The document discusses drug regulations and central testing laboratories in India. It provides information on the Central Drugs Standard Control Organization (CDSCO), which is responsible for regulating drugs in India. It oversees several laboratories across India that test drugs. The document also discusses ethics committees, new drug approvals, and the benefits of accreditation by the National Accreditation Board for Testing and Calibration Laboratories (NABL).
Introduction Central Drug Testing Laboratories & Responsibilities
Role of Central Drugs Testing Laboratory
No of laboratories in India, No of laboratories in each State
Presented by
J. Vinay Krishna
Department of Industrial Pharmacy
A simple and essential guide to obtain a drug manufacturing license for ayurvedic medicine. It covers procedure, minimum requirements, documents & affidavits and all other necessities.
Good regulatory practice are internationally recognized process, system, tools and method for improving the quality of regulation.
It includes
1)COMMUNITY PHARMACY RETAIL AND WHOLESALE PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
2) HOSPITAL PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
3) PHARMA MANIFACTURING
-Dacumentation
-Licenses
-Renewal
-E-governance
4) IMPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
5) EXPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
Introduction Central Drug Testing Laboratories & Responsibilities
Role of Central Drugs Testing Laboratory
No of laboratories in India, No of laboratories in each State
Presented by
J. Vinay Krishna
Department of Industrial Pharmacy
A simple and essential guide to obtain a drug manufacturing license for ayurvedic medicine. It covers procedure, minimum requirements, documents & affidavits and all other necessities.
Good regulatory practice are internationally recognized process, system, tools and method for improving the quality of regulation.
It includes
1)COMMUNITY PHARMACY RETAIL AND WHOLESALE PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
2) HOSPITAL PHARMACY
-Dacumentation
-Licenses
-Renewal
-E-governance
3) PHARMA MANIFACTURING
-Dacumentation
-Licenses
-Renewal
-E-governance
4) IMPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
5) EXPORT OF DRUG AND MEDICAL DEVICE
-Dacumentation
-Licenses
-Renewal
-E-governance
Hospital Formulary - presentation gives the detail idea about Hospital formulary, its advantage, disadvantage, how to prepare Hospital formulary and much more. this will be useful for Pharm.D-IV YEAR students, which was in their Hospital pharmacy subject. regards APOLLOJAMES
The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
This slide contains what is generic drug, what is advantages & disadvantages,reason behind unpopularity of generic drug in India, why generic drugs are important in India, why there is a need of generic drug policy, who are the regulatory authority, what are the act & laws, what policy existing in India for generic drug then Conclusion.
COMMUNITY PHARMACY AND MANAGEMENT – CHAPTER -1................... (1).pptSumit Tiwari
A community pharmacy, often referred to as retail pharmacy or retail drug outlets, is places where medicines are stored and dispensed, supplied or sold
PHARMACIST ROLE IN COMMUNITY PHARMACY , OTC GUIDELINES , PRESCRIPTION PRECAU...VENKATA RAMA RAO NALLANI
IT has covered choice medicine by cost ,taste, safety, Prescription precautions, COMMUNITY PHARMACY AND CLINICAL PHARMACIST RESPONSIBILITIES IN IN PATIENT CARE
An Overview of CDSCO Registration. The CDSCO stands for Central Drugs Standard Control Organisation is the NRA or National Regulatory Authority under the Directorate General of Health Services, Government of India, and Ministry of Health and Family Welfare.
My presentation based on the CDSCO certification, as well as the complete description about the CDSCO and DCGI.
Preclinical Development, Introduction
Definition, Stages of development of a new drug, Objectives of Preclinical studies, Several steps in preclinical trials, Types of studies in Preclinical trials, Importance of preclinical trials
By
Ms. I. Sai Reddemma.
Department of Pharmacology
The Jan Aushadhi scheme launched by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India aims to make available quality generic medicines at affordable prices to all through special outlet known as Jan Aushadhi store opened/to be opened in each district of all the States. The new business plan approved by the Department of Pharmaceuticals in August, 2013 brought out it no. of changes to make the campaign a real success.
An Overview of CDSCO Registration. The CDSCO stands for Central Drugs Standard Control Organisation is the NRA or National Regulatory Authority under the Directorate General of Health Services, Government of India, and Ministry of Health and Family Welfare.
My presentation based on the CDSCO certification, as well as the complete description about the CDSCO and DCGI.
Hospital Formulary - presentation gives the detail idea about Hospital formulary, its advantage, disadvantage, how to prepare Hospital formulary and much more. this will be useful for Pharm.D-IV YEAR students, which was in their Hospital pharmacy subject. regards APOLLOJAMES
The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
This slide contains what is generic drug, what is advantages & disadvantages,reason behind unpopularity of generic drug in India, why generic drugs are important in India, why there is a need of generic drug policy, who are the regulatory authority, what are the act & laws, what policy existing in India for generic drug then Conclusion.
COMMUNITY PHARMACY AND MANAGEMENT – CHAPTER -1................... (1).pptSumit Tiwari
A community pharmacy, often referred to as retail pharmacy or retail drug outlets, is places where medicines are stored and dispensed, supplied or sold
PHARMACIST ROLE IN COMMUNITY PHARMACY , OTC GUIDELINES , PRESCRIPTION PRECAU...VENKATA RAMA RAO NALLANI
IT has covered choice medicine by cost ,taste, safety, Prescription precautions, COMMUNITY PHARMACY AND CLINICAL PHARMACIST RESPONSIBILITIES IN IN PATIENT CARE
An Overview of CDSCO Registration. The CDSCO stands for Central Drugs Standard Control Organisation is the NRA or National Regulatory Authority under the Directorate General of Health Services, Government of India, and Ministry of Health and Family Welfare.
My presentation based on the CDSCO certification, as well as the complete description about the CDSCO and DCGI.
Preclinical Development, Introduction
Definition, Stages of development of a new drug, Objectives of Preclinical studies, Several steps in preclinical trials, Types of studies in Preclinical trials, Importance of preclinical trials
By
Ms. I. Sai Reddemma.
Department of Pharmacology
The Jan Aushadhi scheme launched by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India aims to make available quality generic medicines at affordable prices to all through special outlet known as Jan Aushadhi store opened/to be opened in each district of all the States. The new business plan approved by the Department of Pharmaceuticals in August, 2013 brought out it no. of changes to make the campaign a real success.
An Overview of CDSCO Registration. The CDSCO stands for Central Drugs Standard Control Organisation is the NRA or National Regulatory Authority under the Directorate General of Health Services, Government of India, and Ministry of Health and Family Welfare.
My presentation based on the CDSCO certification, as well as the complete description about the CDSCO and DCGI.
This powerpoint presentation includes all the details regarding the topic Drug approval process with special procedure of Drug approval process in India.
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
CDSCO Biologicals - Rules, Regulations, Guidelines and Standards for Regulato...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Regulations and Legislation for Biologics (MRA 104T)
Unit 2 - Rules, Regulations, Guidelines and Standards for Regulatory Filing of Biologicals
CDSCO Biologicals
Laws and Guidelines on Clinical Trials in India.pptxmehulsarathy
Diving into the Regulatory Framework: Navigating Clinical Trial Laws & Guidelines in India. This academic presentation offers an in-depth analysis of the legal landscape governing clinical research in India. Delve into the intricate web of regulations, ethical principles, and participant protection measures outlined by the Drugs and Cosmetics Act, ICMR guidelines, and recent amendments.
This presentation is about the basic responsibilities and functions of CDSCO explaining the regulatory body's constitution, comprising of functions of state licensing authority and port offices covering the guidelines for new drug approval process, clinical trails and medical devices. this presentation also give a basic note on SUGAM
Indian Regulatory Requirements: Central Drugs Standard Control Organization (CDSCO). The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics. Vision:
To Protect and Promote public health in India.
Mission:
To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. Functions of CDSCO
Certificate of Pharmaceutical Product (COPP): The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO).
COPP establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country.
It is often mentioned in conjunction with the electronic Common Technical Document (eCTD). The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country. The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country.
COPP Importance: It is needed by the importing country when the product in question is infected for Registration (Licensing and Authorization) or renewal of registration.
With the scope of commercialization or distribution in that country.
Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory authorities without proper quality assurance facilities in importing countries to assess the quality of pharmaceutical products as a prerequisite of registration or importation. General Requirements for Submission of Application for Issue of COPP. Documents Required for Applying for Grating or
Revalidation of COPPS:
Application from the manufacturer.
Site master file (as specified under WHO TRS 823).
Cost of manufacturing license.
List of approved products.
List of products applied for issuance of COPPS.
List of SOPs and STPs.
Stability data (3 batches) accelerated/Real-time.
List of equipments and instruments.
List of technical staff, their qualification, and experience, and approval status.
Manufacturing layout plan.
Process validation for 3 batches of each product.
Schematic diagram of water system specifying circulation loop and MOC (Material of construction).
Schematic diagram of HVAC system specifying terminal filter configuration. Export data of the last 2 years in case of revalidation.
Flow chart
-The Central Drug Standard Control Organization (CDSCO) is the main regulatory body of
India for regulation of Pharmaceutical, medical and clinical trials.
➢ The head office of CDSCO is located in New Delhi and it is functioning under the Control
of Directorate General of Health Services, Ministry of Health and Family Welfare,
Government of India.
➢ The CDSCO works with the World Health Organization to promote Good Manufacturing
Practice (GMP) and international regulatory harmony.
➢ It is the central drug authority for discharging functions assigned to the Central Government
under the Drug and Cosmetics Act.
Similar to CENTRAL TESTING LABORATORIES IN INDIA (20)
MYDRIATIC AND MIOTIC AGENTS AND DRUGS USED IN GLAUCOMA Rishabh Sharma
A brief Pathophysiology Presentation on the topic " MYDRIATIC AND MIOTIC AGENTS AND DRUGS USED IN GLAUCOMA "
Includes Both Open Angle and Closed Angle Glaucoma , their Mechanism Of Onset , Pathophysiology and Treatment ( Drugs Used In Glaucoma )
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A brief PROTEINS AND ENZYMES ASSIGNMENT on the topic - ACID PHOSPHATASE . Includes Properties, Reactions and Classification of Acid Phosphatases . Includes significance and functions of Aid Phosphatases as well.
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Includes Extent and nature of monitoring , components of a monitoring plan , Documentation / Monitoring activities , Procedures of Monitoring , Importance of Monitoring Report , Factors to consider when developing a monitoring plan
Biopharmaceutics Presentation - A brief presentation on the topic- BCS Classification and it's role in formulation development . Includes uses of BCS Classification
CLINICAL BIOCHEMISTRY PRESENTATION ON HPLC- HIGH PERFORMANCE LIQUID CHROMATOG...Rishabh Sharma
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A brief presentation of pharmacology on the topic " ANTICHOLINESTERASES " .
Includes Origin,USES, MECHANISM OF ACTION, SIDE EFFECTS , ADVERSE REACTIONS ,
A brief Presentation of Pharmacology on the Drug " Physostigmine " . Includes origin ,Indication, uses, treatment, trade name pharmacodynamics, side effects,
References -https://en.wikipedia.org/wiki/Physostigmine
Professional air quality monitoring systems provide immediate, on-site data for analysis, compliance, and decision-making.
Monitor common gases, weather parameters, particulates.
Nutraceutical market, scope and growth: Herbal drug technologyLokesh Patil
As consumer awareness of health and wellness rises, the nutraceutical market—which includes goods like functional meals, drinks, and dietary supplements that provide health advantages beyond basic nutrition—is growing significantly. As healthcare expenses rise, the population ages, and people want natural and preventative health solutions more and more, this industry is increasing quickly. Further driving market expansion are product formulation innovations and the use of cutting-edge technology for customized nutrition. With its worldwide reach, the nutraceutical industry is expected to keep growing and provide significant chances for research and investment in a number of categories, including vitamins, minerals, probiotics, and herbal supplements.
Earliest Galaxies in the JADES Origins Field: Luminosity Function and Cosmic ...Sérgio Sacani
We characterize the earliest galaxy population in the JADES Origins Field (JOF), the deepest
imaging field observed with JWST. We make use of the ancillary Hubble optical images (5 filters
spanning 0.4−0.9µm) and novel JWST images with 14 filters spanning 0.8−5µm, including 7 mediumband filters, and reaching total exposure times of up to 46 hours per filter. We combine all our data
at > 2.3µm to construct an ultradeep image, reaching as deep as ≈ 31.4 AB mag in the stack and
30.3-31.0 AB mag (5σ, r = 0.1” circular aperture) in individual filters. We measure photometric
redshifts and use robust selection criteria to identify a sample of eight galaxy candidates at redshifts
z = 11.5 − 15. These objects show compact half-light radii of R1/2 ∼ 50 − 200pc, stellar masses of
M⋆ ∼ 107−108M⊙, and star-formation rates of SFR ∼ 0.1−1 M⊙ yr−1
. Our search finds no candidates
at 15 < z < 20, placing upper limits at these redshifts. We develop a forward modeling approach to
infer the properties of the evolving luminosity function without binning in redshift or luminosity that
marginalizes over the photometric redshift uncertainty of our candidate galaxies and incorporates the
impact of non-detections. We find a z = 12 luminosity function in good agreement with prior results,
and that the luminosity function normalization and UV luminosity density decline by a factor of ∼ 2.5
from z = 12 to z = 14. We discuss the possible implications of our results in the context of theoretical
models for evolution of the dark matter halo mass function.
Introduction:
RNA interference (RNAi) or Post-Transcriptional Gene Silencing (PTGS) is an important biological process for modulating eukaryotic gene expression.
It is highly conserved process of posttranscriptional gene silencing by which double stranded RNA (dsRNA) causes sequence-specific degradation of mRNA sequences.
dsRNA-induced gene silencing (RNAi) is reported in a wide range of eukaryotes ranging from worms, insects, mammals and plants.
This process mediates resistance to both endogenous parasitic and exogenous pathogenic nucleic acids, and regulates the expression of protein-coding genes.
What are small ncRNAs?
micro RNA (miRNA)
short interfering RNA (siRNA)
Properties of small non-coding RNA:
Involved in silencing mRNA transcripts.
Called “small” because they are usually only about 21-24 nucleotides long.
Synthesized by first cutting up longer precursor sequences (like the 61nt one that Lee discovered).
Silence an mRNA by base pairing with some sequence on the mRNA.
Discovery of siRNA?
The first small RNA:
In 1993 Rosalind Lee (Victor Ambros lab) was studying a non- coding gene in C. elegans, lin-4, that was involved in silencing of another gene, lin-14, at the appropriate time in the
development of the worm C. elegans.
Two small transcripts of lin-4 (22nt and 61nt) were found to be complementary to a sequence in the 3' UTR of lin-14.
Because lin-4 encoded no protein, she deduced that it must be these transcripts that are causing the silencing by RNA-RNA interactions.
Types of RNAi ( non coding RNA)
MiRNA
Length (23-25 nt)
Trans acting
Binds with target MRNA in mismatch
Translation inhibition
Si RNA
Length 21 nt.
Cis acting
Bind with target Mrna in perfect complementary sequence
Piwi-RNA
Length ; 25 to 36 nt.
Expressed in Germ Cells
Regulates trnasposomes activity
MECHANISM OF RNAI:
First the double-stranded RNA teams up with a protein complex named Dicer, which cuts the long RNA into short pieces.
Then another protein complex called RISC (RNA-induced silencing complex) discards one of the two RNA strands.
The RISC-docked, single-stranded RNA then pairs with the homologous mRNA and destroys it.
THE RISC COMPLEX:
RISC is large(>500kD) RNA multi- protein Binding complex which triggers MRNA degradation in response to MRNA
Unwinding of double stranded Si RNA by ATP independent Helicase
Active component of RISC is Ago proteins( ENDONUCLEASE) which cleave target MRNA.
DICER: endonuclease (RNase Family III)
Argonaute: Central Component of the RNA-Induced Silencing Complex (RISC)
One strand of the dsRNA produced by Dicer is retained in the RISC complex in association with Argonaute
ARGONAUTE PROTEIN :
1.PAZ(PIWI/Argonaute/ Zwille)- Recognition of target MRNA
2.PIWI (p-element induced wimpy Testis)- breaks Phosphodiester bond of mRNA.)RNAse H activity.
MiRNA:
The Double-stranded RNAs are naturally produced in eukaryotic cells during development, and they have a key role in regulating gene expression .
This pdf is about the Schizophrenia.
For more details visit on YouTube; @SELF-EXPLANATORY;
https://www.youtube.com/channel/UCAiarMZDNhe1A3Rnpr_WkzA/videos
Thanks...!
(May 29th, 2024) Advancements in Intravital Microscopy- Insights for Preclini...Scintica Instrumentation
Intravital microscopy (IVM) is a powerful tool utilized to study cellular behavior over time and space in vivo. Much of our understanding of cell biology has been accomplished using various in vitro and ex vivo methods; however, these studies do not necessarily reflect the natural dynamics of biological processes. Unlike traditional cell culture or fixed tissue imaging, IVM allows for the ultra-fast high-resolution imaging of cellular processes over time and space and were studied in its natural environment. Real-time visualization of biological processes in the context of an intact organism helps maintain physiological relevance and provide insights into the progression of disease, response to treatments or developmental processes.
In this webinar we give an overview of advanced applications of the IVM system in preclinical research. IVIM technology is a provider of all-in-one intravital microscopy systems and solutions optimized for in vivo imaging of live animal models at sub-micron resolution. The system’s unique features and user-friendly software enables researchers to probe fast dynamic biological processes such as immune cell tracking, cell-cell interaction as well as vascularization and tumor metastasis with exceptional detail. This webinar will also give an overview of IVM being utilized in drug development, offering a view into the intricate interaction between drugs/nanoparticles and tissues in vivo and allows for the evaluation of therapeutic intervention in a variety of tissues and organs. This interdisciplinary collaboration continues to drive the advancements of novel therapeutic strategies.
Richard's aventures in two entangled wonderlandsRichard Gill
Since the loophole-free Bell experiments of 2020 and the Nobel prizes in physics of 2022, critics of Bell's work have retreated to the fortress of super-determinism. Now, super-determinism is a derogatory word - it just means "determinism". Palmer, Hance and Hossenfelder argue that quantum mechanics and determinism are not incompatible, using a sophisticated mathematical construction based on a subtle thinning of allowed states and measurements in quantum mechanics, such that what is left appears to make Bell's argument fail, without altering the empirical predictions of quantum mechanics. I think however that it is a smoke screen, and the slogan "lost in math" comes to my mind. I will discuss some other recent disproofs of Bell's theorem using the language of causality based on causal graphs. Causal thinking is also central to law and justice. I will mention surprising connections to my work on serial killer nurse cases, in particular the Dutch case of Lucia de Berk and the current UK case of Lucy Letby.
Slide 1: Title Slide
Extrachromosomal Inheritance
Slide 2: Introduction to Extrachromosomal Inheritance
Definition: Extrachromosomal inheritance refers to the transmission of genetic material that is not found within the nucleus.
Key Components: Involves genes located in mitochondria, chloroplasts, and plasmids.
Slide 3: Mitochondrial Inheritance
Mitochondria: Organelles responsible for energy production.
Mitochondrial DNA (mtDNA): Circular DNA molecule found in mitochondria.
Inheritance Pattern: Maternally inherited, meaning it is passed from mothers to all their offspring.
Diseases: Examples include Leber’s hereditary optic neuropathy (LHON) and mitochondrial myopathy.
Slide 4: Chloroplast Inheritance
Chloroplasts: Organelles responsible for photosynthesis in plants.
Chloroplast DNA (cpDNA): Circular DNA molecule found in chloroplasts.
Inheritance Pattern: Often maternally inherited in most plants, but can vary in some species.
Examples: Variegation in plants, where leaf color patterns are determined by chloroplast DNA.
Slide 5: Plasmid Inheritance
Plasmids: Small, circular DNA molecules found in bacteria and some eukaryotes.
Features: Can carry antibiotic resistance genes and can be transferred between cells through processes like conjugation.
Significance: Important in biotechnology for gene cloning and genetic engineering.
Slide 6: Mechanisms of Extrachromosomal Inheritance
Non-Mendelian Patterns: Do not follow Mendel’s laws of inheritance.
Cytoplasmic Segregation: During cell division, organelles like mitochondria and chloroplasts are randomly distributed to daughter cells.
Heteroplasmy: Presence of more than one type of organellar genome within a cell, leading to variation in expression.
Slide 7: Examples of Extrachromosomal Inheritance
Four O’clock Plant (Mirabilis jalapa): Shows variegated leaves due to different cpDNA in leaf cells.
Petite Mutants in Yeast: Result from mutations in mitochondrial DNA affecting respiration.
Slide 8: Importance of Extrachromosomal Inheritance
Evolution: Provides insight into the evolution of eukaryotic cells.
Medicine: Understanding mitochondrial inheritance helps in diagnosing and treating mitochondrial diseases.
Agriculture: Chloroplast inheritance can be used in plant breeding and genetic modification.
Slide 9: Recent Research and Advances
Gene Editing: Techniques like CRISPR-Cas9 are being used to edit mitochondrial and chloroplast DNA.
Therapies: Development of mitochondrial replacement therapy (MRT) for preventing mitochondrial diseases.
Slide 10: Conclusion
Summary: Extrachromosomal inheritance involves the transmission of genetic material outside the nucleus and plays a crucial role in genetics, medicine, and biotechnology.
Future Directions: Continued research and technological advancements hold promise for new treatments and applications.
Slide 11: Questions and Discussion
Invite Audience: Open the floor for any questions or further discussion on the topic.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
The return of a sample of near-surface atmosphere from Mars would facilitate answers to several first-order science questions surrounding the formation and evolution of the planet. One of the important aspects of terrestrial planet formation in general is the role that primary atmospheres played in influencing the chemistry and structure of the planets and their antecedents. Studies of the martian atmosphere can be used to investigate the role of a primary atmosphere in its history. Atmosphere samples would also inform our understanding of the near-surface chemistry of the planet, and ultimately the prospects for life. High-precision isotopic analyses of constituent gases are needed to address these questions, requiring that the analyses are made on returned samples rather than in situ.
A brief information about the SCOP protein database used in bioinformatics.
The Structural Classification of Proteins (SCOP) database is a comprehensive and authoritative resource for the structural and evolutionary relationships of proteins. It provides a detailed and curated classification of protein structures, grouping them into families, superfamilies, and folds based on their structural and sequence similarities.
Cancer cell metabolism: special Reference to Lactate PathwayAADYARAJPANDEY1
Normal Cell Metabolism:
Cellular respiration describes the series of steps that cells use to break down sugar and other chemicals to get the energy we need to function.
Energy is stored in the bonds of glucose and when glucose is broken down, much of that energy is released.
Cell utilize energy in the form of ATP.
The first step of respiration is called glycolysis. In a series of steps, glycolysis breaks glucose into two smaller molecules - a chemical called pyruvate. A small amount of ATP is formed during this process.
Most healthy cells continue the breakdown in a second process, called the Kreb's cycle. The Kreb's cycle allows cells to “burn” the pyruvates made in glycolysis to get more ATP.
The last step in the breakdown of glucose is called oxidative phosphorylation (Ox-Phos).
It takes place in specialized cell structures called mitochondria. This process produces a large amount of ATP. Importantly, cells need oxygen to complete oxidative phosphorylation.
If a cell completes only glycolysis, only 2 molecules of ATP are made per glucose. However, if the cell completes the entire respiration process (glycolysis - Kreb's - oxidative phosphorylation), about 36 molecules of ATP are created, giving it much more energy to use.
IN CANCER CELL:
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
Unlike healthy cells that "burn" the entire molecule of sugar to capture a large amount of energy as ATP, cancer cells are wasteful.
Cancer cells only partially break down sugar molecules. They overuse the first step of respiration, glycolysis. They frequently do not complete the second step, oxidative phosphorylation.
This results in only 2 molecules of ATP per each glucose molecule instead of the 36 or so ATPs healthy cells gain. As a result, cancer cells need to use a lot more sugar molecules to get enough energy to survive.
introduction to WARBERG PHENOMENA:
WARBURG EFFECT Usually, cancer cells are highly glycolytic (glucose addiction) and take up more glucose than do normal cells from outside.
Otto Heinrich Warburg (; 8 October 1883 – 1 August 1970) In 1931 was awarded the Nobel Prize in Physiology for his "discovery of the nature and mode of action of the respiratory enzyme.
WARNBURG EFFECT : cancer cells under aerobic (well-oxygenated) conditions to metabolize glucose to lactate (aerobic glycolysis) is known as the Warburg effect. Warburg made the observation that tumor slices consume glucose and secrete lactate at a higher rate than normal tissues.
2. INTRODUCTION:-
The Central Drugs Standard Control Organization (CDSCO)
is the Central Drug Authority for discharging functions
assigned to the Central Government under the Drugs and
Cosmetics Act. CDSCO has six zonal offices, four sub-zonal
offices, 13 port offices and seven laboratories under its
control.
3. FUNCTIONS:-
Under the Drug and Cosmetics Act, the regulation of manufacture, sale and
distribution of Drugs is primarily the concern of the State authorities while the
Central Authorities are responsible for approval of New Drugs, Clinical Trials
in the country, laying down the standards for Drugs, control over the quality of
imported Drugs, coordination of the activities of State Drug Control
Organisations and providing expert advice with a view of bring about the
uniformity in the enforcement of the Drugs and Cosmetics Act.
4. Major functions of CDSCO:
1.Regulatory control over the import of drugs, approval of
new drugs and clinical trials, meetings of Drugs Consultative
Committee (DCC) and Drugs Technical Advisory Board
(DTAB), approval of certain licenses as Central License
Approving Authority is exercised by the CDSCO
headquarters.
5. FUNCTIONS OF DCGI:-
Drug Controller General of India is responsible for approval of
licenses of specified categories of Drugs such as blood and
blood products, I. V. Fluids, Vaccine and Sera. Central Drugs
Standard Control Organization Head quarter is located at
FDA Bhawan, Kotla Road, New Delhi 110002 and functions
under the Directorate General of Health Services.
6. ABOUT NABL
NABL is a Constituent Board of Quality Council of India. NABL has been
established with the objective of providing Government, Industry Associations and
Industry in general with a scheme of Conformity Assessment Body’s accreditation
which involves third-party assessment of the technical competence of testing
including medical and calibration laboratories, proficiency testing providers and
reference material producers.
7. NABL is a Constituent Board of Quality Council of India. NABL has been
established with the objective of providing Government, Industry Associations and
Industry in general with a scheme of Conformity Assessment Body’s accreditation
which involves third-party assessment of the technical competence of testing
including medical and calibration laboratories, proficiency testing providers and
reference material producers.
NABL provides accreditation in all major fields of Science and Engineering such as
Biological, Chemical, Electrical, Electronics, Mechanical, Fluid-Flow, Non-
Destructive, Photometry, Radiological, Thermal & Forensics under testing facilities
and Electro-Technical, Mechanical, Fluid Flow, Thermal, Optical, Medical Devices &
Radiological under Calibration facilities. NABL also provides accreditation for
medical testing laboratories.
8. BENEFITS OF NABL ACCREDITATION:-
1. Increased confidence in Testing/ Calibration Reports issued by the laboratory
2. Better control of laboratory operations and feedback to laboratories as to whether they
have sound Quality Assurance System and are technically competent
3. Potential increase in business due to enhanced customer confidence and satisfaction.
4. Customers can search and identify the laboratories accredited by NABL for their specific
requirements from the NABL Web-site or Directory of Accredited Laboratories
5. Users of accredited laboratories enjoy greater access for their products, in both
domestic and international markets.
6. Savings in terms of time and money due to reduction or elimination of the need for re-
testing of products.
9. ETHICS COMMITEE :-
For the purpose of the Rule 122DD, an Ethics Committee is a
committee comprising of medical, scientific, non-medical and
nonscientific members, whose responsibility is to ensure the
protection of the rights, safety and well-being of human subjects
involved in a clinical trial and it shall be responsible for
reviewing and approving the protocol, the suitability of the
investigators, facilities, methods and adequacy of information to
be used for obtaining and documenting informed consent of the
study subjects and confidentiality safeguards.
10. Bioavailability (BA) : Bioavailability refers to the relative
amount of drug from an administered dosage from which
enters the systemic circulation and the rate at which the drug
appears in the systemic circulation.
Bioequivalence (BE): Bioequivalence of a drug product is
achieved if its extent and rate of absorption are not
statistically significantly different from those of the reference
product when administered at the same molar dose.
11. The Licensing Authority after being satisfied that the requirements have been
complied with, may grant registration to the Ethics Committee subject to such
conditions as may be stated therein.
The registration of Ethics Committees is valid for a period of three years. The re-
registration applications need to be made within 3 months before the expiry of
registration. Registration remains deemed continued unless otherwise orders are
passed or until the registration is Suspended or Cancelled. Accordingly applicant
shall apply to CDSCO for re-registration as per checklist.
12. ABOUT NEW DRUGS :-
Demonstration of safety and efficacy of the drug product for use in humans
is essential before the drug product can be approved for import or
manufacturing and marketing in the country. The Rules 122A, 122B, 122
DAB, 122DAC, 122 DD and 122E of Drugs and Cosmetics Rules and
Appendix I- XII of Schedule Y, describe the information/data required for
approval of clinical trial and/or to import or manufacture of new drug for
marketing in the country.
13. Background & Rules For Conducting global Clinical Trial :-
Global Clinical Trial means any clinical trial which is conducted as part of multi-
national clinical development of a drug. Clinical Trial means a systematic study of
any new drug(s) in human subject(s) to generate data for discovering and/or
verifying the clinical, pharmacological (including pharmacodynamic and
pharmacokinetic), and/or adverse effects with the objective of determining safety
and/or efficacy of the new drug.
No clinical trial for a new drug, whether for clinical investigation or any clinical
experiment by any institution, shall be conducted except under, and in accordance
with, the permission, in writing, of the Licensing Authority defined in clause (b) of
Rule 21.
14. CENTRAL TESTING LABS IN INDIA:-
There are seven Central Drug Testing Laboratories under CDSCO.
These are at Kolkata, Mumbai, Chennai, Guwahati, Chandigarh,
Kasauli and Hyderabad. The Central Drug Laboratory, Kolkata is the
appellate laboratory for testing of drugs and is NABL accredited for
Chemical and Biological Testing. The Central Drug Testing
Laboratory, Mumbai is a statutory Laboratory involved in testing of
samples of Drugs from the ports, new drugs and oral contraceptive
pills.It is an appellate laboratory for copper T-intrauterine
contraceptive device and tubal rings. The Central Drugs Testing
Laboratory, Chennai is an appellate Laboratory for condoms and is
NABL accredited for both chemical and mechanical sections.
15. The Regional Drugs Testing Laboratory, Guwahati tests the samples
of drugs received especially from States in the East Zone and is
NABL accredited for both chemical Zone and biological testing.