Pharma 4.

0
The term Industry 4.0 (“Industrie 4.0”) first appeared in a German government memo. In its earliest usage, Industry 4.0 referred to
Germany’s attempts to integrate digital technologies into its national manufacturing strategy.

The term quickly caught hold. “Industry 4.0” became common parlance in manufacturing communities by the early 2010s.
 Industry Timeline

1784 1870 1969 Today

Industry 1.0 Industry 2.0 Industry 3.0 Industry 4.0

Mechanization Mass production Automation Cyber physical
Steam Power Assembly line Computers systems
Weaving Loom Electrical energy Electronics Internet of
Things(IOT)
Networks
Industry 4.0
Industry 4.0 is the fusion of technologies [AI, Big Data, IoT,
bioinformatics] and their interaction across the physical, digital, and
biological domains that make the Fourth Industrial Revolution
fundamentally different from previous revolutions — diffusing faster and
more broadly than any of the previous revolutions.

Characteristics of Industry 4.0.

A suite of digital technologies achieving scalability and

ROI in industrial contexts

A changing relationship between humans, machines,

and labor

A dispersion and pace sufficient to earn the title

“revolution”
In general, Industry 4.0 refers to the industrial
industry's expanding tendency toward automation
and data interchange in technologies and
processes.

This automation produces a manufacturing system

in which factory machines are equipped with
wireless connectivity and sensors that allow them
to monitor and see the entire manufacturing
process and make autonomous decisions

With the entire rollout of 5G, wireless networking

and machine augmentation will be substantially
advanced. Faster response times will result,
allowing for near-real-time communication
between systems.

Digital twin technologies are also a part of the

fourth industrial revolution. Virtual copies of real-
world installations, processes, and applications
can be created using these digital technologies.
These can then be thoroughly examined so that
cost-effective decentralized decisions can be
made.
These virtual replicas can then be made in the real world
and linked via the internet of things, allowing cyber-
physical systems to communicate and cooperate with one
another as well as human workers to establish a connected
real-time data exchange and automation process for
Industry 4.0 manufacturing.

Interconnectivity between processes, information

transparency, and technical aid for decentralized decisions
are all part of this automation.

In other words, digital transformation should be possible.

This will enable automated and autonomous
manufacturing through the use of connected systems that
can communicate with one another.

The technology will aid in the resolution of problems and

the tracking of procedures, as well as enhancing
production.
Indian Pharmaceutical Industry
Introduction

India is the largest provider of generic drugs worldwide, with a worth ₹4,000 crore, and contributes 3.5% of total drugs and
medicines exported globally.. Indian pharmaceutical sector supplies over 50% of global demand for various vaccines, 40% of
generic demand in the US and 25% of all medicine in the UK. Globally, India ranks 3rd in terms of pharmaceutical production by
volume and 14th by value. The domestic pharmaceutical industry includes a network of 3,000 drug companies and ~10,500
manufacturing units.

India enjoys an important position in the global pharmaceuticals sector. The country also has a large pool of scientists and
engineers with a potential to steer the industry ahead to greater heights. Presently, over 80% of the antiretroviral drugs used
globally to combat AIDS (Acquired Immune Deficiency Syndrome) are supplied by Indian pharmaceutical firms.

Market Size

According to the Indian Economic Survey 2021, the domestic market is expected to grow 3x in the next decade. India’s domestic
pharmaceutical market is estimated at US$ 42 billion in 2021 and likely to reach US$ 65 billion by 2024 and further expand to
reach ~US$ 120-130 billion by 2030.

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$ 24.44 billion in FY21.
 Market Cap (Cr,₹)
Dr. Lal Pathlabs Ltd

Abbott India Ltd

Lupin Ltd
Leading Indian Pharmaceutical
Alkem Laboratories Ltd.
companies(2020-2021)
Cadila Healthcare Ltd.

Apollo Hospitals Enterprise Ltd

Dr. Reddy's Laboratories Ltd

Sun Pharmaceutical Industries Ltd

0 50000 100000 150000 200000
Pharma 4.0
Pharma 4.0 is a framework for adapting digital strategies to the unique contexts of pharmaceutical
manufacturing.

In practical terms, it means more connectivity, more productivity, simplified compliance, and the marshaling of
production information to respond to problems as they emerge.

“To Manufacture pharmaceutical products with maximum product and process understanding, data
integrity by design, efficiency and optimal resource allocation on the basis of full digital data
transparency–to the benefit of the patient”

Pharma 4.0 envisions a manufacturing paradigm that allows manufacturers to change and iterate, that connects
resources and workers, and that ultimately produces more quality product with better patient outcomes.

The pharma-specific maturity model anticipates:

• The elimination of data silos with better communication across the lifecycle of drugs.
• A lower-touch relationship with regulatory bodies as data collection and sharing improves.
• The elimination of paper-based processes.
• A shift to risk-based regulation.
• Improved agility, connectivity, and productivity–even in highly regulated facilities.
Pharma 4.0 maturity stages
Outlining a strategy for digital transformation isn’t a trivial task. Nor is finding small, scalable opportunities for improvement.
The answer is adopting an agile approach, privileging a steady evolution rather than a rapid revolution.

• Computerization – the first stage of maturity is simply to introduce digital technology to automate simple manual
processes. The goal is to find repetitive tasks that would be better performed by computers and create the basis for digital
infrastructure.
• Connectivity – Here, manufacturing expands IT infrastructure and lays the foundation to integrate IT, manufacturing, and
business functions.
• Visibility – This is the area where many manufacturers will start to see substantial improvements. Connected people,
machines, and processes create a substantial digital record of production that can be used to make real-time, data-driven
decisions.
• Transparency – With more data, new insights about complex systems become available. Advanced analytics find
opportunities for improvements that were previously invisible.
• Predictability – Detail production records enable manufacturers to correct problems before they happen.
• Adaptability – This is the final stage of maturity. Here, systems anticipate problems and initiate the proper action by
themselves. At their most advanced, these are autonomous, self-correcting systems.
 Pharma 4.0 Use Cases
Clean Room Monitoring and
Line Clearance and Regulated Environment
Process Visibility Maintenance
Reduced downtime and
effective scheduling. Reskilling and training
applications to facilitate
OJT

Big Data Analytics

Electronic Batch
Enhanced
Record and Log book
interpretation of the
Digital Logs can be data collected
easily accessed to throughout a product’s
prove compliance lifecycle.
Electronic Batch Record and Log book

• Electronic logbooks automate the recording of key production data, streamlining a manual process and significantly enhancing data integrity.

• These logbooks collect and integrate data from machines and operators, allowing for greater process visibility. Furthermore, unlike paper-based
forms, electronic logs can include images, notes, reason codes, device history records, and locations, providing a more comprehensive record of
production.

• Electronic logbooks guarantee that data is traceable, readable, current, unique, and correct (ALCOA).

• These records can be quickly retrieved to establish compliance because they are digital.

Line Clearance and Process Visibility

• Many line clearance processes are time-consuming and complex. Workers may spend more time looking for the next step or validating the
execution of the previous one when using paper-based processes, and less time going through the method.

• Line clearance can be made easier to browse with interactive, digital line clearance software. Work instructions that are digital and IoT enabled
lead users through SOPs, enhancing efficiency and guaranteeing that work is done correctly and evaluated automatically.

• Even complex procedures like line clearance may be made plain and simple using Pharma 4.0. Paper SOPs are being phased out in favour of
digital work instructions, which ensure compliance.
• In pharmaceutical manufacturing, the greatest barrier to process improvement isn’t always regulatory constraints. In many cases, it can be a lack
of process visibility.

• With IoT devices and human-centric manufacturing applications, manufacturers can break complex processes into their constituent steps, creating
a granular, picture of how workers perform on the line. The applications let engineers track individual operators' performance at each step. This
lets them create identify situations in which more training may be necessary. It also helps engineers differentiate between poor operator
performance and poor process design.

Clean Room Monitoring and Regulated Environment Maintenance

• The IIoT allows you to react to changing environmental circumstances as they occur. Connected sensors can identify when conditions are
approaching or exceeding preset thresholds, alerting operators to take appropriate action before production is disrupted.

• Many manufacturing processes necessitate a substantial amount of training. Manufacturers have a hard time duplicating "real-life" production
circumstances in their training programmes, therefore training might be delayed. This results in higher training expenditures, and if operators
aren't properly taught, quality can suffer.

• Pharma-specific training programmes can be designed by manufacturers to get personnel on the line quickly. Engineers can use targeted modules
to break down multi-stage processes into their constituent elements, and embedded media like as videos and photos can help transmit information
to different learning styles. If taking workers off the line for reskilling isn't an option, training software can be set up to allow for on-the-job
training (OJT).
• Furthermore, by running apps in "offline" mode, manufacturers can replicate processes in production settings. Employees are guided through a
procedure and data is collected on their performance, while regulated execution mode ensures that learners do not disrupt production.
Big Data Analytics

• Manufacturers generate enormous amounts of data in the course of their business. However, the majority of this data isn't used to inform
manufacturing decisions. This is due to the fact that data may be too bulky or unstructured to be useful (also known as "Data Rich, Information
Poor," or "DRIP").

• The improved interpretation of data acquired throughout a product's lifecycle is one of Pharma 4.0's promises. Systems are better able to analyze
and uncover relationships among big data sets because to improvements in AI and machine learning.

• With the help of big data, pharma companies can recruit the right patients for clinical trials, using data such as genetic information, personality
traits, and disease status, which will, in turn, increase the success rate of the drug. This also enables precision medicine, where diagnosis and
treatment of disorders are carried out using relevant data about a patient’s genetic make-up, behavioural patterns, etc. With this approach, pharma
companies can develop personalized medicine that is suitable for an individual patient’s genes and current lifestyle.

• With the insights gained from historical and real-time data sources such as social media, IoT sensors, log files, and patient data, pharma
companies can generate informative analytics.
Pharma 4.0

Advantages

• Built-in data integrity-complete removal of paper

• Continuous verification
• Cost optimization
• Increased productivity
• Integrated planning and training
• Performance based quality
• Preventative and predictive maintenance
• Quality 4.0
• Smart environment monitoring
• Smart equipment
Thank You