India’s pharmaceutical regulatory system faces an uncomfortable truth—the framework that served generic drugs brilliantly for decades is increasingly obsolete. The present structure, developed primarily for chemical generics, struggles mightily to regulate biologics, cell therapy, and cutting-edge advanced medicines requiring specialised standards. Industry experts warn that generics are becoming yesterday’s business as the global pharmaceutical market shifts decisively towards complex biologics and personalised therapies.
India’s regulators have begun evolving, demonstrated by recent moves to separate cell and gene therapy reviews and expedite approval timelines significantly. The Central Drugs Standard Control Organisation now targets reviewing cell and gene therapy applications within 15 days—a dramatic acceleration. Draft guidelines specifically for cell and gene therapies are expected imminently to further clarify regulatory pathways for developers. These reforms reflect India’s ambition to move beyond generic drug manufacturing and foster a vibrant innovation ecosystem aligned with international best practices. But substantial work remains to transform regulatory infrastructure completely.
Biologics and Cell Therapy Require Fundamentally Different Regulatory Approaches
Biologics—including monoclonal antibodies, biosimilars, and gene therapies—represent medicine’s future but demand entirely different regulatory approaches than traditional chemical drugs. The government has recognised this challenge by proposing amendments to the Drugs and Cosmetics Act, 1945, expanding regulations considerably. These amendments formally include cell-based, gene-based, and stem cell therapies under the same licensing and oversight mechanisms as recombinant DNA drugs. This step introduces more rigorous manufacturing standards, licensing requirements, and clinical trial oversight to ensure safety and efficacy of advanced medicines. Despite these regulatory moves, significant challenges persist due to biologics’ complex development processes, manufacturing scale requirements, and quality control demands.
Industry leaders urgently call for accelerating harmonisation with global standards, revising approval processes comprehensively, and creating specialised expert committees handling these therapies’ scientific nuances. India recently approved its first indigenous CAR-T cell therapy, NexCAR19, marking a crucial milestone in advanced therapeutics development. However, this achievement simultaneously underlines the pressing need for broader regulatory infrastructure development to accommodate diverse biologics and advanced medicines effectively. The complexity of biological products demands expertise that traditional drug regulators often lack, requiring substantial capacity building and knowledge transfer initiatives.
Streamlining Processes to Accelerate Innovation and Market Entry
Long, multi-step regulatory processes remain formidable hurdles to swift innovation in India’s pharmaceutical sector, frustrating developers and delaying patient access. Stakeholders consistently call for clearly defined and predictable timelines for regulatory reviews to avoid prolonged approvals that discourage investment. One significant change underway is digitalisation, exemplified by the SUGAM portal for electronic submissions, improving transparency and application tracking considerably. India is moving towards consolidating fragmented regulatory bodies—the Central Drugs Standard Control Organisation and various state authorities— into a cohesive framework.
This consolidation aims to eliminate duplication and variability that currently plague the approval process, creating confusion for pharmaceutical developers. Fast-track pathways for life-saving therapies and orphan drugs are being emphasised to respond to urgent healthcare needs more effectively. Regulatory capacity-building with more trained experts and centralised decision-making will support robust scientific assessments whilst reducing unnecessary delays significantly. Additionally, India aims to adopt a data-driven, risk-based approach balancing patient safety with expedited approvals, essential for global competitiveness. This approach recognises that not all medicines carry equal risk, allowing regulators to focus resources where they’re most needed.
Balancing Innovation with Quality, Safety, and Affordability Imperatives
India’s pharmaceutical sector has long excelled at providing affordable generic medicines, saving consumers an estimated ₹30,000 crore by 2024 alone. However, embracing biologics and advanced therapies requires balancing innovation with continued focus on safety, quality, and accessibility for diverse populations. Regulatory reforms emphasise stringent good manufacturing practices, pharmacovigilance, and post-marketing surveillance to maintain public trust in pharmaceutical products. Experts argue that a robust, transparent regulatory system will encourage substantially more domestic and international investment in biologics research and development. At the same time, affordability remains a critical pillar for India’s healthcare strategy, given the country’s wide socio-economic diversity.
Digital transformation and harmonised guidelines are expected to improve regulatory predictability significantly, fostering innovation whilst ensuring advanced therapies remain accessible. The government’s proactive stance, combined with industry collaboration, aims to transform India from a generic drug hub into a global innovation leader. This transformation requires careful management to avoid pricing advanced medicines beyond reach of ordinary Indians who need them most. Balancing cutting-edge innovation with India’s traditional commitment to affordable healthcare represents perhaps the most challenging aspect of regulatory reform.
India stands at a regulatory crossroads where evolving from traditional generics to advanced biologics and cell therapies is absolutely imperative. Ongoing reforms reflect a clear intention to foster innovation through accelerated, transparent, and science-driven regulatory pathways that match international standards. Expanding the regulatory framework to explicitly include cell, gene, and stem cell therapies, revising approval processes, digitalising submissions, and consolidating agencies will streamline drug development significantly. Whilst challenges remain—especially regarding manufacturing scale and ensuring affordable access—India’s pharmaceutical sector is poised to embrace medicine’s future. Continued emphasis on harmonisation with global standards, capacity building, and robust oversight will prove key to making India a leader in advanced therapeutics. Success will benefit millions domestically whilst boosting India’s global pharmaceutical competitiveness and reputation for quality manufacturing.