IPC to revise draft chapter on alternative Rapid Microbiological methods

As 45 days have been completed, we are removing this chapter from IPC website.

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Last Updated on June 22, 2021 by The Health Master

The Indian Pharmacopoeia Commission (IPC) will soon revise draft general chapter on approach to alternative rapid microbiological methods (RMM) in coordination with microbiology expert towards making efficacious C-19 drugs.

IPC had earlier recommended stakeholders to follow the draft General Chapter on ‘Approach to Alternative Rapid Microbiological Methods’ as an interim measure in the wake of C-19 second wave.

The draft general chapter on “Approach to Alternative Rapid Microbiological Methods” was uploaded on the IPC website on April 9, 2021 for stakeholder’s comments based on which IPC received many comments from various stakeholders.

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“As 45 days have been completed, we are removing this chapter from IPC website. Draft general chapter will be revised in coordination with microbiology expert working group for Indian Pharmacopoeia (IP) and uploaded on IPC website shortly,” as per the IPC notice.

The proposed draft RMM is aimed at faster laboratory testing of the drugs thereby making them accessible to the patients at the earliest without compromising the quality of the product. This approach would be in line with the provisions of the ‘Alternative Methods’ already given in the General Notices of the IP (Volume I, Page 12) wherein it is mentioned that automated procedures utilising the same basic chemistry as the test procedures given in the monograph may also be used to determine compliance.

“C-19 pandemic has warranted for making available quality medicines to the patients at the earliest. This includes, but not limited to, remdesivir injection which has been approved by the Central Drugs Standard Control Organisation (CDSCO) for restricted emergency use for the treatment of patients with severe C-19 infection.

Recently the healthcare system has faced challenges in maintaining continuous supply of C-19 related drugs, particularly remdesivir injection, and it emerged that application of rapid alternative methods to the official Indian Pharmacopoeia methods may help in tackling this challenge,” explained Dr. Rajeev Singh Raghuvanshi, secretary-cum-scientific director, IPC.

The draft was prepared after intense and in-depth consultation with relevant subject experts and approved by IPC’s Expert Working Group- Microbiology. The best practices followed in other countries and the procedures and approaches provided under similar chapters in other Pharmacopoeias like the United States Pharmacopoeia (USP) and British Pharmacopoeia (BP) have also been taken into consideration while preparing this draft.

“Accordingly, the manufacturers may submit validated data of the alternative RMM and obtain the necessary approvals from appropriate drug regulatory authorities under the provisions of the Drugs and Cosmetics (D&C) Act, 1940 and Rules 1945 there under,” Dr Raghuvanshi added.

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