India’s central drug regulatory authority is boldly reshaping its approach to pharmaceutical oversight with a new focus on reducing regulatory burdens while enhancing the rigor and effectiveness of implementation. This strategic shift, announced by Dr. Rajeev Singh Raghuvanshi, India’s Drug Controller General, signals a pivotal moment aimed at boosting innovation, quality, and global competitiveness in India’s pharmaceutical sector.
Key Highlights of the Regulator’s Vision:
A commitment to lighter, more streamlined regulations paired with heavier emphasis on strict execution and monitoring.
Digitization of nearly all regulatory processes, minimizing human intervention for faster approvals and higher efficiency.
Introduction of reforms to simplify export clearances and licensing, taking into account past manufacturer performance.
Strengthening approval frameworks for innovative therapies, including affordable advanced treatments like CAR-T cell therapy.
Launch of the State Health Regulatory Excellence Index (SHRESTH) to benchmark and improve state drug regulatory bodies.
Adoption of internationally recognized standards, including 15 global recognitions for Indian Pharmacopoeia.
Allocation of funds toward building an integrated digital regulatory system to consolidate data for better oversight.
Creation of new guideline frameworks for emerging areas such as cell and gene therapies, and biosimilars aligned with global norms.
Reimagining Regulation: From Heavy Rules to Effective Action
Dr. Raghuvanshi articulated a visionary stance at a recent healthcare summit that India’s pharmaceutical regulation would move away from excessive red tape toward a more balanced framework. The goal is to “be lighter on regulations but heavy on execution,” ensuring rules remain relevant and contextual while compliance enforcement gains vigor. He emphasized the need for contextual changes in regulatory content to match evolving industry and global trends, especially as India transitions beyond generic drug manufacturing to focus on value, discovery research, and innovation.
The digital transformation of regulatory systems is a cornerstone of this new approach. About 99% of drug approval processes have been digitized, replacing legacy physical workflows to accelerate decision-making and reduce manual errors. This systemic overhaul enables resource optimization amid staff constraints, as the regulator manages over 10,000 manufacturing facilities with a workforce of only about 2,000 personnel.
Streamlining Exports and Licensing
One breakthrough reform includes simplifying export clearances by allowing companies’ past export performance to guide future approvals. This change will reduce repetitive paperwork and workload, halving the number of No Objection Certificates issued for export products compared to recent volumes. Licensing requirements for research and drug manufacturing will be eased, promoting ease of doing business and encouraging innovation without sacrificing product safety.
Driving Innovation and Affordability
The regulator aims to create an environment conducive to innovative drug approvals, especially therapies that offer clinical impact and affordability to Indian patients. Notably, CAR-T cell therapy, a cutting-edge cancer immunotherapy, has been approved at a price point representing a tenth of global costs, embodying this philosophy of accessible innovation.
Benchmarking and Enhancing State Regulatory Performance
To address variable quality standards across India’s large pharmaceutical ecosystem, the government has introduced SHRESTH — the State Health Regulatory Excellence Index. This initiative benchmarks state regulatory agencies against comprehensive metrics, aiming to elevate and harmonize standards nationally. It also drives investments in human resources, infrastructure, and digital systems, crucial for maintaining India’s reputation for producing high-quality medicines trusted worldwide.
Global Recognition and Future Guidelines
India has recently secured 15 global recognitions for its pharmacopeia, a significant leap from just three a few years ago, bolstering international confidence in Indian drug quality. The regulator is also preparing guidelines for cell and gene therapies—an emerging frontier—alongside refining biosimilar regulations to align with stringent global benchmarks recommended by the World Health Organization.
Conclusion:
India’s drug regulator is embracing a transformative mindset focused on reducing regulatory complexity while enhancing enforcement effectiveness. This balancing act is expected to boost pharmaceutical innovation, ensure better quality control, and maintain India’s leadership as the world’s pharmacy by meeting global standards with agility and transparency.
Source: Reuters
