Indian Pharmacopoeia 2007 Pharma Medical-Books Pdf

INDIAN PHARMACOPOEIA 2007 Pharma Medical
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ISBN 81 903436 0 3, 2007 Indian Pharmacopoeia Commission. Application for reproduction should be made to the INDIAN PHARMACOPOEIA COMMISSION. Sector 23 Raj Nagar, Ghaziabad 201 002, Tale 91 120 2783401. Fax 91 120 2783311, Web site www ipc gov in E mail ipclab vsnl net. Effective from 31st March 2008, On behalf of GOVERNMENT OF INDIA. MINISTRY OF HEALTH FAMILY WELFARE, Designed produced published by THE INDIAN PHARMACOPOEIA COMMISSION.
CENTRAL INDIAN PHARMACOPOEIA LABORATORY, GOVT OF INDIA MINISTRY OF HEALTH FAMILY WELFARE. SECTOR 23 RAJ NAGAR GHAZIABAD 201 002, Printed by NATIONAL INSTITUTE OF SCIENCE COMMUNICATION. AND INFORMATION RESOURCES NISCAIR, COUNCIL OF SCIENTIFIC INDUSTRIAL RESEARCH. PUSA GATE K S KRISHNAN MARG NEW DELHI 110012, Price Inland Rs 25000 00. Foreign 1000 00, IP 2007 NOTICES, Legal Notices Scientific Director is authorised to issue such amendments.
In India under the Drugs and Cosmetics Act 1940 the current Whenever such amendments are issued the Indian. edition of Indian Pharmacopoeia is a book of standards for Pharmacopoeia would be deemed to have been amended. drugs included therein and the standards as included in the accordingly. Indian Pharmacopoeia would be official Also in several other. laws of India the Indian Pharmacopoeia is recognised as the. Patents And Trade Marks, standard book It is expedient that enquiry be made in each In the Indian Pharmacopoeia certain drugs and preparations. case in order to ensure that the provisions of any such law are have been included notwithstanding the existence of actual. being complied with In general the Drugs and Cosmetics or potential rights in any part of the world In so far as such. Act 1940 the Narcotic Drugs and Psychotropic Substances substances are protected by Letters Patent their inclusion in. Act 1985 the Poisons Act 1919 and the rules framed the Indian Pharmacopoeia neither conveys nor implies licence. thereunder should be consulted These statutes empower the to manufacture without due permission authority or licence. Government agencies to enforce the law using this from the person or persons in whom such rights exist. compendium The monographs of the Indian Pharmacopoeia. The titles given under the individual monographs are public. should be read subject to the restriction imposed by those. property These titles cannot be patented as trade marks and. laws which are applicable, no person is permitted to patent any trade mark devising the. If considered necessary the standards included in Indian root of these titles. Pharmacopoeia can be amended and the Secretary cum. IP 2007 PREFACE, The Indian Pharmacopoeia 2007 is published by the Indian technology and experimental methods widely adopted in India. Pharmacopoeia Commission IPC on behalf of the Government and abroad are being added and updated The contents of. of India Ministry of Health Family Welfare The Government Appendices are revised by and large in consonance with those. of India constituted the IPC vide their Order No Z 14012 IPC nowadays adopted internationally for monitoring the quality. CBP 2003 dated 22nd March 2005 The IPC is a Society under of the drugs The monographs of special relevance to the. the provisions of the Societies Registration Act 1860 Act common disease pattern of this region have been given special. No 21 of 1860 for the registration of Literary Scientific and emphasis by incorporating such medicines. Charitable Societies The functioning of the Commission is In addition emphasis has been put to bring out harmonisation. governed by the provisions of the approved Memorandum of in Appendices to a sound connection between individual. Association Rules and Regulations of the IPC monographs and the relevant appendices and to the. The Commission has set up its headquarters in the campus of standardization of text wording so as to make this edition. the Central Indian Pharmacopoeia Laboratory CIPL Sector precise and well structured The number of monographs in. 23 Raj Nagar Ghaziabad UP The Director CIPL also Appendices are expanded further to incorporate the latest. functions as the Secretary cum Scientific Director of the IPC technological advances and complies with regulatory. The CIPL is the support structure of the Commission requirements Great efforts have been made to unify the. The Indian Pharmacopoeia is being produced in fulfillment of National Drug Standards and to bring them in line with the. the requirement in the Drugs and Cosmetics Rules 1945 of International Standards progressively by addition of. standards of drugs produced in India and in the belief that it monographs of new drugs and current methodology adopted. contributes significantly in the control of the quality of Public Review and Comment Process for Standards Develop. medicinal products The standards of this pharmacopoeia are ment Related to this edition of the Indian Pharmacopoeia have. legally enforceable and are intended to help in the licensing been given special attention to incorporate comments from. and inspection processes stakeholders as shown below. After independence an Indian Pharmacopoeia Committee was. constituted in 1948 which prepared the Pharmacopoeia of. India The Indian Pharmacopoeia 1955 A Supplement to it. was published in 1960 This pharmacopoeia contained western. and also traditional drugs and the same policy continued. while preparing the Pharmacopoeia of India 1966 and its 1975. Supplement In the Pharmacopoeia of India 1985 and its. Addenda 1989 and 1991 traditional drugs were not included. as publication of a pharmacopoeia of traditional system drugs. was taken up separately and only those herbal drugs were. included which had supporting definitive quality control. In the period since the publication of the 1985 Edition there. has been a significant increase in the range of drugs produced. in India Keeping this in mind the Committee has deleted or. added monographs on a system of priorities based on the. medical merit and the extent of use of any given article in the. country in its following 1996 Edition and its addenda in 2000. 2002 2005 and one supplement for Veterninary Products in 2002. The Indian Pharmacopoeia 2007 has been prepared in. accordance with the principles and designed plan decided by. the Scientific Body of the Indian Pharmacopoeia Commission. and completed with untiring efforts made by Commission. members and its Secretariat over almost two years, The Indian Pharmacopoeia 2007 is presented on the user. friendly format The General Notices Monographs and new. testing methods etc based on the introduction of advanced. PREFACE IP 2007, In addition to the traditional way of requesting for comments adopts new style of formatting The improvement of quality in.
the contents of revised appendices and monographs have printing and binding makes this edition look more elegant. been publicized on the website of the Indian Pharmacopoeia The Indian Pharmacopoeia 2007 is published in three volumes. Commission aiming at collecting comments widely from It is presumed that the Pharmacopoeia would play a vital role. various institutions and organizations All the feedbacks and in initiating new prospect for improving the quality of medicines. inputs have been reviewed by the relevant Expert Committee and would also help to accelerate development of Pharma. to ensure the feasibility and practicability of the standards Sector. and methods revised in this edition of Pharmacopoeia and The Commission places on record its appreciation of the. ensure that the principle of openness justice and fairness services of all the persons who have contributed to the. is kept in the process of compiling and editing production of this compendium. In order to make it easy for reading understanding and. interpreting the content of the Indian Pharmacopoeia 2007. IP 2007 INDIAN PHARMACOPOEIA COMMISSION, Indian Pharmacopoeia Commission. The Indian Pharmacopoeia Commission IPC has a three tier To accelerate the process of preparation certification and. structure comprising of the General Body of 19 members distribution of IP Reference Substances including the. Governing Body of 8 10 members and Scientific Body of 15 23 related substances impurities and degradation products. members from different related scientific fields the number of To collaborate with pharmacopoeias like the Ph Eur BP. members of the Scientific Body may vary from time to time USP JP ChP and International Pharmacopoeia with a view. The Secretary Ministry of Health and Family Welfare is the to harmonizing with global standards. Chairman and the the Chairman Scientific Body is the Co. To review existing monographs periodically with a view. Chairman of the Commission, to deleting obsolete ones and amending those requiring. upgradation revision, To organize educational programs and research activities. for spreading and establishing awareness on the need. and scope of quality standards for drugs and related. articles materials, The Governing Body, IPC Structure. The composition of the Governing Body is given below. The primary responsibility of the Scientific Body is to provide Chairman The Secretary Health Family Welfare. guidlines for Standards development related to the Indian Government of India. Pharmacopoeia with assistance of its Expert Committees Ministry of Health Family Welfare. The Indian Pharmacopoeia is published in continuing pursuit Nirman Bhawan. of the Mission Vision and Objectives of the IPC New Delhi 110 011. Mr Prasanna Hota until 30 October 2006, Mission Mr Naresh Dayal from 31 October 2007.
To promote public health in India by bringing out authoritative Co Chairman Dr Nitya Anand. and officially accepted standard for quality of drugs including Ex Director. active pharmaceutical ingredients excipients and dosage Central Drug Research Institute. forms used by health professionals patients and consumers B 62 Nirala Nagar. Lucknow 226 020, Member The Additional Secretary Finance Advisor. To promote the highest standards of drugs for use in humans Ministry of Health Family Welfare. and animals within practical limits of the technologies available Nirman Bhawan. for manufacture and analysis New Delhi 110 011, Objectives Dr Sanjiv Misra until 30 April 2006. Mr Raghubir Singh from 30 May 2006, To develop comprehensive monographs for drugs to be. included in the Indian Pharmacopoeia including active Invitee The Additional Secretary. pharmaceutical ingredients pharmaceutical aids and Ministry of Health Family Welfare. dosage forms as well as medical devices and to keep Nirman Bhawan. them updated by revision on a regular basis New Delhi 110 011. To develop monographs for herbal drugs both raw drugs Mr Deepak Gupta. and extracts formulations therefrom Member The Joint Secretary Drugs. To accord priority to monographs of drugs included in Ministry of Health Family Welfare. the National Essential Drugs List and their dosage forms Nirman Bhawan. To take note of the different levels of sophistication in New Delhi 110 011. analytical testing instrumentation available while framing Ms Rita Teaotia until February 2007. the monographs Mr Debasish Panda from 2 April 2007. INDIAN PHARMACOPOEIA COMMISSION IP 2007, Member The Drugs Controller General I Member The Joint Secretary Drugs. Directorate General of Health Services Ministry of Health Family Welfare. Ministry of Health Family Welfare Nirman Bhawan New Delhi. Nirman Bhawan Ms Rita Teaotia until February 2007, New Delhi 110 011 Mr Debasish Panda from 2 April 2007.
Mr Ashwini Kumar until 31 August 2006, Member The Drugs Controller General I. Dr M Venkateswarlu from 1 September 2006, Directorate General of Health Services. Member The Director Drugs Nirman Bhawan New Delhi, Ministry of Health Family Welfare Mr Ashwini Kumar until 31 August 2006. Nirman Bhawan Dr M Venkateswarlu from 1 September2006. New Delhi 110 011, Member The Director, Mr Rajesh Bhushan until 12 December 2006. National Institute of Biologicals, Dr Asha Thomas from January 2007.
B 62 Institutional Area, Member The Director Noida 201 307. National Institute of Biologicals Dr V K Kashyap, B 62 Institutional Area. Noida 201 307 Member The Director, Dr V K Kashyap Central Drugs Laboratory. 3 Kyd Street, Invitee Dr P R Pabrai Kolkata, Ex Director Central Indian Pharmacopoeia. Dr P K Chatterjee until December 2005, Laboratory, C 568 Sarita Vihar Member The Joint Drugs Controller.
New Delhi 110 076 North Zone, Ghaziabad U P, Member The Director. Secretary Central Indian Pharmacopoeia Laboratory Dr S R Gupta until 30 September 2005. Sector 23 Rajnagar Mr N C Dhawan from 12 July 2007. Ghaziabad 201 002 Member The Director Professor, Dr G N Singh Department of Pharmacology. Jawaharlal Institute of Post graduate Medical, The General Body Education and Research. Pondicherry 605 006, The composition of the General Body is as follows. Dr C Adithan, Chairman The Secretary Health Family Welfare.
Government of India Member Commissioners in charge of Drug Control. Ministry of Health Family Welfare Administration Andhra Pradesh. Nirman Bhawan Mr Ranga Rao, New Delhi 110 011, Member Commissioners in charge of Drug Control. Mr Prasanna Hota until 30 October 2006 Administration Maharashtra. Mr Naresh Dayal from 31 October 2007 Mr A Ram Krishnan. Member Dr Nitya Anand Member Commissioners in charge of Drug Control. The Indian Pharmacopoeia 2007 has been prepared in accordance with the principles and designed plan decided by the Scientific Body of the Indian Pharmacopoeia Commission and completed with untiring efforts made by Commission members and its Secretariat over almost two years The Indian Pharmacopoeia 2007 is presented on the user friendly format

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