In a move poised to redefine drug delivery in maternal healthcare, Akums Drugs & Pharmaceuticals Ltd.—India’s leading pharmaceutical contract development and manufacturing organisation (CDMO)—has secured a patent for its novel extended-release formulation of Doxylamine and Pyridoxine. Designed to treat Nausea and Vomiting in Pregnancy (NVP), this innovation deploys the company’s proprietary ‘tablet-in-tablet’ technology to offer dual-action relief—rapid and sustained—in a single dose.

NVP, commonly referred to as morning sickness, affects up to 80% of pregnant women in varying intensities. While symptoms typically subside by the 16th week of pregnancy, approximately 20% of expectant mothers continue to experience persistent nausea, often impacting their quality of life, nutrition, and mental well-being. Recognising the pressing need for a more effective and patient-friendly treatment option, Akums has introduced a formulation that meets the therapeutic demand with clinical precision.

At the core of this advancement is Akums’ tablet-in-tablet delivery mechanism, a sophisticated technology that houses two distinct layers within a single tablet. The outer layer provides immediate drug release to deliver prompt relief, while the inner core ensures a gradual, sustained release of medication over time. This approach not only reduces dosing frequency but also significantly enhances patient compliance—an essential consideration during pregnancy when safety, simplicity, and adherence are paramount.

“At Akums, we believe real innovation starts with understanding the everyday challenges people face. This new formulation for managing nausea and vomiting during pregnancy underscores our commitment to women’s health, ensuring access to safe and effective care during a critical phase of life. We’re proud to take this step forward, making life a little easier for expectant mothers and helping healthcare move closer to where it should be—accessible, reliable, and full of care,” said Sanjeev Jain, Managing Director, Akums Drugs & Pharmaceuticals Ltd.

The breakthrough formulation has undergone a rigorous bioequivalence study and has been approved by the Drug Controller General of India (DCGI), validating its safety and therapeutic efficacy. While clinical subject numbers remain undisclosed due to regulatory guidelines, the positive study outcomes reinforce the formulation’s promise as a game-changer in NVP management.

For stakeholders across the healthcare and pharmaceutical ecosystem, ranging from hospital networks and OB-GYN specialists to distributors and maternal health program implementers, this patented product presents a robust new treatment avenue. It stands as a testament to how advanced drug delivery technologies can drive innovation in essential care areas, beyond traditional chronic disease domains.

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Broader Impact on India’s Healthcare Landscape

Akums’ innovation not only exemplifies excellence in pharmaceutical R&D but also contributes meaningfully to India’s broader healthcare priorities. By addressing a prevalent yet often under-discussed condition with a clinically validated, patient-centric solution, the formulation aligns with national goals for improving maternal health outcomes.

Moreover, this development strengthens India’s standing in the global pharmaceutical innovation arena, especially in high-value CDMO services. It showcases the country’s capability to deliver intellectual property-backed, scalable solutions that cater to both domestic and international markets.

With over 4,100 commercialised formulations, 220+ innovative products in development, 12 manufacturing units, 4 R&D centres, and a 16,000-strong workforce—including over 400 dedicated scientists, Akums continues to champion operational excellence and therapeutic innovation across a wide spectrum of dosage forms.

This patent win reflects the company’s long-term strategic focus on women’s health and the optimisation of drug delivery platforms, a combination that is increasingly seen as critical for healthcare systems aiming for higher efficacy, patient compliance, and accessibility.

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