INDIAN PHARMACOPEIAL
STANDARD
PRESENTED BY: DIYA PATEL
SUBJECT NAME: LEGISLATIVE REGULATION OF HEALTH
24MPHRGA014
PRODUCTS IN INDIA (PHRGA014)
SEM 1 M.PHARM(RA)
TABLE OF CONTENT
INTRODUCTION
HISTORY OF INDIAN PHARMACOPOEIA
OBJECTIVES OF IPC
EDITIONS OF INDIAN PHARMACOPOEIA
NUMBER OF VOLUMES IN EACH EDITION OF IP
SALIENT FEATURES OF IP 2022
IPS IMPORTANCE IN PHARMA INDUSTRY
MONOGRAPH
ORGANISATIONAL CHART OF INDIAN PHARMACOPOEIA COMMISSION
REFERENCE
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INTRODUCTION
Indian Pharmacopoeia (IP) is published by the Indian Pharmacopoeia Commission
(IPC) on behalf of the Ministry of Health & Family Welfare, Government of India
in fulfillment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules
1945 thereunder.
IP contains a collection of authoritative procedures of analysis and specifications
of drugs for their identity, purity and strength.
IP is recognized as the official book of standards for the drugs being manufactured
and/or marketed in India.
The drugs and other related substances prepared by pharmaceutical manufacturers
must comply with these standards .
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HISTORY OF INDIAN PHARMACOPOEIA
The history of the IP began in the year 1833 when a committee of the East Indian
Company’s Dispensary recommended the publication of a Pharmacopoeia and
Bengal Pharmacopoeia and General Conspectus of Medicinal Plants was published
in 1844, which mainly listed most of the commonly used indigenous remedies.
The government of India published the Indian pharmacopeial list in 1946, as a
supplement to the British Pharmacopoeia.
The government of India constituted a permanent Indian Pharmacopoeia
Committee in 1948.
Indian Pharmacopeial List contain list of drugs both included and not included in
the British Pharmacopoeia along with standards to secure their usefulness, tests for
identity and purity.
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OBJECTIVES OF IPC
To develop comprehensive monographs for drugs to be included in the Indian
Pharmacopoeia, including active pharmaceutical ingredients, pharmaceutical aids and
dosage forms as well as medical devices and to keep them updated by revision on a regular
basis.
To develop monographs for herbal drugs, both raw drugs and extracts/formulations
therefrom.
To take note of the different levels of sophistication in analytical testing/ instrumentation
available while framing the monographs.
To accelerate the process of preparation, certification and distribution of IP Reference
Substances, including the related substances, impurities and degradation products.
To collaborate with pharmacopoeias like the BP, USP, JP, and International Pharmacopoeia
with a view to harmonizing with global standards.
To review existing monographs periodically with a view to deleting obsolete ones and
amending those requiring upgrading /revision.
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EDITIONS OF INDIAN PHARMACOPOEIA
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NUMBER OF VOLUMES IN EACH EDITION OF IP
IP 1955, 1965 and 1985 was published in 1 volume
IP 1996 was published in 2 volumes
IP 2007 and 2010 was published in 3 volumes
IP 2014 was published in 4 volumes
IP 2018 was published in 4 volumes
IP 2022 was published in 4 volumes
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Indian Pharmacopoeia 2022 contains a total of 92 new monographs including 60
SALIENT FEATURES OF IP 2022
Chemical and other products as follows:
New Monographs: 92
APIs: 27
Dosage Forms (Chemicals): 33
Vitamins, Minerals, Amino acids, Fatty Acids etc.: 21
Biotechnology Derived Therapeutic products: 03
Herbs & Herbal Products: 02
Phytopharmaceutical Ingredient: 7
Blood & Blood Related Products: 02
Vaccines and Immunosera for human use: 04
New General Chapters: 12
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IPS IMPORTANCE IN PHARMA INDUSTRY
Ensuring Product Quality
Compliance with Regulatory Requirements
Quality Control and Consistency
Promoting Innovation and Research
Public Health Impact
Risk Mitigation
Global Competitiveness
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MONOGRAPH
Title of the Monograph
Subsidiary or abbreviated title or
synonym
Chemical formula and Molecular
Weight of the substance
Standards
Category
Description
Identification
Tests
Assay
Storage
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ORGANISATIONAL CHART OF INDIAN
PHARMACOPOEIA COMMISSION
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REFERENCE
Indian Pharmacopoeia Commission. (n.d.). Gov.In. Retrieved January 1, 2025,
from https://ipc.gov.in/
Date. (n.d.). Educational book agency (India). Indianpharmacopoeia.In. Retrieved
January 5, 2025, from
https://www.indianpharmacopoeia.in/Salient_Features_of_IP_2022.pdf
JETHS-J Educ Technol Health Sci-J Educ Technol Health Sci. (n.d.). Jeths.org.
Retrieved January 5, 2025, from
https://www.jeths.org/journal-article-images/aHR0cHM6Ly90eXBlc2V0LXByb2
QtbWVkaWEtc2VydmVyLnMzLmFtYXpvbmF3cy5jb20vY
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Thank you!
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