TAMIL NADULicence for Chinese kits issued after validation, drug controller tells HC
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TAMIL NADULicence for Chinese kits issued after validation, drug controller tells HC
Mohamed Imranullah S.CHENNAI 15 JUNE 2020 23:54 ISTUPDATED: 15 JUNE 2020 23:57 IST
However, they showed wide variations in sensitivity in field conditions: ICMR
The office of the Drugs Controller General of India (DCGI) told the Madras High Court that it had issued import licences 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.
Justices R. Subbiah and Krishnan Ramasamy were told that all licences were cancelled on April 29 after the performance of the test kits was found to be unsatisfactory by the Indian Council of Medical Research (ICMR).
The submission was made in reply to a public interest litigation petition which claimed that use of defective kits was posing a challenge in controlling COVID-19.
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A counter affidavit filed on behalf of DCGI stated that import licences were issued based on submission of a host of documents including 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 ICMR, in its counter affidavit, told the court 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.
The council also stated 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 approval to any kits independently as this does not fall under the purview of ICMR,” its counter read.
After taking the counter affidavits on file and hearing preliminary arguments of advocate Kabilan Manoharan, representing the PIL petitioner M.L. Ravi, of Desiya Makkal Sakthi Katchi, who insisted upon the need to use good quality kits to diagnose the disease, the judges adjourned the case to Thursday for hearing Additional Solicitor General G. Rajagopalan.
In his affidavit, the litigant stated that there were two types of test kits: RT-PCR kits and Antibody Rapid Test Kits.
He said nations that had controlled better the spread of COVID-19 were the ones which 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 lockdown. He said test kits with even a 3% false result were not interpretable and those with a 13% false result were useless.
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