The Indian pharmaceutical industry came into existence in 1901, when Bengal Chemical & Pharmaceutical Company started its maiden operation in Calcutta.
The next few decades saw the pharmaceutical industry moving through several phases, largely in accordance with government policies. The development, present status and scope of pharmaceutical industry in India.
Drugs and Magic Remedies (Objectionable Advertisements), 1954 Act,1954 Sagar Savale
An Act to control the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities and to provide for matters connected therewith. This act is not unconstitutional, because it does not interferes with private business and also it does not impose unreasonable restrictions.
Drugs and Cosmetics Act 1940 and Rules 1945 - Objectives, Legal definitionMd Altamash Ahmad
Drugs and Cosmetics Act, 1940 was introduced by Government of India to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. This act can be considered as landmark in the history of drug legislation in India. It is Act no. 23 of 1940 and was introduced on 5th April, 1940 and enacted on 10th April, 1940.
Drugs and Cosmatic Act,1940 and its rules 1945TameshSonkar
Objectives, Definitions, Legal definitions of schedules to the Act and Rules
Import of drugs Classes of drugs and cosmetics prohibited from import
,Import under license or permit. Offences and penalties.
Manufacture of drugs Prohibition of manufacture and sale of certain drugs
Conditions for grant of license and conditions of license for manufacture of
drugs, Manufacture of drugs for test, examination and analysis
,manufacture of new drug, loan license and repacking license.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Dr. amit gangwal ka pharmaceutical patent presentation
highly exhaustive and updated ppt on pharmaceutical patents, a must watch by all those concerned with the same.
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified strengths and dosages under NLEM 2011.
PRESENT SCENARIO OF INDIAN PHARMACEUTICAL INDUSTRY IN VIEW OF GLOBAL ...sridivyaannavarapu
THE INDIAN GOVERNMENT HAS STARTED TO ENCOURAGE THE GROWTH OF DRUG MANUFACTURING BY INDIAN COMPANIES IN THE EARLY 1960s. AT PRESENT THERE ARE MANY NUMBER OF PHARMACEUTICAL COMPANIES IN INDIA WITH MANY NOVEL DRUG INVENTORIES
Drugs and Magic Remedies (Objectionable Advertisements), 1954 Act,1954 Sagar Savale
An Act to control the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities and to provide for matters connected therewith. This act is not unconstitutional, because it does not interferes with private business and also it does not impose unreasonable restrictions.
Drugs and Cosmetics Act 1940 and Rules 1945 - Objectives, Legal definitionMd Altamash Ahmad
Drugs and Cosmetics Act, 1940 was introduced by Government of India to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. This act can be considered as landmark in the history of drug legislation in India. It is Act no. 23 of 1940 and was introduced on 5th April, 1940 and enacted on 10th April, 1940.
Drugs and Cosmatic Act,1940 and its rules 1945TameshSonkar
Objectives, Definitions, Legal definitions of schedules to the Act and Rules
Import of drugs Classes of drugs and cosmetics prohibited from import
,Import under license or permit. Offences and penalties.
Manufacture of drugs Prohibition of manufacture and sale of certain drugs
Conditions for grant of license and conditions of license for manufacture of
drugs, Manufacture of drugs for test, examination and analysis
,manufacture of new drug, loan license and repacking license.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Dr. amit gangwal ka pharmaceutical patent presentation
highly exhaustive and updated ppt on pharmaceutical patents, a must watch by all those concerned with the same.
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified strengths and dosages under NLEM 2011.
PRESENT SCENARIO OF INDIAN PHARMACEUTICAL INDUSTRY IN VIEW OF GLOBAL ...sridivyaannavarapu
THE INDIAN GOVERNMENT HAS STARTED TO ENCOURAGE THE GROWTH OF DRUG MANUFACTURING BY INDIAN COMPANIES IN THE EARLY 1960s. AT PRESENT THERE ARE MANY NUMBER OF PHARMACEUTICAL COMPANIES IN INDIA WITH MANY NOVEL DRUG INVENTORIES
Writekraft Research and Publications LLP was initially formed, informally, in 2006 by a group of scholars to help fellow students. Gradually, with several dissertations, thesis and assignments receiving acclaim and a good grade, Writekraft was officially founded in 2011 . Since its establishment, Writekraft Research & Publications LLP is Guiding and Mentoring PhD Scholars.
Our Mission
“To provide breakthrough research works to our clients through Perseverant efforts towards creativity and innovation”.
Vision
Writekraft endeavours to be the leading global research and publications company that will fulfil all research needs of our clients. We will achieve this vision through:
Analyzing every customer’s aims, objectives and purpose of research
Using advanced and latest tools and technique of research and analysis
Coordinating and including their own ideas and knowledge
Providing the desired inferences and results of the research
In the past decade, we have successfully assisted students from various universities in India and globally. We at Writekraft Research & Publications LLP head office in Kanpur, India are most trusted and professional Research, Writing, Guidance and Publication Service Provider for PhD. Our services meet all your PhD Admissions, Thesis Preparation and Research Paper Publication needs with highest regards for the quality you prefer.
Our Achievements
NATIONAL AWARD FOR BEST RESEARCH PROJECT (By Hon. President APJ Abdul Kalam)
GOLD MEDAL FOR RESEARCH ON DISABILITY (By Disabled’s Club of India)
NOMINATED FOR BEST MSME AWARDS 2017
5 STAR RATING ON GOOGLE
We have PhD experts from reputed institutions/ organizations like Indian Institute of Technology (IIT), Indian Institute of Management (IIM) and many more apex education institutions in India. Our works are tailored and drafted as per your requirements and are totally unique.
From past years our core advisory members, research team assisted research scholars from various universities from all corners of world.
Writekraft Research and Publications LLP was initially formed, informally, in 2006 by a group of scholars to help fellow students. Gradually, with several dissertations, thesis and assignments receiving acclaim and a good grade, Writekraft was officially founded in 2011 . Since its establishment, Writekraft Research & Publications LLP is Guiding and Mentoring PhD Scholars.
Our Mission
“To provide breakthrough research works to our clients through Perseverant efforts towards creativity and innovation”.
Vision
Writekraft endeavours to be the leading global research and publications company that will fulfil all research needs of our clients. We will achieve this vision through:
Analyzing every customer’s aims, objectives and purpose of research
Using advanced and latest tools and technique of research and analysis
Coordinating and including their own ideas and knowledge
Providing the desired inferences and results of the research
In the past decade, we have successfully assisted students from various universities in India and globally. We at Writekraft Research & Publications LLP head office in Kanpur, India are most trusted and professional Research, Writing, Guidance and Publication Service Provider for PhD. Our services meet all your PhD Admissions, Thesis Preparation and Research Paper Publication needs with highest regards for the quality you prefer.
Our Achievements
NATIONAL AWARD FOR BEST RESEARCH PROJECT (By Hon. President APJ Abdul Kalam)
GOLD MEDAL FOR RESEARCH ON DISABILITY (By Disabled’s Club of India)
NOMINATED FOR BEST MSME AWARDS 2017
5 STAR RATING ON GOOGLE
We have PhD experts from reputed institutions/ organizations like Indian Institute of Technology (IIT), Indian Institute of Management (IIM) and many more apex education institutions in India. Our works are tailored and drafted as per your requirements and are totally unique.
From past years our core advisory members, research team assisted research scholars from various universities from all corners of world
Subjects/Areas We Cover
Management, Commerce, Finance, Marketing, Psychology, Education, Sociology, Mass communications, English Literature, English Language, Law, History, Computer Science & Engineering, Electronics & Communication Engineering, Mechanical Engineering, Civil Engineering, Electrical Engineering, Pharmacy & Healthcare
Writekraft Research and Publications LLP was initially formed, informally, in 2006 by a group of scholars to help fellow students. Gradually, with several dissertations, thesis and assignments receiving acclaim and a good grade, Writekraft was officially founded in 2011 . Since its establishment, Writekraft Research & Publications LLP is Guiding and Mentoring PhD Scholars.
Our Mission
“To provide breakthrough research works to our clients through Perseverant efforts towards creativity and innovation”.
Vision
Writekraft endeavours to be the leading global research and publications company that will fulfil all research needs of our clients. We will achieve this vision through:
• Analyzing every customer’s aims, objectives and purpose of research
• Using advanced and latest tools and technique of research and analysis
• Coordinating and including their own ideas and knowledge
• Providing the desired inferences and results of the research
In the past decade, we have successfully assisted students from various universities in India and globally. We at Writekraft Research & Publications LLP head office in Kanpur, India are most trusted and professional Research, Writing, Guidance and Publication Service Provider for PhD. Our services meet all your PhD Admissions, Thesis Preparation and Research Paper Publication needs with highest regards for the quality you prefer.
Writekraft Research and Publications LLP was initially formed, informally, in 2006 by a group of scholars to help fellow students. Gradually, with several dissertations, thesis and assignments receiving acclaim and a good grade, Writekraft was officially founded in 2011 . Since its establishment, Writekraft Research & Publications LLP is Guiding and Mentoring PhD Scholars.
Writekraft Research & Publications LLP
(Regd. No. AAI-1261)
Mobile: 7753818181, 9838033084
Email: info@writekraft.com
Web: www.writekraft.com
Research Paper Writing
Writekraft Research and Publications LLP was initially formed, informally, in 2006 by a group of scholars to help fellow students. Gradually, with several dissertations, thesis and assignments receiving acclaim and a good grade, Writekraft was officially founded in 2011 . Since its establishment, Writekraft Research & Publications LLP is Guiding and Mentoring PhD Scholars.
Our Mission
“To provide breakthrough research works to our clients through Perseverant efforts towards creativity and innovation”.
Vision
Writekraft endeavours to be the leading global research and publications company that will fulfil all research needs of our clients. We will achieve this vision through:
Analyzing every customer’s aims, objectives and purpose of research
Using advanced and latest tools and technique of research and analysis
Coordinating and including their own ideas and knowledge
Providing the desired inferences and results of the research
In the past decade, we have successfully assisted students from various universities in India and globally. We at Writekraft Research & Publications LLP head office in Kanpur, India are most trusted and professional Research, Writing, Guidance and Publication Service Provider for PhD. Our services meet all your PhD Admissions, Thesis Preparation and Research Paper Publication needs with highest regards for the quality you prefer.
Writekraft Research and Publications LLP was initially formed, informally, in 2006 by a group of scholars to help fellow students. Gradually, with several dissertations, thesis and assignments receiving acclaim and a good grade, Writekraft was officially founded in 2011 . Since its establishment, Writekraft Research & Publications LLP is Guiding and Mentoring PhD Scholars.
Counterfeit is a problem of product security.
A counterfeit product is an imitation which infringes upon a production monopoly held by either a state or corporation.
Infringing products are being produced and consumed in virtually all economies.
Counterfeiters and pirates target products where profit margins are high, taking into account the risks of detection, the potential penalties, the size of the markets that could be exploited and the technological and logistical challenges in producing and distributing products.
Pharma duplication remains the biggest area of concern as it is facing the highest level of threat and the consumer of pharmaceuticals products are the worst sufferers.
Rodents used in Drug discovery and research are described.Rodents are mammals of the order Rodentia, which are characterized by a single pair of unremittingly growing incisors in each of the upper and lower jaw.
Well known rodents are mice , rats , squirrel ,porcupines , guinea pigs , hamsters which are used in research because of their genetic and biological similarities.
High Performance Thin Layer Chromatography (HPTLC) instrumentationMadhuraNewrekar
HPTLC is an advancement of TLC. It is a high performance liquid chromatography with automation compared to Thin Layer Chromatography(TLC).Speed, Efficiency and Accuracy are important advantages. Evaluation time is less due to updated automation in instrumentation.
Steps involved in HPTLC and the materials and instruments required in those steps are described in brief.
Gastroretentive drug delivery is an approach to
prolong gastric residence time, thereby
targeting site-specific drug release in the upper
gastrointestinal tract (GIT) for local or
systemic effects. The various approaches are discussed with advantages like sustained drug delivery, increased bioavailability and site specific drug delivery.
Documentation with respect to release of finished pharmaceutical productMadhuraNewrekar
Documentation is a crucial part of the quality assurance system and is needed in every aspect of pharmaceutical manufacturing. Important documentation with respect to final product release in pharmaceutical industry is explained in brief.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?
Present Status and Scope of Pharmaceutical industry in India
1. PRESENT STATUS AND SCOPE OF
PHARMACEUTICAL INDUSTRY IN INDIA
-MADHURA NEWREKAR
1
2. INDIAN PHARMACEUTICAL
INDUSTRY
The Indian pharmaceuticals
market is the third largest in
terms of volume and thirteenth
largest in terms of value.
India is the largest provider of
generic drugs globally with the
Indian generics accounting for
20 per cent of global exports in
terms of volume.
2
3. HISTORY
The Government started to encourage the growth of drug
manufacturing by Indian companies in the early 1960 and
with the Patents act in 1970.
However the economic liberation in 90s by the former prime
minister P.V.Narsimha Rao and then the finance minister Dr
Manmohan Singh enabled the industry to become what it is
today.
The Indian pharmaceutical industry came into existence in
1901, when Bengal Chemical & Pharmaceutical Company
started its maiden operation in Calcutta.
The next few decades saw the pharmaceutical industry
moving through several phases, largely in accordance with
government policies.
3
5. PHARMACEUTICAL INDUSTRY
PHARMACEUTICAL
INDUSTRY
API
1.Largest segment
2. Second largest number in ANDAs
3.World’s leader in DMF application s with US.
CONTRACT RESEARCH AND
MANUFACTURING SERVICES(CRAMS)
1.Fragmented market with 1000 players
2.CRAMS industry is estimated to reach USD
18 billion in 2018
FORMULATIONS
1. Largest exporter of formulations in terms of
volume
2.Domestic market size USD 11.2 billion
3.Double digit growth is expected over the next
five years
BIOSIMILARS
The sector is expected to grow annualy at a
rate of30 percent.
5
6. CURRENT SCENARIO
Leading pharma producer:
Indian pharmaceutical sector accounts for about 2.4 per cent of the
global pharmaceutical industry in value terms and 10 per cent in
volume terms.
One of the highest exports:
India accounts for 20 per cent of global exports in generics.
One of the fastest growing industries:
Rapidly growing health care sector:
Growing generics market:
Ranked 5th in terms of attracting FDI:
6
7. India has more drug-manufacturing facilities that have been
approved by the U.S. Food and Drug Administration than any
country other than the US.
Presently over 80 per cent of the antiretroviral drugs used
globally to combat AIDS (Acquired Immuno Deficiency
Syndrome) are supplied by Indian pharmaceutical firms.
The Indian pharmaceutical market is highly competitive and
remains dominated by low priced, domestically-produced
generics.
The industry is export-oriented and the larger domestic
companies are competing in the global market for both
generics and original products.
7
8. GENERIC DRUGS,OTC AND PATENTED
DRUGS
With 70 % of market share (in terms of
revenues), generic drugs form the
largest segment of the Indian
pharmaceutical sector.
India supply 20 per cent of global
generic medicines market exports in
terms of volume, making the country
the largest provider of generic
medicines globally and expected to
expand even further in coming years.
Over the Counter (OTC) medicines
and patented drugs constitute 21 per
cent and 9 per cent, respectively, of
total market revenues of USD20
billion.
8
9. Indian pharmaceutical market segments by
value
Top five segments contribute nearly 57 per cent to the total drugs
consumption
9
10. NOTABLE TRENDS
R&D :
Indian pharma companies spend 8-11 per cent of their total
turnover on R&D
Expenditure on R&D is likely to increase due to the
introduction of product patents; companies need to develop
new drugs to boost sales.
Export Revenue:
India’s pharmaceutical export market is thriving due to strong
presence in the generics space.
10
11. Joint Ventures:
Multinational companies are collaborating with Indian pharma
firms to develop new drugs.
Cipla formed an exclusive partnership with Serum Institute of
India to sell vaccines in South Africa.
Six leading pharmaceutical companies have formed an alliance
‘LAZOR’ to share their best practices, so as to improve efficiency
and reduce operating costs.
11
NOTABLE TRENDS Continued….
12. Expansion by Indian players abroad:
Cipla, the largest supplier of anti-malarial drugs to Africa, set up a
USD32 billion plant in Africa for the production of anti-retroviral and
anti-malarial drugs.
Sun Pharma, become the world’s fifth largest company worldwide
having 48 manufacturing sites more than 3000 marketed product.
Draft patents (Amendment Rules)2015:
The time limit given for submitting the application for grant has
been reduced to 4 months from 12 months, providing an extension
of 2 months.
Necessary permissions to be taken from the concerned authority
before the grant of patents.
12
NOTABLE TRENDS Continued….
13. Product Patents:
The introduction of product patents in India in 2005 gave a
boost to the discovery of new drugs.
India reiterated its commitment to IP protection following the
introduction of product patents.
Less time for approval:
In order to compete with global players in pharmaceutical
industries, approval process of
drugs have been simplified by the authorities and approval
time for new facilities has been
drastically reduced
13
NOTABLE TRENDS Continued….
17. It is an Indian multinational pharmaceutical company
headquartered in Mumbai, Maharashtra that manufactures
and sells pharmaceutical formulations and active
pharmaceutical ingredients (APIs) primarily in India and the
United States.
Sun Pharmaceuticals was established by Mr. Dilip
Shanghvi in 1983 in Vapi with five products to
treat psychiatry ailments.
The 2015 acquisition of Ranbaxy made the company the
largest pharma company in India, the largest Indian pharma
company in the US, and the 5th largest speciality generic
company globally.
17
18. Lupin Limited is a transnational pharmaceutical company
based in Mumbai . It is the seventh-largest company
by market capitalization ;and the 10th-largest generic
pharmaceutical company by revenue globally. Lupin is the
fifth-largest generic pharmaceutical company in the US by
prescription-led market share and 3rd largest Indian
pharmaceutical company by revenue.
Lupin was founded in 1968 by Desh Bandhu Gupta ,then an
Associate Professor at BITS-Pilani, Rajasthan.
Lupin first gained recognition when it became one of the
world’s largest manufacturers of tuberculosis drugs.
18
19. Dr. Reddy's Laboratories is an Indian multinational
pharmaceutical company based 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.
Dr. Reddy's originally launched in 1984 producing active
pharmaceutical ingredients. In 1986, Reddy's started
operations on branded formulations.
19
20. Cipla Limited is an Indian multinational pharmaceutical
and biotechnology company, headquartered
in Mumbai, India.
It was founded by Dr. Khwaja Abdul Hamied as
'The Chemical, Industrial & Pharmaceutical Laboratories' in
1935 in Mumbai.The name of the Company was changed to
'Cipla Limited' on 20 July 1984.In the year 1985, US FDA
approved the company's bulk drug manufacturing facilities.
They are the world's largest manufacturer of antiretroviral
drugs.
20
21. Aurobindo Pharma Limited is a pharmaceutical
manufacturing company headquartered in Hyderabad, India.
The company manufactures generic pharmaceuticals and
active pharmaceutical ingredients.
The company’s area of activity includes six major
therapeutic/product areas: antibiotics, anti-retrovirals,
cardiovascular products, central nervous system products,
gastroenterologicals, and anti-allergics.
21
23. STRATEGIES ADOPTED
Cost leadership:
Players in the sector are trying to
achieve cost leadership in various
ways. For example,
Sun Pharma is trying to achieve the
same by
Vertical Integration: Complex API,
which require special skills and
technology, are developed and scaled
up for both API and dosage forms.
23
24. Differentiation:
• In 2015, Lupin opened a research and development centre
for inhalation products in Florida, US.
• Sun Pharma is trying to develop technically complex APIs,
such as steroids, sex hormones, peptides, carbohydrates and
taxanes, which require special skills and Technology.
• Dr Reddy’s is investing in technology platforms. It acquired
OctoPlus N.V, a Netherlands-based company, to get access to
the Poly Lactic-Co-Glycolic Acid (PLGA) technology for the
formulation of complex injectables
24
25. Focus on new markets:
Certain players in the sector are focussing on entering new
markets with new opportunities. For example
• Lupin is making inroads into new markets such as Latin
America, Russia and other East European countries.
• Sun Pharma decided to focus on specialty and chronic
therapies such as neurology, oncology, dermatology segments.
25
26. SWOT ANALYSIS
Key strengths:
Cost competitiveness .
Well developed industry with strong manufacturing base .
Well established R and D infrastructure .
Third largest English speaking scientific and technical manpower
in the world .
Strong marketing and distribution network .
Rich biodiversity .
Competencies in chemistry and process development.
No. Of DMFs filed with U.S. FDA : higher than Spain ,Italy, China
and Israel .
26
27. OTC market : Approx. Rs. 35 billion , Growth 18 – 20 % .
Manufacturing Facilities : Largest number of U.S. FDA
approved manufacturing facilities outside U.S.A.
Alternative Medicine : Herbal ,Ayurvedic , etc. – about Rs. 38
billion .
India will now have a TRIPS compliant patent regime . This
will help in attracting more foreign investment .
Move towards a liberal price control regime : scope for profit
and growth
27
28. Major Weaknesses:
Low investments in innovative R and D .
Volume driven but low priced markets – limits value
realization .
Low healthcare spends .
Highly fragmented industry .
Inadequate regulatory standards .
Spurious drug sales .
28
29. Key Opportunities:
Significant export potential .
Licensing deals with MNCs for NCEs and NDDS.
Contract Manufacturing for MNCs .
Opening up of the health insurance sector .
Potential for developing India as a centre for international
clinical trials .
29
30. Threats:
2005 IPR regime implies drying up of product pipeline for
Indian Companies .
Lack of R and D enabling regulatory environment .
Pricing pressure imposed by DPCO .
China threat .
Loopholes in the patent Bill .
30
31. PHARMEXCIL-facilitating agency
for Indian pharma exports
The Pharmaceutical Export Promotion Council of India(PHAREXCIL)
has been set up in 15.05.2014 by Government of India to promote the
Indian pharmaceutical industry around the world.
Key functions of PHARMEIL:
1. Facilitation of exports of drugs , pharmaceuticals ,biotechnology
products, herbal medicines and diagnostics etc.
2. Authorized to issue registration-cum-membership certificate(RCMC)
which is one of the requirements for the importers and exporters of the
commodities.
3. Concerned with giving export thrust to the various products through
visits of delegations to various markets abroad ,organizing the
seminars ,workshops and exhibitions.
4. It also holds buyers/sellers meets and complies detailed data base to
the pharma exports and problems in exporting pharma products.
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33. The main objectives of this policy are :
Ensuring abundant availability at reasonable prices within the
country of good quality essential pharmaceuticals of mass
consumption.
Strengthening the indigenous capability for cost effective quality
production and exports of pharmaceuticals by reducing barriers to
trade in the pharmaceutical sector .
Strengthening the system of quality control over drug and
pharmaceutical production and distribution to make quality an
essential attribute of the Indian pharmaceutical industry and
promoting rational use of pharmaceuticals.
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NPPP 2012
34. Encouraging R and D in the pharmaceutical sector in a
manner compatible with the country’s needs and with
particular focus on diseases endemic or relevant to India by
creating an environment into R and D in pharmaceuticals in
India .
Creating an incentive framework for the pharmaceutical
industry which promotes new investment into pharmaceutical
industry and encourages the introduction of new technologies
and new drugs
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37. FUTURE GROWTH
Competitive and technological changes in the pharmaceutical
industry-from powerful new drug chemistries to innovative
R&D partnerships and marketing plans-are reshaping the
business strategies of many pharmaceutical companies.
India will see the largest number of mergers in
pharmaceutical and healthcare sector.
The growth of Indian pharma companies will be driven by
the fastest growing molecules in the diabetes ,skin care and
eye care treatment.
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38. According to new research from the MIT Program on the
Pharmaceutical Industry (POPI), many companies today are
searching for ways to increase productivity, decrease costs,
and develop new treatment modalities that will enhance
profitability.
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39. REFERENCES
www.ibef.org ; India Brand Equity Foundation (IBEF) ;
January 2016;accesed on 15/6/17.
Darekar A B et al ; Current scenario of Global and Indian
Pharmaceutical Marketing and Management ; Indian Journal
of Pharmaceutical Sciences ; 2016 ; volume 2 ;issue 2 ;Page
no : 95-100.
www.asa.in ; A brief Report on Pharmaceutical Industry in
India ; July 2015.
Gautam Arti and Khariya Anil , currrent scenario of
pharmaceutical industries in India.
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