Need to fast-track regulatory processes for biotech sector: CII Report

There is a need to fast-track regulatory processes and repeal redundant steps to fasten the approval process for the biotech industry as any delay in product introduction leads to huge losses for the sector, according to a report by industry body CII.

The biotech industry is regulated by departments and subcommittees under three ministries and poor redundant coordination between the ministries and steps delay the regulatory processes, as per the report titled ‘Roadmap for Indian Lifesciences @ 2047’.

“A fast-track cell needs to be instituted in India to streamline processes and repeal redundant steps.Currently, a review for a biosimilar batch takes 20 to 25 days in the whole 45- to 90-day manufacturing cycle,” it said.

To address these gaps, industry advisory boards need to be introduced to provide guidance on matters such as identifying subject matter experts, setting up process service-level agreements and SOPs, providing digital solutions, and identifying steps for self-certification, it added.

“There is a need for autonomy in policy making and implementation,” the report released on Friday at the 4th CII Lifesciences Conclave stated.

Developing biosimilar medicines begins with a substantial investment in the specialized infrastructure, expertise, and technology required to create the product.

The time and cost of R&D has a significant impact on the cost of the biosimilar, it added.

“Shortening or lengthening the time to market by even a couple of months can create big gains or losses. Industry experts consider India’s regulatory processes to be extremely slow as well as being prohibitive for innovation,” the report said.

Citing the case of China, it is stated that the country formed a single agency — the China Food and Drug Administration — to replace a large cluster of overlapping regulators.

Similarly, the USFDA is a global best practice of a regulatory body housing both policymaking and implementation under one roof, it said.

The report noted that India needs to focus on segments like the biosimilars in order to stay relevant in the global pharmaceutical space by 2047.

Globally, the biopharma drugs are expected to constitute over 40 per cent of the pharma market by 2030, presenting a significant opportunity for the Indian companies, it added.

India is currently the third largest pharma industry in terms of volume and a source of 60,000 generic brands across 60 therapeutic categories.

“Within these pre-defined moonshot sectors, biosimilars for example are expected to grow over 30 per cent and above,” the report said.

It noted that there is a need for a much higher value capture in the overall pharma sector.

“Currently we are only accounting for 4 per cent value and as a vision 2047 we should move to 20 per cent value, or a USD 500 billion… Pharma sector. This is possible but we need exponential investment in innovation, manufacturing and digital transformation,” the report said.

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