INDIAN PHARMACOPOEIA 2010

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 fulfill 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 inputs 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. ADrugs 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 he 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, antituberculosis and herbal drugs. It further emphasized on biological monographs such as Vaccines, Immunosera for Human use, Blood products, Biotechnological and Veterinary (Biological and non­ biological) 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 informations 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 he 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, antituberculosis and herbal drugs. It further emphasized on biological monographs such as Vaccines, Immunosera for Human use, Blood products, Biotechnological and Veterinary (Biological and non­ biological) 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 informations 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 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 2010 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 2010 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 addition, emphasis has been put to bring out harmonisation in Appendices to establish a sound connection between individual monographs and the relevant appendices, so asto 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 methodology.

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

Volume 1 

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

Volume 2

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

Volume 3

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.

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

(i) The interpretationofamonograph must beinaccordance with allthe 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 2010 incorporates 287 new monographs consisting of APis, excipients, dosage forms and herbal products etc. It is hoped that this edition would play a significant role in improving the quality of medicines which in tum promote public health and accelerate the growth and development of Pharma Sector.

Introduction

This new edition of the Indian Pharmacopoeia entitled 6th edition (Indian Pharmacopoeia 2010) is published by the Indian Pharmacopoeia Commission (IPC) in accordance with a plan and completed through the untiring efforts of its members, Secretariat and Laboratory over a period of about two years. It supersedes the 2007 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 CosmeticsAct, 1940.

Presentation

The Indian Pharmacopoeia 2010 is presented in three volumes. Volume I contains the Notices, Preface, the Structure of the IPC, Acknowledgements, Introduction, and the General Chapters. Volume II contains the General Notice, General Monographs on Dosage Forms, Monographs on drug substances, dosage forms and pharmaceutical aids (A to M). Volume ID contains Monographs on drug substances, dosage forms and pharmaceutical aids (N to Z) followed by Monographs on Vaccines and Immunosera for Human use, Herbs and Herbal products, Blood and blood-related products, Biotechnology products and Veterinary 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, inclusive of commonly used fixed­ dose combinations. Standards for new drugs and drugs used under National Health Programmes are added and the drugs as well as their formulations not in use now a days are omitted from this edition. The number of monographs of Excipients, Anticancer drugs, Herbal products and Antiretroviral drugs have been increased in this edition. Monographs of Vaccines and Immunosera are also upgraded in view of development of latest technology in the field. A new chapter on Liposomal products and a monograph of Liposomal Amphotericin B injection is an added advantage in view of latest technology adopted for drug delivery. A chapter on NMR is incorporated in Appendices. The chapter on microbial contamination is also updated to a great extent to harmonise with prevailing international requirements.

Format

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

Basis of Pharmacopoeial Requirements

As in the past, this compendium provides a publicly available statement concerning the quality of a product 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 inculcate on the manufacturer to ensure that the article is manufactured in accordance with the 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 pharmacopoeia! standards are met until its expiry date 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 monograph, where appropriate, the specified tests and methods of analysis including any reference to the relevant General Notices. Familiarity with the General Notices will facilitate the correct application of the requirements.

Changes

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

General chemical tests for identification of an article have been almost eliminated and the more specific infrared and ultraviolet spectrophotometric 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 more 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 are upgraded by liquid chromatography method in view to have more specificity and to harmonise with other International Pharmacopoeias.

The test for pyrogens involving the use of animals has been virtually eliminated. The test for bacterial endotoxins introduced in the previous edition is now applicable to more items. The test for abnormal toxicity is now confined to certain vaccines.

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. A list of287 new monographs items not included in the 2007

It also includes reference data such as reference spectra, · edition of the Indian Pharmacopoeia and its addendum 2008 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.

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

The chapter on Vaccines: General requirements has been updated. Minor corrections have been made in the appendices entitled Tests onChicken flocks free from specified pathogens for the production and quality control of vaccines and General provisions: Avian viral vaccines-Tests for extraneous agents in seed lot. The peptide mapping test for Inactivated Hepatitis B Vaccine has been deleted. Wherever appropriate, other corrections have also been incorporated and overall presentation improved.

In view of considering the microbiological quality, the whole microbiological general chapter·comprising of effectiveness of antimicrobiitl preservatives, microbial contamination in nonsterile products and microbiological quality of raw material, dosage forms, herbs, processed herbs and herbal products have been extensively revised. For the first time in this chapter the analysis of strain Shigella boydii has been introduced which is possibly not available in other Pharmacopoeias. The addition  of  this  strain  Shigella  boydii  is  essential  as it is acute dysentry causing strain of tropical·region of our country.

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

pertaining to the quality requirements of medicinal substances.A list of 287 new monographs items not included in the 2007 It also includes reference data such as reference spectra, · edition of the Indian Pharmacopoeia and its addendum 2008 typical chromatograms etc. The test methods reflect the sophistication ofanalytical methodology and instru.rilentation.

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.

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

The chapter on Vaccines: General requirements has been updated. Minor corrections have been made in the appendices entitled Tests onChicken flocks free from specified pathogens for the production and quality control of vaccines and General provisions: Avian viral vaccines-Tests for extraneous agents in seed lot. The peptide mapping test for Inactivated Hepatitis B Vaccine has been deleted. Wherever appropriate, other corrections have also been incorporated and overall presentation improved.

In view of considering the microbiological quality, the whole microbiological general chapter·comprising of effectiveness of antimicrobiitl preservatives, microbial contamination in nonsterile products and microbiological quality of raw material, dosage forms, herbs, processed herbs and herbal products have been extensively revised. For the first time in this chapter the analysis of strain Shigella boydii has been introduced which is possibly not available in other Pharmacopoeias. The addition  of  this  strain  Shigella  boydii  is  essential  as it is acute dysentry causing strain of tropical·region of our country.

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

Volume 1

  

Volume 2



Volume 3


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