Lok Sabha Question No. 1110 (UNSTARRED), answered on 2020-09-18
Subject: Faulty COVID-19 Test Kits
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Hibi Eden, Su Thirunavukkarasar

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 1110 TO BE ANSWERED ON 18 TH SEPTEMBER, 2020

## FAULTY COVID - 19 TEST KITS

## 1110. SHRI HIBI EDEN: SHRI THIRUNAVUKKARAS AR SU:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a) whether the Government has imported huge quantity of COVID - 19 antibody testing kits from China,if so, the details thereof;

(b)  the  sequence  of  incidents  which  led  the Government to  withdraw  the  faulty  COVID - 19 antibodytest  kits  from  China  and  the  grounds  on  which  the import  orders  from  China  were cancelled;

(c)  whether  there  exist  any  complaints  against massive  profiteering  and  over - pricing  in  kits importedfrom China, if so, the details thereof;

(d)  whether  the  Government  has  taken  any  action  or proposes  to  take  any  action  against  the persons involved in this serious lapse, if so, the details thereof; and

(e) the steps taken by the Government to ensure availability of genuine tes ting kits to combat the disease?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

## (SHRI ASHWINI KUMAR CHOUBEY)

- (a) ICMR placed purchase orders to Indian firms which were cancelled subsequently witho any payment to any Chinese company. ICMR has not imported huge quantities of antibody te kits from China.

(b) Antibody kits of M/s Aark pharmaceutical (Woldfo) and M/s Gene2me (Livzon) were sent to field. When complaints were received from states of Rajasthan, Punjab, Karnataka rega non- performance of the Antibody test kit in the field, and based upon the said feedback f field, those purchase orders were canceled without any payment. Simultaneously, the licenses of these companies were also cancel l ed by Drug Controller General.

(c) ICMR has informed that they have not received any such complaint. However, a publi grievance was received primarily describi ng a commercial dispute amongst different distributors of the kits supplied by Woldfo company, China. ICMR is not a party to said dispute amo different distributers of a commercial entity. As there was no payment made by ICMR to supplier, there was no further action to be taken by ICMR.

(d) Seventeen  (17)  importers  were  issued  licenses  in  Form  MD - 15  between  26.03.2020  and 22.04.2020 for import of Antibody Rapid Diagnostic Kits from China under Medical Device Rules,2017 subject to various conditio ns.

ICMR reported that the above said Test Kits do not meet the specification in the field an order on 26.04.2020 cancelling the Purchase Orders.

Pursuant  to  above  information  from  ICMR,  the  importers  were  issued  directions 28.04.2020 to stop im port of the said diagnostic kits as well as they were asked to show cau to why action will not be taken to suspend or cancel their licens Subsequently, on 29.04.2020, after verification of the responses, as received, the import directed  tha t  no  batches  of  the  said  Diagnostic  kits  should  be  imported  for  sale/  s distribution or be sold or offered for sale and entire batches imported and supplied, recalled from the market including hospitals and accordingly, their import licenses were made infructuous and cancelled with immediate effect.

(e) Detailed requirements & conditions of the manufacturing/import license required t complied by the licensee are prescribed in the MDR 2017.

In addition to above, following steps have been taken to ensure availability of quality COVID - 19 In - vitro Diagnostic Kits and reagents combat the disease in the country .

ICMR  in  co - ordination  with  CDSCO  has  issued  Guidelines  for  Validation an batch testing of COVID - 19 diagnostic kits & for valida tion centres.

Acceptance criteria for COVID - 19 diagnostic kits & regents has been fixed by the ICMR Experts group for testing product and quality at the ICMR designated labs to ensure the of the product for recommendation to use in the country fo r tes ing patient samples.