Bharat Biotech was the first and only company in India which has made COVAXIN, India‘s indigenous COVID-19 vaccine developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech‘s BSL-3 (Bio-Safety Level 3) high containment facility. The vaccine received DCGI approval for Phase I & II Human Clinical Trials and the trials commenced across India from July, 2020. After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXIN, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centers across India.
This is just about COVID 19 pandemic but in this article we will see how Dr Ella, the first generation entrepreneur started this company and fulfilled the dream of India of providing effective and affordable drugs.
A research scientist in Molecular Biology and university gold medalist Dr. Krishna Ella (b.1969) is currently the Chairman & Managing Director of Bharat Biotech International Limited, which he incorporated in 1996 along with his wife Suchitra Ella. He was born into a Telugu-speaking agriculturist family in Tiruttani village in Tiruvallur district of Tamil Nadu.
Dr Krishna Ella started his academic career with his bachelor’s degree from the Tamil Nadu Agricultural University and joined for a Master’s degree at the University of Agricultural Sciences, Bangalore. Dr Krishna Ella started off his career by joining the pharmaceutical and life sciences company Bayer, as part of its agricultural division but soon left the company and went abroad for higher education. On a Rotary fellowship he completed his master’s degree from University of Hawaii in Plant pathology. He finished his Ph.D, in Biochemistry from University of Wisconsin-Madison (1987-1992).
For four years he worked as a research faculty at the Medical University of South Carolina, Charleston. Dr. Krishna Ella returned back to India in 1996 to start Bharat Biotech in Hyderabad which cost him Rs 12.5 crore. Bharat Biotech shot into the limelight when it launched Revac-B, a recombinant Hepatitis-B vaccine, in October 1998. Priced at $1, almost 25 cents less than its closest competitor produced by Shantha Biotechnics.
Today Bharat Biotech International Limited is a reputed Indian biotechnology company headquartered in Hyderabad, India engaged in the drug discovery, drug development, manufacturing of vaccines, bio-therapeutics, pharmaceuticals and health care products.
The company is now worth over thousands of crores of rupees and has delivered over 4 billion vaccine doses to the underprivileged people in more than 150 developing countries through UNICEF, GAVI and other distribution channels. With more than 140 patents, the company has over 16 vaccines for bio-therapeutics, registered in 116 countries and the WHO prequalified vaccines in its portfolio.
Krishna Ella in the recent press conference said that Bharat Biotech has invested about Rs 1,500 crores into research and manufacturing. The company takes loans, grants, and sold shares to fund research.
Bharat Biotech revenues mainly come from the government of India and other emerging countries, multilateral agencies like UNICEF, WHO, and GAVI and other agencies involved in mass immunisation programmes. Along with OPV, Bharat Biotech’s Rotavirus and Typhoid vaccines are WHO prequalified. WHO prequalification of vaccines makes them eligible for supplies to UN agencies and participate in public tenders in developing countries.
According to the rating firm ICRA, Bharat Biotech FY 2020 revenues have jumped 35 percent year-on-year to Rs 1,079.7 crore, the net profit rose 200 percent to Rs 298 crore. The operating margins saw significant improvement from 22.1 percent in FY2019 to 42 percent in FY 2020.
The company acquired Chiron Behring Vaccines from GlaxoSmithKline Asia in February 2019. Chiron is a WHO pre-qualified manufacturer of rabies vaccines with a manufacturing plant in Ankleshwar, Gujarat, eligible for supplies to UN agencies and has product registrations in more than 20 countries.
On a philanthropical note, Dr Krishna was seen to compromise with the pricing of vaccine in a timely manner because he did not think about profits but the benefits of his discovery. Similarly, in polio pandemic Jonas Edward Salk denied to patent his vaccine. He said however that we had to bear the production cost and yes we took govt support for that but we also prepared our facilities to become global pharmacy of biotech drugs like vaccines, hormones (insulin) etc.
He is also not untouched by critics but he handled them clamly, on the Adar Poonawalla’s statement about BB vaccine as safe as water, he calmly replied that, “Covaxin has shown less than 10% adverse reactions, while others have 60-70% adverse reactions. AstraZeneca was giving 4g paracetamol to volunteers to suppress such reactions. We haven’t given paracetamol to any volunteer,” as ANI quoted. However all this stunt showed that Adar Poonawalla started controversies by bringing down others instead of highlighting his product which he did not invent but only manufacture for foreign partners.
Dr. Ella also added “I haven’t got any (Bill & Melinda) Gates Foundation money, I have not got any money from (the) government of India, I have taken all the risk of creating a BSL-III facility, we have done clinical trials at our own cost, and manufactured 20 million doses at risk, I never said the government should buy, it’s the moral responsibility as a scientist that I should do for the country,”
Bharat Biotech has ties with the Washington University School of Medicine in St Louis, Missouri to manufacture up to a billion doses of a single-dose intranasal Covid-19 vaccine.
For his contributions to science and biotech industry, Dr. Ella has been awarded more than 100 National and International awards including the recent prestigious Padma Bhushan, Asia Pacific BioBusiness Leadership Award 2005 (University of Southern California), Best Entrepreneur Award and Business World, Marico Foundation Innovation Award and many others. Dr. Ella was invited in the Rashtrapati Bhavan to meet President & First Lady George Bush during their visit in India. In 2008, he received Best Technology and INNOVATION award from the Prime Minster of India.
Dr. Ella was also instrumental and advised the Government in setting up Biotech Park in Hyderabad. For more than five years he was the Co-Chairman of Indo-USA High Technology Cooperation Group (HTCG) on behalf of Govt. of India and facilitated Knowledge initiative bill signed by two countries. He gave more than 300 lectures to motivate young Indians on topics like Innovation, Bio-entrepreneurship and Regulatory issues.
Dr. Ella is a Member on numerous committees involved in shaping India’s science education and policy, including his current role on prominent Government of India bodies as Member -Scientific Advisory Committee to the Union Cabinet (SAC-C), Member- Governing Body, Council of Scientific & Industrial Research (CSIR) and Member- Technology, Information, Forecasting & Assessment Council (TIFAC).
Latest about Bharat Biotech
According to the latest press releases of company, the following information were gathered about BB:
Bharat Biotech had been working on the development of three COVID-19 vaccine candidates, two of which are international collaborations with University of Wisconsin-Madison and Thomas Jefferson University. The third is an indigenous vaccine development project in collaboration with ICMR. Covaxin™ is India’s 1st indigenous vaccine developed against COVID-19. The strain of SARS-CoV-2 used in this has been isolated from ICMR-National Institute of Virology (NIV), Pune.
An excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries and the World Health Organization (WHO) Pre-qualifications.
Bharat Biotech has a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution and in the process of development of BSL-4 lab in Bangalore after which it will become world only second such kind of facility.
Bharat Biotech was the first company in the developing world to develop Rotavirus vaccine ROTAVAC ® and also the first company in the world to develop Typhoid Conjugate Vaccine TYPEBAR TCV®. BBIL was the first company to file a global patent on Chikungunya and Zika Virus vaccine in the world too.
Bharat Biotech has a track record of working on neglected diseases since many neglected diseases turns out to be pandemic diseases.
Bharat Biotech received more than $300 million as a Grant from Bill & Melinda Gates Foundation, Welcome Trust and many Governments for the various clinical programmes in the past.
Bharat Biotech has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid.
The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer.
Bharat Biotech is the first to manufacture a preservative-free vaccine (Revac-B mcf Hepatitis B Vaccine), and launch India’s first cell-cultured Swine Flu vaccine.
Bharat Biotech has successfully developed Rotavac, the most affordable vaccine against rotavirus induced diarrhoeal infections and death in the world.
It is also the first company to have proven the efficacy of a TCV through human challenge studies conducted at Oxford University in 2018.
The biggest of all is the Covid-19 vaccine. Ella moved fast, his early collaboration with ICMR to use its SARS-CoV-2 strain is seen as a masterstroke by rivals. Bharat Biotech has grown the virus and inactivated it through a chemical process. The company started testing the vaccine on animals for safety and efficacy as part of pre-clinical studies. With the support from ICMR and the regulatory body – the company was able to accelerate the whole process of pre-clinical studies and got into human testing by July.
Bharat Biotech which had built India’s biggest BSL-3 high-containment facility for manufacturing inactivated polio vaccine, has converted it to manufacture COVID-19 vaccine. This could possibly be the main reason that gave confidence for ICMR to give the SARS-CoV-2 strain it had isolated to Bharat Biotech.