In an effort to cover wider spectrum of biologicals, vaccines, radio pharma and excipients to brought under the regulatory standards, the Indian Pharmacopoeia Commission (IPC) will focus on including more monographs from these areas in the Indian Pharmacopoeia (IP), soon, it is learnt.
The IPC, which has already set up a committee of experts to look into the inclusion of radio pharmaceuticals in the IP, is planning to focus on biopharmaceuticals, vaccines and excipients by collaborating with experts in these fields for preparing monographs in the IP Addendum 2011. The agenda to bring in the addendum will be discussed in the scientific body meeting to be held in the second half of this month.
The IPC is arranging a meeting with experts from biotech industry to probe into the possibilities of including biopharma monographs in the addendum, for which five monographs are already on the ready, said a higher official from the commission. The segment has been identified as a priority area for more works to be carried out and the central health ministry and IPC will address the issues related with the support of technocrats and experts from the industry, he said.
The IP 2010 has introduced 49 vaccine monographs of which eight are added for the first time.
Similar emphasis would be given to include monographs of excipients, which also has a role in deciding the quality of the formulation drug. The commission may look for international organisations for support on preparing the excipient monographs in near future.
Further, a few herbal products with prospects to become blockbusters internationally in the near future are also identified for inclusion in the addendum. The effort is to enable such herbal preparations to get global acceptance with support of strong scientific backing for quality assurance, as part of the government's mission to promote herbal medicines world-wide.
As reported earlier, the IPC has recently initiated efforts to include radiopharmaceuticals, used in the field of nuclear medicine, as tracers in the diagnosis and treatment of various diseases including cancer, in the Indian Pharmacopoeia for the first time. The commission has formed an expert committee consisting of eminent scientists from the field and plans are to add a general chapter and about 25 monographs of radiopharmaceuticals which are widely used for diagnostic and therapeutic use in India in the initial stage.