Nagesh Nanda

Director

The dual challenges of timely product development and cost-effectiveness remain significant hurdles for Indian pharmaceutical companies striving to sustain and expand their global presence. Addressing these challenges requires expertise and precision, which is where Novel Consultants excels. With a team of highly qualified and experienced professionals, the company specializes in key areas of the pharmaceutical industry, including research & development, R&D management, formulation development, NDDS product development, IVIVC evaluation, and Quality by Design (QbD) training and implementation.

Established in 2014, Novel Consultants has emerged as a trusted name in pharmaceutical R&D, specializing in innovative drug delivery systems, complex generics, and efficient R&D management. It is headed by Nagesh Nanda, an internationally acclaimed R&D scientist and strategist with over three decades of experience. The firm benefits from his expertise and vision. A former Blue Resident Card holder of the European Union until 2016, Nagesh has contributed substantially to various quality parameters for pharmaceutical products and serves on the boards of several universities. Committed to optimizing costs and timelines for its clients, Novel Consultants is recognized for its end-to-end support across the R&D lifecycle, including formulation development, Phase III clinical trials, and the launch of NCE molecules. The firm also played a significant role during the COVID-19 pandemic, conducting clinical trials for a European product. With a focus on niche areas and a reputation for innovation, it is a preferred partner for advancing pharmaceutical R&D.

Strategic Excellence and Optimized Clinical Trials
Novel Consultants excels in strategic planning and portfolio management, offering tailored solutions to pharmaceutical companies in India and abroad. The firm advocates for calculated strategies, aligning clients' strengths and expertise with targeted products or technologies to minimize risks and drive sustainable growth. This approach has consistently led to increased turnover and accelerated progress for its clients.

In Phase III clinical trials, Novel Consultants ensures cost-effective and efficient processes by leveraging a strong network of associates and CRO partnerships across India and Europe. Trials are conducted at top-tier hospitals under renowned key opinion leaders (KOLs), ensuring compliance with regulatory standards and market expectations. For international trials, the firm collaborates with local experts to deliver robust outcomes that gain the medical community's trust and strengthen market acceptance.

The development of novel drug delivery systems (NDDS) is key to improving patient compliance and therapeutic outcomes. In India, earlier practices of creating fixeddose combinations for convenience often lacked rigorous clinical validation, leading to suboptimal patient benefits. Regulatory advancements have since necessitated clinical trials and pharmacovigilance, enabling the industry to identify unmet patient needs and refine NDDS approaches. By leveraging existing molecules and enhancing their bioavailability, such systems address gaps in treatment efficacy.

"Novel Consultants distinguishes itself by building deep, collaborative relationships with clients, treating their challenges as its own. Available round-the-clock, the consultancy prioritizes impactful results over volume, selectively working with clients who value scientific precision and seek meaningful guidance. This personalized, result-oriented approach sets us apart in the competitive landscape”, shares Nagesh Nanda, Director, Novel Consultants.

Challenges and Adaptations
Indian pharmaceutical companies face significant challenges in timely product development and cost efficiency. In the generics market, securing regulatory approvals before patent expiry is crucial to capitalize on market opportunities, while delays can lead to revenue losses amid intense competition. Post-patent price erosion, often as high as 70- 90 percent, further necessitates efficient cost structures for viability. Although Indian firms extensively supply to European markets, they primarily rely on multinational companies for product launches, intensifying competition.

While high costs limit investments in New Chemical Entity (NCE) development, Indian pharma companies focus on innovating existing molecules to improve efficacy bioavailability, and reduce side effects. “Novel drug delivery systems, such as transitioning from oral routes to sprays, improve patient outcomes and extend product lifecycles”, says Nagesh Nanda. Highlighting this approach, the firm's innovation, Raloxifene, optimized osteoporosis treatment by reducing the dosage from 50 mg to 4 mg while enhancing bioavailability and minimizing side effects. These advancements reflect the critical role of innovation in meeting global healthcare needs.
                          

A Transformative Vision for NCE Development
Conclusively, Novel Consultants is charting a transformative course that focuses on the development and launch of new chemical entities (NCEs) in India. The firm has already begun collaborating with research organizations from the U.S. and Europe, aiming to conduct Phase III clinical trials for NCE molecules in India, which is a critical and costintensive phase of drug development. By leveraging India's competitive clinical trial costs and a diverse patient pool, the firm aspires to position India as a launchpad for innovative NCE molecules, making the country a pioneer rather than a follower in global pharmaceutical innovation.

This ambitious vision aligns with the firm's commitment to driving meaningful advancements in healthcare. While challenges like significant investment remain, the company is making strides, with progressive Indian companies expressing interest in this venture. If successful, this initiative will not only expedite clinical trials but also establish India as a competitive player in the global pharmaceutical landscape. This roadmap embodies the firm's mission to create impactful, innovative solutions that contribute to improving the healthcare ecosystem.