Bharat Biotech group company Biovet gets CDSCO license for Lumpy Skin Disease vaccine
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-02-10 12:17 GMT | Update On 2025-02-10 12:17 GMT
Bengaluru: Bharat Biotech group company Biovet, an innovative animal health vaccine producer based in Mallur, Karnataka, has announced that its Lumpy Skin Disease (LSD) vaccine for dairy cattle and buffaloes, BIOLUMPIVAXIN, the world's safest and first-ever Differentiating Infected from Vaccinated Animals (DIVA) marker vaccine, has received a license from the Central Drug Standards Control Organization (CDSCO).
"The soon-to-be-launched BIOLUMPIVAXIN is the world's only marker vaccine for LSD. It offers a high safety and efficacy profile while enabling serological differentiation between naturally infected and vaccinated animals with the DIVA concept in it," the Company claimed.
The quality, safety, and efficacy of the vaccine have been extensively tested at ICAR-NRCE and at the Indian Veterinary Research Institute (IVRI), ensuring it meets the highest global standards.
This novel Indigenous live-attenuated marker vaccine was developed using the LSD virus/Ranchi/2019 vaccine strain from Indian Council of Agriculture Research-National Research Centre on Equines (ICAR-NRCE), Hisar, in collaboration with Bharat Biotech’s Biovet.
The vaccine is the result of three years of research by scientists at NRCE, led by Dr. Naveen Kumar (now Director, NIV-Pune) under the leadership of Dr. B. N. Tripathi (former DDG, Animal Sciences, ICAR, now Vice Chancellor, SKUAST, Jammu).
ICAR and its scientists made significant contributions and played a crucial role in the development of this collaborative, world-class vaccine for animal health.
Dr. Krishna Ella, Founder of Biovet, said “This DIVA marker vaccine is a game-changer for veterinary medicine for disease surveillance and eradication programs. Epidemiologists and Field workers can now distinguish if an animal received BIOLUMPIVAXIN or was previously infected with LSD.”
Dr. Ella adds, “The CDSCO licensure for this vaccine is a significant step toward India's self-reliance (Atmanirbhar Bharat) in veterinary healthcare, which avoids dependency on imported vaccines. As India moves towards a disease-free livestock population, this path-breaking vaccine will play a crucial role in ensuring the dairy industry's sustainability.”
Over the past two years, approximately 200,000 cattle have died, and millions more have lost their milk production capabilities due to Lumpy Skin Disease (LSD) nationwide. The LSD vaccine BIOLUMPIVAXIN will very soon be commercially available. The Biovet Mallur facility can produce 500 million doses of BIOLUMPIVAXIN annually.
The dairy industry plays a crucial role in India's GDP and its future economic growth. Dairy cattle provide a consistent daily source of income for hundreds of millions of farmers and women across the country. The impact of preventive vaccines against Lumpy Skin Disease (LSD) will positively affect every village and district in India, supporting the sustainability and growth of the dairy sector.
BIOLUMPIVAXIN, is provided in freeze-dried form with stabilizing agents for long-term stability. Diluent for the reconstitution of freeze-dried vaccine is provided separately. Each vaccine dose contains NLT log10 3.5 /mL. It is a single vaccination regimen given once in a year to cattle and buffaloes above 3 months of age.
The presentation is in multi dose vials from 25 doses up to a maximum of 100 doses per vial and the vaccine is stable at 2-80 C storage temperature.
1.0 mL of the reconstituted volume to be inoculated by subcutaneous (S/C) route of injection.
The vaccine has been shown to be free from extraneous agents and demonstrated safety, immunogenicity, and protective efficacy against challenge infections in a controlled BSL3 animal facility. Additionally, the vaccine virus did not exhibit any signs of reverting to virulence when tested in cattle. Importantly, the vaccine virus was not detected in milk, semen, or other bodily excretions (such as nasal, ocular, or faecal routes) from the vaccinated animals.
Thousands of cattle/buffaloes were vaccinated under field conditions by ICAR-NRCE, Hisar as well as Biovet and the vaccine is found to be safe and efficacious. Also, it is found to be safe in all the groups of animals including pregnant and lactating cattle and buffaloes apart from breeding bulls.
In contrast to other globally available vaccines based on the Neethling LSDV strain, which may cause local reactions, occasional generalized micronodules, fever and temporary reductions in milk yield collectively referred to as the "Neethling effect", the indigenous BIOLUMPIVAXIN did not induce any such reactions. This makes BIOLUMPIVAXIN the safest vaccine option available.
DIVA marker concept: Post-vaccination seromonitoring helps to differentiate infected animals from that of the vaccinated animals for implementing effective LSD control programs.
Lumpy skin disease (LSD) is a transboundary animal disease that has gained significant attention in India due to its severe impact on cattle health and the dairy industry. The disease is characterized by the development of skin nodules across the body, fever, swollen lymph nodes, decreased milk yield and difficulty in movement. LSD virus transmission is largely attributed to vector bites, with mosquitoes, ticks, and other biting insects playing an essential role.
During the 2022 LSD outbreak in India, morbidity rates reached up to 80% with case fatality rates as high as 67%, across states such as Gujarat, Rajasthan, Maharashtra, Uttar Pradesh, Punjab, and Jammu & Kashmir. This caused an estimated economic loss of over ₹18,337.76 crores and a 26% decline in milk production, significantly harming the dairy industry and the rural economy. In India, LSD has emerged as a major threat to dairy productivity, impacting millions of small-scale marginal farmers.
Historically, LSD was first reported in Zambia, Africa, in 1929. For several decades, the disease remained confined to Africa before spreading transcontinental to Egypt in 1988 and Israel in 1989. Over the years, the LSD virus has expanded its geographic range across the Middle East, Europe, and most recently, numerous Asian countries, including India. The first confirmed outbreak in India occurred in 2019, and since then, LSD virus has rapidly spread across multiple states, leading to substantial economic losses and a decline in milk production.
Vaccination has proven to be the most effective strategy for controlling LSD virus, in particular with homologous vaccines. Following vaccination of cattle and buffaloes, the vaccine instructs the immune system to mount a defense mechanism against LSD virus infection in cattle and buffaloes as a prophylaxis measure. It may take 3 to 4 weeks to mount desired immunity in the vaccinated animals. Hence, advance vaccination to be done as a preventive measure in order to protect dairy cattle and buffaloes of all age groups from LSD virus infection.
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