The crude drugs and herbal products committee under the Indian Pharmacopoeia Commission (IPC) has prepared 10 more monographs on herbs and herbal extracts in addition to the 32 herbal monographs included in the Indian Pharmacopoeia 2007 (IP 2007). The committee expects to include the monographs in the IP Addendum 2008, to be published by the end of this year.
The herbal products committee has conducted extensive meetings with the herbal drug manufacturers in the country at Mumbai and Delhi on the effects of monographs added in the Indian Pharmacopoeia 2007. Addition of 10 more monographs comes as a result of suggestions from the manufacturers, according to a source from the committee.
The new monographs also include some of the finished herbal products approved by the Drug Controller General of India (DCGI). Even as the IPC has included 32 herbs in its IP 2007 for the first time, the monographs of extracts would be added to the IP for the first time through this addendum.
"Our target is to include 10 plants including herbal extracts in the addendum and we have to work against a tight schedule. We hope the works would be completed within the year end so that we can go with the addition in the current addendum itself. Preparing monographs on herbs and herbal extracts is very difficult as the cost of markers is huge and currently the expenses are incurred by the players in the industry," said the source.
The committee has also requested the IPC for assistance in preparing monographs. The committee suggests that the cost of markers, which will be varied for preparing monograph of each herb and extract, should be reimbursed by the IPC, as and when the relevant monograph is added to the Pharmacopoeia.
Further, the request also sought approval of a research assistant from the national research organisations like Council of Scientific and Industrial Research (CSIR) to work with the individual companies and research institutes like National Institute of Pharmaceutical Education and Research (NIPER) to hasten the process of preparing monographs.
"At present, the works for monograph are done mainly by the scientists from the industry and the process is consuming more time as the scientists have to work extra hours for the programme. If the commission approves our request, we will have some dedicated research assistants to work with the industry in their labs for preparation of monographs for the Pharmacopoeia. The commission also has to reimburse the expenditure for the research assistants thus relieving the individual companies from the additional expense for preparing the monographs," said the source.
The Indian pharmacopoeia monographs has mandatory identification test by TLC, and a mandatory assay for a marker compound by HPLC for each of the herbs, added the expert. In addition to setting up standards for the herbal monographs, the commission has also included new features in IP 2007 for these monographs like colour photograph of plant part, use of botanical reference substances and chemical reference substance, TLC profiles and chromatograms for guidance of the user.