‘Regulatory harmonisation critical to enhance pharma innovation, compliance’

Hyderabad: India needs diplomatic channels created by the government towards USFDA, EU or Japan to really work with regulatory agencies. There is not much pharma business happening with Japan despite India’s friendly relationship with them because of the regulatory framework, say industry experts. “There is much more than funding that government has to do on […]

Hyderabad: India needs diplomatic channels created by the government towards USFDA, EU or Japan to really work with regulatory agencies. There is not much pharma business happening with Japan despite India’s friendly relationship with them because of the regulatory framework, say industry experts.

“There is much more than funding that government has to do on these lines and there is a lot of scope there,” Sanjiv Navangul, MD & CEO, Bharat Serums and Vaccines said while speaking at a panel discussion titled ‘Drug research and development (R&D): Yesterday, Today, Tomorrow’.

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N Yuvaraj, joint secretary-Policy, Medical Device & Pharma Bureau, Department of Pharmaceuticals, Government of India said, “I endorse Sanjeev’s view that there needs to be a regulatory diplomacy, it’s point well-taken and is required as well.”

Kiran Mazumdar Shaw, executive chairperson, Biocon Group, said, regulatory harmonisation must happen at a faster pace. The credibility of India to innovate at such high levels is lacking.

Sharvil Patel, MD, Zydus Cadila, said, “How we build the regulatory framework to make things easier for companies in India, building relationships with other regulators so that we can have a common programme across the countries will be very critical.”

“For a single organisation, it’s very difficult to do a clinical trial in India, a clinical trial at WHO, for instance. How you reduce work in an adaptive trial design, identifying high-risk individuals for whom the drug can be used and with a close partnership between USFDA, the NIH and companies are necessary to find solutions for neglected diseases or diseases that have no solution. An ecosystem like this will spur a lot of innovation,” Patel added.

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