IPC’s new 2nd edition of Guidance Manual for Monographs Development

Furthermore, the manual also gives the latest Standard Operating Procedures (SOPs)

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IPC
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Last Updated on December 23, 2021 by The Health Master

The Indian Pharmacopoeia Commission’s (IPC) new 2nd edition of the Guidance Manual for Monograph Development of Herbs and Herbal Products, including Phytopharmaceutical Drugs, will facilitate the concerned manufacturers and other stakeholders in understanding the process and development of monographs of herbs and herbal products.

The guidance document also aims to encourage and promote research and development in the quality of herbs and herbal products in India and overseas. Furthermore, the manual also gives the latest Standard Operating Procedures (SOPs) for the development of monographs as well as botanical reference substances (BRS) and phytochemical reference substances (PRS) and invites suggestions for further updating.

The guidance document also aims to encourage and promote research and development in the quality of herbs and herbal products in India and overseas. Furthermore, the manual also gives the latest Standard Operating Procedures (SOPs) for the development of monographs as well as botanical reference substances (BRS) and Phytochemical Reference Substances (PRS) and invites suggestions for further updating.

The Commission indicated that it will look forward to consider submission of data and draft monographs adopting this guidance document for inclusion in upcoming IP edition subject to such data meeting the criteria laid down. According to Dr DBA Narayana, chairman, sub-committee on Herbal and Phytopharmaceutical Drugs, Indian Pharmacopeia Commission, it is important that the processes involved in developing quality monographs for multi component botanicals are documented . This will help botanists and pharmacognists and industrial al R&D personnel and the whole sector to follow common scientific practices.

Noting that it is heartening to see that having led this effort for many years and bringing out an updated edition of the manual is a step in the right direction, Dr Narayana said that the pace at which the monographs are published in IP needs to has to be hastened. Pharmacy college researchers and professors should also contribute to this national effort. Health ministry also needs to enhance the infrastructure within the Indian Pharmacopoeia Commission to achieve it speedily.

Commenting on the release of the Manual for Monograph Development of Herbs and Herbal Products including Phytopharmaceutical Drugs, Rajesh Bhushan, secretary, Ministry of Health and Family Welfare, said that herbal and plant medicine are playing a pivotal role in the diagnosis, prophylaxis and treatment of diseases in humans and animals. Bringing out the 2nd edition is to ensure seamless compliance with standards related to herbal medicine.

“The manual addresses the emerging areas and advanced tools such as DNA for fingerprinting for identification, phytopharmaceutical ingredient (PPI) category monographs. It will control the limits of herbal contamination. This will also open new frontiers of research and development of these products enabling these drugs to gain international recognition. Since this is a dynami document, there is always scope for further amendment, stated Dr. Mandeep K Bhandari, joint secretary, ministry of health and family welfare.

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