New Delhi, 6th May 2025: Akums Drugs & Pharmaceuticals Ltd., one of India’s leading pharmaceutical contract research and manufacturing organisation (CDMO), has been granted a patent for its breakthrough extended-release formulation of Doxylamine and Pyridoxine, designed specifically to address Nausea and Vomiting in Pregnancy (NVP).
Nausea and vomiting of pregnancy (NVP) is one of the most common conditions experienced by expectant mothers, affecting up to 80% of women to varying degrees. While many women find relief by the 16th week, about 20% continue to suffer throughout their pregnancy. NVP can significantly disrupt daily routines, nutrition, and overall well-being. In response, Akums has developed a ground-breaking patented formulation that offers a solution designed to provide longer-lasting relief. This innovation marks a significant step forward in addressing a longstanding gap in maternal healthcare, offering much-needed support to those impacted by this common pregnancy challenge.
At the heart of this innovation is Akums’ advanced “tablet-in-tablet” technology. This unique dosage form combines an outer layer that provides immediate drug release for rapid relief from nausea, with an inner core designed for sustained release, ensuring a longer therapeutic effect. The outer layer provides rapid relief from nausea, while the inner core maintains a prolonged action, reducing the need for frequent dosing. By combining immediate and sustained release in a single tablet, this dual-action design not only improves treatment outcomes but also enhances patient compliance—an essential factor in pregnancy care where safety, simplicity, and consistency are critical.
Following a rigorous bioequivalence study and successful approval from the Drug Controller General of India (DCGI), the extended-release formulation stands validated in terms of efficacy and safety. While specific subject numbers are not publicly disclosed as per regulatory norms, the findings have reinforced the formulation’s promise in improving symptom control and the overall patient experience.
Speaking on the milestone, Mr Sanjeev Jain, Managing Director from Akums said, “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.”
Akums has consistently focused on advancing drug delivery systems. With over 4,100 commercialised formulations and more than 220 Innovative products in development, it has established a strong presence in both Indian and international pharmaceutical markets.
With 12 manufacturing facilities, 4 R&D centres employing over 400 scientists, and a workforce of more than 16,000, Akums focuses on innovation and operational efficiency across a wide range of dosage forms and therapeutic areas in healthcare manufacturing