Regulatory, policy reforms crucial for future of India's pharma R&D: Report

India's regulatory and policy reforms are crucial for shaping the future of pharmaceutical research and development by streamlining approval processes, strengthening IP protections and incentivising innovation, as several policy challenges continue to hinder the growth of R&D in the sector, according to a report.

As the country modernises its regulatory framework and enhances collaboration with global regulatory agencies, India is well-positioned to become a global leader in pharmaceutical innovation, as per the report by 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.

"Additionally, bureaucratic complexities within the regulatory framework led to extended timelines for drug approvals and clinical trials, making India less attractive for conducting high-quality clinical research," it noted.

Another major challenge in this area is the high cost of compliance with global standards, which can be particularly burdensome for Small and Medium-Sized Enterprises (SMEs), the report added.

"Addressing these specific impediments through streamlined processes and clearer regulations is essential for enhancing India's position in global pharmaceutical R&D," it said.

In order to position India as a hub for pharmaceutical research and development, with a robust ecosystem capable of supporting global standards and driving innovative advancements, the report suggested that the government should actively promote the country as a leading hub for pharmaceutical discovery and preclinical and clinical research.

Using its expanding CRO sector, cutting-edge research centres, cost efficiency and diverse patient base, India can position itself as an attractive collaborator for global pharmaceutical companies in these areas, it said.

As most government research grants are limited to institutions and academic centres, with few exceptions for private companies, it said Department of Pharmaceuticals should introduce similar provisions for research grants, financial incentives and funding support to encourage private CROs to participate in early discovery and clinical research in India.

Among others, the report said the government and educational institutions should design and regularly update specialised courses for the pharmaceutical industry, emphasizing AI, data science and best practices.

"These programmes should be tailored to reflect current industry trends and provide comprehensive training in both core subjects and practical applications," it said.