History of

Pharmaceutical
Industry
Pharmaceutical Industry

• The pharmaceutical industry plays a crucial role in global healthcare.

• It focuses on the research, development, production, and distribution of
medications that treat, cure, or prevent diseases.
• As of 2024, the industry is valued at over $1.6 trillion, reflecting its immense
economic and social importance.
 • Medicinal practices date back thousands of
Origins of years.

Medicine • Early civilizations such as the Egyptians,

Greeks, and Chinese developed herbal
remedies and traditional preparations.
• Hippocrates, often considered the father of
medicine, emphasized systematic
observation and natural healing methods,
laying the foundation for pharmacology.
 • Before industrialization, apothecaries
Pre-Industrial prepared medicines manually using natural
products.
Pharmacology • Their formulations relied on empirical
knowledge, and there was no regulatory
oversight.
• Drugs were often compounded directly for
individual patients, reflecting a deeply
artisanal approach to medicine.
Industrial Revolution and Its Impact

The Industrial Revolution marked a turning point.

With industrialization came mechanization and the shift from artisanal to
scientific drug production.
Mechanization enabled large-scale drug production, reducing costs and
improving access.
Chemical synthesis emerged, allowing scientists to create drugs in the lab,
replacing or complementing natural sources.
This period also introduced the first steps toward standardization and quality
control.
The First Pharmaceutical Companies
in Europe
• The pharmaceutical industry emerged from the chemical industry in Europe,
particularly in Germany and Switzerland.
• Bayer, Hoechst, and Merck leveraged expertise in organic chemistry to begin drug
production. Britain and France also contributed key players.
• Europe was home to the earliest pharmaceutical companies.
• Merck, established in Germany in 1668, is recognized as the world's oldest
pharmaceutical firm.
• Bayer, also German, introduced Aspirin in 1899, which became one of the most
widely used drugs globally.
• In the UK, Glaxo began as a nutritional company before expanding into
pharmaceuticals.
European Expansion and Globalization

• European pharmaceutical companies rapidly expanded during the late 19th

and early 20th centuries.
• They exported drugs worldwide and established foreign subsidiaries.
• International patent laws helped secure their commercial interests, laying
the groundwork for today's global pharmaceutical landscape.
Foundations in the USA

• The pharmaceutical industry in the United States began with companies like
Pfizer, Eli Lilly, and Squibb.
• Founded in the mid-19th century, these firms initially produced chemicals
and antiseptics.
• Eli Lilly notably pioneered gelatin capsules, which improved drug delivery
methods and patient compliance.
World Wars and Drug Innovation

• World War II accelerated pharmaceutical innovation, especially in antibiotic

production.
• Penicillin, discovered by Alexander Fleming in 1928, was mass-produced to
treat wounded soldiers.
• Government-industry partnerships during the war set the stage for post-war
pharmaceutical growth.
 Post-War Growth and Regulation
Golden Age and Industry Expansion (1940s-1970s)

• The post-war period, often termed the "Golden Age" of pharmaceuticals, saw a surge in new
drug discoveries, driven by government-funded research and advancements in medical
science.
• Firms like Merck and Pfizer became global leaders. Patent laws evolved, strengthening market
exclusivity for innovators.
• However, the industry's growth brought challenges, including escalating R&D costs and
increasing scrutiny over drug efficacy and safety.
• The creation of the Food and Drug Administration (FDA) brought increased regulation.
Blockbuster drugs emerged, and companies grew into multinational corporations. Safety,
efficacy, and advertising became central regulatory concerns.
Development of Early Drugs
First Synthesized Drugs

• Aspirin, chemically known as acetylsalicylic acid was among the first drugs to
be chemically synthesized.
• Barbiturates soon followed as effective sedatives.
• Other early synthetic drugs included chloral hydrate, a sedative, and
phenacetin, an analgesic later banned due to toxicity.
• This shift marked a departure from traditional extraction-based
pharmacology toward industrial drug manufacturing.
Antibiotics Revolution

• The discovery of penicillin transformed medicine.

• For the first time, bacterial infections could be effectively treated.
• Subsequent antibiotics like streptomycin expanded treatment options,
helping to control diseases such as tuberculosis and revolutionizing clinical
practice.
• Discovery of antibiotics extended the average human lifespan by 23 years.
Introduction of Vaccines

• Vaccination began with Edward Jenner's smallpox vaccine in 1796.

• Later, the development of the polio vaccine in 1955 represented a significant
public health achievement.
• Vaccines have since become central to disease prevention efforts worldwide.
Hormones and Insulin

• The isolation of insulin in 1921 was a landmark event, offering hope to

diabetics.
• Hormonal therapies expanded during the 20th century, addressing
conditions from thyroid dysfunction to infertility.
• These advances highlighted the growing ability to replicate or supplement
human biochemistry.
 Thalidomide Tragedy (1950s-60s)
• Thalidomide, used to treat morning sickness, led to severe birth defects in
thousands of babies across Europe and elsewhere.
• The disaster prompted major reforms in drug approval processes, emphasizing the
importance of rigorous pre-market testing.
 The Thalidomide tragedy was averted in 2 countries

USA

FDA approval is hold by Dr. Frances Oldham Kelsey

Dr. Frances Oldham Kelsey, a pharmacologist and physician

working at the U.S. FDA at the time.
Despite pressure from the drug company, she refused to
approve thalidomide for use in the U.S. because of
insufficient safety data — particularly regarding pregnancy.
 The Thalidomide tragedy was averted in 2 countries

TÜRKİYE

Despite international use, they refused

approval of thalidomide in Turkey — citing
insufficient animal testing, concerns about
neurological side effects, and lack of human
teratogenicity data.
Ankara University
Veterinerian Faculty of Medicine
Bacteriologist Department of Pharmacology
Regulation and Ethical Shifts

Establishment of Regulatory Bodies

• National and international agencies such as the FDA (USA), EMA (EU), and
WHO (global) play vital roles in regulating pharmaceuticals.
• These bodies ensure that drugs meet stringent safety, efficacy, and quality
standards before reaching the market.
Good Manufacturing Practices (GMP)

• Good Manufacturing Practices (GMP) are regulatory guidelines that enforce

strict quality control during production.
• Compliance ensures that products are consistently produced and controlled
to standards appropriate for their intended use.
Ethics in Drug Trials

• After World War II, the Nuremberg Code established principles for ethical
research, emphasizing voluntary informed consent.
• Modern drug trials now operate under strict ethical oversight, including
Institutional Review Boards (IRBs), to protect participants.
Biotech Integration

• The rise of biotechnology in the 1970s marked the beginning of a new era.

• Companies like Genentech introduced revolutionary research methods, focusing on genetic

engineering and molecular biology.

• Biotechnology has transformed drug development. Advances in genetic engineering have

produced innovative treatments like monoclonal antibodies and CAR-T cell therapies, which
target diseases with unprecedented precision.
Access and Global Health Challenges

• Despite scientific advances, access to medications remains uneven.

• Patent protections often limit availability in low-income countries.
Organizations like the WHO work to improve access through initiatives like
essential medicines lists.
• Rising drug prices and healthcare costs led governments to implement cost-
containment strategies, including promoting generic drug use.
• The introduction of the Waxman-Hatch Act in 1984 facilitated generics'
market entry, significantly altering industry dynamics.
Future of Pharmaceuticals
• The future promises breakthroughs in personalized medicine,
• AI-driven drug discovery, and therapies for rare diseases.
• As science progresses, ethical and economic challenges will
continue to shape industry practices.
Pharmaceutical Industry in Türkiye
• The roots of the pharmaceutical sector in Turkey date back to the Ottoman
Empire.
• Apothecaries and herbal medicine dominated the landscape, with
treatments based primarily on traditional and natural remedies.
• The establishment of the first modern pharmacies began in the 19th
century, influenced by European scientific advancements.
• Following the founding of the Republic of Turkey in 1923, modernization of
the healthcare and pharmaceutical sectors became a priority.
• The government supported local production of essential medicines,
reducing dependence on imports.
• Educational reforms also emphasized the development of pharmaceutical
sciences.
Eczacıbaşı

• In 1910, Süleyman Ferit Eczacıbaşı

founded a laboratory in Izmir.
Products included:
• Medical preparations: Ferit tonic
syrup, laxatives, anti-anxiety drops
• Cosmetics: Toothpaste, powders,
colognes, creams
This lab marked the beginning of the
Eczacıbaşı brand in Turkey.
Mustafa Nevzat

• In 1923, Mustafa Nevzat founded a

lab to produce injectable ampoules.
• Known as Mustafa Nevzat
Ampulleri, these served nationwide for
decades.
• The lab became Mustafa Nevzat
Pharmaceutical Industry, a major firm
in Turkey.
Ethem Pertev – A Pioneer in Domestic
Production

• Ethem Pertev created the first mass-produced Ottoman drug,

Sirop Pertev, in 1895.
• In 1924, he opened the Pertev Müstahzarat İmalathanesi in
Istanbul.

• He later produced:
• Medical tablets and syrups (e.g., Dover powders, bicarbonate)
• Cosmetics (e.g., toothpastes, powders, creams, perfumes)

• The lab exported products to Egypt, Syria, and Iran until 1985.
Dr. İbrahim Ethem Ulagay

• After World War I, Dr. İbrahim Ethem Ulagay began

producing:
• Opium tinctures and extracts
• Ipecac syrup
• Injectables like Huile Camphrée and Östragenin
• Tablets such as Fitofor and Pentazol
He pioneered the mass production of liver extract and
vitamin ampoules.
Bacteriology Institute (Bakteriyolojihane-i Şahane) and Vaccine Studies

Established in Istanbul in 1893, the Bacteriology Institute

(Bakteriyolojihane-i Şahane) was among the first institutions in the
Ottoman Empire where modern microbiology and vaccine production
began.
Vaccines for diphtheria, cattle plague, and smallpox were produced in this
laboratory.
 Refik Saydam Hygiene Institute

• With the proclamation of the Republic, comprehensive health reforms

were implemented.

• Founded in 1928, the Refik Saydam Hygiene Institute became Turkey’s first
public health laboratory.
Refik Saydam Hygiene Institute

The institute began producing the oral BCG vaccine in 1931 and
rabies vaccine in 1933.
In 1934, all vaccine production facilities were consolidated
under the umbrella of the Hygiene Institute.
 Refik Saydam Hygiene Institute

• During the cholera outbreak in China between 1938 and 1940, 1 million
cubic centimeters of cholera vaccine produced at Turkey’s Hygiene Institute
were sent as aid to China.

• In 1950, the Influenza Laboratory was recognized by the World Health

Organization as a Regional Influenza Center, and Turkey began domestic
production of influenza vaccines.
 Refik Saydam Hygiene Institute

• During this period, Turkey produced vaccines for BCG, typhoid, dysentery,
cholera, plague, meningococcus, staphylococcus, pertussis, brucella, and
influenza.
• Starting from 1981, vaccines such as BCG, measles, polio, diphtheria,
tetanus, and pertussis began to be included in the national immunization
program.
 Refik Saydam Hygiene Institute

• 1928, the Refik Saydam Hygiene Institute played a critical role in Turkey's
vaccine and serum production for decades.
• However, due to restructuring policies and a shift towards privatization
and imported vaccines, the institute ceased its vaccine production activities
in 1997 and was officially closed in 2011. Its closure marked the end of
state-led vaccine production in Turkey.
Refik Saydam Hygiene Institute

With the closure of Refik Saydam, Turkey lost its main infrastructure for
domestic vaccine research and manufacturing.

This resulted in increased dependency on imported vaccines and reduced

the country's ability to respond rapidly to emerging public health threats.
• Between 1950 and 1980, Turkey saw significant growth in local
pharmaceutical manufacturing.
• Many domestic companies were established, supported by policies
encouraging import substitution.
• This period marked the beginning of large-scale drug production within the
country.
• The liberalization policies of the 1980s opened Turkey’s pharmaceutical
market to foreign companies.
• While this increased competition and variety, domestic companies faced
challenges in maintaining market share.
• Nonetheless, the industry adapted through partnerships and innovation.
• In the 1990s, Turkey accelerated efforts to align with global pharmaceutical
standards.
• Compliance with Good Manufacturing Practices (GMP) became mandatory.
• Additionally, Turkey began collaborating with international organizations
such as the World Health Organization (WHO).
• Since the early 2000s, the Turkish pharmaceutical industry has increasingly
focused on R&D and biotechnology.
• Government incentives have supported clinical research, generic drug
development, and biosimilars, positioning Turkey as an emerging hub for
pharmaceutical innovation.