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Thursday, 2 January 2014

Indian Pharmacopoeia calls for inputs from stake holders for herbal monographs

Indian Pharmacopoeia Commission (IPC) has now called on stake holders of the herbal industry to provide inputs on herbal monographs. In this regard it has issued a circular.
A compilation of the monographs appeared in Editions of IP 1955, 1966, 1985, 1996 and 2010 related to herbs, processed herbs and herbal products has been prepared and has been put up on the website of IPC. The Commission has asked the stake holders to indicate which of these herbs/ processed herbs/ herbal products are currently still in manufacture or were being manufactured and were available in commerce till few years ago.
The Commission has also created a list of herbs/ processed herbs/ herbal products for which a monograph appeared in earlier editions of IP, but got deleted in later editions and the same has been put on the website for stake holders information.
As per Regulations under Drugs and Cosmetics (D&C) Act and Rules, the State licensing authorities/ Drug Controllers normally issue or renew licenses to manufacture and sale only those drugs which have a monograph in its latest edition or  one edition earlier. A few manufacturers who had licenses for some of the herbs and herbal products have brought to the attention of the herbal committee of IPC, that they are facing problems of non-renewability of the product licenses due to lack of the monographs for them in IP.
Hence the Herbal Committee of IPC has called for inputs from the industry on what herbal products like soft extracts, dry extracts, raw herbs, tinctures, elixirs, tablets, capsules, dermal patches, etc need to be re-introduced in IP. The herbal committee wishes to work on these monographs of interest to the industry after due scientific review and development of a monograph for quality, reintroduce in the next addendum of IP 2014, Dr DBA Narayana, chairman, Herbal Products & Crude Drugs Committee, (HPCDC), Scientific Committee of IPC, told Pharmabiz.
The work on IP addendum for IP 2014 has already begun, after the Union Minister for Health & FW released the IP 2014 edition recently in November, 2013, he added.
The Committee will also consider working on monographs for herbs/ processed herbs/ herbal products for which appeared in earlier editions of other pharmacopoeia/pharmaceutical codex other than IP.
According to Dr Narayana, the industry and stakeholder participation in IPC’s public standard-setting process is essential to the development of authoritative, relevant IP monographs. IP is open to work on and re-introduce more monographs on finished herbal products as long as their safety profiles are known and they are in use for treating patients and do not fall under new drug category. Stake holders may also give inputs to the committee whether IP need to consider quality monographs for herbal products sold as supplements in India.

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