Pune-based Gennova Biopharmaceuticals’ mRNA vaccine gets DCGI nod

Gennova already has a license from the Central Drug Standard Control Organisation to manufacture and sell the vaccine and has produced 70 lakh doses at risk.

4 min readPuneUpdated: Jun 29, 2022 07:32 AM IST

A healthcare worker administers a dose of Covid-19 vaccine to a student. (PTI, file)

The country’s first homegrown mRNA Covid-19 vaccine developed at Pune’s Gennova Biopharmaceuticals has received emergency use for the age group 18 and above. In a late-night development, the Drug Controller General of India (DCGI) approved the two-dose mRNA vaccine on Tuesday. The vaccine is stable for storage at 2-8 degree C.

At the Pune-based firm, officials say they are excited and eager for a roll out. “We have to go for scientifically sound and the most advanced technology, which has been proven safe and effective. The challenge in front of Gennova was to make it stable at 2–8 °C to enable the democratisation of the mRNA-based vaccine globally. We are confident that the product will speak on its own merit for acceptability, given the proven track record of safety and efficacy of mRNA vaccines,” Dr Sanjay Singh, CEO, Gennova Biopharmaceuticals, told The Indian Express.

Gennova already has a license from the Central Drug Standard Control Organisation (CDSCO) to manufacture and sell the vaccine and has produced 70 lakh doses at risk. “Now that we have received the EUA, we can ship the material soon after completing all formalities. Our current production capacity is around 40-50 lakh of doses per month, which will be upgraded by two to three fold soon,” Dr Singh said.

The fact that the novel mRNA vaccine candidate, GEMCOVAC™-19, is stable at 2-8 degrees makes it amenable for ease of deployment across the nation. The vaccine will be available for adults above 18 years of age. The two-dose vaccine will have to be administered intramuscularly, 28 days apart. “This has been a learning experience for all of us. Gennova and the subject expert committee have had several discussions on the safety and immunogenicity of GEMCOVAC-19 to ensure that this new technology is safe and effective for Indians,” Dr Singh said.

Vaccines based on mRNA require ultra-low temperature conditions for storage and distribution. India already has a cold supply-chain infrastructure that can handle refrigeration conditions for deployment of the vaccine. “Gennova intended to make an mRNA-vaccine formulation that is stable at 2- 8 °C and can be distributed through the already existing refrigeration supply chain pan-India. Given that early mRNA vaccine developers couldn’t materialise such a product, freeze-drying the large and unstable mRNA molecule with the nanoparticle was a daunting challenge,” an official at the firm said.

Explained

Challenge met

mRNA-based vaccines require ultra-low temperature conditions for storage and distribution. India already has a cold supply-chain infrastructure that can handle refrigeration conditions at 2-8°C, so the novel mRNA vaccine candidate, GEMCOVAC-19, which is stable at 2–8°C, can be distributed through the existing refrigeration supply chain across the country.

“At Gennova, we have invested hundreds of man hours in the hope of lyophilizing the mRNA vaccine in a single vial within a year, thanks to cutting-edge science and our highly dedicated team. This thermostable vaccine was thoroughly tested in various animal models to ensure its safety and immunogenicity before entering human clinical trials involving nearly ~ 4,000 participants. CDSCO approved the vaccine for EUA based on its safety and robust immunogenicity (both humoral and cellular),” Dr Singh said.

While more than 197 crore vaccine doses have been given to citizens 91 crore of whom are fully vaccinated, officials at Gennova said that there still was a potential demand for vaccine for one-third of the population. “There is a need of additional dose vaccination to control the infectivity of the ongoing pandemic and we are very positive that this vaccine will add another tool to the Indian vaccination programme,” Dr Singh added.

Anuradha Mascarenhas

Anuradha Mascarenhas is a Senior Editor at The Indian Express, based in Pune. With a career spanning three decades, she is one of the most respected voices in Indian journalism regarding healthcare, science and environment and research developments. She also takes a keen interest in covering women's issues . Professional Background Education: A gold medalist in Communication and Journalism from Savitribai Phule Pune University and a Master’s degree in Literature. Author: She authored the biography At The Wheel Of Research, which chronicles the life and work of Dr. Soumya Swaminathan, the former Chief Scientist at the WHO. Key Focus: She combines scientific accuracy with storytelling, translating complex medical research into compelling public and human-interest narratives. Awards and Recognition Anuradha has won several awards including the Press Council of India's national award for excellence in journalism under the gender based reporting category in 2019 and the Laadli Media award (gender sensitivity -2024). A recipient of the Lokmat journalism award (gender category-2022), she was also shortlisted for the RedInk awards for excellence in journalism-2021. Her debut book At The Wheel Of Research, an exclusive biography of Dr Soumya Swaminathan the inaugural chief scientist of World Health Organisation was also nominated in the Popular Choice Category of JK Paper AUTHER awards. She has also secured competitive fellowships including the Laadli Media Fellowship (2022), the Survivors Against TB – New Research in TB Media Fellowship (2023) and is part of the prestigious 2025 India Cohort of the WomenLift Health Leadership Journey.” Recent Notable Articles (Late 2025) 1. Cancer & Specialized Medical Care "Tata Memorial finds way to kill drug-resistant cancer cells" (Nov 26, 2025): Reporting on a breakthrough for triple-negative breast cancer, one of the most aggressive forms of the disease. Discipline, diet and purpose; How a 97-year-old professor defies ageing'' (Nov 15, 2025) Report about Prof Gururaj Mutalik, the first Head of Department at Pune's B J Government Medical College who at 97 credits his longevity to healthy habits and a strong sense of purpose. 2. Environmental Health (The "Breathless Pune" Series) Long-term exposure even to 'moderate' air leads to chronic heart, lung, kidney issues" (Nov 26, 2025): Part of an investigative series highlighting that even "safe" pollution levels are damaging to vital organs. "For every 10 µg/m3 increase in PM2.5 level, there was 6-8% jump in medicine sales" (Nov 23, 2025): Using commercial data to prove the direct link between air quality and respiratory illnesses in Pune. 3. Lifestyle & Wellness News "They didn't let cancer, diabetes and heart disease stop them from travelling" (Dec 22, 2025): A collaborative piece featuring survivors who share practical tips for traveling with chronic conditions. At 17, his BP shot up to 200/120 mmHG; Lancet study flags why child and teen hypertension doubled between 2000 and 2020'' (Nov 12,2025)--A report that focusses on 17-year-old-boy's hypertensive crisis and reflects the rising global trend of high blood pressure among children and adolescents. 4. Scientific Recognition & Infrastructure For promoting sci-comm, gender diversity: IUCAA woman prof highlighted in Nature" (Nov 25, 2025): Covering the global recognition of Indian women scientists in gender studies and physics. Pune researchers find a spiral galaxy like the Milky Way from early universe'' (December 3, 2025)- A report on how Indian researchers discovered a massive galaxy that existed when the universe was just 1.5 billion years old , one of the earliest to have been observed so far. Signature Beat: Health, Science & Women in Leadership Anuradha is known for her COVID-19 reportage, where she was one of the first journalists to provide detailed insights into the Covishield and Covaxin trials. She has a dedicated interest in gender diversity in health and science, often profiling women researchers who are breaking the "leaky pipeline" in STEM fields. Her writing style is scrupulous, often featuring interviews with top-tier scientists and health experts from various institutions. ... Read More

Stay updated with the latest - Click here to follow us on Instagram

Tags:
DCGI
pune

Loading Taboola...