Transcript 13 NEW EDITION IP 2007 - Indian Pharmaceutical Association

NEW EDITION OF IP :
THE IP 2007
By
Dr G N Singh
Secretary-cum- Scientific Director
Indian Pharmacopoeia Commission
Ghaziabad
MENACE OF SUBSTANDARD DRUGS
•
Substandard drugs are available in the
market worldwide.
•
WHO estimates that counterfeit drugs
account for approximately 5-8% of the total
worldwide trade in pharmaceuticals.
2
Chemical instability
Inappropriate storage and
transport
Substandard/
Counterfeit drugs
Poor quality control
during mfg.
have
Those drugs which
been tampered with,
Drug resistance adulterated, diluted,
repackaged, relabelled
Treatment failure
3
IP PLAYS A VITAL ROLE IN QUALITY
CONTROL OF DRUGS
• Indian Pharmacopoeia is the compilation of
official
standards
of
drugs
and
pharmaceuticals manufactured in India
and/ marketed in India.
• As per the Drugs and Cosmetics Act 1940,
the Indian Pharmacopoeia is the legally
recognized Book of Standards for the
quality
of
drug
substances
and
preparations included therein.
4
•
The Standards of IP are legally
enforceable.
•
IP Contains the Standards in the
form of Monographs.
Chronology of Publication of IP
Edition
I
II
III
IV
Year of Publication
Main edition
Addenda
1955
Addendum to IP 1955
1960
1966
Addendum to IP 1966
1975
1985
Addendum to IP 1985
1989 & 1991
1996
Addendum to IP 1996
2000
Vet. Suppl.
2000
2002
6
Addendum to IP 1996
V Edition
2005
2007 (In Press)
7
 The new edition of IP (IP 2007) has been
prepared by the Indian Pharmacopoeia
Commission in accordance with a plan
and completed through the untiring
efforts of its members & secretariat
over a period of ~ 2 years.
 It supersedes 1996 edition.
8
NEW EDITION IP 2007
 Upgradation
•
•
•
•
•
General Notices contents
Monographs of IP 1996
: 1250
Appendices
: 300
General Analytical Methods : 300
New Drugs Monographs
: 250
(API + Dosage Forms)
•
Omissions
:
13
9
PRESENTATION
•
•
3
Hard
bound
volumes bearing IPC
seal and a book
number representing
the
official
print
version.
Printed by NISCAIR
(National Institute of
Science
Communication and
Information
Resources),
Pusa,
New Delhi.
10
CONTENTS

Volume I
Notice
Preface
Structure of IPC
Acknowledgements
Introduction
General Chapters
11

Volume II
Monographs on Drug Substances,
Dosage Forms and Pharmaceutical
Aids (A to M).

Volume III
Monographs on Drug Substances
Dosage Forms and Pharmaceuticals
Aids
(N to Z) followed by
Monographs on :
12
• Vaccines and Immunosera for Human
Use
• Herbs and Herbal Products
• Blood and Blood related Products
• Biotechnology Products
• Veterinary Products (form an integral
part, previously these were published
as a Supplement to IP 1996
13
 Scope of Pharmacopoeia extended
to include
• Products of Biotechnology,
• Herbs and Herbal Products,
• Viral Vaccines,
• Additional Antiretroviral Drugs &
Formulations (inclusive of Fixed
dose combinations)
14
FORMAT
• 2 Column format.
• More user friendly.
• Cross
referencing
monographs.
avoided
in
• No multiplicity of fonts.
• Uniformity of presentation of subject
matter.
15
BASIS OF PHARMACOPOEIAL
REQUIREMENTS
• The standards laid down represent the
minimum with which the article must
comply.
• It is incumbent on the manufacturer to
ensure that the article is manufactured
in accordance with GMP.
16
• It is essential that sufficient stringent
limits are applied at the time of release
of a batch of a material/product so that
the pharmacopoeial standards are met
until its expiry date under the storage
conditions specified.
• Valid interpretation of any requirement
of Pharmacopoeia is a must and
General Notices will facilitate the
correct application of the requirements.
17
CHANGES
• Category of drugs, dosage and usual
strength of dosage forms omitted.
• Solubility: Presented as separate
section for all APIs and Pharmaceutical
Aids.
• Title of monographs : Presented in
shorter form.
18
• Classical chemical tests of identification
of an article eliminated.
• Specific
tests
IR
&
Spectrophotometric tests included.
UV
• Chromatographic methods : Greatly
extended to detect impurities in products.
• Pyrogen test : Virtually eliminated.
Bacterial
Endotoxin
Test
(BET)Applicable to more items.
19
GENERAL CHAPTERS
Volume I
• Devoted to test methods applicable to all
articles
of
Pharmacopoeia
&
General
information.
• Reference spectra
• Typical Chromatogram
• Analytical methods included are internationally
accepted methods to
increase
Global
acceptance of a product.
• Section on Containers for Pharmaceutical use
has been enlarged.
20
GENERAL MONOGRAPHS
• General monographs for dosage
forms of API are grouped
together
at
the
beginning
of
Volume II.
• Monographs of API and their dosage
forms are given in Volume II & III
21
BIOLOGICAL PRODUCTS
Monographs
General
Chapter

Vaccines for Human Use
45

Blood Products
21

Biotechnology Products
04
1

Veterinary Vaccines
41
1

Veterinary Diagnostics
14
1
22
VACCINES FOR HUMAN USE
 Total monographs incorporated in IP
2007
: 45
 Bacterial vaccines : 13
 Viral vaccines
: 16
 Mixed Vaccines
: 16
23
BLOOD PRODUCTS MONOGRAPHS = 21
S. No.
Monographs
IP 1996 IP 2007
1
Dried Human Antihaemophilic Fraction
2
Human Albumin
3
Anti-A Blood Grouping Serum
√
4
Anti-B Blood Grouping Serum
√
5
Anti-Human Globulin Serum
√
6
Anti-D Immunoglobulin Human for
Intravenous Use
√24
√
√
√
√
7
Blood Grouping Serums Anti-D, Anti-C,
Anti-E, Anti-c, Anti-e
√
8
Cryoprecipitated Antihemophilic Factor
√
9
Fibrin Sealant Kit
√
10
Human Coagulation Factor IX
√
11
Human Coagulation Factor VII
√
12
Human Coagulation Factor VIII (rDNA)
√
13
Human Normal Immunoglobulin
14
Human Prothrombin Complex
√
√
√
25
√
15
Human Plasma for Fractionation
16
Human Plasma Protein Fraction
√
√
17
Concentrated Human Red Blood Cells
√
√
18
Anti-D (Rho) Immunoglobulin
√
19
Platelet Concentrate
√
20
Whole Human Blood
21
Normal Immunoglobulin for Intravenous
Use
√
√
√
26
BIOTECHNOLOGY PRODUCTS
S. No. Monographs
IP 1996
IP 2007
1
Erythropoietin Concentrated
Solution
x
√
2
Filgrastim Concentrated
Solution
x
√
3
Interferon Alfa-2 Concentrated
Solution
x
√
4
Streptokinase Bulk Solution
x
√
27
VETERINARY PRODUCTS
Total Veterinary Vaccines Monographs :
41
New Veterinary Vaccines
:
05
New Veterinary Drugs
: 02
Rest of the Veterinary Monographs have been
put into new format.
28
NEW VETERINARY VACCINES AND
VETERINARY DRUGS MONOGRAPHS
1. Clostridium Multicomponent Vaccine, Inactivated
2. Inclusion Body Hepatitis (IBH) Vaccine, Inactivated
3. Infectious Coryza Vaccine
4. Laryngotracheitis Vaccine, Live
5. Peste Des Petitis Ruminants Vaccine, Live
6. Ivermectin
7. Ivermectin Injection
29
HERBS AND HERBAL PRODUCTS
1. Amalaki
7.
Coleus
2. Amra
8.
Gokhru
3. Arjuna
9.
Gudmar
4. Artemisia
10. Guduchi
5. Bhibhitaki
11. Haritaki
6. Bhringraj
12. Tulasi
30
HERBS AND HERBAL PRODUCTS
13.
14.
15.
16.
17.
18.
Kutki
Lasuna
Manjistha
Maricha
Pippali Large
Pippali Small
19.
20.
21.
22.
23.
Punarnava
Sarpagandha
Shatavari
Shati
Kunduru
31
OMISSIONS
1.
2.
3.
4.
5.
6.
Astemizole
Astemizole Tablets
Diazepam Capsules
Fenfluramine Hydrochloride
Fenfluramine Hydrochloride Tablets
Pectin
32
OMISSIONS
7. Phenformin Hydrochloride
8. Phenformin Hydrochloride Tablets
9. Succinylsulphathiazole
10. Succinylsulphathiazole Tablets
11. Sulphacetamide Sodium Eye Ointment
33
Supporting Structure for the
Indian Pharmacopoeia Commission
34