The number of Covid-19 cases in India has crossed the 40,000 mark. By the week’s end, it is expected to cross 50,000. Already, 1,389 people are reported to have died from the virus. Yet, even as India eases up on its five-week nationwide lockdown, the country is still desperately short of potentially life-saving equipment in the fight against the virus—ventilators.
According to projections from PD Vaghela, secretary of the department of pharmaceuticals, India requires at least 75,000 ventilators. Vaghela, who is leading a group tasked with procuring medical equipment for the government, says India has fewer than 20,000. To bridge this gap, the government has reportedly ordered upwards of 60,000 ventilators.
Noida-based AgVa is one of the firms that has been tapped for this. The startup is on its way to manufacturing half of the 20,000 ventilators that government-owned HLL Lifecare floated a tender for. With AgVa’s ventilators costing Rs 1.5-2 lakh ($2,000-2,600) per unit, the whole consignment was to be delivered by the end of April.
To date, AgVa—in partnership with automaker Maruti Suzuki—has only delivered 1,500 ventilators. Missed deadlines, though, are hardly the problem. No other Indian ventilator manufacturer has been able to deliver a single ventilator yet. Instead, the issue with AgVa’s ventilators stems from HLL’s tender itself.
Released on 27 March, one of the tender’s requirements was that all ventilators must be certified by the United States Food and Drug Administration (FDA).
AgVa’s ventilator is not FDA certified. Indeed, no Indian manufacturer has an FDA-certified ventilator. AgVa, though, has a certificate from a third-party company that says it is FDA compliant.
There are two problems with this. The FDA doesn’t certify companies, just products. And the FDA compliance can only be issued by the FDA itself.
In 2018, AgVa was certified by Unitas Certification Services, a company with a UK-based address. Unitas, incidentally, doesn’t appear to exist beyond its website. As recently as last month, AgVa received an IEC 60601 IEC 60601 IEC 60601 IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission compliance certificate from NFI Certifications Ltd, another UK-registered entity, which appears to be a shell company. According to company filings, it has assets of £1 ($1.25). AgVa did not respond to questions sent via email.
Legitimate certification bodies in India are accredited by the National Accreditation Board for Certification Bodies (NABCB). Globally, accreditation is done by a member of the International Accreditation Forum (IAF), says Anil Jauhri, CEO of NABCB until July last year.