For the first time in India, a government body i.e. Indian Institute of Science (IISc) Bengaluru is producing non-commercial anti-snake venom (ASV) trial batches to assess the effectiveness of anti-venoms regions to neutralize toxins in region-specific snakebite cases compared to existing cases. As part of this effort, it is collaborating with one of India’s leading anti-venom manufacturers – Bharat Serums and Vaccines (BSV). This may be the key to finding a more effective ASV, which can contain the high snakebite mortality rate and associated disability rates in India.
The country is home to more than 270 species of snakes, 60 of which are poisonous. But a four-year, multicenter study from the Evolutionary Venomics Laboratory at the IISc Center for Ecological Sciences found that available ASVs are ineffective in treating most medically important but overlooked snakebites. The existing products only apply to the Big Four species of snakes – spectacled cobra, common krait, Russell’s viper and saw-scaled viper whose venom collection is limited to two districts of Tamil Nadu.
Once Dr. Kartik Sunagar, who is leading the research, completed the study, IISc partnered with BSV to manufacture test batches of regionally effective antivenoms. He said the new ASVs, for the first time, will offer protection against all clinically important snake species found in the given region, including various species/subspecies of vipers, kraits and cobras.
Citing one example, he said ASVs would offer protection against the Sindh krait, which the lab’s research has shown is India’s most poisonous snake species. “The range of Sindh kraits stretches from Punjab to the northern parts of Karnataka in the west of the country. Considering the toxicity of this snake and the fact that it is potentially responsible for a large number of deaths in these regions, it is imperative to produce effective ASVs against them,” Dr Sunagar added.
The test samples will assess the effectiveness of regional ASVs compared to conventional products. “For example, this research will tell us if we should produce a single anti-venom for western India from Rajasthan to Karnataka, or if we should produce specific anti-venoms for specific regions (e.g. Rajasthan, Maharashtra and Karnataka),” he said. Once proven, IISc will conduct similar studies in other parts of India and identify areas that need specific antivenom.
According to a statement from BSV, “There is an urgent need to develop region-specific anti-venom in the country. This partnership aims to spur the development of anti-venoms that will provide effective snakebite therapy to save the lives, limbs and livelihoods of those who need the treatment.
Every year, snakebites cause more than 50,000 deaths in India. And four times as many suffer injuries resulting in permanent loss of function, such as amputations. The IISc study of the spectacled cobra and Russell’s viper, for the first time, highlighted the importance of venom variation between populations. For example, while some populations of cobras, such as in West Bengal, were extremely neurotoxic (causing paralysis), the population in Rajasthan was extremely cytotoxic or flesh-dissolving. “The result was that the anti-venoms were completely unsuccessful in saving mice that had been injected with venom from Rajasthani cobras. In these studies, we found that the anti-venom was particularly ineffective in the northern parts of India,” said Dr Sunagar.
When asked if they will need to get approval from the Drugs Controller General of India to roll out the new anti-snake venom in the market, he replied that it would not be applicable to “anti-venoms regions” because the production strategies are identical to those used. The only difference between existing and regional anti-venoms would be the source of the venoms.
“Therefore, human clinical trials are not needed for regional antivenoms. While I say that, it is important to clinically test the effectiveness of Indian anti-venoms – regional or conventional – through human clinical trials because they tell us how well they perform in the real world. This is all the more important as Indian anti-venoms have never been clinically validated in humans,” he said.