This document discusses parallel imports of pharmaceuticals. It begins by defining parallel imports as the importation of non-counterfeit products without the authorization of the patent holder, often occurring when prices vary between markets. It then examines reasons for price differentiations internationally and provides examples of large price differences for common drugs between the US and India. The document outlines arguments for and against parallel imports, different countries' legal approaches, and India's stance, concluding that parallel imports have limited practical utility for India.
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
The regulation of medicines in AustraliaTGA Australia
View this presentation for information on:
*the different categories of medicines
* registered (higher risk) medicines and how they are regulated
* listed (lower risk) medicines and how they are regulated
* accessing unauthorised medicines
* medicines advertising
* changing medicine technologies
This presentation explains concepts of Patents and Market Exclusivity. This presentation is compiled from publicly available material on the world wide web.
The regulation of medicines in AustraliaTGA Australia
View this presentation for information on:
*the different categories of medicines
* registered (higher risk) medicines and how they are regulated
* listed (lower risk) medicines and how they are regulated
* accessing unauthorised medicines
* medicines advertising
* changing medicine technologies
Compulsory licensing is when a government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself.
This presentation mainly deals with clinical development of biosimilar products. It also gives enough on non-clinical development so that the audience is well oriented.
Compulsory licensing is when a government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself.
This presentation mainly deals with clinical development of biosimilar products. It also gives enough on non-clinical development so that the audience is well oriented.
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.
Indian Pharmaceutical Export Market - Top Export Destinations for Indian Phar...Irish Pereira
By Mr. Irish Pereira. The report present snapshot of Indian Pharmaceutical industry in both domestic as well as export market. It is collation of facts pertaining to Indian pharma exports and explore key emerging trends pertaining to pharma export market. It describes key players of Indian pharma market and their export orientation as in their target export destinations, their focus therapies etc.
Fact sheet:
1) Indian Pharma Market size 2015
2) Indian pharmaceutical market segments by value
3)Patented (Innovator) Vs Generics Scenario
4)Growth drivers of Indian pharmaceutical industry
5) Indian Pharmaceutical sector – SWOT Analysis
6)PHARMEXCIL – Facilitating agency for Indian Pharma Exports
7) Indian Pharmaceutical Exports (USD bn)
8)Formulations share in Total Pharma Exports (2014-15)
9) Top 25 destination countries of India’s pharmaceutical exports during 2013-14 (INR mn)
10) Major Indian Pharma Companies (By Revenue-USD mn)
11) Pharma players and their export destinations
Sun Pharma,Dr. Reddy’s Lab,
CIPLA, Lupin, Aurobindo, Cadila Healthcare, Torrent Pharma, Wockhardt,
12) Emerging trends in Indian Pharma Market
Intellectual Property Rights with Special Reference to HealthSHUBHAM SINGH
A presentation on "Intellectual Property Rights with Special Reference to Health" by Jasvir Kaur after having a research paper on 'Intellectual Property Rights with Special Reference to Health' from Sardar Patel University of Police, Security & Criminal Justice, Jodhpur.
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Post'1995 Indian patent regime, Loopholes, Advantages, disadvantages, Criticality of sec-3(d), NIB patent war and litigations of foreign nnovator companies, Imatinib, sorafenib, etc...
Challenges in indian pharmaceutical industry due to globalizationvishnugm
Globalisation is a process which involves economic inter-dependence of countries world-wide removing all barriers for economic integration as if the whole world is a single village. Obviously, in this process, the rich nations with their superior financial power, control the scenario and the poor and the developing nations are forced to integrate surrendering their economic independence knowing fully well what they are forced to accept is really prejudicial to their own interest.
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
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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.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
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Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
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2. INTRODUCTION
• What is it ????
It is importation of non-counterfeit product without the authorization of the person holding
the patent rights in the goods – called ‘ GREY MARKET ’
• Why is it ????
When price of patented products varies between two different markets
traders to import the product from cheaper source
Grey Market Goods
they are neither legal nor
illegal and hence fall in the
intervening grey area.
3/19/2015parallel importing 2
4. Price Comparison
Drug Cost / Tab
US INDIA
Ibuprofen
(For Pain)
Rs.10.00* Re.0.60
Amoxicillin
(For Infection)
Rs.90.00** Rs.6.50
Pantoprazole
(For Acidity)
Rs.180.00*** Rs.1.30
15 + times more
expensive
*Advil,**Amoxil, *** Protonix
3/19/2015parallel importing 4
which is compromised primarily
through increased transport and packing activities in the products’ supply chain
5. PARALLEL IMPORTING
• Reduces price of pharmaceuticals by introducing competition
• Fundamental principle of intellectual property law - once an article is sold, its re-sale by
the purchaser wherever he wants cannot be stopped by the IPR holder.
• Concept of exhaustion of intellectual property rights
• Territoriality of IPRs- states that intellectual property rights are limited to the nation
granting them.
3 modes of exhaustion:
National/Territorial Exhaustion
International Exhaustion
Community Exhaustion/Regional Exhaustion
3/19/2015parallel importing 5
6. The Legal Status of Parallel Trade in Pharmaceuticals
• Patents provide inventors of new products and technologies the legal right to exclude
rivals from making, selling, and distributing those inventions.
o National/Territorial Exhaustion: exclusive rights end upon first sale within a country but IPR
owners may exclude parallel imports from other countries.
o International Exhaustion: rights are exhausted upon first sale anywhere and parallel Imports
cannot be excluded.
o Community Exhaustion/Regional Exhaustion: rights end upon original sale within a group of
countries, thereby allowing parallel trade among them, but are not ended by first Sale outside
the region.
• A country could treat parallel imports (PI) and parallel exports (PE) separately.
PI
PE PE
PI
The European Union pursues
regional exhaustion but excludes
PI coming from nonmembers
3/19/2015parallel importing 6
7. • There are now a number of E-commerce "pharmacies" (distributors) offering
prescription, trademarked drugs to consumers at prices below retail.
• Trademark law in USA- could be open to PI subject to its “common-control
exception”. (This rule allows trademark owners to bar PI except when both
the foreign and U.S. trademarks are owned by the same entity or when the
foreign and U.S. trademark owners are in a parent-subsidiary relationship)
• Two legal restraints prevent PI in prescription drugs:
o American patent owners are protected from parallel imports by an explicit right of
importation
o PI of trademarked, prescription drugs are explicitly excluded under terms of a
1988 law covering pharmaceuticals
3/19/2015parallel importing 7
8. • JAPAN allows PI in patented and trademarked goods unless the goods are
explicitly barred from parallel trade by contract provisions or unless their original
sale was subject to foreign price regulation.
• AUSTRALIA generally permits parallel imports in trademarked goods but patent
owners may block them. Thus, Australian consumers cannot benefit from cheaper
drugs available on foreign markets.
• Developing countries, including ARGENTINA, THAILAND, AND SOUTH
AFRICA, recently have enacted laws permitting parallel imports of
pharmaceutical products.
• INDIA follows a regime of international exhaustion in trademarked and patented
goods
3/19/2015parallel importing 8
9. Indian legal regime
• First statutory provision on parallel import was introduced in patent
amendment act of 2002.
• Section 107 A(b) states “importation of patented product by any person
who is duly authorized by patentee to sell or distribute the product, shall
not be considered as infringement of patent rights”
• This was considered restrictive in scope.
• The potential of restrictive interpretation of section 107A and consequent
thwarting of principle of international exhaustion forced Indian parliament
to bring an amendment in 2005.
3/19/2015parallel importing 9
10. Indian Patent Act says about International exhaustion in Patents
Amendment Act, 2005 :
“Importation of patented products by any person from a person
who is duly authorized under the law to produce and sell or
distribute the product shall not be considered as an
infringement of patent rights.”
11. TRIPS compatibility
TRIPS agreement in Article 6 states that this practice cannot be
challenged under the WTO dispute settlement system and so is
effectively a matter of national discretion.
13. • Allows traders from comparatively more expensive market to import
the product from cheaper source
• Effects of parallel trade on various nations differ widely due to
differences in pricing structures, tax structures, transportation costs,
labor costs, consumer tastes and preferences.
• This parallel trade mechanism will succeed only if the pharmaceutical
companies maintain a broad difference in price of their patented
drugs across the globe.
• A nation must first judge the effects of parallel trade on its economy
before taking a decision on parallel trade.
• Pharma sector requires more subtle balance to be drawn between
protecting creative interest of innovator and general public so that to
ensure a steady supply of life saving drugs at affordable price.
3/19/2015parallel importing 13
14. FOR INDIA
• For developing countries like India which is good in generic pharmaceutical industry, this
type of parallel trade holds no attraction. India’s technology base is so strong that during
absence of patent regime all patented drugs were being manufactured at half price.
• Very limited scope for traders of countries like India to import drugs from other countries
to ensure affordable medicines for its population
• It would be necessary to identify the possible sources in world where drugs are cheaper
than India and chances of which are very less.
Parallel trade provisions have no practical utility for India.
3/19/2015parallel importing 14
15. REFERENCES
• Research Paper for the Competition Commission of India, June-July 2010, by Avinash B
amaranth.
• Parallel Trade and its Implication on the Availability of Patented Drugs: A Theoretical
Approach by Mainak Mazumdar, Institute for Social and Economic Change (ISEC),
Bangalore, India.
• Exhausting patent rights in India, by Shamnad basheer Journal of intellectual property
rights, vol 13, September 2008, pp 486-497.
• Parallel imports in pharmaceuticals: implications for competition and prices in developing
countries, final report to world intellectual property organization by Keith E Maskus.
3/19/2015parallel importing 15