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 company asking why their import licence should not be cancelled or suspended.
For any rapid antigen test kit to get approval for sale and use in India, the Indian Council of Medical Research (ICMR) requires it to have a minimum specificity of 95% and sensitivity of 50%.
The regulator did not find the company’s response that “sample collection or procedural error during testing which has resulted in the non-compliance” satisfactory. Soon after, a notice was sent to all state drug controllers to recall all the kits of the particular batch number that was found to be faulty on December 7
“Therefore, in public interest, under the provisions of the Drugs and Cosmetics Act and Rules thereunder, you are hereby directed to recall the product Standard Q Covid-19 Antigen test lot no. ….and to inform all to whom same has been distributed or supplied to stop further use of it with immediate effect,” the order reads.
“And, also you shall not further import or sale or distribute the product Standard Q Covid-19 Antigen Test for a period of seven days,” the order says further.
This was the first rapid antigen kit to hit the market in mid-June, which debuted in Delhi when the government was looking to scale up testing fast amid a surge in the number of cases.
In an initial assessment by the Indian Council of Medical Research and the All India Institute of Medical Sciences, the kits were found to have a specificity of 99.3% to 100% and sensitivity ranging from 50.6% to 84%.
With around 80% of the tests being conducted using the rapid antigen tests, the Delhi government was later criticised as the low sensitivity means that the tests can give a negative report for up to half of all the positive patients.
Despite the kits being found to have a lower sensitivity and specificity than the existing norms, the industry body alleged that the government was favouring the company. “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)…. How come the tender specifications have been modified to now suit only 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 government marketplace, with the tenders not stating any minimum requirement of sensitivity or specificity. This means anyone approved by ICMR could apply.
“From two weeks now, the government has changed this to a minimum 85% sensitivity, which is more than the 80% requirement of the US FDA as well. Now, there is only one company SD Biosensor that qualifies,” said one of the manufacturers of the kits.
“The company had monopolised the market initially, when there were no India kits for the want of patient samples. And, it will do so again. The prices had been brought down from Rs 500 per kit to Rs 50 per kit,” the person said.
The company is yet to respond to queries sent on Saturday evening.