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Centre may seek UNICEF recognition for vaccine monographs in IP
Joe C Mathew, New Delhi | Tuesday, June 7, 2005, 08:00 Hrs  [IST]

The union ministry of health is planning to seek United Nations Children's Fund (UNICEF) recognition for Indian Pharmacopoeia (IP). The move is aimed at helping Indian vaccine manufacturers to be part of UNICEF's global vaccine supply network. Currently, the agency prefers vaccines that are prepared as per US Pharmacopoeia (USP) standards. In the eventuality of IP approval, Indian companies will also be able to participate in UNICEF tenders.

According to sources, the health ministry is to invite experts from UNICEF's vaccine procurement institutions to visit the Indian vaccine manufacturing facilities. The vaccine manufacturing units in Hyderabad, including Indian Immunologicals, may be asked to showcase their capabilities before the UNICEF team. The research institutions like Central Research Institute (CRI), Kasauli and National Institute of Biologicals (NIB), Noida are also to demonstrate the standards of IP.

It should be noted that the newly constituted Indian Pharmacopoeia Commission is likely to come out with the final draft of 55 monographs for about 20 vaccines and sera within a few weeks. The draft would once again be circulated among experts before it gets incorporated in IP by year-end. The entire set of fresh monographs is likely to get included in the forthcoming addendum of Indian Pharmacopoeia (IP). The task of monograph preparation was carried out by CRI in its Central Drug Laboratory (CDL).

The IP already has 20 vaccine and sera monographs in its latest addendum. With the development of a full new set of monographs and a revision of existing ones, biological monographs in IP can very well be accommodated as a separate section. The government's attempt to go for UNICEF recognition gains significance in this context.

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