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Pages from the book. Indian Pharmacopoeia Set of 4 Volumes.
Item Code:. The Indian Pharmacopoeia Commisssion, Ghaziabad. Look Inside the Book. Viewed times since 28th Nov, 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. This was followed by IP , which covered both the drugs of British Pharmacopoeia BP and indigenous drugs used in India, with a Supplement published in incorporating the vernacular names of indigenous drugs and plants.
However, from the BP was made official in India. A Drugs Enquiry Committee appointed in by the government recommended the publication of a National Pharmacopoeia.
After independence, the Indian Pharmacopoeia Committee was constituted in for publication of IP as it main function. Which published the IP in , followed by a Supplement in The pharmacopoeia contained both western and traditional system drugs commonly used in India and the same policy continued while preparing the Pharmacopoeia of India and its Supplement There had been a phenomenal growth and development of the Indian Pharma industry since independence, especially from early , 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 In the Pharmacopoeia of India , its Addenda and , inclusion of traditional system of drugs was limited. In view of the continuing rapid increase in the range of drugs produced in India, are IP , its Addendum , Supplement for Veterinary Products and Addendum were published. The Addendum 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 It provided systematic approach and practices for publication of IP containing new monographs with focus on those drugs and formulations that cover the National Health Care Programmes and the National Essential Medicines and Addendum to the IP containing 72 new monographs.
IP 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 to the IP and also incorporated 52 new monographs. The feedback and inputs have been reviewed by the relevant Expert Committee to ensure the feasibility and practicability of the standards and methods revised. 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: In order to make IP 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 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. This is the seventh edition of the Indian Pharmacopoea.
It comprises of four volumes. Each Volume has got different features. Volume I: Volume II: Volume III: Volume IV: 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: The IP incorporates more than 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.
Introduction The seventh edition of the Indian Pharmacopoeia IP 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 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, Presentations The Indian Pharmacopoeia is presented in four voumes.
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.
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.
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