INTERNATIONAL MEETING OF WORLD PHARMACOPOEIAS 29 February to 2 March 2012 WHO, Geneva 1

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Indian Pharmacopoeia Commission The Indian Pharmacopoeia Commission is the Standards Setting Institution for Drugs in India. It is an autonomous body under the Ministry of Health & Family Welfare, Govt. of India, New Delhi. 3

Indian Pharmacopoeia Commission Vision Topromotethehigheststandards ofdrugsfor use in humans and animals within practical limits ofthe technologiesavailablefor manufacturing and analysis. Mission TopromotepublichealthinIndia bybringing outauthoritativeandofficiallyaccepted standards for quality of drugs including APIs, excipients and dosage forms, used by health professionals, patients and consumers. 4

Mandates of the Commission Publication of Indian Pharmacopoeia the book of standards for Drugs in India Bringing out the National Formulary of India, the reference book for healthcare professionals Providing IP Reference Substances Nodal agencyforestablishingnational/ internationalcollaborationwithsimilarlyplaced bodies 5

Highlights of 6 th Edition IP

IP Herbal Monographs Monographs on herbs and herbal products in IP 2010 include color photograph of crude drugs and TLC/ HPLC/HPTLC chromatogram IP also provided the specifications /details: oForeign organic matter oEthanol soluble extractive oWater soluble extractive oTotal ash and Acid-insoluble ash, oHeavy metal content oLoss on drying, oMicrobial limits/contamination, oAssay method by HPLC/HPTLC/TLC 7

Trends of Herbs and Herbal Products Monographs in IP 8 Monographs IP 1955 IP 1966 IP 1985 IP 1996 IP 2007 IP 2010 Crude drugs Extracts Finished formulations Pharmaceutical aid

Trends of Biopharmaceuticals Monographs in IP 9 Monographs IP 1966 IP 1985 IP 1996 IP 2007 IP 2010 Vaccines & immunosera for Human use Diagnostics for Human use Blood & Blood related Products Biotechnological product 00055

Government Initiatives 10

Industry Perspective 11

Challenges Sharing of information among Pharmacopoeias? o Resources o Working in pockets where there is need for sharing information o Commitment  Let’s begin top 20 selling molecules to service humanity  Monitoring  Harmonization with leading pharmacopoeias 12

Way Forward Toprovide‘Quality harmonized‘Drug monitoringqualityof Medicines’through Standards’and medicinesthrough effective ‘Regulatory System’ 13

International vision with an approach to make IP Standards globally recognized 14