India bans Covid-19 rapid antigen test kits by Korean company for 7 days

India’s apex drug and medical device regulator – the Central Drugs Standard Control Organisation (CDSCO) – has announced a seven-day ban on the import, sale, and distribution of the rapid antigen kits manufactured by the South Korean company SD Biosensors for not complying with the minimum requirement of sensitivity and specificity. The CDSCO had served a show-cause notice to the corporate asking why their import licence shouldn't be cancelled or suspended. For any rapid antigen test kit to urge approval purchasable and use in India, the Indian Council of Medical Research (ICMR) requires it to possess a minimum specificity of 95% and sensitivity of fifty .

India bans Covid-19 rapid antigen test kits by Korean company for 7 days


The regulator didn't find the company’s response that “sample collection or procedural error during testing which has resulted within the non-compliance” satisfactory. Soon after, a notice was sent to all or any state drug controllers to recall all the kits of the actual batch number that was found to be faulty on December 7. a replica of the order is with HT.

“Therefore, publicly interest, under the provisions of the Drugs and Cosmetics Act and Rules thereunder, you're hereby directed to recall the merchandise Standard Q Covid-19 Antigen test lot no. ….and to tell all to whom same has been distributed or supplied to prevent further use of it with immediate effect,” the order reads.

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“And, also you shall not further import or sale or distribute the merchandise Standard Q Covid-19 Antigen Test for a period of seven days,” the order says further.

This was the primary rapid antigen kit to hit the market in mid-June, which debuted in Delhi when the govt was looking to proportion testing fast amid a surge within the number of cases.

In an initial assessment by the Indian Council of Medical Research and therefore the All India Institute of Medical Sciences, the kits were found to possess a specificity of 99.3% to 100% and sensitivity starting from 50.6% to 84%.

With around 80% of the tests being conducted using the rapid antigen tests, the Delhi government was later criticised because the low sensitivity means the tests can provides a negative report for up to half all the positive patients.

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Despite the kits being found to possess a lower sensitivity and specificity than the prevailing norms, the industry body alleged that the govt was favouring the corporate . “ICMR has approved 14 manufacturers for the corona rapid antigen tests with above specifications (Sensitivity 50% and specificity 95%) and various government agencies have purchased (these)…. why the tender specifications are modified to now suit just one Korean manufacturer SD Biosensor,” said a letter to the ICMR director general Dr Balaram Bhargava from the Association of the Indian Medical Device Industry (AIMED) on Saturday.

“The ministry of health and other states were procuring the rapid antigen kits from the govt marketplace, with the tenders not stating any minimum requirement of sensitivity or specificity. this suggests anyone approved by ICMR could apply.

“From fortnight now, the govt has changed this to a minimum 85% sensitivity, which is quite the 80% requirement of the US FDA also . Now, there's just one company SD Biosensor that qualifies,” said one among the manufacturers of the kits.

“The company had monopolised the market initially, when there have been no India kits for the want of patient samples. And, it'll do so again. the costs had been brought down from Rs 500 per kit to Rs 50 per kit,” the person said.

The company is yet to reply to queries sent on Saturday evening.India’s apex drug and medical device regulator – the Central Drugs Standard Control Organisation (CDSCO) – has announced a seven-day ban on the import, sale, and distribution of the rapid antigen kits manufactured by the South Korean company SD Biosensors for not complying with the minimum requirement of sensitivity and specificity.

The CDSCO had served a show-cause notice to the corporate asking why their import licence shouldn't be cancelled or suspended.

For any rapid antigen test kit to urge approval purchasable and use in India, the Indian Council of Medical Research (ICMR) requires it to possess a minimum specificity of 95% and sensitivity of fifty .

The regulator didn't find the company’s response that “sample collection or procedural error during testing which has resulted within the non-compliance” satisfactory. Soon after, a notice was sent to all or any state drug controllers to recall all the kits of the actual batch number that was found to be faulty on December 7. a replica of the order is with HT.

“Therefore, publicly interest, under the provisions of the Drugs and Cosmetics Act and Rules thereunder, you're hereby directed to recall the merchandise Standard Q Covid-19 Antigen test lot no. ….and to tell all to whom same has been distributed or supplied to prevent further use of it with immediate effect,” the order reads.

“And, also you shall not further import or sale or distribute the merchandise Standard Q Covid-19 Antigen Test for a period of seven days,” the order says further.

This was the primary rapid antigen kit to hit the market in mid-June, which debuted in Delhi when the govt was looking to proportion testing fast amid a surge within the number of cases.

In an initial assessment by the Indian Council of Medical Research and therefore the All India Institute of Medical Sciences, the kits were found to possess a specificity of 99.3% to 100% and sensitivity starting from 50.6% to 84%.

With around 80% of the tests being conducted using the rapid antigen tests, the Delhi government was later criticised because the low sensitivity means the tests can provides a negative report for up to half all the positive patients.

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Despite the kits being found to possess a lower sensitivity and specificity than the prevailing norms, the industry body alleged that the govt was favouring the corporate . “ICMR has approved 14 manufacturers for the corona rapid antigen tests with above specifications (Sensitivity 50% and specificity 95%) and various government agencies have purchased (these)…. why the tender specifications are modified to now suit just one Korean manufacturer SD Biosensor,” said a letter to the ICMR director general Dr Balaram Bhargava from the Association of the Indian Medical Device Industry (AIMED) on Saturday.

“The ministry of health and other states were procuring the rapid antigen kits from the govt marketplace, with the tenders not stating any minimum requirement of sensitivity or specificity. this suggests anyone approved by ICMR could apply.

“From fortnight now, the govt has changed this to a minimum 85% sensitivity, which is quite the 80% requirement of the US FDA also . Now, there's just one company SD Biosensor that qualifies,” said one among the manufacturers of the kits.

“The company had monopolised the market initially, when there have been no India kits for the want of patient samples. And, it'll do so again. the costs had been brought down from Rs 500 per kit to Rs 50 per kit,” the person said.

The company is yet to reply to queries sent on Saturday evening.(ANE)