Indian Pharmacopoeia Commission (IPC)
IP Reference Substances (IPRS) & Impurity Standards
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.
For List of 145 Impurities Dec 2019, click below link:
For List of 594-Reference-Substances Dec 2019, click below link:
Important Notifications / Notices / Circulars by IPC, Click below links
IPC dt 12-01-2021 – Draft of General Notices on Phytopharmaceutical Drugs
National Formulary of India (NFI)
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.
4th Edition of National Formulary of India has been published in 2011 by the IPC after a gap of more than 3 decades.
The National Formulary of India would prove to be the authoritative guide to prescribing, dispensing and administering medicines for all healthcare professionals.
It will be useful for framing national drug policies in the country. Ministry of Health and Family Welfare, Govt. of India vides its notifications F. No. X. 11035/2/06-DFQC, dated 8th May 2008 assigned this mandatory responsibility to the Indian Pharmacopoeia Commission, Ghaziabad to publish NFI on regular basis.
History of National Formulary of India (NFI):
The IPC with its mission to be one of the leading scientific institutions under the central government puts stress on keeping transparency, accountability and punctuality and the publication of the NFI.
The National Formulary of India editions are as follows:-
1.National Formulary of India 1960 –The first edition of NFI
2.National Formulary of India 1966 –The Second edition of NFI
3.National Formulary of India 1979 –The Third edition of NFI
4.National Formulary of India 2011 – The Fourth Edition of NFI (With CD)
5.National Formulary of India 2016 – The Fifth Edition of NFI (Current edition)
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