State’s share uncertain even as India receives 5 lakh testing kits

India on Thursday received the much-awaited five lakh rapid COVID-19 testing kits from China on Thursday, the government said. However, health officials here remain uncertain what could be the State’s share and when they might get the kits.

The Head of Epidemiology and Communicable Diseases at ICMR, Dr Raman R Gangakhedkar, however, said these testing kits will be used for surveillance and to monitor whether coronavirus hotspots in the country are increasing or decreasing.

The recent fiasco over 1 lakh rapid test kits ordered by the State getting diverted to United States has triggered a debate among medical fraternity here on the State’s dependence on imported test kits while local firms were also producing the same.

State Health department authorities clarified that have not initiated procurement of the rapid testing kits from the Indian firms manufacturing rapid testing kits for various reasons.

“The approval of the diagnostic kits and their quality check for the manufacturing of the rapid testing kits is a long procedure. The rapid testing kits reached the markets by March when the pandemic was at its peak in the USA, Canada and other European countries. The consignment was thus diverted to other countries before India could procure it. The lockdown in several countries affected the logistics, air cargo and even the workforce. Thus, there was a delay in the arrival of the rapid testing kits. We are completely relying on the PCR testing, and we have adequate number of testing kits,” said Dr K Kolandaisamy, Public Health Director.

With many Indian firms manufacturing rapid testing kits, the State Health department officials state that if the kits are approved by Indian Council of Medical Research (ICMR), the Tamil Nadu Medical Services Corporation would undertake procurement from the Indian firms.

As per the ICMR, every firm that undertakes the manufacturing of rapid testing kits should have the testing kits approved by European CE-IVD or US-FDA. If the rapid testing kits are not approved by CE-IVD/US-FDA, validation by ICMR accredited Institutes such as National Institute of Virology, Pune is mandatory.

The company should also have obtained marketing licence for rapid test kits from Drug Controller General India. Additionally, the kits should be able to differentiate IgM and IgG separately for COVID-19.

Recently, Andhra Pradesh based MedTech Zone had undertaken the production of rapid testing kits and is expected to manufacture 7.5 lakh kits by the end of May.

So far, rapid testing kits by three Indian companies, including Vanguard Diagnostics in New Delhi, HLL Lifecare Limited in Kerala and Voxtur Bio Limited in Gujarat have been validated and their marketing license have been provided, according to ICMR.

Although a couple of TN-based firms claimed to have rapid test kits ready for supply, sources in the department pointed out that these firms were procuring the kits from China-based organisations and reselling them.

Senior officials from Tamil Nadu Medical Services Corporation (TNMSC) said that normally any procurement process will take about a fortnight. “If we have local firms who obtain the licence for marketing of the rapid testing kits after approval from ICMR, the State Health department can undertake procurement of the kits from the local firms,” said a senior official from TNMSC. “We are also looking into it.”