The seventh edition of the Indian Pharmacopoeia (IP 2014) 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 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.
The seventh 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 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.
The Indian Pharmacopoeia 2014 is presented in four volumes. The scope of the Pharmacopoeia has been extended to includes additional anticancer drugs & antiretroviral drugs and formulations, products of biotechnology, indigenous herbs and herbal products, veterinary vaccines. 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 IP 2014 incorporates 2548 monographs of drugs out of which 577 are 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 turn promote public health and accelerate the growth and development of Pharma Sector.
A list of 577 New Monographs not included in IP-2010 and its Addendum-2012 but added in this edition containing 313 New Monographs on drug substances, Dosage forms & Pharmaceutical aids (A to Z), 43 New Drugs Substances Monographs, 10 Antibiotic Monographs, 31 Herbal Monographs, 05 Vaccines & immunosera for human use, 06 Insulin Products, 07 Biotechnology Products etc. alongwith the 19 new General Chapters.
19 New Radiopharmaceutical Monographs & 1 General chapter is first time being included in this edition.
Features of IP Addendum 2015 to IP 2014
IP Addendum 2015 to Indian Pharmacopoeia (IP 2014) is to be published in accordance with a designed plan by the Scientific Body of IPC, in fulfillment of the requirements of the Drugs and Cosmetics Act and the Rules there under.
The Addendum 2015 to Indian Pharmacopoeia 2014 contains the Notices, Preface, 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.
This Addendum has the same authority as the Indian Pharmacopoeia 2014.The General Notices, Monographs, Appendices and other contents of the Indian Pharmacopoeia that are amended by this Addendum supersede the original matter.
This Addendum amends as well as adds new materials to the Indian Pharmacopoeia 2014.
The General Notices and Appendices included in the Indian Pharmacopoeia 2014 apply to the contents of this Addendum as well unless specifically stated otherwise.
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 ingredients and products.
Most of existing Assays and Related substances tests are upgraded by liquid chromatographic method in view to harmonize with other international Pharmacopoeias.
Keeping in view the essential requirement for harmonization of analytical methods with those adopted internationally, steps have been taken for monitoring the quality of drug.
According we have revised general chapters on volumetric glasses, peptide mapping, sterility testing, conductivity, solubility, dissolution test, bulk density and tapped density of powders.
For controlling the microbial quality of all the medicinal product general chapters on microbial contamination in nonsterile products and test for colony forming units have been revised.
Specific Features of Addendum 2015
(i) 57 new Chemical monographs
(ii) 13 new Herbal monographs
(iii) 02 new Human Vaccines Monographs
(iv) 10 Radiopharmaceutical Monographs
(v) 06 Revised monographs
(vi) 29 Revised tests
(vii) About 20 new IR spectras