a concise yet very informative presentation, on drug approval process and clinical trial regulations in India, prepared for clinical research students
Please refer notes for abbreviations and additional information
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
This slide show reflects general considerations of Bio-availability & Bio-equivalence studies for orally administered drugs. The presentation also accommodates US - FDA's approach and specific recommendations for such studies.
International Journal of Drug Regulatory Affairs; 2014, 2(1), 1- 11
Abstract:
Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and India.
This slide show reflects general considerations of Bio-availability & Bio-equivalence studies for orally administered drugs. The presentation also accommodates US - FDA's approach and specific recommendations for such studies.
This powerpoint presentation includes all the details regarding the topic Drug approval process with special procedure of Drug approval process in India.
Medical device and Patency
By MDD 93/42
Any devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
investigation, replacement or modification or support of the anatomy or of a physiological process;
supporting or sustaining life;
disinfection of medical devices; and
control of conception.
What is 510(k) ?
A 510(k) is a premarket submission made to FDA to demonstrate
that the device to be marketed is as safe and effective, that is,
substantially equivalent, to a legally marketed device
(section 513(i)(1)(a) FD&C act).
Medical Devices are notified as DRUGS under Drugs & Cosmetics Act. Section 3 (b) (iv) defines,
Medical Devices as “Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals”
India had no regulation for medical devices in place prior to 2005.
The import, manufacturing, distribution and Sale of medical devices in India are overseen by the Drugs and Cosmetics Act (1940) and Rules (1945)
Control and inspection are carried out by the CDSCO, state drug controllers and central/state laboratories.
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.
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.
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.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
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
Title: Sense of Smell
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 primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
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.
2. INDIAN REGULATORY AUTHORITY
CDSCO(Central Drugs Standard Control organization)-- DCGI
INDIAN REGULATIONS
Drugs and cosmetics act 1940
Drugs and cosmetics rules 1945
Schedule Y( Revised in 2005)
GUIDELINES
Indian GCP
ICMR Ethical guidelines
3. Legal system – comprised of laws
Law(legislation) – different sections ( eg : laws of administration, law of health etc
)
Laws – comprised of acts, regulations, amendments, notifications, bills etc
Act- also a law or a part of law(D&C act, mental health act, Indian patent act )
Rules – simple guidelines for the successful implementation of an act
schedules – sections of appendices to rules (explanations for some sections in
rules )
D&C ACT 1940 – 6 SIX CHAPTERS
D&C RULES 1945 – 19 PARTS(RULES ) AND SCHEDULES A-Y(GUIDELINES
ENFORCED BY LAW)
LEGAL SYSTEM IN INDIA
4. Hierarchy of legal system
ACT
• Drugs and cosmetics act 1940
(statement of law)
RULE
• Drugs and cosmetics rules 1945 (guidelines
for implementation of D&C act)
SCHEDULE
• Schedules A-Y(appendices- detailed explanations for
reference)
5. Rules
122DA - PERMISSION TO CONDUCT CLINICAL TRIAL
122-E - DEFINITION OF IND& ND
Latest Amendments 2013
122 DAA - DEFINITION OF CLINICAL TRIAL
122 DAB - COMPENSATION IN CASE OF TRIAL RELATED INJURY
122DAC - CONDITIONS OF CLINICAL TRIAL PERMISSION
&INSPECTION
122DD - REGISTRATION OF ETHICS COMMITTEE
6. INVESTIGATIONAL NEW DRUG
IND has been defined under Rule 122-DA (3) of Drugs
and Cosmetics Rules 1945 as a new chemical entity or
a product having therapeutic indication but which have
never been earlier tested on humans.
8. IND
IND DISCOVERED IN INDIA
PHASE I – PHASE III IS MUST
PHASE III MIN 500 SUBJECTS (IN10
-15 CENTRES ) IS MANDATORY
IND DISCOVERED IN OTHER
COUNTRIES
CT ALLOWED ONLY IF PHASE 1
DATA IS AVAILABLE
REPEAT PHASE I / START FROM
PHASE II
PHASE III MIN 100 SUBJECTS IN 3-
4 CENTRES IS MANDATORY
9. IND & ND
IND
A NCE or product having
therapeutic indication
Which has never been tested
earlier on human beings
ND
A new substance of chemical ,
biological or BT origin
Which has not been used to
any significant extent in the
country except during CT
Modified or new
indication,dosage form,RA
FDC
All new vaccines
A new drug continues to be considered as new drug for a period of 4 years
from its approval or its inclusion in Indian Pharmacopoeia.
10. INDA PROCESS IN INDIA
No clinical trial for a new drug/IND for any purpose be
conducted without permission , in writing, of the Licensing
Authority (DCGI).
Application for conducting clinical trials in India require
submission by the sponsor on Form 44 along with requisite fee
(Rs 50k) and documents as provided under Schedule Y to
Drugs and Cosmetics Rules 1945.
12. RULE 122 E –Definition of Drugs
New substances having therapeutic indication,
Modified or New claim,
New RA for already approved drug,
FDC
Detailed review by IND committee
IND Applicant CDSCO HQ
Refer to IND committee
Technical committee
Apex committee
Recommendation to DCGI
Approval
13. CDSCO - A new face
IN COMPLIANCE TO HONBLE SUPREME COURTS ORDER
DATED ON 3/1/2013
A SUPERVISION OVER CDSCOS ACTION BY
TECHNICAL COMMITTEE - Under health secretory
APEX COMMITTEE – under DGHS
WITHIN CDSCO
IND COMMITTEE
Evaluation of IND( discovered in India)
chaired by – DG (ICMR), Secretary (DHR)
12 NEW DRUG ADVISORY COMMITTEES
Evaluation of all applications of CT and new drug approvals
except IND & subsequent approval of already approved drug
& BE studies
14. After receiving the application,
the CDSCO Headquarters in
New Delhi refer it to
IND committee/New Drug
Advisory committee, who
reviews and submits its report
to DCGI-Who Approves/
Declines/Comments
Approvals granted by DCGI are
reviewed by tech. committee and
recommendations are sent to
Apex committee, who
approves/recommends
15. INITIATION
APPLICATION IN FORM 12
TEST LICENCE IN FORM 11
NOTE: Once DCGI approves INDA NOC FOR CT +TEST LICENCE in FORM
11 is issued together
APPLICATION IN FORM 30 + TEST LICENCE OR NOC ( FOR INDIAN IND
)
MANUFACTURING LICENSE IN FORM 29
TEST LICENCE (TO IMPORT /MANUFACTURE FOR TEST
PURPOSE)
MANUFACTURING LICENSE FROM STATE DRUG RA
16. FORM 44
Application for the grant of permission to import or
manufacture a New drug or to under take clinical trial
A. Permission to conduct a clinical trial (INDA)
B. Permission to market a new drug (NDA)
C. Subsequent approval/permission for manufacture of
already approved new drug
D. Approval/permission for fixed dose combination
E. Subsequent approval/approval for new indication
17. FORM 44 PROCESS
APPLICATION FORM 44
1. import of FF
2. Import of RM
3. Mfg of FF
4. Mfg of RM
5. CT
1.APPROVAL FORM 45 (IMP FF)
2.APPROVAL FORM 45A (IMP
RM)
3.APPROVAL FORM 46 (MFG
FF)
4.APPROVAL FORM 46A (MFG
FF)
5.NOC FOR CT + TEST
LICENCE IN FORM 11)
18. INDA (Data to be submitted) –sch Y
Data to be submitted along with the application on Form44 to
conduct clinical trials (2 hard copies and 2 soft copies i.e.,
CDs in PDF format)
1. Application on Form 44
2. Introduction of the drug
3. Fee Rs 50K through challan form
4. Chemical and Pharmaceutical information as per Appendix I of Schedule Y
5. Animal Pharmacology as per Appendix IV
6. Animal Toxicology as per Appendix III
7. Human/Clinical Pharmacology data as per Appendix I ( For foreign trials)
8. Regulatory status in other countries as per Appendix I.
19. DOCUMENTS – sch Y & Indian GCP
Proposed protocol (appendix X)
Investigators brochure
Informed consent document
Investigator’s undertaking
Case report forms
Ethics committee clearance if available
NOTE : application for test licence in form 12 may b submitted along with
CT application or separately
21. REVIEW TIME OF INDA- From 2006
CT which has got
approval by RA of
9 regions of world
Mainly global trials
2-4 weeks
Practically 6-8
weeks
CATEGORY
A
All other trials
Mainly domestic
8-12 weeks
Practically 5-6
months
CATEGORY
B
22. • It takes 4-6 months for the approval but it is not documented.
• The Ethical Committee also requires 1-3 months time.
• Thus, it almost takes 7-9 months for approval of INDA from
DCGI.
• For international applicants, import license to import IP
samples and permission from Director General Foreign Trade
to export blood samples is also needed.
IND SUBMISSION…
23. NEW DRUG APPLICATION (NDA)
The New Drug Application is the vehicle through which
the drug sponsors formally propose DCGI to approve
a new drug for sale and marketing after Phase IIIA
trials.
24. NEW DRUG:
Import FF/Mfg FF Rs. 50,000/-
Import RM + Mfg FF Rs. 50,000/-
APPROVED DRUG:
Application by the same
applicant after 1 year
of approval Rs.15,000/-
Import/Mfg of FDC Rs.15,000/-
CONDUCT OF CLINICAL TRIAL(with ND/IND) :
Phase I Rs.50,000/-
Phase II Rs.25,000/-
Phase III Rs.25,000/-
NO SEPARATE FEES TO BE PAID ALONG WITH APPLICATION FOR
IMPORT/MFG AFTER THE SUCCESSFUL COMPLETION OF CLINICAL TRIAL
APPLICATION FEES
25. REFERENCES
1. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3612334/
2. http://www.mondaq.com/india/x/244304/Healthcare/Latest+Amendments+In+2013+To
+The+Drugs+And+Cosmetics+Rule+1945
3. https://www.amarexcro.com/articles/docs/RAPS_Focus_Practical_Feb2009.pdf
4. https://www.scribd.com/doc/7275483/Latest-Amendment-in-Schedule-Y#scribd
5. http://cdsco.nic.in/writereaddata/Guidance_for_New_Drug_Approval-23.07.2011.pdf
6. http://www.cdsco.nic.in/writereaddata/CDSCO-GuidanceForIndustry.pdf
7. https://www.pharmamedtechbi.com/~/media/Supporting%20Documents/Pharmasia%2
0News/2012/May/DCGI%20report.pdf
8. http://www.isporindia.com/wp-content/uploads/2013/04/Dr.Surinder-Singh.pdf
9. http://www.cdsco.nic.in/writereaddata/GUIDANCE%20DOC.pdf
10. Indian GCP and schedule y
FDC: Fixed Drug Combination
RA: route of administration
BT:biotechnological
DGHS: Director General of Health Services
DG: Director General
ICMR: Indian council of Medical Research
DHR:Department of health research
BE:bioequivalent
FF: Finished Formulation
RM: Raw Materials
MFG: manufacturing
IMP: import
NOC: No objection certificate
CT: Clinical trials
9 Regions : include USA, UK, Switzerland, Australia, Canada, Germany, South Africa, Japan, Europe(EMA approved)
