ISB Alumni-Led Garbha.ai Secures CDSCO License

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Ushering in a Revolution in Infertility Care

(Dr. Shankar Chatterjee)

This article is based on ‘Revolution in Infertility Care,’ which will bring a smile and joy to the many couples who were depressed for not being blessed with a baby. Fertility refers to the ability to conceive and have a healthy pregnancy, encompassing both male and female reproductive health. It’s a complex process influenced by various factors, including age, lifestyle, and overall health. While many people associate fertility with women, it’s crucial to understand that male reproductive health also plays a significant role in conception. In a breakthrough for reproductive healthcare, Garbha.ai, an Indian School of Business (ISB) alumni–led health tech startup, recently received approval from the Central Drugs Standard Control Organization (CDSCO) for its flagship solution, ‘Garbha AI – Embryo Score’. The platform, the first of its kind in India to be licensed in its category, harnesses artificial intelligence to assist embryologists in embryo grading and tracking marking a new chapter in India’s infertility care ecosystem.

It may be noted that more than 30 million couples in India are struggling with infertility, and more than 5 lakhs are undergoing in vitro fertilisation (IVF) cycles performed annually; the success rate is below 35 percent. The most critical step in embryo selection has long been subjective. On the other hand, Embryo Score introduces precision, consistency, and explainable science-backed decision-making, aiming to improve IVF outcomes significantly. In vitro fertilisation (IVF) is a process of fertilisation in which an egg is combined with sperm in vitro

“Garbha AI Embryo Score is a revolution in infertility care. By combining clinical expertise with AI trained on an indigenous dataset tailored to Indian demographics, we are ensuring that our solution is not only globally benchmarked but also deeply relevant to India’s unique patient population,” said Bharani Kumar Depuru, Founder & CEO of Garbha.ai, ISB alumnus, and visiting faculty at ISB, and London Business School.

(Dr Bharani Kumar Depuru)

The platform supports both time-lapse imaging systems and static images of embryos, adheres to international standards such as the Istanbul Consensus and Gardner’s grading system, and provides explainable AI heatmaps for transparency.

Beyond embryo grading, Garbha.ai is building a comprehensive fertility AI pipeline that covers:

• Egg and sperm selection powered by morphological and genetic insights.

• Endometrial Receptivity Analysis (ERA) to determine the optimal window for embryo transfer.

• Reproductive PGx (pharmacogenomics/pharmacodynamics) to personalize fertility medications and improve treatment response.

• AI-enabled care programs for holistic, continuous support to couples throughout their IVF journey.

Industry experts highlight that India’s assisted reproductive technology (ART) market is projected to cross USD 3.5 billion by 2030. With the CDSCO license, Garbha.ai is positioned not only to transform IVF labs across India but also to establish a globally scalable, end-to-end fertility innovation platform built on indigenous data and Artificial Intelligence (AI) excellence. This is the first of its kind AI based infertility platform to get CDSCO clearance.

 (Author is Former Prof & Head (CPME), NIRD&PR (Govt. of India), Hyderabad)

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