The Indian Pharmacopoeia Commission will publish the IP Addendum 2008 by December this year, adding around 80 new monographs to cover almost all the drugs approved in different categories so far.
Currently, working on a war-footing, the preparation of the addendum was progressing and 72 draft monographs were already published, seeking suggestions from the stakeholders, sources said.
"The draft monographs have been posted on the website (www.ipc.gov.in) so the stakeholders can put in their remarks and suggestions before including them in the addendum. They are the latest version drugs,'' said IPC sources.
The fifth edition of Pharmacopoeia in three volumes including over 1600 monographs has been published in December last and is going to be made effective from July 1. The IP 2007 has been received well by the stakeholders so far, sources said.
The IPC is also at present working on new IP Reference Substances and is hoping to publish it within three months by including 101 molecules in different areas.
Meanwhile, in a major impetus to the standard setting efforts in the pharmaceutical segment, the IPC has got autonomous status with the Centre issuing notification, in line with a Cabinet decision in this regard on March 2. Thus the Central Indian Pharmacopoeia Laboratory has been merged with the IPC for its exclusive use of pharmacopoeia-related tests and other scientific validations.
The staff, assets and liabilities including buildings and all other existing infrastructure belonging to the CIPL, Ghaziabad would be now with the IPC. The Centre had also approved foreign exchange saving by using IP Reference Substances instead of importing USP/BP/International Pharmacopoeia Chemical Reference Substances.
IPC sources hoped that the newly-accorded autonomy, which has been a long-desired goal to make it a competent legal entity, would go a long way to help improve the standards of drugs in the country.