Pharma industry: India seeks global leadership through policy on R&D and innovation

Indian pharma industry, generic drugs industry
Balancing affordability and innovation in the face of data exclusivity clauses becomes crucial for India's generic drugs industry.

Policy for pharma industry: The Union government has unveiled the National Policy on Research & Development and Innovation in the pharma-MedTech sector. The primary objective of the policy is to reduce the nation’s reliance on imports, particularly in products such as orphan drugs and treatments for rare diseases. In addition to this, fostering research, development, and innovation within the pharmaceutical sector is a key goal as India strives to establish itself as a global leader in the pharmaceutical industry.

Strengthening the Indian pharmaceutical sector has remained a central policy focus for the government as it continues to champion the concept of Atmanirbhar Bharat or self-reliant India. In the context of pharmaceuticals, this self-reliance translates to an enhanced R&D infrastructure that can facilitate broader access to life-saving medications, ultimately positioning India as a hub for global pharmaceuticals and medical device exports. As part of the policy’s provisions, the government will identify nine drug and medical device manufacturers to undertake research in six critical areas, with an estimated cost of Rs 5,000 crore from the exchequer.

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Proposals under new policy for pharma industry

The National Policy on R&D in pharma and medical devices proposes extensive reforms aimed at streamlining regulatory processes and reducing approval timelines for drugs. The government acknowledges the presence of numerous bottlenecks within the system, including multiple agencies with distinct mandates and expertise that innovator firms must navigate. This hampers progress within the sector. To address this, the government is exploring a mechanism that mandates regulators to collaborate, thereby minimizing process overlaps and establishing defined timelines for essential approvals.

With these recent adjustments, it is anticipated that the time required for regulatory approvals for innovative products will be halved within the next two years. Another significant proposal involves the creation of a comprehensive end-to-end digital portal that serves as a unified interface between innovators and regulators. This aligns with the government’s overarching objective of improving the ease of doing business and reducing compliance burdens.

Currently, India faces a shortage of facilities capable of conducting pre-clinical trials, presenting a significant hurdle. The new policy recommends the establishment of new facilities to expedite clearances, allowing for joint inspections and licensing mechanisms for traditional medicinal products.

Incentivizing research and innovation across both the pharmaceutical and MedTech sectors is a central focus of the policy. It emphasizes the provision of suitable fiscal and non-fiscal incentives through direct or indirect funding. Support could also be explored from existing and forthcoming government initiatives such as the National Research Foundation (NRF) and the Biotech Innovation Fund.

Recognising that industry-academia collaboration is essential for success, the policy outlines measures to foster an enabling ecosystem by fostering a linkage between the two. The policy acknowledges that at times, outdated curricula hinder progress, and industry involvement is crucial for modernizing and diversifying pharmaceutical education in line with the National Education Policy, 2020. Collaboration across institutions and sectors throughout the entire product development cycle, spanning drug discovery, delivery, device design, clinical trials, and innovations, is also emphasized due to the multidisciplinary nature of the process.

Despite its strong fundamentals, the Indian pharmaceutical sector faces challenges that demand attention for sustained growth. Notably, the sector grapples with high import dependence on active pharmaceutical ingredients (API) and key starting materials (KSMs). Additionally, the country lags behind in the development of biologics, biosimilars, and other emerging global products and trends.

While India holds a 3.4% market share in the global pharmaceuticals industry, this figure appears modest when considering the nation’s substantial population. Moreover, despite having around 450 documented rare diseases, India invests comparatively little in R&D for such conditions. Globally, the lion’s share of value capture in the pharmaceutical industry belongs to companies that focus on innovation-driven products. The new policy, if effectively implemented, has the potential to reshape India’s prospects in this domain.