The Indian Pharmacopoeia Commission (IPC) plans to include the monographs of most of the drugs that are marketed in the country along with its IP reference substances in the seventh edition of the Indian Pharmacopoeia (IP) 2014. The aim behind this move is to ensure availability of high quality medicines to all the patients across the country by coming out with as many monographs as possible along with efforts to harmonise the monographs that are already in place with the international standards.

This strategic decision was taken during the 25th scientific meeting that was recently concluded in Delhi, wherein it was agreed upon by all that there is a need for more monographs in IP 2014. Considering this demand, IPC has short listed 413 items for inclusion as monographs in the IP 2014 and of which 170 had been cleared by the Committee headed by Sipahimalani.

Out of these, 140 monographs of chemical moity including APIs, formulations and excipients had been put on public domain for the stakeholders' views and opinions. The rest of the list is expected to be updated and uploaded at two weeks’ interval. It is understood that the latest standards set in by the commission in the IP 2014 will be released by December 2013 and is expected to be enforceable across the country from January 1, 2014.

On the progress of the 7th edition of the IP, with respect to modernisation of the existing monographs, Dr G N Singh, secretary cum scientific director of IPC informed that out of 75 monographs that needed upgradation of test methods, forty involving use of sophisticated instruments had already been placed on the official website for comments and would be finalised soon. He further pointed out that steps are being taken to initiate the completion of work relating to other monographs based on the expertise available in the industry along with the collaboration with other pharmacopoeias.

He stressed, “We are working on many other modalities which can be introduced in the IP 2014, provided that it is found to be suitable for adoption. One of the important areas for focus is the biological monographs, and we are planning to work on it to develop our knowledge and expertise in this field so that we can be ahead of other pharmacopoeias in this segment. In fact some monographs on vaccines are already validated by IP and with the help of the NIB further needs can be addressed in the matter.”

Dr Singh who is also the Drug Controller General of India (DCGI) further added that to fill up the gap between monographs available in IP 2010 and drugs marketed in India, there is an urgent need to add at least another 400 monographs in the next edition of IP. For this purpose IPC is planning to have a high level meeting with the industry and other think tanks on possible monographs that can be added for the benefit of the patients in Baroda from September 24 to 28 in Baroda.