BANGALORE, Feb 5: Noting that the industry has voiced concerns regarding regulations on clinical trials in the country, Union Health Minister Ghulam Nabi Azad today said there is need to strike a balance on the issue.
“…Industry feels that regulations we have made are too difficult; …I think, what we need to do is strike a balance…,” Azad told reporters here.
Speaking on the sidelines after inaugurating Baxter Global Research Center at Syngene here, he said “…What we are hearing from the industry is that earlier the number of clinical trials which was taking place has dropped to half, more than half.”
“While we are happy that the new dispensation is in the interest of the country and is in the interest of the patient on whom the trials were taking place, at the same time we should also see that new innovations should come up and whole industry should not fall short of holding clinical trial…,” he said.
Stating that we have done our best having gone through observations made by the Supreme Court, NGOs and Parliamentarians, Azad said, “At the same time, we will have to accommodate the view point of the industry as well.”
To a question whether any “tinkering” was going on in the government about the same, he said “no, not at the moment”.
Earlier, speaking at the inaugural event, Biocon Chairperson Kiran Mazumdar Shaw said, “…There are some key challenging aspects to drug innovation in our country, especially when it comes to clinical trial. I do hope we will be able to create a very very important regulatory framework that enables us to pursue research in unhampered way.”
“I think today we do realise that the regulatory system requires both reform and reinforcement, I’m sure with the right approach the more expeditious approach to solving this problem, India can once again regain its position as a innovator and as a supplier of a very important and affordable drug to patients across the world,” she said.
Global pharmaceutical company Baxter International Inc today announced the inauguration of Baxter Global Research Center here in collaboration with Syngene, a contract research organisation and a wholly-owned subsidiary of Biocon Limited.
The Baxter Global Research Center (BGRC) at Syngene, is a
part of Baxter’s global strategy of building R&D collaborations with strategic partners. This collaboration will support Baxter in the Research and Development of medical products and devices to serve patients both in India and around the world, officials said.
They said a team of over 100 multidisciplinary Syngene scientists will be based at this dedicated Center of Excellence at Syngene in Biocon Park, Bangalore.
Syngene team, working closely with Baxter scientists, will engage in a wide range of R&D activities centered on product and analytical development and pre-clinical evaluation in parenteral nutrition and renal therapy, they said. (PTI)
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