Indian Pharmacopoeia Commission (IPC)

Last Updated on November 15, 2021 by The Health Master

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Download the latest from 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.  

List of impurities

For List of Impurities, click the below link:

List of Reference Standards

For List of Reference Standards, click the below link:

Important Notifications / Notices / Circulars by IPC

IPC Notice dt 26-07-2021 – IP Addendum 2021 shall be effective from 31-12-2021

IPC dt 24-06-21 – Revised Draft General Chapter on Approach to Alternative Microbiological Methods

IPC 10-03-2021 – Omission of Monographs of ‘Lorcaserin Hydrochloride Hemihydrate’ and Lorcaserin Tablets’ from the Indian Pharmacopoeia

IPC dt 26-02-2021 – Clarification on Alternative Methods in the Indian Pharmacopoeia

IPC dt 25-02-2021 – Amendment List-08 to IP-2018

IPC 19-02-2021 – Release of Guidance Document for Drafting and Formatting of Monographs for Indian Pharmacopoeia

IPC dt 12-01-2021 – Draft of General Notices on Phytopharmaceutical Drugs

Guidance documents by IPC

IPC dt 16-09-2021 – Guidance document on Calibration of Gas Chromatograph

IPC dt 16-09-2021 – Guidance document on Calibration of HPLC

IPC dt 16-09-2021 – Guidance document on Compliance with Indian Pharmacopoeia Standards

IPC dt 16-09-2021 – Guidance document on Good Documentation Practices

IPC dt 16-09-2021 – Guidance document on Legal Status of Indian Pharmacopoeia

IPC dt 16-09-2021 – Guidance document on Process for Development of Indian Pharmacopoeia Monographs

IPC dt 16-09-2021 – Guidance document on Quality Management System in Testing Laboratory

IPC dt 16-09-2021 – Guidance document on Validation of Analytical Methods

For other Notifications / Notices / Circulars by IPC, Click here

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.

National Formulary of India (NFI) 2011

To download National Formulary of India (NFI) 2011, click below link

National Formulary of India (NFI) 2011

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
6.National Formulary of India 2021 – The Sixth Edition of NFI  (current edition)

Contents List for NFI 2016

Salient features of NFI 2016

Salient features of NFI 2021

Rates and Procedure to purchase of different volumes of IP and NFI

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