On July 17, CDSCO sent these 18 companies a showcause notice stating that “as per notification by the US Food and Drug Administration (USFDA) the…product has been removed with direction that it should not be distributed”. (Representational)

Citing a ban by the US government, the Central Drugs Standard Control Organisation (CDSCO), under the country’s apex drugs regulator DCGI, has canceled kit import licences of three firms and suspended those of 15 others.

While most licences were for Chinese rapid antibody test kits that never entered the country, at least two others have been sold in the Indian market.

One is an ELISA antibody test kit (different from rapid antibody test kit) owned by Mumbai-based Transasia, which said they have sold 3 lakh kits since June to different hospitals. Deals for 5 lakh more are currently in the pipeline, the company said.

In addition, 1 lakh supply of a suspended rapid antibody test kit made by South Korean SD Biosensor was sold to Andhra Pradesh in April, a company representative told The Sunday Express.

On July 17, CDSCO sent these 18 companies a showcause notice stating that “as per notification by the US Food and Drug Administration (USFDA) the…product has been removed with direction that it should not be distributed”. It gave the firms time until July 20 to respond.

On July 21, CDSCO said their responses to the showcause was not “satisfactory”.

The cancelled licences were of MDAAC International, Cadila Healthcare, and N.W. OVERSEAS.

The suspended licences were held by Aracion Technology, DiaSys Diagnostic, Jettalabs, Saffron Naturele Products, Cosmic Scientific Technologies, Inbios India, Vishram Distributors, SD Biosensor, Transasia, Accurex, Biohouse Solutions, V S Yarns, Raymed Trading Group, Sowar, and Trivitron.

Barring Transasia and SD Biosensor, all these firms were approved to import a set of seven Chinese antibody test kits that were banned by US FDA in June. The Sunday Express spoke to seven of these Indian companies, all of whom said they had not imported these kits since rapid antibody test kits fell out of government strategy around May.

Transasia owns California-based Calbiotech, which manufactures the kit called ErbaLisa. As one of the first ELISA antibody test kits to be approved in the country, it remains on the most recent Indian Council of Medical Research (ICMR) validation list of July 22.

Calbiotech’s response to CDSCO on July 20, seen by The Sunday Express, included an ICMR-National Institute of Virology validation approval on June 3, US license documents-authorising export, and an Air Force Central Medical Establishment report citing satisfactory results on July 8.

Calbiotech and Transasia stated that the USFDA decision should not stop export of the kit to India, that the US FDA’s removal was not due to performance issues but a policy change, that the company’s application is awaiting a reply from the US agency, and that it never claimed USFDA approval in their validation process in India.

Transasia’s MD Suresh Vazirani said he plans to file a legal complaint in Delhi High Court. “Somehow we don’t believe our own testing protocol. We are discarding ICMR approval because USFDA has done something,” he said.

Vazirani said USFDA has not reached out to the company about their removal.

Dr Arvind Lal, chairman and MD of Lal PathLabs, said this test kit failed their internal validation three weeks ago. Thyrocare chairman and MD Arokiaswamy Velumani said they had used 20,000 of these ELISA test kits nationwide up until 10 days ago.

Companies go through three batches of ICMR trials before the agency sends their validation to the Director Controller General of India (DCGI) for final approval. If a test kit already has USFDA approval, it skips ICMR validation for DCGI approval.

ICMR’s senior scientist Nivedita Gupta answered queries on July 18 by stating that “pertinent action will be taken by CDSCO/DCGI”.

CDSCO, which sits under DCGI, did not respond to repeated attempts at comment.

When asked what the protocol is when the US bans a kit, an official in charge of kit validation at one of ICMR’s institutes said, “If a kit banned by the US comes to us, we do consider if it is banned at that time.”

Another ICMR scientist in the Delhi headquarters said it would be a “red flag” to see the US ban any test kits that ICMR or CDSCO has approved.

A USFDA spokesperson said Calbiotech’s removal occurred in early June. While not commenting on specific kits, they wrote on May 4 of a policy change to begin taking action against manufacturers who do not address their concerns: “FDA has become aware that a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation by the NIH (National Institute of Health).”

In mid-March, the USFDA allowed test kits with external validation to bypass their validation process. After US Congress committee findings criticised their leniency, they began cracking down on “poor performance or misleading statements” and began publishing “removed” manufacturers on May 21.

SD Biosensor’s duo rapid antibody test kit was revoked by USFDA on June 24 and was under a list sent to labs and healthcare providers on June 22 of kits that were “less than optimal performance, and should not be used clinically”.

Company sales director Attaullah Khan said the test kit was approved by ICMR-NIV, but SD Biosensor transitioned to a new combo rapid antibody test kit in April and, thus, did not reapply for FDA approval for their duo test kit. They still hold an Indian manufacturing licence to make the duo and combo test kit in the country, even though few entities use rapid antibody tests.

When ICMR banned several Chinese antibody kits, the Indian Ambassador to South Korea visited SD Biosensor’s facility on April 22 to facilitate a shift to South Korean brands. Biosensor was also the first company to sell the heavily-used antigen test kits in India.

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