What is the name of your organization?
Foundation for Innovative New Diagnostics
What is the name of your solution?
TRUST: Smart Tech 4 SF AMR
Provide a one-line summary or tagline for your solution.
TRUST: Tackling substandard & falsified antimicrobials with Reliable User friendly, Smart Technology- evaluation and pilot to empower drug inspectors
In what city, town, or region is your solution team headquartered?
New Delhi in India
In what country is your solution team headquartered?
CHE
What type of organization is your solution team?
Nonprofit
Film your elevator pitch.
What specific problem are you solving?
SF medicines in India range ~3-20% of the market (Singh, BR, 2017); SF medicine causes serious health harm, erodes trust, and worsens antimicrobial resistance (AMR). Rampant availability of SF medicines has raised alarm (BMJ 2024) and highlights regulatory gaps. While India’s Central Drugs Standard Control Organization (CDSCO) oversees new medicine quality, licensing and monitoring of older essential medicines is state regulated. This fragmentation allows manufacturers to exploit weaknesses to supply not of standard quality (NSQ) medicines. Although the CDSCO has intensified efforts—conducting >400 risk-based inspections in 2022–23 and issuing notices—antibiotic focused inspections are absent (discussion with state drug inspector, Delhi). India has an expansive private pharmacy network (>800,000); current inspection processes remain slow, ineffective and reliant on lengthy lab testing. The CDSCO acknowledges the need for a major overhaul, especially to detect SF medicine/practices including missing, reduced or tampered active ingredients/counterfeit packaging, done sometimes in complicity of local chemists. Antimicrobials containing too little Active Pharmaceutical Ingredient (API) or impaired dissolution are likely to be important drivers of AMR.
Rapid detection methods focused on the community can provide a targeted approach to regulating antibiotic quality; a critical step to protection of the health of individual and society.
What is your solution?
Our solution generates Indian evaluation, cost analysis data for portable technologies (imaging and spectrometry) to identify SF medicines with a use-case of application (including suggested workflow, periodicity) at the community pharmacy, beyond formal health systems. Findings will be presented to regulators with advocacy towards adoption. Currently, regulators use “visual inspection with tedious, lengthy lab testing processes” insufficient to curb systemic malpractices. While there is ample awareness of new-age technologies, doubts were raised on performance or applicability, due to unavailability of Indian evaluation data, current high costs (verbal from CDSCO).
In response, we will evaluate market-available imaging and spectrometry-based technology. The imaging technologies use computer vision to analyse packaging, colour, shape, size of pills while spectrometry-based solutions are based on natural UV absorption and identification of unique chemical bonds to confirm sample composition and measure API levels. The advantages of this method are ease of use and short turnaround time compared to lab testing. A future use-case for imaging apps could be use by consumer protection groups for data backed screening/whistleblowing.
Several portable screening tools are available (previous landscape analysis and evaluation by FIND of 3 technologies), offering a new tool for field-level triaging with follow-up laboratory analysis.
Who does your solution serve, and in what ways will the solution impact their lives?
Currently, regulators rely on consumer complaints to initiate investigations: a “reactive” process, post damage. In India, this is often the ONLY pathway beyond limited “spot checks” that rely on central drug laboratory (CDL) testing with backlogs of “2 to many months”. Our solution is a game-changer, empowering drug inspectors rather than the community for SF antibiotic reporting without months of waiting. Our solution serves:
1. The community: community members bear a staggering health, financial and human cost of SF antibiotics. We support the regulator to increase safety and efficacy of antibiotics in the resource-poor community, reducing treatment failure, AMR instances and improving health outcomes.
2. State drug inspectors: We empower the 10,000+ Indian drug inspectors with a ready to use solution to detect SF medicines.
3. CDSCO: We respond to the concerns raised by CDSCO in our discussions with them related to current effectiveness of new tech tools for Indian settings.
4. Procurers: We empower procurers with a ready to use solution to detect SF medicine in their supply chain.
5. Government bodies: Our pilot, evaluation allows government bodies (ICMR, MoH and CDSCO) to provide guidance on use of such tools and evidence to scale up for SF detection.
