Regulatory, policy reforms crucial for future of India's pharma R&D: Report
Deloitte and industry chamber ASSOCHAM.
It acknowledged that India's pharmaceutical ecosystem is transforming significantly, supported by comprehensive regulatory and policy reforms to foster innovation and growth.
The regulatory framework, which governs drug discovery, development and commercialisation, is being actively enhanced to streamline approval processes, increase transparency and reduce barriers to entry for innovative products.
However, the report said «several policy challenges continue to hinder the growth of India's pharmaceutical R&D sector, such as inadequate capacity for drug regulation, the need for advanced testing facilities and the lack of a strong framework for monitoring quality compliance in manufacturing units».
There is scope for harmonisation between state and central policies to ensure a uniform regulatory environment across the country. There is also a lack of alignment among different regulatory bodies, resulting in overlapping jurisdictions and inconsistent regulatory outcomes, the report said.
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