IP (Indian Pharmacopoeia) is recognized as the official book of standards for the drugs being manufactured and/or marketed in India. IP contains a collection of authoritative procedures of analysis and specifications of drugs for their identity, purity and strength. The standards of the IP are authoritative in nature and are enforced by the regulatory authorities for ensuring the quality of drugs in India.
The Govt. of India has created a separate, dedicated, autonomous institution in the form of the Indian Pharmacopoeia Commission (IPC) to deal with matters relating to timely publication of the Indian Pharmacopoeia, in terms of the Second Schedule to the Drugs and Cosmetics Act, 1940 so as to specify the standards of identity, purity and strength of the drugs imported, manufactured for sale, stocked or exhibited for sale or distributed in India.
In 2005, there was a proposal of IPC to publish IP Regularly & a timely. Before 2005 All edition of the Indian Pharmacopoeia was published under the IP committee while after 2005, all edition of Indian Pharmacopoeia has been published under Indian Pharmacopoeia Commission (IPC).Pharmapedia
The Commission has become fully operational from 1st January, 2009 as an Autonomous Body, fully financed by the Central Government.
The Indian Pharmacopoeia commission has a three‐tier policy formulation and execution setup comprising of the General Body, Governing body and Scientific Body with experts drawn from various Science & Technology areas.
Office of IPC is situated at Ghaziabad ‐ 201002, Uttar Pradesh
The Secretary, Ministry of Health and Family Welfare, is the Chairperson and the Chairman-Scientific Body is the Co-Chairman of the IPC.
The function of IPC: –
Publication & Revision of the Indian Pharmacopoeia and National formulary of India on behalf of the Ministry of Health & Family Welfare, Government of India in fulfilment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules 1945 thereunder.
Composition of Commission
Objective of IPC
- To develop comprehensive monographs for drugs to be included in the Indian Pharmacopoeia, including active pharmaceutical ingredients, pharmaceutical aids and dosage forms as well as medical devices and to keep them updated by revision on a regular basis.
- To develop monographs for herbal drugs, both raw drugs and extracts/formulations therefrom.
- To accord priority to monographs of drugs included in the National Essential Medicines List and their dosage forms.
- To take note of the different levels of sophistication in analytical testing/ instrumentation available while framing the monographs.
- To accelerate the process of preparation, certification and distribution of IP Reference Substances, including the related substances, impurities and degradation products.
- To collaborate with pharmacopoeias like the Ph Eur, BP, USP, JP, ChP and International Pharmacopoeia with a view to harmonizing with global standards.
- To review existing monographs periodically with a view to deleting obsolete ones and amending those requiring upgrading /revision.
- To organize educational programs and research activities for spreading and establishing awareness on the need and scope of quality standards for drugs and related articles /materials.
- To publish the National Formulary of India for updating medical practitioners and other healthcare professionals.
- To act as a National Coordination Centre for Pharma-covigilance Programme of India.
International Cooperation of IPC
- World Health Organization (WHO)
- European Directorate for the Quality of Medicines (EDQM)
- Japanese Pharmacopoeia (JP)
- United States Pharmacopeia (USP)
- Chinese Pharmacopoeia (ChP)