Comments
The regulatory system that governs drug development — the Drug and Cosmetic Act, 1940 — is most rudimentary in India, said Krishna Ella, CMD of Bharat Bio International Ltd. He was recounting the multiple challenges his company faced while developing Covaxin — India's first indigenous Covid-19 vaccine.
“How do you change the Act to suit the current situation? If we had new laws, we could have come out with the vaccine before Pfizer. But, we lost out to Pfizer and Moderna because our regulatory system was a hassle. We had to do clinical; animal challenge; phase I, phase II and phase III. But for Pfizer, there was no animal, no toxicology, no efficacy in animal challenges and they went straight to human trials 28 days after the virus was first announced in Wuhan with the sequence data. It took nearly six months for us to get into phase I. We lost that precious time,” he said.
‘Didn’t have moral support’
“The bureaucracy, the system is still in 1949 and this colonial mindset of the regulatory system is controlling the country. The software industry is not controlled by this regulatory system but the healthcare is. It needs a lot of changes. Everything was a problem,” he said..
“The system does not believe India can innovate. It believes innovation can be done only by Americans and Europeans. So, when you have an Indian innovation, its enemy is Indian only. That’s the one thing that I learned in this game. Media was bashing and trying to politicise that I belonged to the BJP. Even if you don’t belong to any political party, they politicise and make you belong to something,” he said while speaking at the CII Southern Region Annual Meeting, here on Wednesday.
“If you copy a drug, you are respected, but if you innovate, there is no respect. Neither the scientists nor the industry gave moral support to the company. As a society, we think about ourselves but not about the country at large. One virus could collapse the economy, and we don’t need a nuclear war,” he said speaking in a fireside chat with S Chandrakumar, Founder and Executive Chairman of Kauvery Hospital, on the topic “Re-imagining leadership in an uncertain world”.
A number of country’s ambassadors while visiting the company’s plant were shocked that an Indian company could predict the pandemic and develop the vaccine. They asked do you get government help? “I said, we don’t get any government help. If the government does not interfere itself, it is the greatest help for us,” he said.
Challenges and opportunities
“When I was not sure if I would make it or not, the government said it would give money for the project. We spent almost ₹700 crore on the project and said we don’t want any money from the government. We will put our money. The country is suffering, people are suffering and this is the time to give back to the society,” he said.
The good thing is that challenges give opportunities too. When you have so many bottlenecks, big companies in the US cannot come and settle down easily. This gives an opportunity for the Indian companies to excel because you understand the system and the weakness of the country, too, Ella added.
Comments
COMMENT NOW
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.