India is the 3rd largest in terms of volume and 13th in terms of value all over the world as we still struggle in terms of quality so in this ppt i show some challenges faced by Indian Pharmaceutical Industry
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
plasma master file is a EU requirement for the apploval of the biologics or the biosimilars to the EU in a eCTD format or Nees as per the requirement type and should contain the above given details
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal.
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
UNDERSTANDING GENERIC VS INNOVATOR BUSINESSKabin Maleku
This presentation includes the basic difference between generic and innovator medicines and outline about various filling pathways for US FDA and Exclusivity and few case studies
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible (able to be believed), accurate and that the rights, integrity and confidentiality of trial subjects are protected.
"Brief Introduction of China Food & Drug Administration" by Chang Yongheng, China Centre for Food and Drug International Exchange, China Food & Drug Administration
Introduction Indian Pharmaceutical market, SWOT analysis, PEST Analysis, Timeline analysis of Sun Pharma, Glaxo Smith Kline, Mankind, CIPLA and Zydus Cadila.
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal.
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, March 22, 2018
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
UNDERSTANDING GENERIC VS INNOVATOR BUSINESSKabin Maleku
This presentation includes the basic difference between generic and innovator medicines and outline about various filling pathways for US FDA and Exclusivity and few case studies
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible (able to be believed), accurate and that the rights, integrity and confidentiality of trial subjects are protected.
"Brief Introduction of China Food & Drug Administration" by Chang Yongheng, China Centre for Food and Drug International Exchange, China Food & Drug Administration
Introduction Indian Pharmaceutical market, SWOT analysis, PEST Analysis, Timeline analysis of Sun Pharma, Glaxo Smith Kline, Mankind, CIPLA and Zydus Cadila.
This powerpoint presentation includes all the details regarding the topic Drug approval process with special procedure of Drug approval process in India.
Regulatory Affairs in the Pharmacy Curriulum A Reviewijtsrd
The Indian pharmaceutical industry is expanding quickly, and there is a need of regulatory affairs specialists to meet the present demands of companies in the face of international competition. The goal of governments to protect public health has led to the development of a relatively new profession known as regulatory affairs. Pharmaceuticals, veterinary medications, medical gadgets, pesticides, agrochemicals, and cosmetics are among the industries where the government regulates the safety and effectiveness of products. And alternative treatments. The pharmaceutical firms in charge of these drugs discovery, development, testing, clinical trials, production, manufacturing, and marketingItems also want to make sure that they are providing products that are secure and beneficial to the health and welfare of the general public. legislative issuesThe international regulatory bodies and the pharmaceutical businesses are connected via specialists. It is needed that they. Akshay Kaware | Prof. Santosh Waghmare | Dr. Hemant Kamble "Regulatory Affairs in the Pharmacy Curriulum: A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-7 , December 2022, URL: https://www.ijtsrd.com/papers/ijtsrd52279.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/52279/regulatory-affairs-in-the-pharmacy-curriulum-a-review/akshay-kaware
Project on Production and Packaging in Pharmaceutical Industry Emcure By Nikh...Nikhil Dhawan
This is the Complete Project that I`ve Completed on 7/08/2014 and It is Now Brand New Project Report Suitable for Students doing MBA, PGDBM and Having Topics like Marketing or HR. No Ads, No Price, No Money!
You Can Contact Me for More Free Projects! Just Download the Project and Enjoy! Cheers!!
Best of Luck
Nikhil Dhawan
9018580277, 9622334428
nikdhawan@outlook.com.
contactnikhildhawan@gmail.com.
contact_nikhildhawan@gmail.com
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
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.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
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
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
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...
Current regulatory challenges in indian pharmaceutical industry
1. Current RegulatoryChallenges in IndianPharmaceutical Industry
MASTER OF PHARMACY
(DRUG REGULATORY AFFAIRS)
BY
VIKAS RATHEE
80000802005
UNDER THE GUIDANCE OF
Department of Pharmaceutical Sciences
Chaudhary Bansi Lal University
Bhiwani-127021
Mrs. Neelam
Assistant Professor
Supervisior
Dr. Shahbaz Alam
CMD, Meher Pharma Int.
Co-Supervisior
2. Table of Contents :
Aim & Objective
Introduction
Major Bodies Regulating Drugs and Pharma
Key Challenges : Data Integrity, Credibility of Clinical Trial Data, IPR, R&D
Key Issues of Concern : Patent Protection, Lack of Regulatory Data Protection,
Government Price Control, Clinical Trials
Methodology
References
3. AIM : To Study the Current Regulatory Challenges in Indian Pharmaceutical Industry.
Objective :To study
the overview of
regulatory laws and
regulatory
environment in India.
To study the current
regulatory challenges faced
by Indian Pharmaceutical
Industry (lack of access to
resources of CDSCO).
To study the increase
of spurious and
substandard drugs in
Indian market
To study the problems
faced by low scale
Pharmaceutical
Industries.
To study the
transparency of
licensing authority
Lack of price control
(Indian pharmaceutical
companies face high
effective import duties for
active ingredients).
4. INTRODUCTION:
Major Bodies Regulating Drugs and
Pharma:
The principal regulatory bodies entrusted with
the responsibility of ensuring the approval,
production and marketing of quality drugs in
India at reasonable prices are as follows:
5.
6.
7. Data Integrity
Multiple data integrity issues reported by the
investigators include failure to record activities
contemporaneously; document backdating; copying
existing data as new information; re-running
samples to obtain better results; and fabricating or
discarding data
8. Credibility of Clinical Trial Data
India has emerged as the ideal location to conduct clinical trials given its diverse pool of
patients with diverse treatment needs, and access to a large, scientifically skilled,
workforce
Capacity to regulate clinical trials has not kept pace with this growth leading to a number
of reported unethical practices such as: limited patient compensation for adverse events;
approval of drugs without clinical trials; and lapses in informed consent procedures
9. IPR
Patent laws in India compliant with the TRIPS Agreement
Granting of compulsory licenses (CLs) have been contentious
While CLs have been viewed as a necessary evil, in a developing
country, like India, they have also caused grave concerns in the
industry due to the revenue loss that CLs tend to cause
10. R&D
According to the Patent & Trademark Office (drug development and the rest has been on new processes, new
dosage forms and drug delivery PTO) patents granted to Indian pharma companies constitute only 5 per cent for
the new systems
The trade liberalization measures though have attracted foreign investment in pharmaceutical R&D in India in the
form of contract research, collaborative research projects, out-licensing and in-licensing partnerships, the scope for
transfer of technology and joint ownership of technology has been very limited.
Further, the Indian pharmaceutical industry is also witnessing regulatory challenges with respect to uncertainties
over the FDI policy, the new pharmaceutical pricing policy, a uniform code for sales and marketing practices, and
compulsory licensing. These challenges have been slowing down the growth of the industry.
11.
12. Patent protection
India’s legal and regulatory systems pose procedural and substantive barriers at every step
the process, ranging from the impermissible hurdles to patentability posed by Section 3(d)
the India‘s patents act, to the threat of compulsory licensing on specious grounds, to pre-
grant and post-grant opposition proceedings.
Since early 2012, at least fifteen products have had their patent rights undermined in India.
addition, the Government of India is considering issuance of compulsory licenses (CLs)
through a Ministry of Health Committee on the grounds of national emergency; extreme
urgency, and public non-commercial use.
13. Lack of regulatory data protection
The Indian Regulatory Authority relies on test data submitted by originators to another
country when granting marketing approval to follow-on pharmaceutical products.
This indirect reliance results in unfair commercial use prohibited by the World Trade
Organization (WTO)Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPS) and discourages the development of new medicines that could meet unmet medical
needs.
14. Government price controls
The Department of Pharmaceuticals (DoP) has proposed an international reference pricing scheme
with a purchasing power parity adjustment for government procured patented medicines and
those patented medicines provided through health insurance.
This proposal would create an unviable government pricing framework and business environment
for medicines whose price levels in India are already low in comparison to other countries. The
Drug Price Control Order (DPCO) 2013 includes a provision discriminating against foreign products
by exempting only indigenous research and development.
15. Clinical trials
New clinical trials were halted after the Indian Ministry of Health and Family Welfare adopted rules that require
broader compensation for participants who claim to have been injured due to a clinical trial. Most recently, the
Drug Controller General of India (DCGI) ordered that, in addition to obtaining written informed consent,
audio-visual recording of the consent of each subject is mandatory in a clinical trial and effective immediately.
Such uncertainty in the regulatory process for clinical trials threatens the overall clinical research environment
in India, as well as the availability of new treatments and vaccines for Indian patents.
16. METHODOLOGY
The mentioned aims and objective will be achieved by literature survey of various
challenges face by the pharmaceutical industries such as Non harmonizdation between
Central and SLA, lack of assurance of approval, lack of acceptance criteria for fixed dose
combination, High import duties on Pharmaceutical API and lack of vigilance on spurious
and substandard rugs. It is high time to radically clean the anarchy in drug regulation in
India for improved quality, safety & efficacy of medicinal product in public health and
welfare. Official website of CDSCO and NPPA will be referred for the requirement and
guidelines for product registration, approval of FDC and for pricing control.
17. Reference :-
Indian Pharmaceutical Industry : Key Challenges [Internet]. Eximbankindia.in. 2019 [cited
11November2019].Availablefrom:https://www.eximbankindia.in/Assets/Dynamic/PDF/Publication-
Resources/ResearchPapers/39file.pdf
Current Regulatory Scenario in India [Internet]. 2019 [cited 11 November 2019]. Available
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