Indian Pharmacopoeia Commission (IPC)
In the healthcare system, Indian Pharmacopoeia Commission (IPC) plays an important role particularly in matters related to the quality standards, safety and rational use of medicines in the country. IPC was set up on 01st January, 2009 as an autonomous Institution under the Ministry of Health and Family Welfare (MoHFW), Government of India. The Secretary, MoHFW is the Chairman and Secretary-cum-Scientific Director is the Chief Executive
Officer of IPC.
IPC is recognized as the Scientific and Industrial Research Organization (SIRO) w.e.f.22.03.2016 by the Department of Scientific and Industrial Research (DSIR), Ministry of Science and Technology, Government of India In order to achieve its objectives, IPC functions are continuously monitored and reviewed by the General Body, Governing Body,
Scientific Body and National Consultative Committee. The functions of IPC are carried out in close coordination and cooperation with the experts and stakeholders from throughout India such as regulatory authorities-Central Drugs Standards Control Organization (CDSCO), analytical laboratories-Central and State Drug Testing Laboratories, Pharmaceutical industry, healthcare professionals etc. IPC has its Mission, Vision and Major Functions as under:
To promote public and animal health in India by bringing out authoritative and officially accepted standards for quality of drugs including active pharmaceutical ingredients, excipients and dosage forms, used by health professionals, patients and consumers.
To promote the highest standards of drugs for use in human and animals within practical limits of the technologies available for manufacture and analysis, and Major Functions
i. Publishing Indian Pharmacopoeia (IP) and its Addenda at regular intervals.
ii. Preparation, certification and distribution of IP Reference Substances (IPRS) to the
iii. Publishing National Formulary of India (NFI) for rational use of medicines by health
iv. Running Pharmacovigilance Programme of India (PvPI) through National Coordination
Centre (NCC) at IPC.
v. Analysis of the new drug candidate materials by Indian Pharmacopoeia laboratory (IPL)
for their marketing authorization.
vi. Skill development, International collaborations etc.
IP is the officially recognised book of standards for drugs included therein, in terms of the second schedule to the Drugs and Cosmetics Act, 1940 so as to specify the standards of identity, purity and strengths for the drugs imported, manufactured for sale, stocked or exhibited for sale or distributed in India. The standards prescribed in IP are authoritative.
The standards in IP are in the form of general monographs (e.g. Tablets, Capsules, Injections) and specific drug monographs such as of active pharmaceutical ingredients and their dosage forms (e.g. Paracetamol, Paracetamol Oral Suspension), pharmaceutical aids etc.
To fulfil the intended purpose of IP monographs, IPC also establishes and supplies the IPRS both for drug substances as well as the impurities to the stakeholders. These are highly characterized materials used for the purpose of comparison. IPC is accredited as Reference Material Producer in accordance with the ISO Guide 34.
Furthermore, IPC promotes the rational use of generic medicines by publishing NFI which is a guidance document essentially meant for the healthcare professionals, students, nurses and pharmacists for appropriate selection of medicines. The NFI covers the drugs based on their therapeutic merit, the extent of their use in the current medical practices, drugs listed in National List of Essential Medicines of India, and drugs used in National Health
Since April, 2011, IPC is functioning as the NCC for PvPI. The main functions of PvPI are to collect, collate and analyze Adverse Events, establishing the correlation between the drug administered to the patient and Adverse Drug Reactions (ADRs) caused based on causality assessment scale and recommending appropriate regulatory intervention(s) to CDSCO. IPC has a network of ADR Monitoring Centres throughout the country and the ADRs reported online from these centres through VigiFlow are assessed for their quality at NCC and then sent
to the global ADR database maintained at WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden. This system of ADRs reporting, monitoring and analysing helps the regulatory authority of India in taking decisions for safe use of medicines, hence strengthening the same.
Indian Pharmacopoeia Laboratory (IPL), a WHO pre-qualified and NABL accredited laboratory, ensures the compliance with the quality management system – ISO/IEC 17025:2005 in the field of chemical and biological testing. Laboratory is equipped with all modern analytical instruments like NMR, Mass Spectrometer, LC-MS, IR Spectrometer, ICPMS, AAS, HPLC, HPTLC, GC, GC-MS, DSC, TGA, Q-TOF, Thermocycler, Particle Size Analyzer and a separate facility for sterility testing. IPL has the main function of monograph verification of the chemical and biological drugs for inclusion in IP, research and development, and also of new drugs testing for their marketing authorization by CDSCO.
In line with the objectives of ‘Skill Development’, IPC provides hands-on training to the regulators, researchers, scientists, analysts, academicians and students in the areas related to standard setting for drugs, drug analysis, pharmacovigilance and other related areas. As a part of training IPC also organises seminars, conferences and hands-on workshops throughout the year for the benefit of stakeholders. For the sake of harmonisation, IPC collaborates with its international counterparts on pharmacopoeia related matters.
For further information, please contact:
Indian Pharmacopoeia Commission
(Ministry of Health and Family Welfare, Government of India)
Sector 23, Raj Nagar, Ghaziabad – 201 002, India
Phones: +91-120-2783400, 2783401, 2783392, Fax: +91-120-2783311
Website : www.ipc.gov.in