The Indian Council of Medical Research (ICMR) had placed purchase orders for COVID-19 antibody test kits to Indian firms which were cancelled subsequently with no payment made to any Chinese company, the Lok Sabha was told on Friday. In a written reply to a question, Minister of State for Health Ashwini Choubey said the ICMR has not imported huge quantities of antibody test kits from China.
Narrating the sequence of incidents which led the government to withdraw the faulty COVID-19 antibody test kits from China and the grounds on which the import orders were cancelled, Choubey said antibody kits of M/s Aark Pharmaceuticals (Wondfo) and M/s Gene2me (Livzon) were sent to the field.
"When complaints were received from states of Rajasthan, Punjab, Karnataka regarding non-performance of the antibody test kit in the field, and based upon the said feedback from the field, those purchase orders were cancelled without any payment," the minister said in his reply.
"Simultaneously, the licenses of these companies were also cancelled by Drug Controller General," he said.
The minister further replied in negative to a question on whether there exists any complaints against massive profiteering and over-pricing in kits imported from China.
However, a public grievance was received primarily describing a commercial dispute amongst different distributors of the kits supplied by Wondfo company, China, Choubey said.
The ICMR is not a party to the said dispute among different distributors of a commercial entity.
As there was no payment made by ICMR to any supplier, there was no further action to be taken by ICMR.
Stating whether the government has taken any action or proposes to take any action against the persons involved in this serious lapse, the minister said that 17 importers were issued licenses between March 23 and April 24 for import of antibody rapid diagnostic kits from China under Medical Devices Rules, 2017 subject to various conditions.
ICMR reported that the above test kits do not meet the specification in the field and issued orders on April 26 cancelling the purchase orders.
Pursuant to above information from ICMR, the importers were issued directions on April 28 to stop import of the said diagnostic kits as well as they were asked to show cause as to why action will not be taken to suspend or cancel their licenses.
Subsequently, on April 29, after verification of the responses, as received, the importers were directed that no batches of the said diagnostic kits should be imported for sale/stock/distribution or be sold or offered for sale.
Further, they directed that entire batches imported and supplied, should be recalled from the market including hospitals and accordingly, their import licenses were made infructuous and cancelled with immediate effect, Choubey said.
Informing the steps taken by the government to ensure availability of genuine testing kits to combat the disease, the minister said detailed requirements and conditions of the manufacturing/import license required to be complied by the licensee are prescribed in the MDR 2017.
In addition, the ICMR in co-ordination with CDSCO has issued guidelines for validation and batch testing of COVID-19 diagnostic kits and for validation centres.
Acceptance criteria for COVID-19 diagnostic kits and regents has been fixed by the ICMR experts group for testing product and quality at the ICMR designated labs to ensure the quality of the product for recommendation to use in the country for testing patient samples, the minister said.
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