It is a pharmacopoeia published yearly by the United States Pharmacopoeia Convention, a non-profit organization.
The USP is published in combination with the National Formulary known in conjunction as USP-NF.
Drugs which are subject to USP standard include both human (prescription, over the counter or otherwise) drugs as well as veterinary drugs.
These standards have a role in the US federal law. For e.g. a drug or an API with a name in the USP-NF is labelled as adulterated if it does not meet the standards given in the pharmacopoeia for strength, quality and purity.
It also sets standards for dietary supplements and food ingredients as per the Food Chemicals Codex.
However, enforcing these standards is the responsibility of the Food and Drug Administration (FDA) and other government authorities worldwide.
The USP is printed in 3 volumes. Volume I contains the general chapters while volumes II and III contain the monographs.
It has 16 appendices which describe the tests required to be carried out.
It is an official document meant for the overall quality control and assurance of pharmaceutical products marketed in India by contributing to their safety, efficacy and cost.
The IP has a collection of procedures of analysis and specifications of drugs.
IP prescribes standards for the identity, purity and strength of drugs essentially needed from the perspective of health of human beings and animals.
The IP standards are authoritative in nature meaning that they are enforced by the regulatory authorities for the quality control of pharmaceuticals in India.
These standards are legally acceptable during quality assurance and in a court of law when there are disputes.
The first edition of the Indian Pharmacopoeia was published in 1955.
The latest edition of the IP was published in 2022 in four volumes.
The IP 2022 has 92 new monographs consisting of APIs, dosage forms, vitamins, minerals, amino acids, fatty acids, biotechnology derived products, etc.
It is a compilation of various Ayurvedic pharmaceutical formulations i.e. their formula and their methods of preparations.
It is published by the Ayurvedic Pharmacopoeia Commission (APC) which was founded in 1962 by the Government of India.
APC also prescribes the working standards for compound Ayurvedic formulations including the tests for their identity, purity, strength and quality.
Ayurvedic Pharmacopoeia of India has two parts, Part I and Part II out of which Part I has a total of 10 volumes which contain 540 medicinal plants along with others.
API volumes 7 and 10 deal with metals and minerals.
A total of 665 monographs have been published in the API Part I.
A typical monograph format:
Name of the formulation ; definition
Formulation/Composition
Method of Preparation
Description
Identification; Physicochemical Parameters
Storage; Therapeutic Uses
Dose; Anupana (Liquid taken with drug or food intake or after drug or food intake)
In earlier times, the information on various classical Ayurvedic books was scattered.
This entire information was compiled in a book which is known as the Ayurvedic Formulary of India.
A list of single drugs of plant, mineral and animal origins has been prepared on the basis of names appeared in the formulations.
Also, their official names and English equivalents are given for easy identification.
The Ayurvedic Formulary of India is divided into 3 parts, Part I, Part II and Part III.
Part I was published in 1976 and contains 444 monographs, Part II was published in 2000 and contains 192 monographs while Part III was published in 2011 and contains 350 monographs.
There are over 800 formulations in all the three parts of Ayurvedic Formulary of India combined.
Along with the monographs, there are four appendices in the AFI, appendix I, appendix II, appendix III and appendix IV.
Appendices I and II contain definitions of various terminologies in Ayurveda, Shodhana (purification) and Ashta samskara (the processes for purification) of Parada (mercury) respectively.
Appendices III and IV contain the therapeutic indices (both formula wise and disease wise) and the list of diseases/technical terms and their English equivalents respectively.
