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INTERNATIONAL CLASSIFICATION
OF DISEASE,INTERNATIONAL
NON-PROPRIETARY NAMES FOR
DRUGS
SUBJECT NAME : CLINICAL RESEARCH AND PHARMACOVIGILANCE
GUIDED BY : PROFESSOR SMITA SADAR
PRESENTED BY : ANKITA SANDESH HALDAKAR
(M. PHARM 1ST YEAR PHARMACOLGY)
D.Y.PATIL COLLEGE OF PHARMACY AKURDI, PUNE
INTRODUCTION
 The International Classification of Diseases (ICD) is the international
"standard diagnostic tool for epidemiology, health management and
clinical purposes". Its full official name is International Statistical
Classification of Diseases and Related Health Problems.
 The ICD is maintained by the World Health Organization (WHO), the
directing and coordinating authority for health within the United Nations
System.
 The ICD is originally designed as a health care classification system,
providing a system of diagnostic codes for classifying diseases, including
classifications of a wide variety of signs, symptoms, abnormal findings,
complaints, social circumstances, and external causes of injury or
disease.
PURPOSE AND USES OF ICD
 This system is designed to map health conditions to corresponding generic
categories together with specific variations, assigning for these a designated
code, up to six characters long.
 Thus, major categories are designed to include a set of similar diseases. ICD-
10 is a major step forward, because it has the necessary terminological and
ontological elements for seamless use in digital health.
 The ICD is published by the WHO and used worldwide for morbidity and
mortality statistics and automated decision support in health care.
 Easy storage, retrieval and analysis of health information for evidenced- based
decision-making.
Conti….
Sharing and comparing health information between
hospitals, regions, settings and countries.
Data comparisons in the same location across
different time periods.
Monitoring of the incidence and prevalence of
diseases, observing reimbursements and resource
allocation trends, and keeping track of safety and
quality guidelines.
Counting of deaths as well as diseases, injuries,
symptoms, reasons for encounter, factors that
influence health status, and external causes of disease.
TABULAR LIST OF INCLUSION AND
FOUR CHARACTER SUB CATEGORIES
I. Certain infectious parasitic diseases
II. Neoplasms
III. Diseases of the blood and blood forming organs and certain disorders involving the
immune mechanism
IV. Endocrine, nutritional and metabolic diseases
V. Mental and behavioral disorders
VI. Disease of nervous system
VII. Disease of eyes and adnexa
VIII. Disease of Ear and Mastoid Process
IX. Disease of Circulatory System
X. Disease of Respiratory System
XI. Diseases of Digestive System
XII. Diseases of Skin and Subcutaneous Tissue
XIII Diseases of the Musculoskeletal System and
Connective Tissue
XIV Diseases of the Genitourinary System
XV Pregnancy, Childbirth and Puerperium
XVI Certain Conditions Originating in the Perinatal
Period
XVII Congenital Malformations, Deformations and
Chromosomal Abnormalities
XVIII Symptoms, Signs and Abnormal Clinical and
Laboratory Findings Not Elsewhere Classified
XIX Injury, Poisoning and Certain Other Consequences of
External Causes
XX External Causes of Morbidity and Mortality
XXI Factors Influencing Health Status and Contact with
Health Services
CLASSIFICATION OF DISEASE IN ICD
CHAPTER I
 Intestinal infectious diseases (A00-A09)
 A00 Cholera
 A01 Typhoid and paratyphoid fevers
 A02 Other Salmonella infections
 A03 Shigellosis
 A04 Other bacterial intestinal infections
 A05 Other bacterial foodborne intoxications, not elsewhere classified
 A06 Amoebiasis
 A07 Other protozoal intestinal diseases.
 A08 Viral and other specified intestinal infections
 A09 Other gastroenteritis and colitis of infectious and unspecified origin
 Tuberculosis (A15-A19)
 A15 Respiratory tuberculosis, bacteriologically and histologically confirmed
 A16 Respiratory tuberculosis, not confirmed bacteriologically or histologically
 A17 Tuberculosis of nervous system
 A18 Tuberculosis of other organs
 A19 Miliary tuberculosis
Certain zoonotic bacterial diseases (A20-A28)
 A20 Plague
 A21 Tularaemia
 A22 Anthrax
 A23 Brucellosis
 A24 Glanders and melioidosis
 A25 Rat-bite fevers
 A26 Erysipeloid
 A27 Leptospirosis
 A28 Other zoonotic bacterial diseases, not elsewhere classified
 Other Bacterial diseases (A30-A49)
 A30 Leprosy [Hansen disease]
 A31 Infection due to other mycobacteria
 A32 Listeriosis
 A33 Tetanus neonatorum
 A34 Obstetrical tetanus
 A35 Other tetanus
 A36 Diphtheria
 A37 Whooping cough
 A38 Scarlet fever
 A39 Meningococcal infection
 A40 Streptococcal sepsis
 A41 Other sepsis
 A42 Actinomycosis
 A43 Nocardiosis
 A44 Bartonellosis
 A46 Erysipelas
 A48 Other bacterial diseases, not elsewhere classified
 A49 Bacterial infection of unspecified site
Infections with a predominantly sexual mode of transmission (A50-
A64)
 A50 Congenital syphilis
 AS1 Early syphilis
 A52 Late syphilis
 A53 Other and unspecified syphilis
 A54 Gonococcal infection
 A55 Chlamydial lymphogranuloma (venereum)
 A56 Other sexually transmitted chlamydial diseases
 AS7 Chancroid
 A58 Granuloma inguinale
 A59 Trichomoniasis
 A60 Anogenital herpes viral (herpes simplex) infection
 A63 Other predominantly sexually transmitted diseases, not elsewhere classified
 A64 Unspecified sexually transmitted disease.
Other spirochaetal diseases (A65-A69)
 A65 Nonvenereal syphilis
 A66 Yaws
 A67 Pinta
 A68 Relapsing fevers
 A69 Other spirochaetal infections
 Other diseases caused by chlamydia (A70-A74)
 A70 Chlamydia psittaci infection
 A71 Trachoma
 A74 Other diseases caused by chlamydia
 Rickettsioses (A75-A79)
 A75 Typhus fever
 A77 Spotted fever [tick-borne rickettsioses]
 A78 Q fever
 A79 Other rickettsioses
 Viral infections of the central nervous system (A80-A89)
 A80 Acute poliomyelitis
 A81 Atypical virus infections of central nervous system
 A82 Rabies
 A83 Mosquito-borne viral encephalitis
 A84 Tick-borne viral encephalitis
 A85 Other viral encephalitis, not elsewhere classified
 A86 Unspecified viral encephalitis
 A87 Viral meningitis
 A88 Other viral infections of central nervous system, not elsewhere classified
 A89 Unspecified viral infection of central nervous system
ADVANTAGES AND LIMITATIONS
OF ICD
 ADVANTAGES
1) fast aggregation of health
data.
2) To know the real time
information about current health
situation.
3) Wider analysis of community
health.
4) Global assessment.
 LIMITATIONS
1) Discussion is limited to
classified diseases
2) Common term descriptions of
diseases
3) Covers the most common
diseases
4) Country specific
modifications of certain
diseases
INTRODUCTION OF INN
 An International Nonproprietary Name (INN) identifies a pharmaceutical
substance or active pharmaceutical ingredient by a unique name that is
globally recognized and is public property.
 A nonproprietary name is also known as a generic name.
 The INN system was managed by WHO.
 Since the name is available in the public domain it may be used freely.
However, it should not be registered as a trade-mark since this would
prevent its use by other parties.
 INN is designated for the active part of the molecule only, to avoid the
multiplication of entries in cases where several salts, esters, etc. are
actually used.
 In such as cases, the user of the INN has to create a modified
INN(INNM).Ex: mepyramine maleate (a salt of mepyramine with maleic
acid)
AIM OF INN SYSTEM
 To provide health professionals with unique name to
identify each pharmaceutical substance
 Aim to clear identification, safe prescription and
dispensing of medicines to patients.
 For communication and exchange of information among
health professionals and scientists world wide.
 Non proprietary names are intended for use in pharma,
labelling, product information, advertising and other
promotional material.
SELECTION OF INN
 The INN are selected by the world Health Organization on the advice of
experts from the WHO Expert Advisory Panel on the International
Pharmacopoeia and Pharmaceutical Preparations.
 The process of INN selection follows three main steps:
1. A request/application is made by the manufacturer or inventor to WHO
secretariat
2. After a review of the request a proposed INN is selected and published
for comments for objection for 4 months.
3. After completion of 4 months the proposed INNS is finalized and
published as recommended INNs, which is the final name of
substances, which cannot be changed throughout life
ELEMENTS OF INNs
 Proposed INNs
 Recommended INNs
 Modified INNs
 Cumulative INNs
 PROPOSED INNs:
 Proposed INNS are list of drug substances which under objection period
 Newly selected, proposed INNs are then published in WHO Drug
Information, which indicates a deadline for a 4-month objection period.
 This period is allowed for comments and/or objections to the published
names to be raised.
 The reasons for any objection must be stated clearly and these will be
evaluated by the experts for further action• Two lists of proposed INNs are
published yearly
RECOMMENDED INNs
• The final stage of the selection process is the recommended INN.
• Once a name has been published as a recommended INN it will not normally
be modified further and is ready for use in labelling, publications, on drug
information.
• It will serve to identify the active pharmaceutical substance during its lifetime
worldwide.
• Recommended INNs are published in the WHO Drug Information as a
consequence of the objection procedure applied to proposed INNs
• As from 1997, two lists of proposed INNs are published yearly and as from list
37 of recommended INNs with its graphic formulae are selected.
 MODIFIED INNMs:
• If a "radical and group name" is used in conjunction with an INN, they are
referred to as International Non proprietary Name (Modified) or INNM.
• For example, oxacillin and ibufenac are INNs and their salts are named
oxacillin sodium and ibufenac sodium. The latter are called modified INNS
(INNMS).
• for radicals and groups which are used in conjunction with INNs and which are
also referred to as INNM, and the document international Non proprietary
Names.
 CUMULATIVE LIST:
 All names selected as proposed and recommended INNs are published in a
Cumulative list, which is updated periodically.
 The generic names are presented in alphabetical order by Latin name
 Each entry includes:
 equivalent non proprietary names:: in Latin, English, French, Spanish, Arabic,
Chinese and Russian, as well as reference to other common names
 a reference to the INN list in which the name was originally proposed or
recommended, or last amended;
 A reference to names of substances that have been abandoned or never been
marketed;
 reference to national non proprietary names;
 reference to pharmacopeial monographs or similar official references.
 reference to names issued by the International Organization for Standardization
(ISO)
 reference to the Convention of Psychotropic Substances, if applicable;
 reference to the List of Narcotic Drugs under International Control, if applicable
 the molecular formula;
 its Chemical Abstracts Service (CAS) number.
PRINCIPLE OF SELECTION OF INNs
 The primary principles for selection:
 Distinctive in sound and spelling
 Not too long; and Not liable to confusion with other names in common
use.
Ex: anti-inflammatory agents, ibufenac derivatives
Coxib for COX-2 inhibitors, a type of anti-inflammatory drugs (e.g. celecoxib)
 Do not select names for mixtures of substances
 Do not select for herbal substances (vegetable drugs) or for
homoeopathic products.
 Do not select names for those substances that have a long history of use
for medical purposes under well-established names such as those of
alkaloids (e.g. morphine, codeine), or trivial chemical names (e.g acetic
acid)
USE OF STEMS:
 Usually, an INN consists of a random, fantasy prefix and a common stem;
 substances belonging to a group of pharmacologically related substances
show their relationship by the use of a common stem.
 e.g. olol for -adrenoreceptor antagonists and antihypertensive, -teplase for
tissue- type-plasminogen activators activators.
 A list of common stems used in the selection of INNs may be found in
Annex 3.
STEREOISOMERS
 Steric characteristics of the chemical names(5) are indicated by using
specific prefixes.
 For a different enantiomer or for the racemic form of the compounds, the
following prefixes should be added to the existing INN:
a) For the levo form, the lev-/levo- prefix is used,e.g. levocarnitine,
levamisole.
b)For the dextro form, the dex- prefix is used,e.g. dexamisole, dexibuprofen.
c)For the racemic form, the rac-/race- prefix is used,e.g. racepinefrine
 RADIOACTIVE ISOTOPES:
A name for a drug substance containing a radioactive atom should list, in the
following order:
1) the name of the substance containing the radioactive atom,
2) the isotope number,
3) the element symbol, and
4) the name of the carrier agent, if any,
e.g. cyanocobalamin (60 Co), technetium (99m Tc) bicisate, technetium (99m
Tc)
 SPECIFIC GROUPS OF BIOLOGICAL SUBSTANCES
specific groups of biological substances names were assigned to antibiotics,
synthetic peptides, hormones and other proteins.
Example:
• Insulin human was proposed for the recombinant protein and it was first
recommended recombinant protein
• New stems for- tissue plasminogen activators – plase
for naming monoclonal antibodies- they use stem – mab
• Within the INN Programme, names have not been assigned to natural human
blood products or vaccines.
 PROTECTION OF INN
• WHO Expert Committee recommended
• "Enact rules or regulations, as necessary, to ensure that international non-
proprietary names.. Should be protected
• Develop policy guidelines on the use and protection of international non-
proprietary names, and to discourage the use of names derived from INNS,
and particularly names including INN stems in trademarks
 USE OF INNS IN INDIA:
• In India, section 13 (b) of the Trade Marks Act, 1999 prohibits the
registration of names of chemical elements or INNs which have been declared
by the World Health Organization (WHO) and notified by the Registrar of
Trade Marks.
• The WHO has brought the same to the attention of the Drug Controller
General of India.
• Use of INNs to coin brand names
INN- vinleurosine Stem- osine Brand name- Virosine DR company
Reference :-
• Park's textbook of preventive and social medicine, 23rd edition K.PARK
• Textbook of preventive and social medicine, 4th edition SUNDER LAL,
ADARSH, PANKAJ.
• Textbook of preventive and social medicine, 4th edition - MAHAJAN AND
GUPTA.
• Textbook of community medicine -KULKARNI.
Google reference :
⚫www.cdc.gov/nchs/cd9.htm• International classification of diseases
(WHO) archived from the original on 12th feb, 2015. Retrived 14th march
2015.
⚫^WHO. List of official ICD updates.• ^ICD revision time lines and ICD-
coding Tool. Note: ICD-10 in hospital settings: WHO's ICD-10 online
browser located at
http://apps.who.int/classification/icd10/browse/2015/en#/20.0 you
THANK YOU

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REGULATORY GUIDELINES FOR CONDUCTING TOXICITY STUDIES BY ICH.pptx

  • 1. INTERNATIONAL CLASSIFICATION OF DISEASE,INTERNATIONAL NON-PROPRIETARY NAMES FOR DRUGS SUBJECT NAME : CLINICAL RESEARCH AND PHARMACOVIGILANCE GUIDED BY : PROFESSOR SMITA SADAR PRESENTED BY : ANKITA SANDESH HALDAKAR (M. PHARM 1ST YEAR PHARMACOLGY) D.Y.PATIL COLLEGE OF PHARMACY AKURDI, PUNE
  • 2. INTRODUCTION  The International Classification of Diseases (ICD) is the international "standard diagnostic tool for epidemiology, health management and clinical purposes". Its full official name is International Statistical Classification of Diseases and Related Health Problems.  The ICD is maintained by the World Health Organization (WHO), the directing and coordinating authority for health within the United Nations System.  The ICD is originally designed as a health care classification system, providing a system of diagnostic codes for classifying diseases, including classifications of a wide variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease.
  • 3. PURPOSE AND USES OF ICD  This system is designed to map health conditions to corresponding generic categories together with specific variations, assigning for these a designated code, up to six characters long.  Thus, major categories are designed to include a set of similar diseases. ICD- 10 is a major step forward, because it has the necessary terminological and ontological elements for seamless use in digital health.  The ICD is published by the WHO and used worldwide for morbidity and mortality statistics and automated decision support in health care.  Easy storage, retrieval and analysis of health information for evidenced- based decision-making.
  • 4. Conti…. Sharing and comparing health information between hospitals, regions, settings and countries. Data comparisons in the same location across different time periods. Monitoring of the incidence and prevalence of diseases, observing reimbursements and resource allocation trends, and keeping track of safety and quality guidelines. Counting of deaths as well as diseases, injuries, symptoms, reasons for encounter, factors that influence health status, and external causes of disease.
  • 5. TABULAR LIST OF INCLUSION AND FOUR CHARACTER SUB CATEGORIES I. Certain infectious parasitic diseases II. Neoplasms III. Diseases of the blood and blood forming organs and certain disorders involving the immune mechanism IV. Endocrine, nutritional and metabolic diseases V. Mental and behavioral disorders VI. Disease of nervous system VII. Disease of eyes and adnexa VIII. Disease of Ear and Mastoid Process IX. Disease of Circulatory System X. Disease of Respiratory System XI. Diseases of Digestive System XII. Diseases of Skin and Subcutaneous Tissue
  • 6. XIII Diseases of the Musculoskeletal System and Connective Tissue XIV Diseases of the Genitourinary System XV Pregnancy, Childbirth and Puerperium XVI Certain Conditions Originating in the Perinatal Period XVII Congenital Malformations, Deformations and Chromosomal Abnormalities XVIII Symptoms, Signs and Abnormal Clinical and Laboratory Findings Not Elsewhere Classified XIX Injury, Poisoning and Certain Other Consequences of External Causes XX External Causes of Morbidity and Mortality XXI Factors Influencing Health Status and Contact with Health Services
  • 7. CLASSIFICATION OF DISEASE IN ICD CHAPTER I  Intestinal infectious diseases (A00-A09)  A00 Cholera  A01 Typhoid and paratyphoid fevers  A02 Other Salmonella infections  A03 Shigellosis  A04 Other bacterial intestinal infections  A05 Other bacterial foodborne intoxications, not elsewhere classified  A06 Amoebiasis  A07 Other protozoal intestinal diseases.  A08 Viral and other specified intestinal infections  A09 Other gastroenteritis and colitis of infectious and unspecified origin
  • 8.  Tuberculosis (A15-A19)  A15 Respiratory tuberculosis, bacteriologically and histologically confirmed  A16 Respiratory tuberculosis, not confirmed bacteriologically or histologically  A17 Tuberculosis of nervous system  A18 Tuberculosis of other organs  A19 Miliary tuberculosis Certain zoonotic bacterial diseases (A20-A28)  A20 Plague  A21 Tularaemia  A22 Anthrax  A23 Brucellosis  A24 Glanders and melioidosis  A25 Rat-bite fevers  A26 Erysipeloid  A27 Leptospirosis  A28 Other zoonotic bacterial diseases, not elsewhere classified
  • 9.  Other Bacterial diseases (A30-A49)  A30 Leprosy [Hansen disease]  A31 Infection due to other mycobacteria  A32 Listeriosis  A33 Tetanus neonatorum  A34 Obstetrical tetanus  A35 Other tetanus  A36 Diphtheria  A37 Whooping cough  A38 Scarlet fever  A39 Meningococcal infection  A40 Streptococcal sepsis  A41 Other sepsis  A42 Actinomycosis  A43 Nocardiosis  A44 Bartonellosis  A46 Erysipelas  A48 Other bacterial diseases, not elsewhere classified  A49 Bacterial infection of unspecified site
  • 10. Infections with a predominantly sexual mode of transmission (A50- A64)  A50 Congenital syphilis  AS1 Early syphilis  A52 Late syphilis  A53 Other and unspecified syphilis  A54 Gonococcal infection  A55 Chlamydial lymphogranuloma (venereum)  A56 Other sexually transmitted chlamydial diseases  AS7 Chancroid  A58 Granuloma inguinale  A59 Trichomoniasis  A60 Anogenital herpes viral (herpes simplex) infection  A63 Other predominantly sexually transmitted diseases, not elsewhere classified  A64 Unspecified sexually transmitted disease. Other spirochaetal diseases (A65-A69)  A65 Nonvenereal syphilis  A66 Yaws  A67 Pinta  A68 Relapsing fevers  A69 Other spirochaetal infections
  • 11.  Other diseases caused by chlamydia (A70-A74)  A70 Chlamydia psittaci infection  A71 Trachoma  A74 Other diseases caused by chlamydia  Rickettsioses (A75-A79)  A75 Typhus fever  A77 Spotted fever [tick-borne rickettsioses]  A78 Q fever  A79 Other rickettsioses  Viral infections of the central nervous system (A80-A89)  A80 Acute poliomyelitis  A81 Atypical virus infections of central nervous system  A82 Rabies  A83 Mosquito-borne viral encephalitis  A84 Tick-borne viral encephalitis  A85 Other viral encephalitis, not elsewhere classified  A86 Unspecified viral encephalitis  A87 Viral meningitis  A88 Other viral infections of central nervous system, not elsewhere classified  A89 Unspecified viral infection of central nervous system
  • 12. ADVANTAGES AND LIMITATIONS OF ICD  ADVANTAGES 1) fast aggregation of health data. 2) To know the real time information about current health situation. 3) Wider analysis of community health. 4) Global assessment.  LIMITATIONS 1) Discussion is limited to classified diseases 2) Common term descriptions of diseases 3) Covers the most common diseases 4) Country specific modifications of certain diseases
  • 13. INTRODUCTION OF INN  An International Nonproprietary Name (INN) identifies a pharmaceutical substance or active pharmaceutical ingredient by a unique name that is globally recognized and is public property.  A nonproprietary name is also known as a generic name.  The INN system was managed by WHO.  Since the name is available in the public domain it may be used freely. However, it should not be registered as a trade-mark since this would prevent its use by other parties.  INN is designated for the active part of the molecule only, to avoid the multiplication of entries in cases where several salts, esters, etc. are actually used.  In such as cases, the user of the INN has to create a modified INN(INNM).Ex: mepyramine maleate (a salt of mepyramine with maleic acid)
  • 14. AIM OF INN SYSTEM  To provide health professionals with unique name to identify each pharmaceutical substance  Aim to clear identification, safe prescription and dispensing of medicines to patients.  For communication and exchange of information among health professionals and scientists world wide.  Non proprietary names are intended for use in pharma, labelling, product information, advertising and other promotional material.
  • 15. SELECTION OF INN  The INN are selected by the world Health Organization on the advice of experts from the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations.  The process of INN selection follows three main steps: 1. A request/application is made by the manufacturer or inventor to WHO secretariat 2. After a review of the request a proposed INN is selected and published for comments for objection for 4 months. 3. After completion of 4 months the proposed INNS is finalized and published as recommended INNs, which is the final name of substances, which cannot be changed throughout life
  • 16. ELEMENTS OF INNs  Proposed INNs  Recommended INNs  Modified INNs  Cumulative INNs  PROPOSED INNs:  Proposed INNS are list of drug substances which under objection period  Newly selected, proposed INNs are then published in WHO Drug Information, which indicates a deadline for a 4-month objection period.  This period is allowed for comments and/or objections to the published names to be raised.  The reasons for any objection must be stated clearly and these will be evaluated by the experts for further action• Two lists of proposed INNs are published yearly
  • 17. RECOMMENDED INNs • The final stage of the selection process is the recommended INN. • Once a name has been published as a recommended INN it will not normally be modified further and is ready for use in labelling, publications, on drug information. • It will serve to identify the active pharmaceutical substance during its lifetime worldwide. • Recommended INNs are published in the WHO Drug Information as a consequence of the objection procedure applied to proposed INNs • As from 1997, two lists of proposed INNs are published yearly and as from list 37 of recommended INNs with its graphic formulae are selected.  MODIFIED INNMs: • If a "radical and group name" is used in conjunction with an INN, they are referred to as International Non proprietary Name (Modified) or INNM. • For example, oxacillin and ibufenac are INNs and their salts are named oxacillin sodium and ibufenac sodium. The latter are called modified INNS (INNMS). • for radicals and groups which are used in conjunction with INNs and which are also referred to as INNM, and the document international Non proprietary Names.
  • 18.  CUMULATIVE LIST:  All names selected as proposed and recommended INNs are published in a Cumulative list, which is updated periodically.  The generic names are presented in alphabetical order by Latin name  Each entry includes:  equivalent non proprietary names:: in Latin, English, French, Spanish, Arabic, Chinese and Russian, as well as reference to other common names  a reference to the INN list in which the name was originally proposed or recommended, or last amended;  A reference to names of substances that have been abandoned or never been marketed;  reference to national non proprietary names;  reference to pharmacopeial monographs or similar official references.  reference to names issued by the International Organization for Standardization (ISO)  reference to the Convention of Psychotropic Substances, if applicable;  reference to the List of Narcotic Drugs under International Control, if applicable  the molecular formula;  its Chemical Abstracts Service (CAS) number.
  • 19. PRINCIPLE OF SELECTION OF INNs  The primary principles for selection:  Distinctive in sound and spelling  Not too long; and Not liable to confusion with other names in common use. Ex: anti-inflammatory agents, ibufenac derivatives Coxib for COX-2 inhibitors, a type of anti-inflammatory drugs (e.g. celecoxib)  Do not select names for mixtures of substances  Do not select for herbal substances (vegetable drugs) or for homoeopathic products.  Do not select names for those substances that have a long history of use for medical purposes under well-established names such as those of alkaloids (e.g. morphine, codeine), or trivial chemical names (e.g acetic acid)
  • 20. USE OF STEMS:  Usually, an INN consists of a random, fantasy prefix and a common stem;  substances belonging to a group of pharmacologically related substances show their relationship by the use of a common stem.  e.g. olol for -adrenoreceptor antagonists and antihypertensive, -teplase for tissue- type-plasminogen activators activators.  A list of common stems used in the selection of INNs may be found in Annex 3. STEREOISOMERS  Steric characteristics of the chemical names(5) are indicated by using specific prefixes.  For a different enantiomer or for the racemic form of the compounds, the following prefixes should be added to the existing INN: a) For the levo form, the lev-/levo- prefix is used,e.g. levocarnitine, levamisole. b)For the dextro form, the dex- prefix is used,e.g. dexamisole, dexibuprofen. c)For the racemic form, the rac-/race- prefix is used,e.g. racepinefrine
  • 21.  RADIOACTIVE ISOTOPES: A name for a drug substance containing a radioactive atom should list, in the following order: 1) the name of the substance containing the radioactive atom, 2) the isotope number, 3) the element symbol, and 4) the name of the carrier agent, if any, e.g. cyanocobalamin (60 Co), technetium (99m Tc) bicisate, technetium (99m Tc)  SPECIFIC GROUPS OF BIOLOGICAL SUBSTANCES specific groups of biological substances names were assigned to antibiotics, synthetic peptides, hormones and other proteins. Example: • Insulin human was proposed for the recombinant protein and it was first recommended recombinant protein • New stems for- tissue plasminogen activators – plase for naming monoclonal antibodies- they use stem – mab • Within the INN Programme, names have not been assigned to natural human blood products or vaccines.
  • 22.  PROTECTION OF INN • WHO Expert Committee recommended • "Enact rules or regulations, as necessary, to ensure that international non- proprietary names.. Should be protected • Develop policy guidelines on the use and protection of international non- proprietary names, and to discourage the use of names derived from INNS, and particularly names including INN stems in trademarks  USE OF INNS IN INDIA: • In India, section 13 (b) of the Trade Marks Act, 1999 prohibits the registration of names of chemical elements or INNs which have been declared by the World Health Organization (WHO) and notified by the Registrar of Trade Marks. • The WHO has brought the same to the attention of the Drug Controller General of India. • Use of INNs to coin brand names INN- vinleurosine Stem- osine Brand name- Virosine DR company
  • 23. Reference :- • Park's textbook of preventive and social medicine, 23rd edition K.PARK • Textbook of preventive and social medicine, 4th edition SUNDER LAL, ADARSH, PANKAJ. • Textbook of preventive and social medicine, 4th edition - MAHAJAN AND GUPTA. • Textbook of community medicine -KULKARNI. Google reference : ⚫www.cdc.gov/nchs/cd9.htm• International classification of diseases (WHO) archived from the original on 12th feb, 2015. Retrived 14th march 2015. ⚫^WHO. List of official ICD updates.• ^ICD revision time lines and ICD- coding Tool. Note: ICD-10 in hospital settings: WHO's ICD-10 online browser located at http://apps.who.int/classification/icd10/browse/2015/en#/20.0 you