated Rs. 2,970 crore (US$ 407.84 million), up from Rs. 2,122 crore (US$

291.39 million).

• India plans to set up a nearly Rs. 1 lakh crore (US$ 1.3 billion) fund to provide

boost to companies to manufacture pharmaceutical ingredients domestically

by 2023.

(via.ibef.org)
 Covid-19 impact on Indian pharmaceutical industry

The domestic pharma market turnover in India has reached Rs. 1.4 lakh crores (equivalent to

$ 20.03 billion) in 2019 as per the government data. This is actually an increase from Rs. 1.29

lakh crores in 2018.

In India, the healthcare industries consist of both private sector and public sector. India plays

an important role in the global pharma sector, and has a great pool of scientists/engineers

with good potential to steer the industry ahead to greater heights.

The Indian pharmaceutical industry supply for over 50 per cent of global demand for various

vaccines. India is the 3rd largest producer of drugs in terms of volume and vaccine

production accounts to 60 per cent global production. India contributes substantially to WHO

demand for BCG, Pertussis, Diphtheria and Tetanus vaccines, which accounts 40 to 70 per

cent. India also supports the global demand for vaccine for the treatment of measles and it

accounts to 90 per cent.

The generic drugs manufactured in India and supplied worldwide confer safety and quality.

India contributes to the second largest share of pharmaceutical and biotech workforce in the

world. The average growth rate of India's biotechnology industry comprising

biopharmaceuticals, bio-services, bio-agriculture, bio-industry, and bioinformatics is

expected to be 30 per cent and to reach US$ 100 billion by 2025.

Indian pharma products are exported to more than 200 countries in the world, with US being

the key market. The Indian pharmaceutical exports, including drug formulations,

intermediates, bulk drugs, biological, surgicals and Ayush and herbal products has reached

US$ 16.28 billion in FY 20. It was estimated that 80 per cent of the antiretroviral drugs used

globally to combat AIDS (Acquired Immune Deficiency Syndrome) are supplied by Indian

pharmaceutical firms. The medical device industry in India market is expected to grow US$

25 billion by 2025.
Covid impact, challenges and opportunities

The coronavirus pandemic and its resultant lockdown badly affected all major sectors of the

economy, but it has come as a boon in disguise to the Indian pharmaceutical sector. Though

some part of pharmaceutical business was affected such as supply chain and import of active

pharmaceutical ingredients from China, Covid-19 has provided some opportunities in the

pharmaceutical sector, especially India.

In generic market, India is facing high competition from China for the supply of APIs at

lower cost. India imports 70 per cent of the API needs from China. This created a lot of

hardship to some of the domestic pharmaceutical firms manufacturing certain key APIs.

India’s health security was under threat due to heavy dependence on China coupled with

shortage in supply of key APIs.

Some of the key APIs were crucial to mitigate the burden of accelerating disease like

tuberculosis, diabetics and cardiovascular diseases in India. The current dependence of Indian

pharmaceutical companies on Chinese APIs created a serious concern for national health

security, prompting the GoI to set up a taskforce for reviewing the internal API sector.
In view of the Covid-19 pandemic situation, the GoI should take important steps for

removing the technical and financial barriers, which will spur the pharmaceutical industry to

ramp up API production-thereby reducing the dependency of pharmaceutical industry with

China.

The GoI has taken important steps by proposing an incentive package of Rs. 13.76 billion for

the promotion of domestic manufacturing of critical key starting materials, drug

intermediates, APIs and medical devices.

Several key representatives from the pharmaceutical industry and NITI Aayog have

suggested that fostering the approvals of pharmaceutical infrastructure developments,

clearance from environment ministry and providing tax exemptions and subsidies for the

development and promotion of the pharmaceutical industry hubs could benefit the market.

Amidst pandemic situation, urgent action is needed to boost medical supply of sanitizer, face

masks, disinfectants, surgical gloves, protective gears for health personnel, scanners, infrared

thermometers, test kits, inhalers, ventilators etc. Most of the items require low level of

technology and can be manufactured easily.

The MSME sector needs high focus in the above endeavor for twining public health and

economic development. The Covid situation could be made as an opportunity for MSME for

producing low end technology items in medical and sanitary equipment’s like masks, gloves,

cottons etc. and this could even revive the stagnant sectors.

In the last few years, since 2014 the frequency of people visiting India for medical treatment

has increased at about 55 per cent. The Government has relaxed the rules for promoting India

as a better medical tourist destination by issuing fast-track medical visas, rapid airport

clearances for those visiting as medical tourists. The key players in medical tourism are in

private sector. The government agencies could do better by opening new avenues in the years

ahead.
Investments and recent developments

During the Covid pandemic, several initiatives were taken by the Union Cabinet to boost

pharma industry, which include the amendment of existing Foreign Direct Investment policy

to allow FDI to invest up to 100 per cent under the automatic route for manufacturing

medical device subject to certain conditions.

According to the data by DPIIT, the pharma sector attracted cumulative FDI inflow worth

US$ 16.54 billion during April 2000 to 2020 June. Some of the investments made in the

pharma sector during the Covid crisis include sterilization devices and germicidal cabinet,

portable and rechargeable car sanitizer, alcohol-free and bleach-free sanitizers and wheeled

sterilisation unit especially for hospitals by researchers from reputed organization.

Six generic drug makers signed MoUs with Hidalgo (Mexico) to establish a large pharma

cluster for the production and logistics in Mexico. The Jubilant Generics Ltd has entered into

a non-exclusive licensing agreement with Gilead Sciences Inc for the manufacture and sale of

potential Covid drug Remdesivir in 127 countries, including India.

The Telangana Government has proposed to the Union Government to set up Hyderabad

Pharma city with a financial aid of Rs. 3418 crore. A record sale of Rs. 52 crore was reported

by the PMBJP at an affordable rate to the public.

India unveiled plans to collaborate with Netherlands with an aim to provide digital health

facilities. The Government initiated PLI scheme for the pharma sector worth Rs. 15,000

crore.

India has planned to set up Rs. one lakh crore fund for boosting the pharma sector to

manufacture pharmaceutical ingredients domestically by 2023. The Government has

approved extension/renewal of extant pharmaceutical purchase policy adding one additional

product alcoholic hand disinfectant to the existing list of 103 medicines.

The National Health Protection Scheme, a Government funded healthcare programme, which

benefit 100 million poor families in the country, provides an insurance cover of up to Rs. 5

lakh per family per year for secondary and tertiary care hospitalization.
The fund allocated to health insurance scheme Ayushman Bharat Pradhan Mantri Jan Arogya

Yojana (AB-PMJAY) is Rs. 6400 crore. The Pharma Vision 2020 is an initiative by GoI for

making India a global leader in drug manufacture and approval time for new facilities for

manufacturing has been reduced to boost the investment. The government has offered Rs.

6,940 crore production linked incentives between 5-20 per cent for incremental sales and

plans to set up three mega drug parks to drive sustainable cost competitiveness.

The medicine spending in India is expected to grow between 9-12 per cent over the next five

years, leading India to become one of the top 10 countries in terms of medical spending. The

better growth in domestic sales would also depend on the ability of companies to align their

product portfolio towards chronic therapies for diseases such as cardiovascular, anti-diabetes,

anti-depressants and anti-cancers, which are on the rise.

The government has taken many initiatives to reduce cost and bring down the healthcare

expenses. Speedy introduction of generic drugs into the market has remained in focus and is

expected to benefit the Indian pharmaceutical companies. The thrust on rural health

programmes, lifesaving drugs and preventive vaccines will provide space for development of

pharmaceutical companies.
 REVIEW OF LITERATURE

Reddy and Rao (2017), in their article “Opportunities and Challenges for Indian
Pharmaceutical Companies in overseas markets and need of digital tools for
sustainable success”, pointed out that Indian pharmaceutical companies are
experiencing difficulty to survive in global markets knowledge, complex
regulatory pathway, and not embracing the latest digital technologies. The
study’s main objective is to find out the use of various digital tools available for
different pharma industry domains to become successful in global markets.
They find out that there is a clear need for domain-based digital tools for Indian
pharma companies to compete and sustain in global markets.

Dhar and Joseph (2019), in their article, “The challenge, opportunities and
performance of the Indian pharmaceutical industry post- TRIPS,” pointed out
that India’s generic pharmaceutical producers are facing numerous challenges
after the country’s patent law was amended to make it compatible with the
agreement on trade-related aspects of intellectual property rights ( TRIPS ).

They find out that leading generic companies of the industry have mixed
performance.
 OBJECTIVE

• To find out the potential and challenge faced by the pharmaceutical

industry.
• To come up with some proposals for the pharmaceutical industry
• To find out the application of AI in the pharmaceutical industry.

Potential of the Indian Pharmaceutical Industry

The Indian pharmacology sector has the capacity to grow. According to the
capacity to grow. According to the INDIAN PHARMACEUTICAL
ALLIANCE (IPA), one of the emerging organization of pharmacists in India,
the Indian pharmaceutical industry is one of the largest in global markets.
According to them, the Indian pharmaceutical industry has to intend
advancement to realize its true potential. In the pharma industry, ther are four
key drivers of growth. They are :-

1. Increasing economic growth in India,

2. Strong growth in the US market,
3. To introduce new innovative products, and
4. Increased grip in markets, such as, Japan.

In India, about 2.7 million jobs have been created both directly and indirectly
due to growth in this industry. The current compound annual growth rate
(CAGR) is estimated to be between 7 and 8%, and this would result in being
worth up to $90 billion by 2030. But in fact, the industry has the potential to
rise at a CAGR of up to 11–12%, potentially reaching $120–130 billion by 2030.
The IPA presents four goals as the outcome for their potential.

1. As an ideal manufacturer, by manufacturing high-quality medicines

at an affordable price, low-pdrugs are needed to reduce patients’
costs as part of the scheme to implement universal healthcare in the
country.
2. As a contributor to the economy; at present, pharmaceutical
companies contribute about $11 billion, and they can bring more
economy to India.
3. As a world leader; Indian pharma has to set a goal of 3–5 molecular
entities launched or in late clinical trial phases and about 10–12
innovations launches per year by 2030.
Some Challenges for the Indian Pharmaceutical Industry

In their report, the IPA says that there are still some problems in this industry. They are:

• A lack of a stable pricing and policy environment-The challenge

created by unexpected and frequent domestic pricing policy
changes in India. It has created a vague environment for
investments and innovations. IPA suggests both the government
and stakeholders work together to develop a plan to produce
affordable Indian patients’ drugs.
• Lack of capabilities in the innovation space-India is rich in its
manpower and talent. The government needs to invest in
research initiatives and talent to grow India’s innovation. The
government should support the clinical trials and subjectivity in
certain regulatory decision-making removed.
• Generics market exporting-Due to price attrition, the success of
generic exports to the United States has started to plateau. Due
to increased buyer consolidation and higher competition, this
market is starting to fade.
• Effect of external markets-Reports comments that India is
heavily dependent on other countries for active pharmaceutical
ingredients (API) and other intermediates. 80% of the APIs are
imported from China. So India is, therefore, at the mercy of
supply disruptions and unpredictable price fluctuations.
Implementation of infrastructure improvement in the field of
internal facilities is necessary to stabilize supply.
• Quality compliance inquiryQuality compliance inquiry-India has
undergone the highest number of Food and Drug Administration
(FDA) inspections since 2009; therefore, continuous investment for
upgrading quality standards will distract the capital away from
other areas of development and growth is reduced.

Some Proposals for Pharma Industry

To achieve the goals, Indian pharma companies have to take some bold
strategic moves into uncharted territories. In a report, IPA suggests some
actionable steps to encourage the growth of the pharma industry .

Good communication is needed for the development of any business.

Similarly, improving communication between the industry stakeholders
and Indian regulators would help build a stronger pharma platform .
Policies should be framed to develop more faith around drug costs to a
steady regulatory atmosphere. Establishing an independent body or a
separate ministry would enable better coordination and faster decision-
making. Another suggestion is to focus on API manufacturing so that they
can less rely on imported APIs. This can be fulfilled in several ways,
including constructing dedicated zones for the manufacture of APIs.

Several state governments in India have already undertaken positive steps

to encourage industry growth. Provinces, such as, Andhra Pradesh and
Uttar Pradesh announced their intention to build “pharma parks,” which
will provide the industry with a competitive edge. Regulatory authorities
have to simplify the approval process because investment in emerging
research and development (R & D) fields is much higher than generic
ones. Working with other global regulatory bodies could help encourage
pharmaceutical growth in India.
Application of Artificial Intelligence (AI) in Pharma Industry

Artificial intelligence and machine learning have revolutionized the

industry and led to inventions, like virtual assistants, chatbots, robotic
treatment, and much more. In this modern world, companies worldwide
adopt big data and AI, where the pharmaceutical industry is no exception.
AI can contribute a lot of opportunities for business transformation. Big
data and AI powered analytics have brought a radical shift in the pharma
industry’s innovation paradigm. AI can significantly improve pharma
companies’ value by driving innovation and creating new business
models. AI can be used in almost every pharmaceutical industry face
starting from drug discovery, development manufacturing, and
marketing. AI can make all business operations efficient, cost-effective,
and hassle-free. AI can be a powerful tool in the research and
development of the pharmaceutical industry. We can look at some of the
most worthy applications of AI in the pharmaceutical industry.

• Research and development (R & D)-Machine learning algorithms

and AI-based tools contribute very much to streamlining the drug
discovery process. These intelligent tools are designed to identify
the complicated patterns in large data-sets. This capability results in
drastic measures for studying various disease patterns and
recognizing which drug compositions would suit treating specific
traits of a particular disease. Pharma companies can invest in such R
& D of drugs, which has the highest chance of success.

• D process from designing and identifying target-based Drug

development-AI has the potential to improve the R & drug
 validation. According to an MIT study, only 13.8% of drugs are
successful in passing clinical trials. A pharma company has to pay
about the US $161 million to US$ 2 billion for a drug to get through
the complete clinical trial process and get FDA approval. That is
why pharma companies rely more on AI to improve the success
rates of new drugs in more affordable drugs by reducing operational
costs.
• Diagnosis-Maintaining electronic medical record (EMR) is a very
important application of AI. EMR can store sensitive patient data
securely in the cloud or any centralized storage system. Doctors
can use advanced machine learning systems to collect, process,
and analyze wide volumes of patients’ healthcare data. Machine
Learning (ML) and AI-based tools can process and analyze big
data very quickly. It can boost up the diagnosis process, thus,
helps to save millions of lives.
• Disease prevention-Generally, pharmaceutical companies, do not
spend their time and resources to find treatment for rare
diseases. According to Global Genes, nearly 95% of rare diseases
do not have FDA approved treatment or cures. Pharma
companies can use AI to develop cures for these rare diseases .

• Epidemic prediction-Many pharma companies and health care

providers are already using AI and ML to monitor and forecast
epidemic outbreaks across the globe. These technologies gather
data from all possible sources on the web, analyze various
geological, environmental, and biological factors on the health of
the population of different geographical locations and connect all
 the factors and previous epidemic outbreaks. A very big example in
recent times was the prediction of the novel coronavirus. This
infection began in China, but a Canadian AI startup based in
Toronto had marked this infection first. “Blue Dot” is another AI-
based infectious disease surveillance system that searches the world
24 × 7 for large scale disease spread. These AI-based platforms got
an indication of the possible pandemic around December 30, 2019.
The company alerted their clients about this “unusual pneumonia.”
Nine days after this, the WHO issued their alert about the
emergence of SARS-CoV-2. Such AI models become especially
useful for underdeveloped economies that lack the medical
infrastructure and financial framework to deal with an epidemic
outbreak.
• Remote monitoring-It is a breakthrough in the pharma and
healthcare sectors. Many companies have already developed
wearable powered by AI algorithms that can remotely monitor
their patients suffering from a life-threatening illness. For
example, if a person with diabetes, the AI tool will monitor
insulin sensitivity, duration of action, blood sugar levels, physical
activity, etc. If the condition worsens or demands a treatment
upgrade, the AI will alert the physician and arrange a checkup.
Remote setups like these help eliminate the need to travel back
and forth to the doctor’s clinic by saving patients the bother to
travel and wait.

• Manufacturing-AI can replace conventional time-consuming

manufacturing techniques. So the pharma companies can launch
 drugs in the market much faster and at cheaper rates. By limiting
human intervention in the manufacturing process, AI would also
eliminate any human error scope. Companies can work with higher
productivity, improved efficiency, and faster production of life-
saving drugs. AI can improve all aspects of the manufacturing
process, including quality control, predictive maintenance, waste
reduction, process automation, and design optimization.

• Marketing-Though the pharmaceutical industry is a salesdriven

sector, with the help of AI, pharma companies can explore and
develop unique marketing strategies that can assure high revenues.
AI can help to study the taste of customers, thereby allowing
companies to frame a marketing technique. The same way pharma
companies can aim at needy marketing strategies that can lead to
most conversions and increase revenues. AI can analyze various
marketing campaigns and can compare the results to identify the
most profitable campaign. Moreover, AI tools can predict the
success or failure rate of marketing campaigns.
 Conclusion

There is still room for the industry to grow. Improving communication

between stakeholders and Indian regulators would help to build a
stronger platform for the Indian Pharmaceutical Industry. Big
pharmaceutical companies are no longer providing the service they once
did. India has joined “Global Partnership on Artificial Intelligence ”
(GPAI) as a founder member, which is a positive attitude by the
government to support responsible and human-centric development and
AI use. Being a developing country, India has to focus on similar mind
situations in the future too. So the government should create an
environment to start healthcare startup firms so the patients and
companies can co-exist without being a burden on each other.
 References

Reddy, A. V. J., & Rao, B. M. (2017). Opportunities and challenges for

Indian Pharmaceutical companies in overseas markets and need of digital
tools for sustainable success. Indian Journal of Pharmaceutical Education
and Research, 51(2).
Dhar, B., & Joseph, R. K. (2019). The Challenges, Opportunities and
Performance of the Indian Pharmaceutical Industry Post-TRIPS.
In Innovation, Economic Development, and Intellectual Property in India
and China (pp. 299-323). Springer, Singapore.