Indian Pharmacopoeia Commission (IPC) and United States Pharmacopoeia (USP) are in the final stages of their discussion to develop a collaborative agreement specifically for sharing information on chemical reference substances produced by USP. USP officials informed that if things go as planned, IPC will be getting exclusive rights to get access to select data on some of the chemical reference substances from USP's database.
According to sources, as of now active dialogue is going on between the two standard setting body on finalising the reference substances. It is understood that as of now IPC have identified about four to five chemical substances and are in the process of identifying some more.
Dr V Srini Srinivasan, executive vice president for international sites and standards at USP, “We have been closely working with IPC from some time now and seeing the way our collaborative efforts are turning out we want to develop and strengthen it further. It would be interesting to see how our ongoing dialogues with IPC will turn out as it is aimed at improving the quality and standard of medicines, a joint agenda of both the organisations.”
As sign of strengthening relation between the two regulatory bodies, USP and IPC have shared many of its research data with the other to ensure deliverance of high quality medicines for the benefit and safety of general public across the world.
Giving further details on the status of sharing chemical reference substance with IPC, Dr Praveen Tyle, executive vice president and chief science officer at USP said, “Due to governmental proceedings it may take some time to comment on by when things will fall into place with respect to sharing of information on chemical reference substances. But from our side we are very keen to go ahead with this initiative which is mutually beneficial and are waiting for a positive response from the IPC officials at the latest.”
In the light of the recently concluded scientific body meeting in Delhi, it is expected that IPC may come out with its decision soon on this matter.
Apart from this, IPC is also said to be considering to enter into a collaboration with USP to get information on their biologics reference substance. The officials from both sides stressed that talks regarding the same are still under going and at initial stage. However they did point out that, IPC and USP are actively working towards strengthening its collaboration in the field of biologics to develop biological standards and references substance that will enable the companies to manufacture quality medicines for people across the world.
Dr Srini informed that as a part of confidence building measure, three officials from the office of Indian pharmacopoeia are being sent to USP's headquarters at Rockville in April this year. During their visit the officers will be trained for developing monographs, reference substances etc., so that they can get themselves acquainted with the way USP works.