Indian Pharmacopoeia Commission (IPC) is an Autonomous Institution of the Ministry of Health and Family Welfare, Govt. of India. IPC is created to set standards of drugs in the country. Its basic function is to update regularly the standards of drugs commonly required for treatment of diseases prevailing in this region. It publishes official documents for improving Quality of Medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP). It further promotes rational use of generic medicines by publishing National Formulary of India. IP prescribes standards for identity, purity and strength of drugs essentially required from health care perspective of human beings and animals. IPC also provides IP Reference Substances (IPRS) which act as a finger print for identification of an article under test and its purity as prescribed in IP.

Indian Pharmacopoeia (IP) is published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Ministry of Health & Family Welfare, Government of India in fulfillment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules 1945 there under. IP 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. During quality assurance and at the time of dispute in the court of law the IP standards are legally acceptable. The Standards prescribed in the IP are to establish the compliance with regulatory requirements on an article. The criteria to be adhered are: The interpretation of a monograph must be in accordance with all the general requirements, testing methods, texts and notices pertaining to it, in the IP. A product is not of standard quality unless it complies with all the requirements of the monograph.

The National Formulary of India is essentially meant for the guidance of the members of the medical profession; medical students, nurses and pharmacists working in hospitals and in sales establishments. In the preparation of this Formulary, the expert opinion of medical practitioners, teachers in medicine, nurses, pharmacists and Pharmaceutical manufacturers has been obtained. The selection of drugs for inclusion in the National Formulary has been made taking into consideration the relative advantages and disadvantages of the various drugs used, the extent of their use in current medical practice and their availability in the country. Thus the National Formulary of India represents a broad consensus of medical opinion in respect of drugs and their formulations and provides the physician with carefully selected therapeutic agents of proved effectiveness which form the basis of national drug therapy.

Reference Substances. Certain monographs require the use of a chemical reference substance or a biological reference preparation or a reference spectrum These are authentic specimens chosen and verified on the basis of their suitability for intended use as prescribed in the Pharmacopoeia and are not necessarily suitable in other circumstances. IP Reference Substances, abbreviated to IPRS (and referred to as RS in the individual monographs) are issued by the Indian Pharmacopoeia Commission (IPC). They are the official standards to be used in cases of arbitration. Secondary Standards (Working Standards) may be used for routine analysis, provided they are standardized at regular intervals against the Reference Substances Biological Reference Substances, also abbreviated to IPRS and Standard Preparations of antibiotics are issued by agencies authorised by the IPC. They are standardized against the International Standards and Reference Preparations established by the World Health Organization (WHO). The potency of these preparations is expressed in International Units.

Analytical Research and Development (AR&D) Division firmly reinforces the mission and vision of IPC by bringing highest standards of drugs through its dynamic research activities. AR&D Division continuously promulgates changes to analytical test procedures according to the latest technological requirements. AR&D Division is also responsible for validation and verification of monographs included in IP. The division also aims to R&D activities towards monographs modernization.

The Pharmacovigilance Programme of India (PvPI) was launched with a broad objective to safe guard the health of 1.27 billion people of India. Adverse drug Reactions (ADRs) are reported from all over the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base. NCC-PvPI monitors the ADRs among Indian population and helps the regulatory authority of India (CDSCO) in taking decision for safe use of medicines. I invite all the health care professionals and patients/consumers to join us in our mission to promote patient safety.

Pharmacopoeial Forum 

A. Monograph Submission

B. Stakeholder Comments

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