Indian Pharmacopoeia 2014 (Addendum 2016)

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Addendum-2016 to Indian Pharmacopoeia (IP 2014) is published the Indian Pharmacopoeia Commission (IPC) on behalf of the Government of India, Ministry of Health & Family Welfare. The Indian Pharmacopoeia (IP) 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 and Addendum are authoritative and legally enforceable. It intends to help in the licensing of manufacturing, inspection and distribution of medicines. Addendum-2016 to IP-2014 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 bodies, Industrial houses, academic institutions, national individual scientists and others. Publication IP and its addendum at regular and shorter intervals is one of the main mandates of the Commission.

IP addendum-2016 contains procedures for analysis and specifications for the determination of quality of pharmaceutical substances and dosage forms. IP Addendum 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 and 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 were published in 1844, which mainly listed 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 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 totally transformed the profile of the Indian Pharmaceuticals market 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 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, while only those herbal drugs which had definitive quality control standard 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 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 List of 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 products, Biotechnological and veterinary (Biological and non-biological) preparations. Addendum 2012 to the IP 2010 was published which had taken care of the Amendments to 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 this edition, the contents of new monographs, revised appendices and other informations have 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 fairness” is kept in mind during compiling and editing the contents of this edition.

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 methodology 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 teachnological 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 as well as incorporating the new monographs of drug substances based on clinical use of medicines in India and improving their rest 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 addition, emphasis has been put to bring out harmonisation 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 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.

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 (www.ipc.gov.in).

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

(i) The interpretation of a monograph must be in accordance with all the general requirements, testing method, 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.

In accordance to the regular publication, Addendum 2015 of IP 2014 was published which consisted of amendments to IP 2014 and also incorporated 82 new monographs including 57 new chemical monographs, 13 herbal monographs, 02 vaccine monographs and 10 radiopharmaceutical monographs.

Subsequently, Addendum 2016 to IP 2014 has taken care of the amendments to IP-2014 and has also incorporated 89 new monographs including 64 new chemical monographs, 03 vaccines and immunosera for human use, 14 herbs and herbal product , 01 blood and blood related products, 04 biotechnology monographs and 03 radiopharmaceutical preparations.

This Addendum to 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 requirements of the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder and completed through the unitiring efforts its members, Secretariat and Laboratory over a period of about one year.

Presentation

The Addendum-2016 to Indian Pharmacopoeia 2014 contains the Notices, Preface, the Structure of the IPC, Acknowledgements, Introduction and the General Chapters. Monographs on dosage forms, Monographs on drug substances, Monographs on Vaccines and Immunosera for human use, Herbs and herbal products, and Radiopharmaceutical preparations and Index.

Format

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

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 expected 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 in 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 a drug product so that the pharmacopoeial standards are met until expiry when stored under the storage condition specified.

It must be noted that a valid interpretation of any requirement of the Addendum should be done in the context of the monograph as a whole, the relevant general monographs, where appropriate, the specified tests 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

General chemical tests for identification of an article have been almost eliminated and the more specific infrared, ultraviolet spectrophotometric, HPLC and HPTLC 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 chromatography method in view to have the specificity and to harmonise with other International Pharmacopoeias to the extent necessary.

General Chapters

Keeping in view the essential requirement for harmonization of analytical methods with those adopted internationally, step have been taken for monitoring the quality of drug.

Accordingly we have included new general chapters on Glycoprotein and glycan analysis and Drug substances manufactured by cell culture/fermentation. Few general chapters such as Thin Layer Chromatography, Sterility, General monograph on Parenteral preparations and Vaccines: General Requirements have been revised.

Monographs

The general monograph for the API and the dosage form have been grouped together initially. They are followed by herbs and herbal products, vaccines and immunosera for human use and finally radiopharmaceutical preparations.

Special emphasis has been given to the radiopharmaceutical preparation and dosages form for API whose dosage forms were not in IP-2014.