In a report released by CII titled ‘Roadmap for Indian Biology-2047’, it has been said that the biotechnology industry is regulated through several departments and sub-committees under the three ministries. However, due to the lack of coordination between them and the now-proven measures, the regulatory process gets delayed.
According to the report, “There is a need to set up a ‘Fasttrack’ cell to streamline the regulatory processes related to the bio-technology sector in India and eliminate wasteful provisions. At present, a ‘bio-similar’ batch is reviewed in 20- It takes 25 days while the entire manufacturing process itself takes 45-90 days.”
The CII report suggests setting up of industry advisory boards to bridge this gap. These circles will guide on issues such as identification of subject experts, formation of service level agreements, introduction of digital solutions and self-certification steps.
According to this report, there is a need for autonomy in policy-making and implementation.
According to this, the development of ‘bio-similar’ drugs requires massive investment in specialized infrastructure, expertise and technology. The time and cost involved in research and development in this area has a significant bearing on the cost of ‘bio-similar’ drugs.
Citing the example of China and the US, it has been said in this report that these countries worked to prevent the contradictions of the regulators by forming a unified agency in the biotechnology field. The report suggests India to pay special attention to segments like ‘bio-similars’.
India is currently the third largest country in the world in terms of quantity in the field of medicine.
Source: navbharattimes.indiatimes.com
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