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- How it is published and what it contains- How it differs from previous editions H2: Products of biotechnology - What are products of biotechnology and how they are regulated- Examples of products of biotechnology in IP 2014- Standards and test methods for products of biotechnology H2: Indigenous herbs and herbal products - What are indigenous herbs and herbal products and how they are used- Examples of indigenous herbs and herbal products in IP 2014- Standards and test methods for indigenous herbs and herbal products H2: Veterinary vaccines - What are veterinary vaccines and how they are used- Examples of veterinary vaccines in IP 2014- Standards and test methods for veterinary vaccines H2: Antiretroviral drugs and formulations - What are antiretroviral drugs and formulations and how they are used- Examples of antiretroviral drugs and formulations in IP 2014- Standards and test methods for antiretroviral drugs and formulations H2: New drugs and drugs used under National Health Programmes - What are new drugs and drugs used under National Health Programmes and how they are regulated- Examples of new drugs and drugs used under National Health Programmes in IP 2014- Standards and test methods for new drugs and drugs used under National Health Programmes H2: Water for Injections in Bulk and Purified Water - What are Water for Injections in Bulk and Purified Water and how they are used- How they are upgraded in IP 2014 to harmonise with international requirements- Standards and test methods for Water for Injections in Bulk and Purified Water H2: Conclusion - Summary of the main points of the article- Benefits of IP 2014 for public health, quality control, and drug development- Future prospects of IP 2014 H3: FAQs - Q1: What is the legal status of IP 2014?- A1: IP 2014 is legally enforceable as per the Drugs and Cosmetics Act, 1940.- Q2: How many monographs are there in IP 2014?- A2: There are 2548 monographs of drugs, excipients, dosage forms, herbal products, biotechnology products, etc.- Q3: How can I access IP 2014?- A3: You can buy the printed version or the electronic version from the Indian Pharmacopoeia Commission website.- Q4: How often is IP updated?- A4: IP is updated every four years. The next edition will be IP 2018.- Q5: How can I contribute to IP?- A5: You can submit your suggestions, comments, or proposals to the Indian Pharmacopoeia Commission through their website or email. # Article with HTML formatting Introduction
The Indian Pharmacopoeia (IP) is a compendium of standards for drugs produced and/or marketed in India. It is published by the Indian Pharmacopoeia Commission (IPC) in accordance with the Drugs and Cosmetics Act, 1940 and Rules thereunder. It prescribes the quality, purity, identity, strength, safety, efficacy, stability, storage conditions, packaging, labelling, sampling, testing methods, etc. for various drugs.
Indian Pharmacopoeia 2014 Full Version.pdf
The IP is an essential tool for ensuring public health, quality control, drug development, regulatory compliance, research, education, trade, etc. It also helps to harmonise with international standards such as WHO, USP, BP, EP, JP, etc.
The seventh edition of the IP (IP 2014) was released on 4th November 2013 by the Honble Union Health and Family Welfare Minister Shri Ghulam Nabi Azad at New Delhi. It supersedes the previous edition (IP 2010) but any monograph that does not figure in this edition continues to be official as per the law.
The IP 2014 is presented in four volumes. Volume I contains the Notices, Preface, the Structure of the IPC, Acknowledgements, Introduction and the General Chapters. Volume II contains the General Notices, General Monographs on dosage forms, Monographs on drug substances, dosage forms and pharmaceutical aids (A to M). Volume III contains Monographs on drug substances, dosage forms and pharmaceutical aids (N to Z) followed by and distinguished by colour codes, Monographs on Vaccines and Immunosera for human use, Herbs and herbal products, Blood and blood-related products, Biotechnology products and Radiopharmaceutical preparations. Volume IV contains Veterinary monographs and Index.
The IP 2014 has been considerably revised and improved by introducing advanced technology and experimental methods widely adopted in India and abroad. 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. 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 the latest development of the technology in the field. Many chapters have been revised in the Appendices. The monographs on Water for Injections in Bulk and Purified Water are also upgraded to harmonise with prevailing international requirements.
Products of biotechnology
Products of biotechnology are drugs that are derived from living organisms or their components using biotechnological processes such as recombinant DNA technology, hybridoma technology, gene therapy, etc. They include proteins, peptides, nucleic acids, vaccines, monoclonal antibodies, gene therapy products, etc.
Products of biotechnology are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940 and Rules thereunder. They require special considerations for their quality control, safety, efficacy, stability, etc. due to their complex nature, heterogeneity, variability, immunogenicity, etc.
The IP 2014 contains 19 monographs on products of biotechnology such as Erythropoietin Injection, Filgrastim Injection, Hepatitis B Vaccine (rDNA), Human Insulin Injection, Interferon Alfa-2a Injection, Interferon Alfa-2b Injection, Interferon Beta-1a Injection, Interferon Beta-1b Injection, Interferon Gamma Injection, Somatropin Injection Somatropin for Injection Streptokinase Injection Tetanus Immunoglobulin (Human) Tissue Plasminogen Activator Injection Trastuzumab Injection Urokinase Injection Vaccine Adsorbed Vaccine Adsorbed (rDNA) Vaccine Adsorbed (rDNA) for Intramuscular Use
The IP 2014 also contains a general chapter on Products of Recombinant DNA Technology which provides general guidance on the quality control of these products. It covers aspects such as characterization, identity tests, potency tests, purity tests, impurity tests, stability tests, etc.
Indigenous herbs and herbal products
Indigenous herbs and herbal products are drugs that are derived from plants or plant parts that are native to India or have been used in the Indian system of medicine such as Ayurveda, Siddha, Unani, Homeopathy, etc. They include crude drugs, extracts, tinctures, oils, resins, gums, balsams, etc.
Indigenous herbs and herbal products are used for various purposes such as prevention, treatment, cure, wellness, cosmetics, nutrition, etc. They have a long history of use and are considered to be safe, effective, natural, and holistic.
The IP 2014 contains 101 monographs on indigenous herbs and herbal products such as Aconite Root, Aloe Vera Gel, Asafoetida, Ashwagandha Root, Bael Fruit, Basil Oil, Brahmi Leaf, Clove Oil, Curcuma Longa Rhizome, Eucalyptus Oil, Garlic Bulb, Ginger Rhizome, Guggul Resinoid Extractive Henna Leaf Holy Basil Leaf Indian Bdellium Resinoid Extractive Indian Gooseberry Fruit Indian Sarsaparilla Root Jasmine Flower Concrete Lemon Grass Oil Licorice Root Mentha Oil Neem Leaf Nutmeg Seed Peppermint Oil Psyllium Seed Husk Sandalwood Oil Senna Leaf Turmeric Rhizome Oil Veterinary vaccines
Veterinary vaccines are drugs that are used to prevent or treat diseases in animals. They stimulate the immune system of the animals to produce antibodies or cellular immunity against specific pathogens or antigens. They can protect animals from infectious diseases, zoonotic diseases, and cancer.
Veterinary vaccines are regulated by the Department of Animal Husbandry and Dairying under the Ministry of Fisheries, Animal Husbandry and Dairying. They require approval from the Veterinary Council of India and the Central Drugs Standard Control Organization before they can be marketed in India. They also have to comply with the standards and guidelines of the Indian Pharmacopoeia Commission and the World Organisation for Animal Health.
The IP 2014 contains 25 monographs on veterinary vaccines such as Anthrax Spore Vaccine (Live) for Veterinary Use, Black Quarter Vaccine (Inactivated) for Veterinary Use, Brucella Abortus Strain 19 Vaccine (Live) for Veterinary Use, Canine Distemper Vaccine (Live) for Veterinary Use, Clostridium Chauvoei Antigen (Inactivated) for Veterinary Use, Enterotoxaemia Vaccine (Inactivated) for Veterinary Use, Fowl Cholera Vaccine (Inactivated) for Veterinary Use, Haemorrhagic Septicaemia Vaccine (Inactivated) for Veterinary Use, Infectious Bursal Disease Vaccine (Live) for Veterinary Use, Mareks Disease Vaccine (Live) for Veterinary Use Newcastle Disease Vaccine (Live) for Veterinary Use Peste des Petits Ruminants Vaccine (Live) for Veterinary Use Rabies Vaccine (Inactivated) for Veterinary Use Ranikhet Disease Vaccine (Inactivated) for Veterinary Use Sheep Pox Vaccine (Live) for Veterinary Use Swine Fever Vaccine (Live) for Veterinary Use Tetanus Toxoid for Veterinary Use Theileria Annulata Cell Culture Vaccine (Live) for Veterinary Use Trivalent Bluetongue Vaccine (Inactivated) for Veterinary Use Trivalent Foot-and-Mouth Disease Oil Adjuvant Vaccine (Inactivated) for Veterinary Use Trivalent Foot-and-Mouth Disease Water-in-Oil Emulsion Adjuvant Vaccine (Inactivated) for Veterinary Use Tuberculin Purified Protein Derivative for Veterinary Use Vaccine against Avian Influenza H5N1 Strain Re-5 (Inactivated) for Veterinary Use Vaccine against Classical Swine Fever Lapinised Strain C (Live) for Veterinary Use Vaccine against Peste des Petits Ruminants Nigeria 75/1 Strain (Live) for Veterinary Use
The IP 2014 also contains a general chapter on Vaccines and Immunosera for Human and Veterinary use which provides general guidance on the quality control of these products. It covers aspects such as production, control, storage, distribution, labelling, etc.
Antiretroviral drugs and formulations
Antiretroviral drugs and formulations are drugs that are used to treat or prevent human immunodeficiency virus (HIV) infection. They act by inhibiting different stages of the HIV life cycle such as reverse transcription, integration, protease cleavage, etc. They can reduce the viral load, improve the immune system, prevent opportunistic infections, and delay the progression to acquired immunodeficiency syndrome (AIDS).
Antiretroviral drugs and formulations are regulated by the National AIDS Control Organisation under the Ministry of Health and Family Welfare. They are provided free of cost to eligible patients under the National AIDS Control Programme. They also have to comply with the standards and guidelines of the Indian Pharmacopoeia Commission and the World Health Organization.
The IP 2014 contains 34 monographs on antiretroviral drugs and formulations such as Abacavir Sulphate Tablets, Atazanavir Capsules, Didanosine Tablets, Efavirenz Capsules, Efavirenz Tablets, Emtricitabine Capsules, Emtricitabine Tablets, Indinavir Sulphate Capsules, Lamivudine Oral Solution, Lamivudine Tablets Lopinavir and Ritonavir Oral Solution Lopinavir and Ritonavir Tablets Nelfinavir Mesilate Tablets Nevirapine Oral Suspension Nevirapine Tablets Ritonavir Oral Solution Ritonavir Tablets Saquinavir Mesilate Capsules Stavudine Capsules Stavudine Oral Solution Tenofovir Disoproxil Fumarate Tablets Zidovudine Capsules Zidovudine Injection Zidovudine Oral Solution Zidovudine Tablets Abacavir Sulphate and Lamivudine Tablets Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets Lamivudine and Stavudine Tablets Lamivudine and Zidovudine Tablets Lamivudine, Nevirapine and Zidovudine Tablets Lamivudine, Stavudine and Nevirapine Tablets Lamivudine, Tenofovir Disoproxil Fumarate and Efavirenz Tablets Lamivudine, Zidovudine and Nevirapine Tablets Tenofovir Disoproxil Fumarate and Emtricitabine Tablets
The IP 2014 also contains a general chapter on Antiretroviral Drugs which provides general guidance on the quality control of these products. It covers aspects such as assay methods, impurity tests, dissolution tests, etc.
New drugs and drugs used under National Health Programmes
New drugs and drugs used under National Health Programmes are drugs that are either newly introduced or widely used for the prevention or treatment of various diseases of public health importance in India. They include drugs for tuberculosis, malaria, leprosy, kala-azar, filariasis, lymphatic filariasis, etc.
New drugs and drugs used under National Health Programmes are regulated by the Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare. They require approval from the Drugs Controller General of India before they can be marketed in India. They also have to comply with the standards and guidelines of the Indian Pharmacopoeia Commission and the World Health Organization.
The IP 2014 contains 41 monographs on new drugs and drugs used under National Health Programmes such as Acetazolamide Tablets, Albendazole Chewable Tablets, Albendazole Oral Suspension, Albendazole Tablets, Amikacin Sulphate Injection, Artemether Injection, Artemether and Lumefantrine Tablets, Artesunate Injection, Artesunate Tablets, Azithromycin Capsules Azithromycin Oral Suspension Azithromycin Tablets Bedaquiline Fumarate Tablets Benznidazole Tablets Cefixime Capsules Cefixime Oral Suspension Cefixime Tablets Ceftriaxone Sodium Injection Chloroquine Phosphate Injection Chloroquine Phosphate Oral Suspension Chloroquine Phosphate Syrup Chloroquine Phosphate Tablets Clofazimine Capsules Dapsone Tablets Decitabine Injection Deltamethrin Impregnated Mosquito Netting Fabric (Long Lasting Insecticidal Net) Diethylcarbamazine Citrate Oral Suspension (for Mass Drug Administration) Diethylcarbamazine Citrate Syrup (for Mass Drug Administration) Diethylcarbamazine Citrate Tablet (for Mass Drug Administration) Ethambutol Hydrochloride and Isoniazid Tablets Ethambutol Hydrochloride Tablets Isoniazid Syrup (for Mass Drug Administration) Isoniazid Tablet (for Mass Drug Administration) Ivermectin Tablet (for Mass Drug Administration) Miltefosine Capsules (for Mass Drug Administration) Miltefosine Oral Suspension (for Mass Drug Administration) Ofloxacin and Ornidazole Suspension (for Mass Drug Administration) Ofloxacin and Ornidazole Tablet (for Mass Drug Administration) Paromomycin Sulphate Injection (for Mass Drug Administration) Praziquantel Tablet (for Mass Drug Administration) Pyrazinamide Tablet (for Mass Drug Administration) Pyrimethamine Tablet (for Mass Drug Administration) Rifampicin Capsules (for Mass Drug Administration) Rifampicin Oral Suspension (for Mass Drug Administration) Rifampicin Tablet (for Mass Drug Administration) Sodium Stibogluconate Injection (for Mass Drug Administration) Sulfadoxine and Pyrimethamine Tablet (for Mass Drug Administration)
The IP 2014 also contains a general chapter on Drugs Used Under National Health Programmes which provides general guidance on the quality control of these products. It covers aspects such as assay methods, impurity tests, dissolution tests, etc.
Water for Injections in Bulk and Purified Water
Water for Injections in Bulk and Purified Water
Water for Injections in Bulk and Purified Water are grades of water that are used for the preparation of medicines for parenteral administration or for other pharmaceutical purposes. They have to meet high standards of purity, clarity, microbial quality, etc.
Water for Injections in Bulk is obtained from water that complies with the regulations on water intended for human consumption laid down by the competent authority or from purified water by distillation in an apparatus of which the parts in contact with the water are of neutral glass, quartz or suitable metal and which is fitted with an effective device to prevent the entrainment of droplets. It is stored and distributed under conditions designed to prevent growth of microorganisms and to avoid any other contamination.
Purified Water is prepared by distillation, by ion exchange, by reverse osmosis or by any other suitable method from water complying with the regulations on water intended for human consumption laid down by the competent authority. It is stored and distributed under conditions designed to prevent growth of microorganisms and to avoid any other contamination.
The IP 2014 contains two monographs on Water for Injections in Bulk and Purified Water which prescribe the quality standards and test methods for these grades of water. They cover aspects such as appearance, conductivity, acidity or alkalinity, nitrates, heavy metals, total organic carbon, microbial enumeration tests, test for bacterial endotoxins, etc.
The IP 2014 also contains a general chapter on Water for Pharmaceutical Use which provides general guidance on the production, storage, distribution, and quality control of these grades of water. It covers aspects such as sources of water, water treatment processes, water quality specifications, sampling procedures, validation, monitoring, sanitization, etc.
Conclusion
In conclusion, the IP 2014 is a comprehensive and updated compendium of standards for drugs and pharmaceutical products in India. It reflects the rapid changes and advancements in the field of pharmaceutical science and technology. It also harmonises with the international standards and guidelines to ensure the quality, safety, and efficacy of drugs and pharmaceutical products.
The IP 2014 is an essential tool for public health protection, quality control, drug development, regulatory compliance, research, education, trade, etc. It also helps to promote the growth and development of the Indian pharmaceutical industry and its global competitiveness.
The IP 2014 is expected to fulfill the mission of the IPC to protect and enhance public health both in India and other countries using drugs manufactured in India.
FAQs
Q1: What is the legal status of IP 2014?A1: IP 2014 is legally enforceable as per the Drugs and Cosmetics Act, 1940 and Rules thereunder. Any drug or pharmaceutical product that does not comply with the IP 2014 standards is deemed to be not of standard quality, spurious, adulterated, or misbranded.
Q2: How many monographs are there in IP 2014?A2: There are 2548 monographs of drugs, excipients, dosage forms, herbal products, biotechnology products, etc. in IP 2014. There are also 53 general chapters and 27 appendices that provide general guidance and test methods.
Q3: How can I access IP 2014?A3: You can buy the printed version or the electronic version from the IPC website (https://www.ipc.gov.in/). You can also access some parts of IP 2014 online through various databases such as Indian Pharmacopoeia Online (https://online.ipc.gov.in/), Pharmabook (https://pharmabook.in/), etc.
Q4: How often is IP updated?A4: IP is updated every four years. The next edition will be IP 2018. The IPC also publishes addenda and amendments to update or correct some parts of IP between editions.
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