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We, the Indian pharma industry stands at the beginning of a transformative era. Already earned global recognition as the “Pharmacy of the World” for its dominance in the generics market, India is now moving towards innovation-driven growth, a long pending one. The U.S. share (>40% of generic prescriptions, see Table 1) underlines how dependent key regulated markets are on Indian manufacturers. The focus is shifting from replicating existing formulations to creating novel, patient-centric, individualized, cost- effective and technology-enabled drug delivery systems.
The next phase of progress in Indian pharma lies in advancing drug formulation —from the development of Novel Drug Delivery Systems (NDDS) to the exploration of 3D printing technologies and personalized medicines. This technology not only increases therapeutic efficacy and patient compliance but also align with the evolving expectations of global healthcare systems that emphasize precision, sustainability, and accessibility.
NDDS redefining therapeutic efficiency
The concept of NDDS in India has evolved markedly from simple controlled-release tablets to highly advanced systems such as nanoparticles, liposomes, niosomes, phytosomes, microspheres, and transdermal patches. The goal of NDDS is not merely to improve bioavailability but to achieve targeted, sustained, and safer drug delivery.
From conventional to advanced systems
India’s initial NDDS efforts focused on oral sustained-release systems in the 1990s. Gradually, Indian scientists and formulators embraced polymeric systems, osmotic pumps, and mucoadhesive technologies. Today, the emphasis has expanded toward nanotechnology-based systems such as:
- Liposomal and niosomal carriers (e.g., Amphotericin B liposomes),
- Polymeric nanoparticles for anticancer and antiviral agents,
- Solid lipid nanoparticles (SLNs) for poorly soluble drugs,
- Microneedle and transdermal systems for painless delivery.
Many Indian pharma companies and research oriented academic institutions are actively engaged in this space.
The Department of Pharmaceuticals’ Pharma Innovation Programme (PRIP), Indian Council of Medical Research and Biotechnology Industry Research Assistance Council (BIRAC) have funded projects in NDDS, especially in oncology, airborne diseases, diabetes, and infectious diseases.
Challenges and opportunities
Despite strong research output, technology conversion remains limited, due to some say, not enough funding and venture capitalists in pharma industry is negligible. Bridging the gap between laboratory-scale pilot plant innovation and commercial manufacturing is a critical need. Regulatory clarity for advanced delivery systems, GMP adaptation, and skilled manpower are areas that require attention. Nevertheless, the increasing collaboration between academia, start-ups, and established pharmaceutical companies offers optimism that NDDS will soon become a mainstream strength of Indian pharma.
3D Printing: Revolutionizing Drug Design and Manufacturing
The pharmaceutical application of three-dimensional (3D) printing represents one of the most exciting technological innovations in formulation development. It enables on-demand manufacturing, structural precision, and personalization at an unprecedented level.
How 3D Printing works in pharma
3D printing allows the layer-by-layer fabrication of dosage forms using various technologies such as:
- Fused Filament Fabrication (FFF) or Fused Deposition Modelling (FDM) – extrusion-based fabrication of thermoplastic drug-loaded filaments,
- Poly Jet 3D Printing – deposition of liquid formulations onto substrates,
- Direct Metal Laser Sintering (DMLS) – fusion of powdered materials using laser energy.
Each approach offers unique advantages in tailoring drug release kinetics, combination therapies, and complex geometries. The first FDA-approved 3D-printed tablet, Spritam® (levetiracetam), demonstrated how rapid disintegration and high-dose loading could be achieved through such methods. The production speed has increased with the introduction of latest technology brought down the cost of the medicine. Other products are under testing by FDA.
Indian context and emerging efforts
In India, academic research groups from National Institution of Pharmaceutical Education and Research - NIPERs, and leading pharmacy institutions have initiated work on 3D-printed oral tablets, transdermal patches, and implantable systems. The technology holds immense promise for customized paediatric and geriatric formulations, polypills for chronic diseases, and on-site hospital manufacturing.
However, large-scale industrial adoption remains nascent. The primary challenges include:
- High cost of equipment and validation, (new technologies on test, it will be taken care of in near future)
- Regulatory uncertainty regarding process reproducibility, (authorities are trying to find basic requirement to kick start the
- process)
- Integration with existing GMP frameworks.
Government-led programs under Make in India and Digital India could play a crucial role in enabling 3D printing hubs for pharmaceutical prototyping and clinical manufacturing. Once cost and compliance barriers reduce, India could position itself as a global centre for personalized formulation technologies. India cannot afford to lose its leadership position in global supplier of medicines.
Personalized medicine and precision formulation
The traditional “one-size-fits-all” model of pharmacotherapy is increasingly replaced with personalized medicine, where treatment is tailor-made to an individual’s genetic makeup, disease phenotype, and metabolic profile. This shift is being propelled by advances in pharmacogenomics, biomarker identification, and data analytics.
Relevance to formulation development
Personalized medicine redefines formulation design. Instead of producing large batches of uniform tablets, manufacturers may develop customized dosages, release profiles, or combinations for each patient segment. 3D printing, mini-tablets, and modular drug delivery platforms can enable such precision.
Indian developments
- Genome India Project: Launched in 2020, this project aims to collect 10,000 genetic samples from people across India to understand genetic diversity, which is essential for developing population-specific diagnostics and treatments. It is a landmark initiative for precision medicine in India. This shows Indian pharma sector should not fall behind
- Phenome India National Biobank (2025): Established at CSIR-Institute of Genomics and Integrative Biology, this project is creating a comprehensive health and genomics database for Indians, similar to the UK Biobank. The goal is to enable early diagnosis, support AI-powered health analytics, and foster research on genetic diseases, cancer, diabetes, and rare disorders tailored to Indian needs.?
- NIDAN Kendra Program: These centres focus on preventing and managing inherited genetic disorders by offering genetic counselling and support for expecting parents.
3D Printing in medicine:- Indian hospitals like Sparsh Hospitals (Bengaluru) and research centres such as IIT Madras are using 3D printing for patient-specific implants, prosthetics, and advanced surgical planning. Initiatives like #Right2Face are helping Black Fungus survivors with custom 3D-printed facial implants, improving quality of life.
- Researchers are working on 3D-printed personalized medications, though these are not yet on the market.?
- Growth in genetic testing: The Indian genetic testing market reached approximately Rs 4,544.5 crore ($61 million) in 2022, with rapid growth expected by 2028. Increased affordability and access to telemedicine further drive personalized healthcare.
- Collaboration and policy support: Significant government, academic, and industry collaboration is pushing personalized medicine forward. The Indian government and agencies like the Indian Council for Medical Research (ICMR) are funding and supporting integrated policies for adopting precision medicine.
Regulatory and manufacturing considerations
The adoption of NDDS, 3D printing, and personalized formulations demands regulatory modernization and approaches. India’s Central Drugs Standard Control Organisation (CDSCO) has initiated guidelines for innovative products and devices, but dedicated frameworks for additive manufacturing and nano formulations are still evolving.
Current gaps
- Absence of specific pharmacopeial standards for 3D-printed products,
- Limited GMP guidelines addressing continuous and additive manufacturing,
- Inadequate infrastructure for bioequivalence and stability testing of NDDS.
Emerging positive steps- PLI and bulk drug park schemes now include advanced formulation facilities.
- Innovation-focused incubators (such as BIRAC’s BioNEST and Atal Innovation Mission) encourage translational research.
- Academic consortia and skill development programs are being established to train formulation scientists in modern manufacturing technologies.
A phased regulatory roadmap—covering pilot testing, GMP adaptation, and global harmonization—will be essential for India to move from laboratory innovation to international market competitiveness.
The academia–industry synergy
India’s strength lies in its vast network of pharmaceutical education and research institutions. Universities and colleges are already exploring NDDS and advanced formulations, but a structured academia–industry interface is crucial. The research has to be taken to the higher level.
Collaborative initiatives such as industry-sponsored research centres, technology transfer cells, and joint doctoral programs can accelerate the journey from innovation to commercialization. Institutions like NIPERs, IITs, and private universities can play a catalytic role in developing prototype formulations that small and mid-size pharma companies can adopt.
Government incentives for contract research and pilot-scale translation facilities within academic campuses could significantly boost India’s innovation pipeline.
Sustainability and digital integration
The next generation of formulation development will also be defined by sustainability and digital integration. Green chemistry principles, solvent-free manufacturing, and biodegradable polymers are gaining traction. At the same time, AI-driven formulation design, digital twins, and predictive modelling are optimizing development timelines and reducing experimental costs.
In the Indian context, digital transformation can bridge the knowledge gap between small manufacturers and global best practices. Affordable digital tools, cloud-based formulation databases, and e-validation systems can democratize access to advanced technology.
The road ahead
The Indian pharmaceutical industry has mastered cost-effective production by employing indigenous technology and global supply chain reliability. The next phase—marked by research, innovation, adaptability, and patient-centric design—will define its sustainability of leadership in the world stage.
To realize this vision, the following steps are essential:
- Policy Alignment in consonance with global requirement: Dedicated regulatory pathways for NDDS and 3D-printed drugs.
- Infrastructure Development for NDDS: Establishment of formulation innovation hubs and pilot-scale GMP facilities.
- Skill Empowerment with Pilot plant hubs: Training formulation scientists in materials science, data analytics, and automation.
- Collaborative Ecosystems: Partnerships between academia, industry, and government to translate research into viable products.
- Global Integration: Adoption of international quality and sustainability benchmarks to enhance export potential.
Conclusion
The convergence of NDDS, 3D Printing and personalized medicine is reshaping the very foundation of formulation development. For India, this evolution represents more than just technological advancement—it symbolizes the transition of Bharath from a generic manufacturing base to a knowledge-driven innovation hub.
With a vibrant research ecosystem, supportive government policies, hunger for innovation, and an expanding talent pool, India is well poised to lead in the era of next-generation formulation technologies. The challenge now lies in integrating science, regulation, and strategy to ensure that the innovations born in Indian laboratories become global success stories on the CPhI & PMEC stage and beyond. ?
(Dr. Suriyaprakash is Professor of Pharmaceutics, College of Pharmacy, Hindustan Institute of Technology and Science, Padur, Chennai and
Dr Sumathi is Professor of Pharmaceutics, Nanda Colleg of Pharmacy, Erode, Tamil Nadu)
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