As the pandemic restricts imports of reagents and kits, India’s biotechnologists are making their own, writes Somdatta Karak* in this guest post.
India’s Prime Minister Narendra Modi recently called for self-reliance in the country’s fight against the COVID-19 crisis. Being a biologist by training, the question that came to my mind immediately was: are India’s biologists and biotechnologists self-reliant in their laboratories across the country?
I walked down to one such example-setting lab earlier this month – the CSIR-Indian Institute of Chemical Technology in Hyderabad – where chemist Anthony Addlagatta and his lab members have been working to scale up the production of reverse transcriptase (RT), an enzyme at the heart of the diagnostic test that detects the novel coronavirus SARS-CoV-2.
RT was discovered in 1970 and it changed our understanding of how information flows in our living cells. Information does not flow in just one direction from DNA to RNA to proteins. RT makes the reverse possible – a conversion of RNA to DNA. Combined with the power of Polymerase Chain Reaction (PCR), invented in the 1980s, the duo ‘RT-PCR’ became an indispensable tool in biology labs across the globe. PCR helps amplify minute stretches of DNA in micro test-tubes.
Fast forward half a century as the world struggles with COVID-19 and urgently needs enough diagnostic kits that use the RT enzyme and Taq DNA polymerase, a bacterial enzyme used in PCR for its ability to amplify short DNA segments.
Though India has been using these enzymes for a few decades now, there is not a single ‘Made in India’ kit in the market. With India’s ability to import reagents and kits for its fairly limited use, the motivation to make a completely home-grown kit has been missing. Now, in times of a pandemic when imports are restricted, we are forced to think of developing these reagents ourselves.
In Addlagatta’s lab, a 10-litre fermentor has been brewing a bacterial culture cloned to produce the RT enzyme. The lab procured this fermentor for one of their industrial projects. Armed with the know-how of producing RT and Taq DNA polymerase, they wanted to develop their own resources and found the right industry partners in Genomix Biotech, who provided oligonucleotides for an RT-PCR kit. Oligonucleotides are short stretches of DNA or RNA molecules that initiate a reverse transcriptase or PCR reaction. Together they are validating these tests and hope to be in the market with test kits soon. A few kilometres down the road at the Atal Incubation Centre of the Centre for Cellular and Molecular Biology (CCMB), Nasar Khaja is also developing RT-PCT kits at his company BioArtis, which manufactures oligonucleotides.
Many other companies across India are developing these diagnostic kits using RT-PCR as well as other methods. Are such home-grown RT-PCR kits going to be in demand only as long as COVID-19 lasts? Can they sustain even after the pandemic?
The quality of these kits will drive their demand when import bans lift. Limited funding and bureaucratic hassles to procure reagents is a huge deterrent for scientists in India to try newer products of unestablished brands. Biotechnologists like Khaja feel that it is the scientific community’s responsibility to groom the home-grown brands. The newer kits might need a bit more enzyme or a few extra steps as opposed to established brands but will give the exact same results at cheaper prices, he says. In the bargain, the scientific community will have supported new start-ups, fostering a culture of product development.
The current Indian market size for many of these home-grown products is too small for start-ups to sustain. Biotech companies in India will have to compete with their global counterparts in quality and price. Another way of dealing with this challenge could be to attract multinational companies to set up manufacturing units in India. The downside here is that global businesses may not share India-centric goals.
Adversities have often shaped cultures and national objectives. In the 90s, India proactively boosted the vaccine industry to fight Hepatitis-B in the country. This industry is now at the global forefront and also actively participating in the race for a vaccine against the novel coronavirus. Would the COVID-19 crisis be able to spawn entrepreneurship in other areas of biotechnology in India?
[*Somdatta Karak is the Science Communication and Public Outreach Officer at CSIR-Centre for Cellular and Molecular Biology in Hyderabad, India.]