Global Launch of RTS Carbetocin Ferring at KLE-JNMC, Belagavi on Friday

 Pragativahini News, Belagavi – Excessive bleeding after delivery (postpartum haemorrhage, PPH) is the most common cause for death of mothers. Globally, around 35% of all maternal deaths are associated with PPH. Oxytocin is the standard medication for the prevention of postpartum haemorrhage, but it requires storage and transportation in refrigerators, which is difficult to achieve in settings like India.

A large multi-country CHAMPION trial was conducted in 10 countries (Argentina, Egypt, India, Kenya, Nigeria, South Africa, Singapore, Thailand, Uganda, United Kingdom), across 24 Hospitals; between July 7, 2015 and January 30, 2018 to compare a novel formulation of room temperature stable (RTS) carbetocin with oxytocin. A total of 29,645 women were randomized in the trial. JNMC Women’s and Children’s Health Research Unit lead site for the six Indian Hospitals (KLES Dr Prabhakar Kore Hospital, Belagavi; S N Medical College, Bagalkot, BLDE DU’s Sri B M Patil Medical College, Vijayapur; Lata Medical Research Foundation and Daga Memorial Hospital, Nagpur; SCB Medical College, Cuttack & Institute of Medical Sciences, Banaras Hindu University, Varanasi) with a contribution of 7,100 participants (> 25% of the study participants). This trial showed that RTS Carbetocin had a similar effect as compared to oxytocin for the prevention of blood loss after delivery. This heat stable formulation of RTS Carbetocin offers an additional option for preventing excessive bleeding after childbirth without any stringent storage temperature requirements. The trial was sponsored by WHO and was supported by funding from Merck Sharpe & Dohme (MSD) and, RTS carbetocin was provided by Ferring Pharmaceuticals and oxytocin by Novartis free of charge during this trial.

This is another major milestone for the JNMC Women’s and Children’s Health Research Unit. A journey that started 20 years ago with the first community based randomized, placebo-controlled of oral Misoprostol 600 mcg for prevention of postpartum haemorrhage and consequent reduction in maternal mortality, sees yet another major milestone with the release of Room Temperature Stable (upto 30 deg. C) Carbetocin Ferring 100 mcg/ml. This was indeed an exciting and fulfilling journey from conception of the research (March 2013) through implementation of the trial (May 2016 to January 2018), publication of the results in New England Journal of Medicine (June 2018), updating of the WHO recommendations for the use of uterotonics for prevention of PPH (December 2018), inclusion in the WHO List of Essential List of Medicines (March 2019) to regulatory approval for manufacturing and marketing by Central Drugs Standard Control Organization (Drugs Controller General of India) (September 2018) and now release for public use (July 23, 2021) at a public sector pricing (INR 28.93 inclusive of GST) on par with standard Oxytocin. The JNMC Research Unit had also hosted the CHAMPION Trial Steering Committee Meeting in Belagavi twice in March 2016 and March 2018.

The global launch of RTS Carbetocin has been organised by JNMC Women’s and Children’s Health Research Unit in KLE Centenary Convention Center, JNMC Campus on 23^rd July 2021 at 10.30AM. The first dose of this injection will be given in KLES Dr Prabhakar Kore Charitable Hospital on this day. This function  will be presided by Dr Prabhakar Kore, Chairman, KLE Society and  Chancellor, KLE Academy of Higher Education and Research, Belagavi and attended by leading obstetricians including Dr Shanta Kumari, President FOGSI, Senior Consultant OBGYN, Yashoda Hospitals, Hyderabad, Dr Hema Divakar, Consultant OBGYN & Medical Director, Divakar’s Speciality Hospital, Bengaluru & Co-Chair FIGO Pregnancy and NCD Committee, Dr Sheela Mane, Past Vice-President FOGSI and Governing Council Member ICOG, Dr N Rajkumar, Deputy Director Maternal Health, Govt of Karnataka, Bengaluru and representatives from Ferring Pharmaceuticals and Merk for Mothers.

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