The scientific body of the Indian Pharmacopoeia Commission (IPC) has prepared 300 additional monographs to be included in the fifth edition of the Indian Pharmacopoeia, expected to be released by the end of next month.
The list of new monographs includes chemicals and dosage forms, vaccines, immunosera, herbs, herbal products, blood and blood-related products, biotechnology and veterinary products.
The scope of the IP has been extended to include additional antiretroviral drugs and formulations inclusive of commonly used fixed-dose combinations. The standards for veterinary drugs and products which were published as a supplement last time would form an integral part of the present compendium, sources said.
The new edition would supersede the 1996 edition but the existing monographs were not disturbed and not included in the present edition as they would continue as official. Cross-referencing would be avoided to make each monograph complete in itself for convenience.
The IPC had published IP Addendum 2005 to IP 1996 with amendments in existing monographs and adding 46 new monographs and it was made effective from June 30, 2006. The 1996 edition had 1250 monographs. Ever since, the IPC secretariat has been on the huge task of bringing out the new edition in a comprehensive and more user-friendly format.
``As part of simplifying the labelling of medicines, the main titles for monographs of formulated preparations are given in the shorter form in terms of the active moiety rather than of the salt. 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,'' sources at the IPC explained.
A list of items not included in the 1996 edition of the Indian Pharmacopoeia and its addenda but added in this edition is given below:
● Admissions
● Monographs
● Abacavir Oral Solution
● Abacavir Tablets
● Abacavir and Lamivudine Tablets
● Abavavir, Lamivudin and Zidovudine Tablets
● Acarbose
● Acarbose Tablets
● Aceclofenac
● Aceclofenac Tablets
● Ambroxol Hydrochloride
● Amlodipine Besilate
● Amlodipine Tablets
● Amoxycillin and Potassium Clavulanate Injection
● Amoxycillin and Potassium Clavulanate Oral Suspension
● Amoxycillin and Potassium Clavulanate Tablets
● Amphotericin B Injection
● Arteether
● Artemether
● Artimisinin
● Atorvastatin Calcium
● Atorvastatin Tablets
● Azathioprine
● Azathioprine Tablets
● Azithromycin
● Azithromycin Capsules
● Azithromycin Oral Suspension
● Azithromycin Tablets
● Baclofen
● Baclofen Oral Solution
● Baclofen Tablets
● Betahistine Dihydrochloride
● Betahistine Tablets
● Betamethasone Eye Drops
● Bleomycin Injection
● Bronopol
● Budesonide
● Calcium Stearate
● Capreomycin Sulphate
● Capreomycin Injection
● Carbomers
● Cefaclor
● Cefaclor Capsules
● Cefaclor Oral Suspension
● Cefaclor Sustained-release Tablets
● Cefoperazone Injection
● Cefoperazone Sodium
● Ceftriaxone Injection
● Ceftriaxone Sodium
● Cefuroxime Axetil
● Cefuroxime Axetil Tablets
● Cetirizine Hydrochloride
● Cetirizine Tablets
● Chlorhexidene Aceate
● Chorhixidene Hydrochloride
● Chlorobutanol
● Ciclesonide
● Ciclesonide Inhalation
● Ciprofloxacin Eye Drops
● Clarithromycin
● Clarithromycin Tablets
● Clobazam
● Clobazam Capsules
● Clomipramine Capsules
● Clomipramine Hydrochloride
● Clonazepam
● Clonazepam Injection
● Croscarmellose Sodium
● Crospovidone
● Dicyclomine Injection
● Didanosine Capsules
● Diethylphenyl Acetamide
● Diethyl Phthalate
● Docusate Sodium
● Domperidom Maleate
● Domperidom Tablets
● Donepezil Hydrochloride
● Donepezil Tablets
● Emtricitabine
● Emtricitabine Cpasules
● Ethambutol and Iosoniazid Tablets
● Ethyl Cellulose
● Etoposide
● Etoposide Capsules
● Etoposide Injection
● Fluticasone Propionate
● Fluticasone Propionate Inhalation
● Fluticasone Propionate Powder for Inhalation
● Formoterol Fumarate and Budesonide Powder for Inhalation
● Formoterol Fumarate Dihydrate
● Gatifloxacin
● Gatifloxacin Infusion
● Gatifloxacin Tablets
● Glipizide
● GlipizideTablets
● 2-Deoxy-D-Glucose
● Imipenem
● Imipenem and Cilastatin Injection
● Ipratropium Bromide
● Irinotecan Hydrochloride Trihydrate
● Irinotecan Injection
● Lamivudine And Tenofovir Disoproxil Fumerate Tablets
● Lamivudine, Nevirapine and Stavudine Dispersible Tablets
● Lamotrigine
● Lamotrigine Dispersible Tablets
● Levocetrizine Dihydrochloride
● Levocetrizine Tablets
● Levofloxacin Hemidrate
● Levofloxacin infusion
● Levofloxacin Tablets
● Lisinopril
● Lisinopril Tablets
● Lopinavir and Ritonavir Capsules
● Lopinavir And Ritonavir Tablets
● Losartan Potassium
● Losartan Tablets
● Meropenem
● Meropenem Injection
● Nandrolone Phenylproprionate Injection
● Nelfinavir Mesylate Oral Powder
● Nifedipine Sustained-release Tablets
● Norfloxacin Eye Drops
● Ofloxacin
● Ofloxacin Infusion
● Ofloxacin Opthalmic Solution
● Ofloxacin Tablets
● Olanzapine
● Olanzapine Tablets
● Oseltamivir Phosphate
● Oseltamivir Capsules
● Oseltamivir Oral Suspension
● Paclitaxel
● Paclitaxel Injection
● Potassium Clavulanate
● Potassium Clavulanate Diluted
● Prednisolone Sodium Phosphate
● Prednisolone Sodium Phosphate Injection
● Prothionamide
● Prothionamide Tablets
● Rabeprazole Sodium
● Rabeprazole Tablets
● Ramipril
● Ramipril Capsules
● Ramipril Tablets
● Rifampicin Tablets
● Rifampicin and Isoniazid Tablets
● Rifampicin, Isoniazid and Ethambutol Tablets
● Rifampicin, Isoniazid and Pyrazinamide Tablets
● Rifampicin, Isoniazid, Pyrazinamide and Ethambutol Tablets
● Purifid Rayon
● Rosiglitazone Maleate
● Rosiglitazone Tablets
● Rosuvastatin Calcium
● RosuvastatinTablets
● Roxithromycin
● Roxithromycin Tablets
● Salmeterol Xinafoate
● Salmeterol and Fluticasone Propionate Inhalation
● Salmeterol and Fluticasone Propionate Powder for Inhalation
● Saquinavir Mesylate Tablets
● Secnidazole
● Secnidazole Tablets
● Stavudine Oral Solution
● Tenofovir Disoproxil Fumartea
● Tenofovir Disoproxil Fumarate Tablets
● Tenofovir Disoproxil Fumarate and Emtricitabine Tablets
● Tiotropium Bromide Monohydrate
● Tiotropium Powder for Inhalation
● Tizanidine Hyrochloride
● Tizanidine Tablets
● Topotecan Hydrochloride
● Topotecan Injection
● Vinorelbine Tartrate
● Vinorelbine Injection
● Zidovudine Injection
Biotechnology Products
● Erythropoietin Concentrated Solution
● Filgrastism Concentrated Solution
● Interferon Alfa-2 Concentrated Solution
● Streptokinase Bulk Solution
Blood and Blood Products
● Anti-A Blood Grouping serum
● Anti-B Blood Grouping serum
● Anti-D (Rho) Immunoglobulin
● Anti-D Immunoglobulin for Intravenous use
● Anti-Human globulin serum
● Blood Grouping Serums Anti-D, Anti-C, Anti-E, Anti-c, Anti-e
● Cryoprecipitated Anthihaemophilic fractor
● Fibrin Sealent Kit
● Human Coagulation Factor IX
● Human Coagulation Factor VII
● Human Coagulation Factor VIII (r DNA)
● Human Normal Immunoglobulin
● Human Prothrombin Complex
● Plasma for fractionation
● Platelet Concentrate
Herbs and Herbal Products
● Amalaki
● Amra
● Arjuna
● Artemisia
● Bhibhitaki
● Bhringraj
● Coleus
● Gokhru
● Gudmar
● Guduchi
● Haritaki
● Kunduru
● Kutki
● Lasuna
● Manjistha
● Maricha
● Pippali Large
● Pippali Small
● Punarnava
● Sarpagandha
● Shatavari
● Shati
● Tulasi
Vaccines for Human Use
● Adsorbed Diphtheria, Tetanus and Hepatitis B (rDNA) Vaccine
● Adsorbed Diphtheria, Tetanus and Pertussis (Acellular Component) and Haemophilus Type B Conjugate Vaccine
● Adsorbed Diphtheria, Tetanus and Pertussis (Acellular Component) and Hepatitis B (rDNA) Vaccine
● Adsorbed Diphtheria, Tetanus and Pertussis (Acellular Component), Inactivated Poliomyelitis Vaccine and Haemophilus Type B Conjugate Vaccine
● Adsorbed Diphtheria, Tetanus, Pertusis and Poliomyelitis (Inactivated) Vaccine
● Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component) and Inactivated Poliomyelitis Vaccine
● Adsorbed Diphtheria, Tetanus, Pertussis, Poliomyelitis (Inactivated) and Haemophilus Type B Conjugate Vaccine
● Adsorbed Pertussis Vaccine (Acellular Component)
● Adsorbed Pertussis Vaccine (Acellular, Co-purified)
● Diphtheria and Tetanus Vaccine (Adsorbed) for Adults and Adolescents
● Diphtheria Vaccine (Adsorbed)
● Diphtheria, Tetanus, Pertussis (Whole Cell) and Haemophilus Type B Conjugate Vaccine (Adsorbed)
● Diphtheria, Tetanus, Pertussis (Whole Cell) Hepatitis B (rDNA) and Haemophilus Type B Conjugate Vaccine (Adsorbed)
● Diphtheria, Tetanus, Pertussis (Whole Cell) Hepatitis B (rDNA) Vaccine (Adsorbed)
● Haemophilus Type b Conjugate Vaccine
● Hepatitis A (Inactivated) and Hepatitis B (rDNA) Vaccine (Adsorbed)
● Inactivated Hepatitis B Vaccine
● Measles and Rubella Vaccine (Live)
● Measles, Mumps and Rubella Vaccine (Live)
● Meningococcal Polysaccharide Vaccine
● Pertussis Vaccine
● Pneumococcal Polysaccharide Vaccine
● Poliomyelitis Vaccine (Inactivated)
● Rabies Vaccine, Human
● Typhoid (Strain Ty 21a) Vaccine, Live (Oral)
● Typhoid Polysaccharide Vaccine
● Typhoid Vaccine
● Typhoid Vaccine (Freeze Dried)
A list of items included in the 1996 edition of the Indian Pharmacopoeia but deleted in this edition is given below
● Omissions
● Astemizole
● Astemizole Tablets
● Diazepam Capsules
● Fenfluramine Hydrochloride
● Fenfluramine Hydrochloride Tablets
● Pectin
● Phenformin Hydrochloride
● Phenformin Hydrochloride Tablets
● Phthalysulphathiazole
● Phthalysulphathiazole Tablets
● Succinylsulphathizole
● Succinylsulphathizole Tablets
● Sulphacetamide Sodium Eye Ointment