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Shardul Nautiyal, Mumbai January 10 , 2023
The Indian Pharmacopoeia Commission (IPC) has published draft monograph revision proposals for stakeholders’ recommendations and comments by February 20, 2023. These are to be included in Indian Pharmacopoeia (IP) Addendum 2024 with tentative effective date of April, 2024.

IP Addendum is published by the IPC on behalf of the Union health ministry in fulfilment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules 1945 thereunder. A monograph is a written document that reflects the quality attributes of medicines approved by the drug regulator.
IPC has urged the stakeholders to submit the suggestions, feedback or comments at lab.ipc@gov.in.

IPC is an autonomous institution under the Union health ministry to deal with matters relating to timely publication of the IP which is the official book of standards for drugs to specify the standards of identity, purity and strength of the drugs imported, manufactured for sale, stocked or exhibited for sale or distributed in India.

“IPC has published 8 new monographs for inviting public comments. Till date a total of 64 monographs have been published under the category of pharmaceuticals and veterinary monographs,” informed Dr Rajiv Singh Raghuvanshi, secretary-cum-scientific director, IPC.

IP is a compilation of official standards for drugs manufactured and/or marketed in India. A monograph states the quality or test parameters, the acceptance criteria and details of the tests that are to be performed to determine compliance with the criteria.

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.

Pharmaceuticals Monographs can be accessed at https://ipc.gov.in/mandates/indian-pharmacopoeia/monographs/monographs-under-preparation/30-monographs-under-preparation/addendum-2020-to-ip-2018-chemical-monographs/623-addendum-2020-to-ip-2018-chemical-monographs.html

Veterinary Monographs can be accessed at https://ipc.gov.in/mandates/indian-pharmacopoeia/monographs/monographs-under-preparation/8-category-en/1024-veterinary-monograph%20.html

Union minister for health and chemicals and fertilisers Dr. Mansukh Mandaviya released the ninth edition of IP on July 1 at Vigyan Bhawan, New Delhi.

IP 2022 contains a total of 92 new monographs including 60 chemical, 21 vitamins, minerals, amino acids, fatty acids etc., 3 biotechnology-derived therapeutic products, 4 human vaccines, 2 blood and blood related products, 2 herbs and herbal related products, and 7 phytopharmaceutical ingredient category monographs.

This has led to the total number of 3152 monographs in the current edition of IP. In addition, 12 new general chapters have also been introduced. Several monographs and general chapters have also been revised to update them as per current global requirements and to harmonize with other pharmacopoeias like US Pharmacopoeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), etc.

The harmonization of standards with global standards is expected to help IP getting recognized and accepted in foreign countries.

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