What is Pharmacopeia
Pharmacopoeia is a book prepared under the authority of the government (of respective countries), that contains a list of medicinal substances, crude drugs and formulae for making preparations from them. The word “Pharmacopoeia” is derived from the Greek words ‘pharmakon’ meaning ‘drug’ and ‘poieo’ means ‘to make’. Pharmacopoeia contains a list of drugs and other related substances, with their sources, descriptions, standard tests, formulae for preparations, action, uses, doses, storage conditions etc. It revised from time-to-time to introduce the latest information available as early as possible.
Example of various Pharmacopeias are:
- Indian Pharmacopoeia (I.P)
- British pharmacopoeia (B.P)
- United States Pharmacopoeia (U.S.P)
- European Pharmacopoeia (Ph. Eur.)
- International Pharmacopoeia (Int. Ph.) etc.
Indian Pharmacopeia
The Indian Pharmacopoeia (IP) is the official compendium of standards for drugs in India. It is published by the Indian Pharmacopoeia Commission (IPC), an autonomous institution under the Ministry of Health and Family Welfare, Government of India. The IP is recognized by the Drugs and Cosmetics Act, 1940, and it plays a crucial role in ensuring the quality of pharmaceuticals in India.
Key points about the Indian Pharmacopoeia:
Legal Status: The IP is a required document in India, and drug manufacturers and regulators must follow its standards.
Scope: It covers a broad range of drugs, including active ingredients, finished products, and herbal medicines.
Monographs: These are detailed specifications for each drug, regularly updated to include new information and technology.
Inclusions: Standards for traditional and modern medicines, along with guidelines for testing materials.
Quality Control: Helps manufacturers maintain consistent product quality.
Harmonization: Collaborates with global pharmacopoeias for international acceptance.
Updates and Revisions: Regularly updated to keep up with scientific and technological advancements.
Reference Standards: Authentic and standardized samples used for testing and quality control.
Brief history of I.P
The history of the Indian Pharmacopoeia (IP) traces back to the early 20th century.
- In 1946 Government of India issued one list known as “The Indian Pharmacopoeia list”. Committee under the chairmanship of Sir R. N. Chopra along with 9 members prepared “The Indian Pharmacopoeia list”.
- In 1948 Government of India appointed Indian Pharmacopoeia committee for preparing Pharmacopoeia of India. Tenure of this committee was for five years.
- Indian Pharmacopeia committee under the chairmanship of Dr. B. N. Ghosh Published first edition of IP in 1955. It is written in English & official titles of monographs given in Latin. It covers 986 monographs. Supplement to this edition was published in 1960.
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Second Edition of IP was published in 1966 under the chairmanship of Dr. В. Mukherji. Official titles of monographs given in English. Supplement to this edition was published in 1975. 126 new monographs have been included & 250 monographs have been amended.
- Third edition of IP was published in 1985 with two volumes and nine appendices under the chairmanship of Dr. Nityanand.
- Fourth edition of IP was published in 1996 under the chairmanship of Dr. Nityanand. It covers 1149 monographs and 123 appendices.
- Fifth edition of IP published in 2007.
- Sixth edition of published in 2010 under the chairmanship of Mr. P. K. Pradhan. This edition is represented in three volumes.
- The seventh edition of the Indian Pharmacopoeia (IP 2014) is published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Government of India, Ministry of Health & Family Welfare. The IP 2014 Incorporates 2548 monographs of drugs out of which 577 are new monographs.
Latest Edition of I.P
Union Minister for Health and Family Welfare and Chemicals and Fertilisers, Dr. Mansukh Mandaviya chaired IPC Conference 2022 on July 1, 2022 and released 9th edition of Indian Pharmacopoeia at Vigyan Bhawan, New Delhi.
Salient features of I.P 2022:
IP 2022 contains-
- a total of 92 new monographs including 60 Chemical,
- 21 Vitamins, Minerals, Amino acids, Fatty acids etc.
- 3 Biotechnology-derived Therapeutic Products
- 4 Human Vaccines
- 2 Blood and Blood Related Products
- 2 Herbs and Herbal Related Products, and
- 7 Phytopharmaceutical Ingredient Category monographs
- This has led to the total number of 3152 monographs in the current edition of IP. In additions, 12 new general chapters have also been introduced.
- Several monographs and general chapters have also been revised to update them as per current global requirements and to harmonize with other pharmacopoeias like USP, BP, EP, etc.
- The harmonization of standards with global standards is expected to help IP getting recognized and accepted in foreign countries.
Current Status
The Indian Pharmacopoeia continues to be regularly updated and revised to incorporate new monographs, testing methods, and other relevant information. It remains a vital tool for ensuring the quality and safety of pharmaceutical products in India.
Mahadeva Lal Schroff
A Monograph is a thorough document that outlines the characteristics, quality criteria, and testing procedures for an individual pharmaceutical substance, ensuring uniformity and adherence to regulations in the production of drugs.
A Pharmacopoeia is a collection of lists and standard of medicinal substances, formulations & testing protocols which helps in ensuring the quality, safety, and efficacy of pharmaceuticals.