Defective COVID Test Kits: Licence for Chinese kits issued only after validation, DCGI tells court

Chennai: The Drugs Controller General of India (DCGI) recently responded to a PIL filed in the Madras High Court seeking to draw attention towards the use of defective COVID Test Kits manufactured by two Chinese firms. DCGI told the court that it had issued import licenses for procuring SARS-CoV-2 antibody test kits manufactured by Guangzhou Wondfo Biotech and Zuhai Livzon Diagnostics only after obtaining a validation report from the National Institute of Virology (NIV) in Pune.

This came following a PIL moved by M.L. Ravi, of Desiya Makkal Sakthi Katchi who submitted that use of defective kits was posing a challenge in controlling COVID-19. The petitioner stressed the need to use good quality kits to diagnose the disease.

Medical Dialogues had earlier reported that India had ordered more than half a million Chinese kits for testing for antibodies to the coronavirus in April as a way to boost its screening, among the lowest per capita in the world. The antibody tests taken from blood samples do not always pick up early-stage infections but show whether a person had the virus in the past, even if the person had no symptoms.

In comparison, the standard swab test determines whether a person has the virus at that moment by looking for it in secretions. Several Indian states told the Chinese tests had produced conflicting results. Officials in Rajasthan state said the kits were initially used for testing patients who already had a confirmed infection for coronavirus but some results came back negative.

Also Read: China Says Indian Criticism Of COVID-19 Test Kits Is 'Irresponsible'

In the instant case, the litigant, in his affidavit, stated that there were two types of test kits namely RT-PCR kits and Antibody Rapid Test Kits.

He further went on to state that the countries that had controlled better the spread of COVID-19 were the ones that had done extensive and effective testing using good quality kits and cited South Korea, Taiwan, and Hong Kong which achieved success without resorting to measures such as a lockdown. He said test kits with even a 3% false result were not interpretable and those with a 13% false result were useless.

Responding to the PIL, the office of DCGI stated that it had issued import licenses to various importers between March 26 and April 22 for procuring SARS-CoV-2 antibody test kits manufactured by Guangzhou Wondfo Biotech Co. Ltd in China only after obtaining a validation report from the National Institute of Virology (NIV) in Pune.

DCGI further filed an affidavit specifying that the import licenses were issued based on submission of a host of documents including the power of attorney, free sale certificate issued by the national regulatory authority of country of origin (China), in-house performance evaluation report, stability report and validation/evaluation report from NIV, Pune.

The court was further informed via a counter affidavit by the Indian Council of Medical Research (ICMR) that clarified that the kits of Guangzhou Wondfo Biotech and Zuhai Livzon Diagnostics were evaluated in field conditions and the results showed wide variations in their sensitivity. Hence, on April 27, all State governments were advised to stop using the kits procured from the two companies and return them to the suppliers.

A bench of Justices R. Subbiah and Krishnan Ramasamy was further told by the Council that it validates new diagnostic kits for COVID-19 if they had not been approved by US-FDA or European CE.

"The kits which are found promising, after validation, are referred to the DCGI for approval and marketing permission. The ICMR is not according to approval to any kits independently as this does not fall under the purview of ICMR," the Council's counter read as quoted by The Hindu.

After the preliminary hearing of the petitioner's advocate K Manoharan, and taking the counter-affidavits on file, the judges adjourned the case to June 18, 2020, for hearing Additional Solicitor General G. Rajagopalan.