'One quality, one standard': Bharat Biotech chairman calls for FDA merger

“We want to make ‘one world, one health’ a ground reality,” says Dr Krishna Ella

MoU signing Bharat Biotech Chairman and Ella Foundation Director Dr. Krishna Ella, with UW-Madison GHI Director Dr. Jorge Osorio signing MoU - to establish the first-ever “UW-Madison One Health Center” in India

At a time when India is facing criticism over certain quality lapses in manufacturing of drugs like cough syrups and an eye drop, leading vaccine maker Bharat Biotech’s chairman Dr Krishna Ella has suggested merging state Food and Drug Administration (FDAs) with the central FDA to ensure “one quality, one standard.” The suggestion comes in the backdrop of allegations that the Indian-manufactured cough syrups had caused deaths in Gambia and Uzbekistan, and more recently a death caused by an eye drop from a Chennai-based pharma company.

According to Dr Ella, some of the licenses of the companies related to the cough-syrup deaths, were given by state FDA, and not the central FDA. He, therefore, suggested merging the state FDA with the central FDA – the Central State Drugs Control Organization (CDSCO) -- to bring a centralised system of checks and quality control as well as a robust regulatory mechanism.

“When we merge all the FDAs, there will be one quality, one standard,” he added.

Dr Ella, however, pointed out that it will be a political decision and it is up to the government to take a call. “The central and state governments should also talk to each other to resolve the issue soon," he emphasised.

Dr Ella was speaking on the sidelines of signing of a Memorandum of Understanding (MoU) in New Delhi on Sunday between the University of Wisconsin (UW)-Madison Global Health Institute (GHI) and the Ella Foundation, to establish “UW-Madison One Health Center” in Bengaluru. The centre is aimed at advancing the development and production of new vaccines and build research capacity in the country.

The issue of merger of state and central FDA is significant as India is one of the leading drug manufacturers in the world earning it the tag of the “pharmacy of the world."

“We are the pharmacy for helping the global health. One or two bad cases should not be viewed as ‘India is a bad guy,” said Dr Ella. On whether Bharat Biotech is facing any scrutiny outside India as a manufacturer, he said, “We are not facing any scrutiny. In a country of 1.4 billion people, we have 40,000 pharma companies. Out of 40,000, if 10 commit a mistake, we can’t say all the others are bad.”

But Dr Ella stressed that ‘one world, one health’ needs to become a ground reality soon. “We are partnering with the Global Health Institute (GHI) from the University of Wisconsin, so that we can work this concept. People are talking about it a lot, but I want to make it a ground reality. For that, we need to work on both, the veterinary side and human side, and also other environmental parts like oceans, fish and agriculture.”

On the union budget for the healthcare sector announced recently, he said, “The budget is more for the rural economy, growing pesticide-free food and crops important from the nutrition point of view. For instance, millets help in healthcare and provide nutrition. I think the healthcare sector has got due attention during Covid times in the budget.”

On how prepared the medical sector is to fight Covid variants in future, he said, “We are nowhere inferior to any country in the world. We are well-prepared. If any contingency comes, we know how to gear up fast.” He added that Bharat Biotech is working on Chikungunya and Zika vaccines, among others.

Meanwhile, the Ella Foundation’s partnership with the GHI is aimed at giving a fillip to outreach efforts to create a global network , opening new doors for research, education and provide actionable outcomes. The partnership will enable collaboration across disciplines and geographic boundaries, providing Indian students and researchers access to UW expertise and training, and build research capacity in the country.

“This will benefit humans, animals and ecosystems and advance equitable and sustainable health across India and the world,” said Dr Jorge Osorio, Director, UW-Madison, GHI. The India One Health Centre joins a global network that includes Africa and Latin America.

Established in 2002, Ella Foundation is a non-profit autonomous research organisation located in Hyderabad, recognised by the Department of Scientific and Industrial Research (DSIR). Dr S Chandrashekhar, Secretary in Department of Science and Technology (DST), who was present at the event, lauded the country for its pioneering efforts in grassroot innovation.