Indian Pharmacopoeia Commission (IPC) released the guidance manual for developing Herbal Monographs and Quality Manual for Pharmacovigilance Programme of India (PvPI). This also includes the phytopharmaceutical drugs.
The guidance was released by ministry of health and family welfare secretary, C K Mishra, during the governing body meeting of IPC at New Delhi last week.
This guidance deals with processes involved in developing quality monographs for botanicals/herbs. In fact IPC has been working for over 10 years to develop objectively assessable quality standards for herbs, processed herbs and herbal drugs with a view to provide monographs to the stakeholders. Now 150 monographs of this area are included in Indian Pharmacopoeia (IP)-2014 and its two Addenda published so far.
The scientists during this process have evolved various standard operating procedures for the monograph development. These monographs included in IP have received wide acceptance globally and some of these now appear in pharmacopoeias of other nations with or without further changes.
The Commission felt the need to share this information to stimulate greater work in this area. There had been criticism that quality monographs on herbs and botanicals that were removed from earlier editions of IP. With the resurgence of use of herbs in healthcare and emerging phytopharmaceuticals as drugs, there was a need to provide quality specifications for them.
Now the IPC is taking the initiative to form a separate working group of scientists for this work at the Commission’s laboratory supported and guided by an eminent expert committee on herbs and herbal product as IP is a regulatory book of standards. The manual compiles the knowledge of the process of developing monographs to help the industry and scientists and other stakeholders working in this area.
The manual covers various steps in the monograph development criteria, SOPs for monograph development, botanical reference substance, phytochemical reference substances (marker compounds), extracts, herbal product monographs, photography of the candidate material of the monograph. It also includes a non-exhaustive list of suppliers who can provide marker compounds.
Other organisations like the Ayurvedic Pharmacopoeia Committee, Indian Council of Medical Research have contributed immensely to this area. The manual acknowledges and provides information on these publications.
The Commission views that the publication of this manual should help in speeding up the research to provide quality herbals including phytopharmaceutical drugs in consumer interest covering a larger number of herbs.
The efforts of the secretary-cum-scientific director, IPC, Dr DBA Narayana, chairman of the Herbals Committee of IPC, Dr Jai Prakash, senior principal scientific officer, IPC and the associated team are noteworthy, pointed out the Commission.
The Quality Manual for PvPI aims to ensure systems, standard operating procedures to perform the various activities. It was prepared by National Coordination Centre (NCC) for PvPI and was approved by its Quality Review Panel.
While speaking on the occasion, health secretary Mishra, stressed the need of a such quality manual in ensuring harmonized systems and procedure to perform all the elements of PvPI.