Indian Pharmacopoeia 2010

The sixth edition of the Indian Pharmacopoeia (IP 2010) 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 fulfilment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules thereunder. It prescribes the standards for drugs produced and/or marketed in India and thus contributes in the control and assurance of the quality of the medicines. The standards of this pharmacopoeia are authoritative and legally enforceable. It 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 in puts from regulatory, industrial houses, academic institutions, national laboratories, individual scientists and others. Publication of IP at regular and shorter intervals is one of the main mandates of the Commission. 

Indian Pharmacopoeia contains procedures for analysis and specifications for the determination of quality of pharmaceutical substances, excipients and dosage forms. IP

monograph for an official substance or preparation includes the article's definition, description, identification, packaging, storage, specifications, impurities, assay and specific tests, one or more analytical procedures for each test, acceptance criteria, other requirements etc.

The history of the IP began in the year 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 was 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 its main function, which published the IP in 1955, followed by a Supplement in 1960. This 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 had totally transformed the profile of the Indian Pharmaceuticals market. Indian Pharma industry had emerged as one of the important global supplier 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 were limited. However, most of the . new drugs manufactured and/or marketed were included, while 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, the IP 1996, its Addendum 2000, Supplement 2000 for Veterinary Products and Addenda 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 and 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 has been established in year 2005. It provided systematic approach and practices for publication of IP 2007 with focus on those drugs and formulations that cover the National Health Care Programmes and the National Essential Medicines. It contained monographs on antiretroviral, anticancer, anti tuberculosis and herbal drugs. It further emphasized on biological monographs such as Vaccines, Immunosera for Human use, Blood products, Biotechnological and Veterinary (Biological and nonbiological) preparations. Addendum 2008 to the IP 2007 was published which had taken care of the Amendments to IP 2007 and also incorporated 72 new monographs.

The sixth edition of Indian Pharmacopoeia 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 this edition, the contents 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 were 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 this edition.

This is the sixth edition of the Indian Pharmacopoeia. It comprises of three volumes. Each volume has got different features.

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

Volume ll: General Notices; Dosage Forms (General Monographs); Drug Substances, Dosage Forms and Pharmaceutical Aids (A to M).

Volume Ill: 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; Veterinary Products and Index. 

Download IP 2010 

Post a Comment


Table of Contents