Indian Pharmacopoeia Commission (IPC) recently released the guidance document for monographs development of herbs and herbal products. This manual is aimed to provide guidelines for the stakeholders of IP who intend to submit herbs and herbal products monographs, candidate material for phytochemicals reference substances and botanical reference substances to IPC.
The objective of the document is to help and guide the concerned manufacturers and other stakeholders in understanding the process and development of monographs of herbs and herbal products. And also encourage and promote research and development to enhance the quality of herbals in India and overseas. The manual also gives current standard operating procedures (SOPs) for development of monographs as well as botanical reference substances (BRS) and phytochemicals reference substances (PRS).
The draft states, “This manual has been developed with a goal of providing assistance to stakeholders i.e. industry, health care professionals, analysts and researchers on how they can assure high quality procedures for successful development of the monographs. Appearance of herbal drug monograph does not mean its approval as a drug under the law; it is to provide qualitative and quantitative standards of quality for the herbs, its use either as a food item or as supplement or ingredient, as a drug and or as an ingredient in cosmetics.”
The committee who worked on this manual was leaded by Dr G N Singh secretary-cum-scientific director of the IPC who is also the DCGI as the chairman, while other key members of this committee included Dr D B Anantha Narayana, chairman of the Herbal Products Expert Group (HPEG) IPC; B Murali, senior manager - quality control of Natural Remedies; Professor S S Handa, former director of the Indian Institute of Integrative Medicines (formerly RRL); Dr C K Katiyar, chief executive officer of Emami Healthcare; Dr Amit Agarwal, director- R&D of Natural Remedies and Dr George Patani, director- R&D Inga Pharmaceuticals.
It is understood that this document, which was released in June end, is to be read in conjunction with the IP 2014 and addendum 2015. And can be utilised as a starting point for the development of new monographs by the stakeholders for IP to ensure quality of the herbal products by the manufacturers, analysts etc. IPC which acts as the national coordinating centre (NCC) for the pharmacovigilance programme of India (PvPI) has invited the comments for the same by August 9.
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