COVID Test Kits: Why Does Govt Circular Favour Only Gujarat-Based Firm, Yechury Asks PM

New Delhi: Amid lockdown in 16 states and curfew in Punjab in the wake of mounting cases of novel coronavirus, what is making things worse is the acute shortage of testing kits in the country. With the Narendra Modi government waking up to this reality now and allowing about 60 private labs to do testing, there is need for more approved kits, but then came a circular on Saturday from the Health Ministry.

According to a report in Times of India, the circular issued by the Health Ministry permits only those testing kits to be used which have been cleared by the US FDA and the European Union. And here’s the catch – as per the ToI report, which has cited many local manufacturers, this criterion seems to fit only one company in India – Cosara Diagnostics. This company is based in Ahmedabad and is a joint venture between Ambalal Sarabhai Enterprises and Co-Diagnostics Inc of Utah, US. The CEO of the company is Mohal Kartikeya Sarabhai, who was in the forefront with PM Modi while welcoming US President Donald Trump’s visit to Sabarmati Ashram on February 25 this year.

Incidentally, Cosara is the first Indian company to get a licence just last Tuesday (March 17) for manufacture of COVID-19 testing kits in its Vadodara plant from Central Drugs Standards Control Organisation (CDSCO).

“We have received the licence from the CDSCO and will begin manufacturing shortly. We have ordered raw materials from our partners in the US and these will be arriving soon,” Sarabhai was quoted in a report in Ahmedabad Mirror.

Why the Health Ministry circular raises questions is: Can one firm fulfill the virus  testing needs of a country of India’s size, with a population of 130 crore?

There are several Indian manufacturers who have already made these testing kits and have been waiting for a go-ahead from the government for quite some time. Now, with the Health Ministry circular specifying the USFDA and EU guidelines, these companies feel betrayed, as they have spent loads of funds in research & development.

Veena Kohli of the Association of Diagnostic Manufacturers told ToI that they would write to the government against these guidelines. They said they were disheartened that the Health Ministry was not respecting India’s regulatory processes and endorsing overseas regulatory approvals that keep out Indian manufacturers.

Taking up cudgels on behalf of the suffering people of India and the gravity of the situation in India, the Communist Party of India (Marxist) general secretary, Sitaram Yechury has shot a letter to Prime Minister Narendra Modi, seeking immediate withdrawal of the Health Ministry’s circular.

“All testing kits approved by the National Institute of Virology must be utilized. It is strange that the Union Health Ministry has issued a circular that only those testing kits approved by the US FDA and European EC alone will be used. Reports indicate that there is only one manufacturer in Gujarat who produces such kits.In view of the gravity of the situation, this circular must be withdrawn and all kits approved by the NIV must be deployed for use, urgently,” says Yechury’s letter.

The CPI(M) also demanded that crores of families living on daily wages and BPL persons be transferred at least Rs. 5,000 in their Jan Dhan accounts. Also, ration kits must be supplied to the families of the children who used to benefit from the mid-day meal scheme.  Free ration through PDS to all BPL/APL families should be given for a month.

Read the full letter below:

Dear Pradhan Mantri ji,

The country and the people are in the midst of the grim battle against the spread of COVID-19.  In many states, a general lockdown is being enforced to stop the community spread of this lethal virus.

During such lockdowns, it is imperative to scale up the testing of people particularly those with declared symptoms.  On this basis, specific areas that are vulnerable can be identified and a lockdown to be enforced in such areas.

All testing kits approved by the National Institute of Virology must be utilized. It is strange that the Union Health Ministry has issued a circular that only those testing kits approved by the US FDA and European EC alone will be used. Reports indicate that there is only one manufacturer in Gujarat who produces such kits.  In view of the gravity of the situation, this circular must be withdrawn and all kits approved by the NIV must be deployed for use, urgently.

Crores of families that survive on the daily earnings of their family are currently suffering grievously because of such lockdowns.  It is necessary that immediately at least Rs. 5,000 should be transferred to the Jan Dhan accounts and BPL beneficiaries. 

Ration kits must be supplied to the families of the children who used to benefit from the mid-day meal scheme.  Free ration through PDS to all BPL/APL families should be given for a month.

Many countries in the world have announced that the government will guarantee the payment of at least 80 per cent of the salaries being drawn by workers who are now unable to attend work.  Government of India should do likewise.  Alongside there should be a moratorium on bank loans for a year for SMEs and retail traders as well as on EMIs.

Now that the Finance Bill has been approved by the Parliament, the Central government must set aside separate funds for a substantial package to save the lives and livelihood of crores of people.

This is the time to use our resources for saving lives and not be preoccupied by concerns to maintain fiscal discipline.

Regards,

Yours truly

Sd/-

(Sitaram Yechury)