After the launch of IP Addendum-2015 to IP-2014, the Indian Pharmacopoeia Commission (IPC) has already started the work on Addendum 2016. For this, a list of 53 monographs has already been identified by the experts for phase I drafting, which are approved by CDSCO along with 13 monographs provided by the stakeholders.
Out of these, 17 monographs are already drafted awaiting comments from the stakeholders. Sources inform that this Addendum will also have monographs that were not included in IP-2014 and its Addendum-2015, but are in the compiled list of monographs that are CDSCO approved, available in NLEM and accepted in market.
Interestingly, as a breather for many, formulations whose API monographs were not included in IP-2014 and in it’s Addendum-2015 may also be considered to be included in this. This is along with the monographs proposed by the stakeholders as deemed fit by the IPC.
It is understood that the experts will take important decision regarding the new addendum and erratas, in a three-day working committee meeting, which started off in IPC Ghaziabad on December 15. Erratas basically deals with monographs and appendices in IP 2014 and addendum 2015 that needed corrections based on scientific in-puts.
Dr Raman Mohan Singh, principal scientific officer, quality manager and coordinator, Indian Pharmacopoeia Laboratory, IPC informed that they have already issued erratas 001 and 002 to IP 2014 in October itself by Dr G N Singh the secretary-cum-scientific director of IPC, for immediate compliance of the stakeholders. He said that this meeting would further discuss about details to be included in erratas 003.
“IPC is committed towards its aim to ensure availability of only the best and highest quality of medicines in the country. It is in continuation with this, we have decided to not only keep on upgrading the already existent monographs but also adding new to our list,” Dr Singh added.
IPC has already completed the preparation of list of new monographs and revised tests for the new Addendum, while work is going on to acquire and verify new monographs, expected to be completed by end of December 2014. Dr Raman Singh informs that, if things go as planned, IPC plan to release the Addendum by September 2015 for its expected implementation in January 2016.