Accelerating Innovation in Vaginal Formulations in Support of Women's Health

Grand Challenges India - Biotechnology Industry Research Assistance Council (GCI-BIRAC) announce an open call on 'Accelerating Innovation in Vaginal Formulations in Support of Women's Health,' a program directed at addressing challenges that limit effective local drug delivery for women's health, particularly in managing reproductive tract infections (RTIs) and sexually transmitted infections (STIs) in low- and middle-income countries (LMICs).

This initiative seeks to catalyze the development of context-driven innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products. By promoting discovery research informed by high-quality end-user input, the call emphasizes the importance of coupling scientific innovation with women's preferences, cultural contexts, and lived experiences.

Background

Local vaginal drug delivery remains an underexplored and underutilized approach for the prevention and treatment of female-specific conditions, despite its clear potential advantages, including discreetness, potent local efficacy, large surface area for drug absorption, potential for lower API doses, and fewer systemic side effects as well as providing autonomy and empowerment of women. Progress in this area has been limited by a lack of mechanistic understanding of the vaginal milieu, especially in high-burden, low- and middle-income countries (LMICs), and by persistent misconceptions regarding the acceptability of vaginally administered products among women and their partners.

Vaginal formulations hold significant promise for the management of reproductive tract infections (RTIs), sexually transmitted infections (STIs), contraceptive innovation, and maintenance of a healthy vaginal microbiome. Emerging scientific and translational opportunities make this an opportune time to reposition vaginal products as both public health tools and user-preferred interventions, for immediate, on-demand use. Evidence suggests that women's interests often extend beyond primary therapeutic or preventive functions to include secondary benefits such as odor control, sexual enhancement, and privacy of use.

While there has been meaningful progress in delivery systems such as gels, films, and intravaginal rings, major gaps remain in acceptability, scalability, affordability, and integration into routine care in LMICs (Das Neves et al., 2021; Hussain et al., 2022). Addressing these gaps will require the development of innovative, scientifically rigorous formulations that integrate end-user perspectives and are adaptable to diverse settings.

Therefore, this initiative seeks to catalyze the development of innovative technologies and approaches that can safely and effectively deliver a wide range of vaginal products with strong user appeal, promoting self-care and other beneficial features that women value, while coupling discovery research with high-quality end-user insights.

The Challenge

GCI-BIRAC are soliciting applications that contribute to development of vaginal formulations that promote optimal drug delivery within the vaginal compartment while positively supporting the vaginal milieu, and that also possess beneficial effects, even if unrelated to the API intended effect, that a user might consider desirable, such as enhancement of sexual pleasure. GCI-BIRAC anticipate identifying product-agnostic features that promote vaginal health and that broadly appeal to women to advance product development and formulations for women's health.

GCI-BIRAC welcome innovations at any stage of development that meet the scope of this call.

Applicants may apply to address one or more of the following objectives of this challenge:

Leverage biology for vaginally administered products: In this objective, GCI-BIRAC seeks: 1) innovative formulations and delivery approaches that leverage the biology of the vaginal microenvironment to support development of novel delivery technologies and that have high potential for scalable, low-cost manufacturing options; and 2) novel components that could be incorporated into and improve existing formulations (e.g. films, tablets/inserts) that would promote maintenance of or transition to an optimal vaginal microbiome and/or promote other benefit to the vaginal mucosal epithelium. Specifically, GCI-BIRAC seek to assess and de-risk novel approaches to vaginal delivery that can leverage and support features of the vaginal milieu including mucus, host cells and microbes for drug delivery and as such we anticipate proposals including evaluation of the impact of these novel approaches or components on changes in the microbiome and vaginal host components (cells/cytokines, mucins, glycans, lectins, etc.).
Define characteristics of an ideal vaginal product: In this objective, GCI-BIRAC seeks to support qualitative studies aimed at identifying and understanding specific features of a vaginally administered product that would most appeal to women such that many women, especially those of reproductive age in LMICs, would seek to use such a product (for example, 'what would you hope to achieve when using this product in your vagina?'). GCI-BIRAC is particularly interested in defining ancillary benefits (such as odor control, sexual enhancement, etc.) that could be derived from a vaginally delivered product that would likely not be supported by other routes of administration, as well as identifying major hurdles that may prevent a woman from seeking out or preferring a vaginal product. GCI-BIRAC acknowledges that there may be regional, cultural, demographic or other preference differences, and are seeking to identify desires or barriers that are commonly expressed by women across these demographic differences. Applicants may propose methods to prioritize preferences such that the vaginal product developed can benefit as many women as possible. In sum, it is aimed to gather insights into preferred and achievable characteristics that would transform vaginal products from 'tolerable' to 'desirable'.

Call to Action

India has the opportunity to lead the world in transformative women's health innovation, being home to over 400 million women of reproductive age. The unique biological, cultural, and healthcare realities of Indian women, spanning diverse geographies from urban metros to rural communities, demand locally relevant, affordable, and acceptable vaginal health solutions.

The initiative aims to bridge the critical gap between cutting-edge vaginal formulation science and ground-level implementation in India. The initiative is calling on innovators, researchers, and product developers to push the boundaries of women's health by creating context-driven, bold, transformative solutions for vaginal formulations. GCI-BIRAC encourages applications that combine scientific rigor with creativity, integrating both biological insights and the real-world preferences of women.

This is an opportunity to design products that are not only therapeutically effective but also genuinely desirable, products that women will choose to use because they address their needs, enhance their well-being, and fit seamlessly into their lives.

GCI-BIRAC welcome proposals at any stage of development, from early-stage discovery to near-market innovations. Your work could redefine what is possible in vaginal health, uncover new ways to leverage the vaginal microenvironment, and identify product features that resonate across diverse populations. By coupling cutting-edge science with user-centered design, you have the chance to deliver products that are safe, effective, and widely embraced.

Through this initiative, India can demonstrate global leadership in women's health, catalyze low-cost, high-impact technologies, and inspire the next generation of innovators to think boldly and inclusively.

Deliverables

By the end of this program, the initiative aims to generate actionable knowledge and prototype innovations that are regulation-ready, market-viable, and designed for widespread adoption across India's diverse contexts. The initiative will deliver outcomes across two strategic objectives:

Objective 1: Biology-Driven Formulation Innovation (Leveraging the Vaginal Microenvironment for Indian Women)

Novel Formulations or Components: Proof-of-concept mechanisms adapted to Indian environmental and storage conditions, low-cost, locally sourced, with potential for extended or on-demand delivery
Biological Characterization: Impact on vaginal microbiome, epithelial health, pH, mucosal immunity; compatibility with common vaginal conditions; preliminary safety/tolerability
Scalability Roadmap: Cost analysis, manufacturing pathways, stability testing under Indian conditions, regulatory alignment with CDSCO.

Objective 2: User-Centered Design Research (Defining characteristics of an ideal vaginal products)

Comprehensive User Insights: Preferences, barriers, ancillary benefits (odor control, sexual wellness, menstrual support), across ≥3 demographic segments.
Actionable Design Principles: Prioritized features, regional/cultural mapping, discreet vs. conspicuous formats, preferred delivery formats.
Implementation Framework: Messaging, distribution channels, pricing/willingness-to-pay, community engagement strategies.

GCI-BIRAC is looking for proposals that:

Focus on vaginally delivery approaches that do not require retrieval and disposal after use and can be adapted for extended- or slow-release of active ingredients.
Use innovative, rigorous qualitative approaches that improve or deepen our understanding of standard acceptability metrics.
Generate biological or end-user data from low- and middle-income regions and comply with national regulations on data security, data protection and privacy.
Propose rigorous scientific approaches to study a clear research question and whose rationale is clearly supported by peer-reviewed literature.
Demonstrate feasibility with preliminary data in support of the proposed approach; if no preliminary data exists then the proposal should be limited in scope.
Request the appropriate funds and time to achieve the objectives of the proposed work. Exploratory projects of lower cost but higher risk are strongly encouraged and will be prioritized.

GCI-BIRAC will not fund proposals that:

Evaluate the impact of currently available vaginally inserted products on the vaginal milieu (e.g. menstrual products, contraceptive devices, over-the-counter probiotics, etc.).
Focus on approaches that would not be feasible or affordable in India and low- and middle-income countries, including personalized medicine. If these approaches are included, the feasibility of scalable, low-cost development should be explicitly stated.
Focus on the development of therapeutics or interventions for specific conditions, such as treatment for STIs or contraceptive products. While these types of interventions may be used as a test case within the proposal, the work itself should focus on formulations.
Are focused solely on basic exploratory scientific research without a clear translational pathway, including potential end-use scenarios, scalability considerations and regulatory or manufacturing implications.
Center solely on focus groups and interviews. These methods or qualitative approaches are acceptable if embedded within rigorous mixed-methods study designs that generate quantitative, actionable insights beyond anecdotal data or standard acceptability metrics such as affective attitudes.
Do not consider end user preferences or assume end-user preferences. For the purposes of this RFP, end-users can be defined as women of reproductive age in India and low- and middle-income countries. Proposals may focus on subgroups (e.g., adolescents, post-partum women), but the target group must be explicitly defined and justified.
Primarily depend on traditional acceptability questionnaires or surveys (e.g., “if x hypothetical product existed, how interested would you be in using it?”).
Do not directly address one of the core objectives as outlined above.
Cannot be accomplished within a two-year maximum project duration or within the stipulated budget maximum.
Support researchers or research teams who are affiliated with the tobacco industry, or who receive (or are applying for) funding from the tobacco industry, which includes manufacturers and distributors of e-cigarettes or vaping products.