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
Carbamazepine Extended-release Tablets
Cefixime Oral Suspension
Cefpodoxime Oral Suspension
Fluoxetine Oral Solution
Diluted Isosorbide Mononitrate
Isosorbide Mononitrate Tablets
Ketorolac Tromethamine Injection
Ketorolac Tromethamine Tablets
Mosapride Citrate Dihydrate
Mosapride Citrate Tablets
Pyrantel Pamoate Oral Suspension