a brief description about Pharmacopoeia

 

Pharmacopoeia

       Introduction of Pharmacopoeia:

·       Pharmacopoeia has been the authoritative organization working to ensure the consistency and quality ofmedicines.

·       Pharmacopoeia is the formulation of drugs. It is the standard book for preparation of drugs. The book is published in a country under the authority of its own government.

·       Pharmacopoeia is derived from Greek word Pharmakon - Drugs Copoeia - Means to make

·       Type of Pharmacopoeia / List of Pharmacopeia

o   We cannot call it a specific type because every country has a own Pharmacopoeia.

·       Indian Pharmacopoeia

·       British Pharmacopoeia

·       United States Pharmacopoeia

A pharmacopoeia is a comprehensive and authoritative reference book or standard that contains information about pharmaceutical substances and medicinal products. It serves as a guide for healthcare professionals, including pharmacists, physicians, and regulatory bodies, ensuring the quality, safety, and efficacy of medicines.

Here are key points about pharmacopoeias:

1. Purpose and Development: Pharmacopoeias establish standards for the identity, purity, strength, and quality of drugs and their formulations. They are developed by national or international bodies to promote uniformity in pharmaceutical practices and facilitate the harmonization of regulations across countries.

2. Content: Pharmacopoeias typically include monographs for individual drugs or drug substances, which provide detailed information about their characteristics, manufacturing processes, specifications, and tests for quality assurance. They may also include general chapters on topics such as dosage forms, stability testing, analytical methods, and quality control.

3. Legal Status: Pharmacopoeias often have a legal status, meaning that compliance with their standards and requirements is mandatory for the production, distribution, and sale of medicines within a specific jurisdiction. Regulatory agencies refer to pharmacopoeial standards to assess the quality of pharmaceutical products and ensure patient safety.

4. International Pharmacopoeias: In addition to national pharmacopoeias, there are international pharmacopoeias developed by organizations such as the World Health Organization (WHO) and the European Pharmacopoeia (Ph. Eur.). These provide globally recognized standards and are widely used in many countries.

5. Updates and Revisions: Pharmacopoeias are periodically updated to incorporate new scientific knowledge, advances in manufacturing processes, and changes in regulations. Revisions ensure that the standards remain relevant and reflect the latest developments in pharmaceutical sciences.

6. Pharmacopoeial Compendia: In some countries, pharmacopoeias are published alongside supplementary compendia. For example, the United States Pharmacopeia (USP) is accompanied by the National Formulary (NF), which provides additional information on drug formulations and compounding.

7. Harmonization and Mutual Recognition: Efforts are made to harmonize pharmacopoeial standards across different regions to facilitate global trade and ensure consistency in drug quality. Mutual recognition agreements between countries acknowledge the equivalence of pharmacopoeial standards, allowing products tested and approved in one jurisdiction to be accepted in another.

Pharmacopoeias are essential tools for ensuring the quality, safety, and efficacy of medicines. They provide healthcare professionals with vital information for prescribing, dispensing, and using medications, while also serving as a regulatory framework to protect public health.

·       Indian Pharmacopoeia:

·       The Indian Pharmacopoeia is published by the Indian Pharmacopoeia commission (IPC) on behalf of the ministry of health and family welfare Government of India.

·       Bengal Pharmacopoeia 1844 - But this book was not made public, just this name was kept.

·       Legal and official book published by IPC-1945.

 

·       Indian Pharmacopoeia Headquarter - Ghaziabad (Uttar Pradesh)

·       Indian Pharmacopoeia commission (IPC) regulated by Ministry Of Health And Family Welfare.

·       Indian Pharmacopoeia is written in English and official title of monographs given in Latin.

·       The Indian Pharmacopoeia is being processed to fulfill the requirement in the Drug And CosmeticsAct 1940 and rules 1945.

·       In 1946 the government of India published the Indian Pharmacopoeia list which served as thesuppliment to British Pharmacopoeia.

·       After publication of list the government of India constituted a parmanent Indian Pharmacopoeiacommittee in 1948.

·       Indian Pharmacopoeia committee under chairmanship of Dr. B.N. Ghosh published First Edition ofIndian Pharmacopoeia in 1955.

·       (Dr. B.N. Ghosh professor of pharmacology. R.Gkar medical College Kolkata who died 1958. After Dr. B.N. Ghosh, Dr. B Mukerji Director Central Drug Research Institute Lucknow (CDRI) was appointed as chairman of the Indian Pharmacopoeia committee.)

·       Second Edition of Indian Pharmacopoeia was published in 1966. Supplement to this edition waspublished in 1975.

·       (On 30 June 1978 the Indian Pharmacopoeia committee was reconstituted by the government of India Ministry Of Health and Family Welfare) under the Chairmanship Dr. Nityanand Directer of Central Drug Research Institute Lucknow (CDRI).

·       Third Edition of Indian Pharmacopoeia was published in 1985.

·       This Pharmacopoeia include two Addendum with two Volumes.

·       Addendum (Volume-1) to Indian Pharmacopoeia published in 1989. They contain legal notice prephase acknowledgement, Introduction, General notice and monographs from A to P.

·       They contain 46 new monographs added and 126 amended.

·       Addendum (Volume-2) was published in 1991 contain monographs from Q to Z and they contain 62 new monographs added and 110 amended.

·       Fourth edition of Indian Pharmacopoeia was published in 1996 under the chairmanship of Dr.Nityanand.

·       In Fourth edition addendum from veterinary product in 2002, 2005 and supplement volume-1 A toP, Volume-2 Q to Z.

·       The veterinary supplement to Indian Pharmacopoeia 1996 contain 208 monographs.

 

·       Fifth Edition of Indian Pharmacopoeia was published in 2007 and addendum to this edition waspublished in 2008.

·       Fifth Edition Indian Pharmacopoeia is presented in three (3) Volume.

·       Volume-1st contains general notices and general chapters.

·       Volume-2nd contains general monographs on Drugs substances Dosage forms and PharmaceuticalAids.

·       Sixth edition of Indian Pharmacopoeia was published in 2010.

·       The 6th edition of the Indian Pharmacopoeia 2010 is published by the Indian Pharmacopoeiacommission (IPC).

·       The Indian Pharmacopoeia 2010 is presented in 3 volumes.

·       Volume-1st contains the notices, Preface the structure of the IPC, Acknowledgements,Introduction and the general chapters.

·       Volume-2nd contains the General notice, monographs on Dosage forms and monographs on Drug substances, dosage forms and Pharmaceutical Aids (A to M).

·       Volume-3rd contains monographs on Drug substances, dosage forms and Pharmaceutical Aids (N to Z) followed by monographs on Vaccines and Immunosera for human use.

·       Herbs and Herbal products. Blood and blood related products biotechnology product andveterinary products.

·       The seventh edition of the Indian Pharmacopoeia was published in 2014 by the Indian Pharmacopoeia commission (IPC) on behalf of the Government of India Ministry of Health AndFamily Welfare.

·       The Indian Pharmacopoeia 2014 is presented in four Volumes.

·       The Indian Pharmacopoeia 2014 incorporates 2550 monograph of drugs out of which 577 are new monographs consisting of APIs, Excipients, Dosage forms and herbal products etc.

·       The Eight edition of Indian Pharmacopoeia was published in 2018 by the IPC on behalf of the Ministry of Health and Family Welfare, Government of India.

 

·       Indian Pharmacopoeia 2018 salient features-

 

o   Incorporating with 4 volume.

o   220 New monographs

o   170 New chemical monographs

o   49 API

o   64 Formulation

o   53 Fixed dose formulations

o   02 Excipients

o   02 Antibiotics

o   15 New herbs and Herbal products monographs

o   03 New Radiopharmaceutical monographs.

o   14 New veterinary Non-biological monographs.

o   18 New Biological monographs

o   02 Vaccines and Immunosera for human use

o   06 Biotechnology derived therapeutic products.

o   10 Blood and Blood related products.

 

o   Silent features of Indian pharmacopoeia

·       I.P is published in continuing pursuit of the mission of I.P.C to improve the health of thepeople through ensuring the quality, safety and efficacy of medicines.

·       I.P contains procedures for analysis and specifications for the determination of quality of pharmaceutical substances, excipients, and dosage form.

·       General chapter on volumetric glassware, conductivity, dissolution test, disintegration test, dimensions of hard gelatin capsule shell etc. have been revised.

·       I.P has been extended to include products of biotechnology indigenous herbs and herbals products, veterinary vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed dose combinations (FDC).

·       I.P contains the 170 chemical monographs, 15 herbal monographs, 10 blood and blood related products monographs, 6 biotechnology monographs, 3 pharmaceuticals monographs, 2 vaccines and immune- sera monographs, 14 veterinary and non biological products monographs.

·       I.P monograph for an official substances or preparation includes the articles definition, description, identification, packaging, storage, specifications, impurities, assay and specifictests, one or more analytical procedures for each test, acceptance criteria, other requirementetc.

·       General chemical tests and TLC for identification of an article have been almost eliminated and more specific infrared, ultraviolet spectrophotometer and HPLC tests have given emphasis.

·       The uses of chromatographic methods have been greatly extended to cope with the need for more specificity in assays and in particular, in

assessing the nature and extent of impurities in ingredients and products.

·       For controlling the microbial quality of all the medicinal products- Maintenance, preservation, identification, disposal of microorganism have been revised and pyrogen tests have replaced by Bacterial Endotoxin Test(BET) in parenteral preparation.

 

 

 

Edition	Year	Addendum         / Supplement	Chairmanship	Volume
1St	1955	1960	D. B.N. Ghose	One
2nd	1966	1975	Dr. B. Mukherjee	One
3rd	1985	1989/1991	Dr. Nityanand	Two
4th	1996	2000/2002/200 5	Dr. Nityanand	Two
5th	2007	2008	Dr. Nityanand	Three
6th	2010	2012	Shri K.Chandramouli	Three
7th	2014	2015/2016	Gulam     Nabi                   Azad (HealthMinister)	Four
8th	2018	2019/2021	Dr. C.K. Mishra	Four

 

·       United States Pharmacopoeia (USP)

·       The United States Pharmacopoeia has been authoritative organization working to ensure the constituencyand quality of medicine and vitamin.

·       USB United States pharmacopeia standards are recognised by the FDA as the standard for testing vitamins and medicines against, ensuring quality products that contribute to public health and wellness.

·       United States Pharmacopeia-National Formulary

·       The United States Pharmacopeia-National Formulary (USP-NF) is a book of public pharmacopeial standards. It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements.

British Pharmacopoeia (BP)

·       British Pharmacopoeia was published by the Health ministry of the United Kingdom. In is also known as National Pharmacopoeia of the United Kingdom.

·       British Pharmacopoeia

 

·       Headquarters: London, United Kingdom