The association claims that changes in specifications of IVD kits will favour a Korean company, SD Biosensor, in govt tenders
The Association of Indian Medical Device Industry (AiMED) has written a letter to the Indian Council of Medical Research (ICMR) requesting to continue with the previous outlined specifications for the corona antigen rapid test tenders.
It is noted that on the one-stop Government e-Market Place (GeM) portal, the mentioned specifications of the corona rapid antigen test (RAT) has been changed from < 50 per cent sensitivity to 84 per cent and < 95 per cent specificity to 100 per cent, which is disturbing the Indian manufacturers.
In the letter, the association has significantly highlighted that “all of sudden, on the GeM portal tender specifications have been changed to match the results of SD Biosensor Korea’s new ICMR approved IFA corona antigen rapid test kit, which requires a machine to read the results of the rapid tests.”
“Indian manufacturers will sit idle and not be able to participate in the tender while the SD Korea will again get monopoly with 100 per cent government tender business and sell this product at very high price to the government agencies. Therefore, we advise to the concerned agencies to continue with the previous ICMR specifications for corona antigen rapid antibody test tenders, so that SD Korea is not able to walk away with 100 per cent tenders business as sole bidder and help the Indian in-vitro diagnostic (IVD) industry to continue participation in the government tenders,” stated in the letter.
Reportedly, on December 10, the DCGI has asked the all state licensing authorities to recall the batches of rapid antigen IVD Kits of SD Biosensor Healthcare along with Labcare Diagnostics India for non-compliance to the minimum acceptance criteria of sensitivity and specificity as stipulated by Indian Council of Medical Research (ICMR).
“If previous specifications were found to be good enough, how come the tender specifications have been modified to suit only one Korean manufacturer SD Biosensor, whose FDA licence was suspended by DCGI on December 10, 2020 due to poor quality,” mentioned Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry.
“According to the US FDA requirements for the sensitivity requirements of corona antigen rapid test is 80 per cent and specifics requirement is 100 per cent, whereas the ICMR has arbitrarily fixed the sensitivity at 84 per cent, which indicates that the authority is favouring SD Biosensor Korea, which is beyond the specifications approved by the US FDA. Therefore, it indicates that the agency is trying to keep the Indian manufacturers out of the government tenders business,” an industry source informed.
It is also reported that SD Korea continued to supply more than 80 per cent of government tenders for corona antigen tests at all-time high prices of Rs 400 plus GST till the time Indian manufacturers got the approval from the ICMR. This though resulted in healthy market competition and forced the price down to Rs 50 plus GST.
Till now, with the previous specifications criteria, the ICMR has approved 16 manufacturers for corona antigen rapid test, and so far, various government agencies have purchased between Rs 6,000-7000 crores worth of corona antigen rapid test kits, according to reports.