Indian Pharmacopoeia 2014 (Set of 4 Volumes)

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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 Indian Pharmacopoeia (IP) is published in fulfillment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules thereunder. It prescribes the standards for drugs produced and/or marketed the standards for drugs produced and/or marked in Indian and thus contributes in the control and assurance of the quality of the medicines. The standards of this pharmacopoeia are authoritative and legally enforceable. In intends to help in the licensing of manufacturing, inspection and distribution of medicines. IP is published in continuing pursuit of the mission of IPC to improve the health of the people through ensuring the quality, safety and efficacy of medicines. The commission has been receiving significant inputs from regulatory, industrial houses, academic institutions, national laboratories, individual scientists and other. Publication of IP at regular and shorter intervals is one of the main mandated of the Commission.

Indian Pharmacopoeia contains procedures for analysis and specification for the determination of quality of pharmaceutical substance, excipients an dosage forms. IP monograph for an official substance or preparation includes the article’s definition, description, identification, packaging, storage, specification, impurities, assay and specific tests, one or more analytical procedures for each test, acceptance criteria and other requirements etc.

The history of the IP began in the years 1833 when a Committee of the East India Company’s Dispensary recommended the publication of a Pharmacopoeia and Bengal Pharmacopoeia and General Conspectus of Medicinal Plants were published in 1844, which mainly listed most of the commonly used indigenous remedies. This was followed by IP 1868, which covered both the drugs of British Pharmacopoeia (BP) 1867 and indigenous drugs used in India, with a Supplement published in 1869 incorporating the vernacular names of indigenous drugs and plants. However, from 1885 the BP was made official in India. A Drugs Enquiry Committee appointed in 1927 by the government recommended the publication of a National Pharmacopoeia.

After independence, the Indian Pharmacopoeia Committee was constituted in 1948 for publication of IP as it main function. Which published the IP in 1955, followed by a Supplement in 1960. The pharmacopoeia contained both western and traditional system drugs commonly used in India and the same policy continued while preparing the Pharmacopoeia of India 1966 and its Supplement 1975. There had been a phenomenal growth and development of the Indian Pharma industry since independence, especially from early 1970, both in the range of Active Pharmaceutical Ingredients (APIs) and the dosage forms produced. This, totally transformed the profile of the Indian Pharmaceuticals markets and Indian Pharma industry emerged as one of the important global suppliers of pharmaceutical products, both to the developed and developing countries. These developments posed major challenges for the IP to reflect the quality standards of the marketed drugs, which the subsequent editions of IP tried to address.

In view of these rapid advances, it was decided to publish a new edition of the Pharmacopoeia and its Addenda at regular and shorter intervals for which the Indian Pharmacopoeia Committee was reconstituted in 1978. In the Pharmacopoeia of India 1985, its Addenda 1989 and 1991, inclusion of traditional system of drugs was limited. However, most of the new drugs manufactured and/or marketed were included, which only those herbal drugs which had definitive quality control standards had got place in it. In view of the continuing rapid increase in the range of drugs produced in India, are IP 1996, its Addendum 2000, Supplement 2000 for Veterinary Products and Addendum 2002 were published. The Addendum 2005 was published by the IPC which included a large number of antiretroviral drugs and raw plants commonly used in making medicinal products not covered by any other pharmacopoeias, which attracted much global attention. The IP Committee decided to delete the obsolete or less used product monographs and added monographs based on the therapeutic merit, medical need and extent of use of such articles in the country.

The Indian Pharmacopoeia Commission was established in year 2005. It provided systematic approach and practices for publication of IP 2007 containing 271 new monographs with focus on those drugs and formulations that cover the National Health Care Programmes and the National Essential Medicines and Addendum 2008 to the IP 2007 containing 72 new monographs.

IP 2010 contained monographs on antiretroviral, anticancer, antituberculosis and herbal drugs. It further emphasized on biological monographs such as Vaccines, Immunosera for human use, Blood product, Biotechnological and veterinary (Biological and non-biological) preparations. Addendum 2012 to the IP 2010 and also incorporated 52 new monographs.

The seventh edition of Indian Pharmacopoeia (IP- 2014) is published in accordance with the principles and designed plan decided by the Scientific Body of the IPC. To establish transparency in setting standards for the edition, the contexts of new monographs, revised appendices and other information’s have been publicized on the website of the IPC, besides following conventional approach of obtaining comments. The feedback and inputs have been reviewed by the relevant Expert Committee to ensure the feasibility and practicability of the standards and methods revised. The principle of “openness, justice and fairness” is kept in mind during compiling and editing the contents of the editions.

Public Review and Comment Process for standards development related to this edition of the Indian Pharmacopoeia has given special attention to incorporate comments from stakeholders. The methology adopted is appended below:

The IPC Secretariat and Indian Pharmacopoeia Laboratory (IPL) Staff, with the support of different advisory Expert Committee and Expert Members of the Scientific Body have examined the suitability of the standards. In order to make IP 2014 user friendly, the existing formatting pattern has been suitably revised. The standards prescribed in this edition are encouraged to adhere with the concept of harmonization, keeping in view the technological status for manufacture and analysis of drugs and pharmaceuticals in the country without compromising with the quality of the products. It strives to update the existing monographs as well as incorporating the new monographs of drug substances based on clinical use of medicines in India and improving their test protocols. The IP 2014 has been considerably revised and improved in respect of the requirements of monographs, appendices and testing protocols by introducing advanced technology. The contents of Appendices are by and large revised in consonance with those adopted internationally. The monographs of special relevance diseases of this region have been given special attention.

In additions, emphasis has been put to bring out harmonization in Appendices to establish a sound connection between individual monographs and the relevant appendices, so as to make this edition precise and well structured. Number of monographs and appendices are expanded further to incorporate the latest technological advancement and regulatory compliance. Constant efforts have been made to unify the National Drug Standards and to bring them in line with the International Standards progressively by addition of monographs of new drugs and adopting current methology.

IPC provides the official Indian Pharmacopoeia Reference Substances (IPRS) as primary reference standards to the stakeholders and the list of available IPRS is updated from time to time on the official website of IPC .

This is the seventh edition of the Indian Pharmacopoea. It comprises of four volumes. Each Volume has got different features.

Volume I: Notices; Preface; About Indian Pharmacopoea Commission; Acknowledgements; Introduction; General Notices; General Chapters and Reference Data.

Volume II: General Notices; Dosage Forms (General Monographs); Drug Substances, Dosage Forms and Pharmaceutical Aids.

Volume III: General Notices; Drug Substances, Dosage Forms and Pharmaceutical Aids (N to Z); Vaccines and Immunosera for Human Use; Herbs and Herbal Products; Blood and Blood-related Products; Biotechnology Products and Radiopharmaceutical Preparation.

Volume IV: General Notices; Notices; Veterinary Products and Index.

The Standards prescribed in the Indian Pharmacopoeia are to establish the compliance with regulatory requirements on an articles. The criteria to be adhered to are:

i) The inaterpretation of a monograph must to in accordance with all the general requirements, testing methods, texts and notices pertaining to it, in the IP.
ii) A product is not of standard quality unless it complies with all the requirements of the monograph.

The IP 2014 incorporates more than 577 new monographs consisting of APIs, excipients, dosage forms, radiopharmaceuticals, herbal and veterinary products etc. It is intended that this edition would play a significant role in improving the quality of medicines with in turn promotes public health and accelerates the growth and development of Pharma sector.

The seventh edition of the Indian Pharmacopoeia (IP 2014) is published by the Indian Pharmacopoeia Commission (IPC) in accordance with a designed plan by the Scientific Body of IPC, in fulfilment of the requirement of the Drugs and Cosmetics Act and the Rules thereunder and completed through the untiring efforts of its members, Secretariat and Laboratory over a period of about two years. It supersedes the IP 2010 edition but any monograph of the earlier edition that does not figure in this edition continues to be official as stipulated in the second Schedule of the Drugs and Cosmetics Act, 1940.

Presentations

The Indian Pharmacopoeia 2014 is presented in four voumes. Volume I contains the Notics, Preface, the Stucture of the IPS, Acknowledgements, Introduction and the General Chapters. Volume II contains the General Notics, Genreral Monographs on dosage forms. Monographs on drug substances, dosage forms and pharmaceutical aids (A to M). Volume III contains Monographs on drug substances, dosage forms and pharmaceutical aids (N to Z) followed by and distinguished by colour codes, Monographs on Vaccines and Immunosera for human use, Herbs and herbal products, Blook and blood-related products. Biotechnology prooducts and Radiopharmaceutical preparations, Volume IV contains Veterinary monographs and Index.

The scope of the Pharmacopoeia has been extended to include products of biotechnology, indigenous herbs and herbal products, veterinary vaccines and additional antiretroviral drugs and formulations, includive of commonly used fixed-dose combinations. Standards for new drugs and drugs used under National Health Programmes are added. Standards for new drugs and drugs used under National Health Programmes are added and the drugs as well as their formulations currently not used are omitted from this edition. The number of monographs of Excipients, Anticancer drugs, Herbal products and Antiretroviral drugs have been increased in the edition. Monographs of Vaccines and Immunosera are also upgraded in view of the latest development of the technology in the field. Many chapters have been revised in the Appendices. The monographs on Water for Injections in Bulk and Purified Water are also upgraded to harmonise with prevailing international requirements.

Format

In an effort to make the Pharmacopoeia more user-friendly, the design of the texts of the monographs and test methods are kepts same. Cross-referencing has been avoided to make each monograph complete in itself, thus making it convention to the user.

Basis of Pharmacopoeial Requirements

As in the past, this compendium provides a publicly available statement concerning the quality of a products that can be expected and demonstrated at any time throughout the accepted shelf-life of the article. The standards laid down represent the minimum with which the article must comply and it is for the manufacturer to ensure that the article is manufactured to accordance with Good Manufacturing Practices (GMPs). It is essential that sufficiently stringent limits are applied at the time of release of a batch of a drug substance or drug product so that the Pharmacopoeial standards are met until its expiry when stored under the storage conditions specified.

It must be noted that a valid interpretation of any requirement of the Pharmacopoeia should be done in the context of the monograph as a whole, the relevant general monographs, where appropriate, the specified tests and methods of analysis including any reference to the relevant General Notices, Familiarity with the General Notices with facilitate the correct application of the requirements.

Changes

Keeping in view the essential requirement under the Drugs and Cosmetics Act, 1940 and Rules thereunder, the information on the category of a drug, dosage and usual available strengths of dosages and usual available strengths of dosage forms has been kept in this edition.

General chemical tests for identifications of an article have been almost eliminated and the more specific infrared, ultraviolet spectrophotometric and HPLC tests have been given emphasis. The concept of relying on published infrared spectra as a basis for identification has been continued.

The use of Chromatographic methods has been greatly extended to cope with the need for the specificity in assays and in particular, in assessing the nature and extent of impurities in drug substances and drug products. Most of the existing assays and related substances tests have been upgraded to liquid chromatography method in view to have the specificity and to harmonise with other International Pharmacopoeias to the extent necessary.

In most of the parenteral preparation and other monographs, the test of pyrogens involving the use of animals has been almost eliminated and replaced with Bacterial Endotoxin test. In some blood and blood related monographs, the Bacterial Endotoxin test has been incorporated. The test for Shigella has been added along with Salmonella in the Microbial Contamination test of several monographs. Several new monographs on antibiotics have been added where the Assay is by microbiological methods.

More essential oils monographs, crude herbal drugs and extracts have been incorporated and also some existing monographs have been revised under the section Herbs and Herbal Products in Volume III. For the first time , 19 monographs on radiopharmaceutical preparations along with a chapter on Radiopharmaceuticals have been added in Volume III, of this edition.

A separate volume for veterinary monographs as Volume IV of this edition of Indian Pharmacopoeia has been designed to provide comprehensive information to those concerned with the quality control of veterinary medicines. For the first time, a general chapter on cell cultures for the production of veterinary vaccines and other general monographs has been incorporated. Several monographs on chemicals along with a number of monographs on veterinary vaccines, diagnostic, immunosera and surgical materials have been given place in this volume. Many monographs just on the basis of usual strength and doses have been mentioned in this volume while complete monographs are mentioned in other volumes of IP.

The monograph on Salmonella pullorum antigen to Salmonella pullorum coloured antigen has been fully revised and the monograph of Brucella abortus coloured antigen has been omitted. The inactivation test has been added in many monographs. Any necessary corrections have been incorporated in this edition.

General Chapters

Volume I is devoted mainly to test methods that are applicable to all the articles of the pharmacopoeia and general information pertaining to the quality requirements of medicinal substances. It also includes reference data such as reference spectra, typical chromatograms etc. The test methods reflect the sophistication of analytical methodology and instrumentation.

Analytical methods are, in general, in harmony with those adopted internationally for monitoring the quality of drugs. The steps taken for harmonization have been initiated by the need to cope with the increasing demand for drugs manufactured in the country to meet globally accepted standards. Accordingly we have introduced in 19 new chapters based on current technologies used by the stakeholders and harmonized with other international pharmacopoeias; like mass spectroscopy, inductively coupled mass spectroscopy and polymorphism etc.

The trend towards controlling the microbial quality of all medicinal products has been recognized and the requirement regarding limits of microbial contamination, even of products for oral administration and topical application, so that adequate controls are exercised by the manufactures by the adoption of GMPs has been continued.

General chapters on Bacterial Endotoxins, Microbial contamination of non-sterile products Microbiological quality of pharmaceutical preparations. Microbiological assay of antibiotics and Sterility has been extensively revised. The general chapters of Microbial contamination of non-sterile products and Microbiological quality of pharmaceutical preparations have been merged together. For the first time, a general chapters on (i) Transfusion and infusion assemblies and similar medical devices and (ii) Amino acid analysis have been also included first time. The general monographs on Purified Water and Water for Injections in bulk have been fully revised and a comprehensive note on Drinking Water has been incorporated in the general chapter of Water for pharmaceutical use.

In the Herbs and herbal products section, the Chapter on DNA based authentication techniques of herbal drugs and determination of flash point of essential oils has been incorporated.

The chapter on biotechnology derived therapeutic products has been fully revised. Special emphasis has been given on monoclonal antibodies antisera.