The country has demonstrated resolve in attaining self-reliance in the critical In-Vitro Diagnostics or IVD manufacturing landscape in face of Covid-19 pandemic, writes Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD.)

As India geared up to fight the Covid-19 crisis, Indian IVD manufacturers relentlessly worked to address the crisis with rapid ramp-up of testing for Covid, as testing was considered most critical to containing Covid-19. The staggering demand for Covid19 diagnostic tests sent shock waves through the (In-Vitro Diagnostics) IVD industry.

The Government of India through its flagship ‘Make in India’ initiative relied heavily on the Indian manufacturers to meet the rising demand of essential healthcare equipment for the country, pushing the Indian medical devices sector to become Atmanirbhar or self reliant.

Amid the clarion call given by the Hon’ble PM to become Atmanirbhar, from immediately developing all required Covid-19 test kits to producing millions and millions of tests, the Indian IVD Industry was the solution provider in the biggest healthcare crisis of our nation.

The IVD industry of the world and entire India has observed phenomenal changes in the ways it supported the diagnosis of Covid-19 samples. From logistics capabilities to testing capacities to reporting, all activities were observed a turnaround in the way they used to function before Covid-19. India alone has registered 400% growth in the number of new labs which started molecular testing during the pandemic. By mid-March 2021, India crossed 2400 molecular laboratories performing Covid-19 PCR testing. This is a huge step toward making India Atmanirbhar for complex disease testing where molecular techniques are proven to be the gold standard. While the disease remains uncontained, such demand is likely to keep growing.

Demand for IVD products of all kinds—reagents, instruments and systems used to diagnose and monitor Covid-19, heart disease, diabetes and other conditions— is surging. Prominent players, including 3B Blackbio Biotech, Himedia, Trivitron Healthcare, Mylab are expanding in the market very quickly. And they are meeting an increasingly supportive regulatory landscape for product development and commercialisation.

Today, 3B Black bio Biotech has developed more than 100 molecular tests which cover technologies like Real-Time PCR and Next Generation Sequencing (NGS). Soon after ICMR approved their RT-PCR kit for Covid-19, they started receiving more than 100 calls a day as they were the only second kit to get approval in India. From the production capacity of 5,000 tests a day, they started scaling up their efforts to produce more than 1,00,000 tests per day.

3B Blackbio Biotech India became the first-ever Indian molecular diagnostics company to receive US-FDA EUA (Emergency Use Authorization) to make their mark on the global IVD industry. This led to more than 50 countries enquiring about their kit. They further also received EUA on our RT-PCR kit for Saliva samples.

Today, they are happy to acknowledge more than 400 private laboratories and an almost equal number of government laboratories who used their kits and relied on their world-class quality. By the end of January 2020, 3B Blackbio has produced and sold over 6 million tests not just in India but in other nations too. Under a new quota system, they are now exporting their RT-PCR kits to the United States of America. With this new zeal, 3B Blackbio Biotech’s team is even more committed to offering reliable and affordable molecular testing solutions to India for its Atmanirbharta and to the entire world.

Being ranked among the top-3 bio suppliers in India, HiMedia whose mission is to deliver world-class quality products at an affordable cost was at the forefront of the fight against Covid from day one. Himedia undertook the task of fighting the Covid-19 pandemic by developing a vast array of diagnostic products and tools that include VTM, a range of ELISA-based kits (viral detection kit), RNA extraction kits, RT-PCR kits, RNA extraction machine, and RTPCR machines. HiMedia’s capacity was to produce 5 Lakh (0.5 Million) VTM tests per Annum for the last 12 years. However, at the request of the DPIIT they ramped up to 35 Crore tests (350 million tests) per Annum, over the months of April and May-2020. This was a 700-fold or a 70,000% increase.

All the above steps helped India to be Atmanirbhar in this vital field of Covid Viral Sampling. They ramped up to 350 million tests at that time and helped to test almost 95% of the patients. All components & raw material of VTM is manufactured by HiMedia.

Himedia has developed both qualitative and quantitative ELISA based antibody detection kit for Covid-19 infection. The antibody detection kit is the only way to determine whether a person have developed immunity against of SARS-CoV-2 and with the mass vaccination drives happening, it will be really important from a clinical point of view to determine the immunological status of the people before and after vaccination.

When the pandemic had only just begun, India hardly had infrastructure to develop Covid-19 testing solutions and was heavily dependent on imports. Trivitron Healthcare, a leading medical devices organisation took the beginner steps and invested heavily in manufacturing a comprehensive range of Covid-19 solutions including RT-PCR Tests, RNA Extraction kits, Viral Transport Media, Total Antibody ELISA Test, ELISA IgG &Covid Antigen testing kits. This pandemic triggered an unprecedented demand for high performance health technology products with extremely short turnaround time and unmatched precision. Keeping abreast of the contagion, existing infrastructure and logistics support, and the demand, Trivitron converged the majority of their efforts in the production of new Covid-specific products.

Trivitron had established new production facilities for large scale manufacturing of Covid-19 products and is committed to manufacturing and scale-up cost-effective and globally accepted high-quality kits, and other Covid-19 solutions.

With India beginning the biggest vaccination drive reaching one and all, Trivitron has begun to look beyond existing developed covid products. Trivitron research & development team is working on developing Lyfoung RT PCR tests, RT PCR Direct which will enable to reduce the steps and turnaround time for testing, Over The counter Antibody testing point of care test kits for Covid.

In March 2020, despite being the first and only Indian company to get approval from the Indian FDA for Covid-19 test kits, Mylab placed society first and offered Covid-19 kits at one fourth the cost borne by the government. They are working with the central and state governments, ICMR and NIV to ensure kits are available in the remotest parts of the country and to the friends of India. They want to develop end-to-end molecular diagnostics products for India including tests and machines.

They have developed an automated machine called Compact XL to bring lab in a box and lab in a Van. The product makes it possible to establish molecular diagnostics laboratories in space and resource constrained environments such as airports, national borders, country-side establishments. During the Covid-19 pandemic, the world realised that RT-PCR testing is the most reliable way to find infections. The compact XL product enables RT-PCR testing for all infections such as HIV. Hepatitis, Dengue, Malaria, Tuberculosis and hundreds more.

The IVD industry is expected to record a year on year growth of 30% in the year 2020. This will be double the rate at which the industry has been growing in the past decade. The size of IVD industry in the year 2019 was Rs 7500 crore which was slated to grow at a CAGR of about 15% before the Covid crisis. COVID related products have already added Rs 3400 crore to the market size during the first half of the year and by the end of the year, this figure is expected to touch an estimated amount of Rs 7300 crore. Even if the size of non-Covid routine diagnostics products plummets to one-third of its original value, a base value of Rs 2500 crore will still remain, taking the total industry size to a value of Rs 9800 crore.

The de-growth in the IVD industry may sound alarming but the sharp surge in Covid test and large production of indigenous products will more than makeup for the loss this year.

The IVD market has been propelled by the Covid-19 pandemic for much of this year, and the global response to the crisis is expected to continue to drive diagnostics growth. But it is not the only driver.

Also pushing the market for IVDs will be a number of factors. First, as diagnostics laboratories increasingly use fully automated instruments, they will decrease hands-on time, reduce batch testing, and provide doctors with quicker tests compared to non automated instruments. Second, the integration of biomarkers and the availability of biomolecular tools are predicted to help in the development of a new set of condition-specific tests, thus creating new opportunities for the growth of IVD market size. And last, the IVD market will be driven by the use of personalised medicine products in treating cancer and other chronic diseases, along with increasing technological advances related to artificial intelligence and machine learning, which makes it possible to achieve higher levels of diagnostic precision.

Up to date, the development of Covid-19 tests has ramped up massively. The rapidness of disease spreading and the urge to carry out large-scale testing has led to the commitment of the diagnostic industry to concentrate its production and development capacities on one common goal. Despite the pace and urgent need, it remains critical to ensure a test’s reliability. Therefore, despite the high number of tests required to be readily available, Indian developers are ensuring in-depth quality control and quality assurance infrastructure to maintain accuracy and comparability.

We recognized that the government interventions helped the medical devices industry scale up production during the pandemic. We enjoyed an unprecedented teamwork and rapid proactive communication from NPPA who became a facilitator instead of a Regulator and Department of Pharma, DPIIT, Invest India and MSME Ministry as they set up help desks to address production bottlenecks of all medical Devices especially, those related to Covid viz Covid IVD test kits, sanitisers, masks, ventilators, and Gloves.

The number of Indian firms manufacturing RNA extraction kit listed with AiMeD before the outbreak of Covid-19 was Zero, but today 16 Indian firms listed with AiMeD are manufacturing 265.4 million pcs/annum.

Similarly, the number of Indian firms manufacturing diagnostic kit (PCR Kit) went from zero to 8 manufacturing 1.47 billion plus pcs/annum, Covid-19 rapid diagnostic test kit from zero to 3 manufacturing 46.5 million pcs/ annum and VTM from zero to 10 manufacturing 3.77 billion pcs/ annum listed with AiMeD.

Covid-19 crisis has shown that the Indian medical devices sector can rise to the challenge. When imports got disrupted, specific devices detailed with quantified production shortages and a focused Inter Ministry Group coordinating with domestic manufacturers via AiMeD had addressed production bottlenecks and challenges so that not only capacity got utilised but also ramped up rapidly.

Prime Minister Narendra Modi’s call for Aatmanirbhar Bharat will not only see India emerging as a manufacturing superpower but will also, strengthen India to vie for being the second factory in the world for medical devices and a dependable manufacturer of quality products in global supply chain. We have shown the ability and capability of Indian entrepreneurs to Make in India when we have the support of our government.

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