IPC asks cos to follow ‘Approach to Alternative Rapid Microbiological Methods’ to make Covid-19 drugs

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In order to make Covid-19 related efficacious drugs available, particularly remdesivir injection, the Indian Pharmacopoeia Commission (IPC) has recommended stakeholders to follow the draft General Chapter on ‘Approach to Alternative Rapid Microbiological Methods’ as an interim measure in the wake of Covid-19 second wave.

The recommendations have also been shared with Dr. Mandeep K. Bhandari, Joint Secretary (Regulations), Union health ministry, Dr. V.G. Somani, Drugs Controller General India (DCGI), Central Drugs Standard Control Organization (CDSCO) and all the State Drug Controllers (SDCs).

The proposed draft Rapid Microbiological Methods (RMM) would enable faster laboratory testing of the drug(s) 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.

“As we are aware that Covid-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 CDSCO for restricted emergency use for the treatment of patients with severe Covid-19 infection. Recently the healthcare system has faced challenges in maintaining continuous supply of Covid-19 related drugs, particularly remdesivir injection, and it emerged that application of rapid alternative methods to the official Indian Pharmacopoeia (IP) methods may help in tackling this challenge,” explained Dr. Rajeev Singh Aghuvanshi, secretary-cum-scientific director, IPC.

“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.

IPC had proposed a new General Chapter on ‘Approach to Alternative Rapid Microbiological Methods’ and the draft have been posted on the IPC website (www.ipc.gov.in) on April 9, 2021 for inviting comments, if any, from all the stakeholders.

The draft has been 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.

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