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April 21, 2021
Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare, Government of India has introduced a new draft General Chapter on ‘Approach to Alternative Rapid Microbiological Method’. The proposed methods would enable faster laboratory testing of the drug(s) like Remdesivir injection, thereby making them accessible to the patients at the earliest without compromising the quality of the product. 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 method to the official Indian Pharmacopoeia (IP) method may help in tackling this challenge.
As per the current procedure, the injectable formulations has to mandatorily undergo a sterility test besides other tests, before release into the market. The sterility test itself takes a minimum of 14 days. Hence, an injection batch manufactured today shall be available to the public a minimum after 14 days.
Approach to Alternative Rapid Microbiological Methods shall reduce the testing time from 14 days to almost 3-4 days, hence, enhancing the availability of remdesivir injection in this pandemic situation. The 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 utilizing the same basic chemistry as the test procedures given in the monography may also be used to determine compliance.
However, the manufacturers have to submit the validated data of the alternative Rapid Microbiological Methods and obtain the necessary approvals from appropriate Drug Regulatory Authorities under the provisions of the Drugs and Cosmetics Act 1940 and Rules 1945 there under before implementing the said procedure.
The draft Approach to Alternative Rapid Microbiological Method 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 USP, BP etc.) have also been taken into consideration while preparing this draft.
Central Drugs Standard Control Organization (CDSCO), the national drug regulatory agency of India has already taken numerous steps to ensure the availability of quality medicines to the patients at the earliest. CDSCO has also approved Remdesivir injection for restricted emergency use for the treatment of patients with serve COVID-19 infection.
IPC is mandated to revise and publish Indian Pharmacopoeia and National formulary of India on regular basis besides providing IP Reference Substances and training to the stakeholders on Pharmacopoeial issues.
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