The Gujarat Food and Drug Control Administration (FDCA)’s rapid microbiological testing lab at Vadodara has successfully tested 156 batch samples of remdesivir injections towards making its consistent availability in the country.
It generally takes two-week time for testing of remdesivir injection samples but the Vadodara based rapid microbiological lab brought down the turnaround time for drug testing from 14 days to just 3 hours.
It tested 74 samples from Cadila Pharma, 17 samples from Syngene, 16 samples from BDR Pharma, seven samples from Mylan Laboratories, nine samples from Cipla, three samples from Bharat Parenterals and 30 samples from Jubiliant.
According to Gujarat FDCA Commissioner Dr HG Koshia, “Each batch comprises around 20,000 injections which need to be tested for efficacy and safety at the rapid microbiological testing lab for final distribution. During the sudden surge of the second wave of Covid-19 in the past few months, the rapid microbiological testing lab has come as a savior by timely analysis of life-saving Covid-19 drug remdesivir in a record turnaround time of just 3 hours instead of 14 days.”
Estimated to have been completed at a cost of around Rs.4.5 crore, the laboratory which is housed at Food and Drug Testing Lab (FDL), Vadodara, is India’s largest drug testing lab and also has the distinction of being Asia’s first government rapid microbiological testing lab.
In order to make Covid-19 related efficacious drugs available, particularly remdesivir injection, the Indian Pharmacopoeia Commission (IPC) has also 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 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.
The lab is fully equipped to check contamination in medicines imported and exported as per global regulatory requirements. The lab project has been implemented with the support of French company BioMérieux by Gujarat Medical Services Corporation Ltd (GMSCL) in collaboration with Gujarat FDCA.
Setting up of a rapid microbiological testing lab is based on an MoU signed between BioMérieux and Gujarat FDCA as part of strategic partnership to usher in knowledge sharing on microbiological testing technologies for the pharmaceutical sector.
The partnership has been offering knowledge sharing, services and products to upgrade microbiological technology which includes media preparation, quality testing for media -growth promotion testing, environmental monitoring, active and passive air sampling, sterility testing of raw material and end product testing for filterable and non-filterable products.
French company BioMérieux has also trained Gujarat FDCA inspectors to audit drug quality.
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