The Indian Pharmacopoeia Commission (IPC) has recently released the Addendum 2008 to the Indian Pharmacopoeia 2007, adding 73 new monographs on different therapeutic groups representing synthetic, herbals and biological drugs.
Sources in the IPC said the amendments to the IP 2007 were made into effect immediately while the new monographs would become effective from July 1, 2009. The addendum was released by Secretary of Health Naresh Dayal on the occasion of the second general body meeting of the commission in Delhi recently.
The IPC has taken in all the major and significant suggestions from the stakeholders and made amendments to the IP 2007 which has been well received by the industry and others so far, sources said. The suggestions were incorporated in the general chapters, appendixes, monographs, impurities and other quality related issues. Experts and the scientific body of the commission had vetted the amendments. The IP 2007, which was made effective from July last, has already over 1600 monographs.
"IP 2007 and its addendum will facilitate the manufacturers and other stakeholders to ensure compliance with the technological advancements taken place in the related fields. As India has emerged as one of the developers of generic drugs and also poised for phenomenal growth of pharmaceutical industry, both in terms of volume and value of production, there is an urgent need to frequently upgrade the new monographs by incorporating the changes in the existing analytical procedures. Regular updating of the Indian Pharmacopoeia is the necessity of the day for bringing out an overall improvement in quality of drugs in the country. This Addendum is a step forward in this direction to achieve the said objectives," sources said.
New Monographs in Addendum
Arginine
Buclizine Hydrochloride
Buspirone Hydrochloride
Buspirone Tablets
Calcitriol
Calcitriol Capsules
Carbamazepine Extended-release Tablets
Carvedilol
Carvedilol Tablets
Cefepime Hydrochloride
Cefepime Injection
Cefixime
Cefixime Oral Suspension
Cefixime Tablets
Cefpodoxime Proxetil
Cefpodoxime Oral Suspension
Cefpodoxime Tablets
Cetirizine Syrup
Citalopram Hydrobromide
Citalopram Tablets
Clonazepam Tablets
Clopidogrel Bisulphate
Clopidogrel Tablets
Clozapine
Clozapine Tablets
Esomeprazole Magnesium
Esomeprazole Tablets
Fexofenadine Hydrochloride
Fexofenadine Capsules
Fexofenadine Tablets
Fluoxetine Hydrochloride
Fluoxetine Capsules
Fluoxetine Oral Solution
Fluoxetine Tablets
Diluted Isosorbide Mononitrate
Isosorbide Mononitrate Tablets
Ketorolac Tromethamine
Ketorolac Tromethamine Injection
Ketorolac Tromethamine Tablets
Ketotifen Fumarate
Mosapride Citrate Dihydrate
Mosapride Citrate Tablets
Nebivolol Hydrochloride
Nebivolol Tablets
Ondansetron Hydrochloride
Ondansetron Injection
Ondansertron Tablets
Ornidazole
Ornidazole Tablets
Oxcarbazepine
Oxcarbazepine Tablets
Pioglitazone Hydrochloride
Pioglitazone Tablets
Piracetam
Pyrantel Pamoate
Pyrantel Pamoate Oral Suspension
Quetiapine Fumarate
Quetiapine Tablets
Tamsulosin Hydrochloride
Topiramate
Topiramate Tablets
Zolpidem Tartrate
Zolpidem Tablets
--Vaccines and Immunosera for Human Use
Snake Venom Antiserum
--Herbs and Herbal Products
Ajwain
Anantmula
Daruharidra Roots
Daruharidra Stems
Kalmegh Dry Extract
Saunf
Senna Dry Extract
Senna Tablets
Yasti Dry Extract