The Indian Pharmacopoeia Commission (IPC), an Autonomous Institution of the Ministry of Health and Family Welfare, Govt. of India, has been working since 2009 to develop quality standards for drugs and dosage forms used by the pharmaceutical industry, health professionals and other stakeholders. It is committed to promote the quality of drugs and pharmaceuticals, rational use of generic medicines and to ensure safety of medicines in order to protect human and animal health.
IPC publishes Indian Pharmacopoeia and its addenda, updates National Formulary of India and organizes training and research activities on quality standards for drugs. IPC also provides IP Reference Standards (IPRS) and Impurity Standards which act as a finger print for identification and purity of an article under test. The IP Standards are authoritative in nature and are enforced by the Regulatory Authorities for quality control of medicines in India.
The Indian Pharmacopoeia Laboratory of IPC is a WHO pre-qualified and NABL accredited in the field of chemical and biological testing as well as a Reference Material Producer and Proficiency Testing Provider in compliance with ISO. It is equipped with modern sophisticated analytical instruments like NMR, LC-MS-MS, ICP-MS, AAS, HPTLC, etc.
IPC has published the eighth edition of IP, IP 2018 having 2928 monographs including new monographs of chemical category and FDCs, biotechnology products, herbal Products, veterinary vaccines, anti-cancer drugs, anti-retroviral drugs as well as drugs used under National Health Programmes. Further to promote rational use and economic prescribing of medicines in the country, IPC has brought out latest edition of the NFI in 2016 which contains 33 chapters by therapeutic categories, 521 specific drug monographs and value added 22 Appendices which are not available in Formularies across the world.
IPC performs preparation, certification and distribution of IPRS at affordable cost, including the related substances, impurities and degradation products. Till date, IPC has developed about 550 reference substances and more than 100 impurity standards. IPC has a vision to develop 900 IPRS and 500 impurities by 2030.
The new drugs candidate materials are exclusively analysed at IPC based on which marketing authorization to new drugs are granted by Central Drugs Standards Control Organization.
Since April, 2011, IPC has been entrusted with the responsibility as the National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI) and since 2015, for Materio-Vigilance Programme of India (NCC-MvPI) - aimed at improving patient safety by monitoring drug and medical device safety. Taking note of the quality of work in Pharmacovigilance, the WHO has recognized the NCC-PvPI as the “WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services”.
IPC conducts national and international level training and skill development programmes for enhancing the technical competence of working professionals – the Analysts, Regulators, Research Students and other Stakeholders. Trainings /awareness drives on basics and regulatory aspects of Pharmacovigilance for healthcare professionals and consumers are conducted throughout the year.
IPC is evolving as the centre of excellence being recognized by WHO, USP, BP and the EDQM. It has been granted “Observer” Status by the EDQM Council of Europe. Further, IPC and USP have signed a MoU to collaborate in the identification, development and dissemination of science-based standards in medicines.
IPC has an excellent library for information resources with special reference to pharmacopoeias and pharmaceutical sciences journals and books.
IPC is striving hard to stand tall before the world community by ensuring high quality and safe medicines for protecting and promoting public and animal health.
Dr. G. N. Singh