INDIA – Sun Pharmaceutical Industries Limited today announced that one of its wholly owned subsidiaries has entered into a license agreement with Ferring Pharmaceuticals Pvt. Ltd. (Ferring), a subsidiary of Switzerland-based biopharmaceuticals MNC Ferring Pharmaceuticals, to commercialize a Room Temperature Stable (RTS) formulation of obstetric drug, CARITEC® (Carbetocin RTS) in India.
CARITEC ® is an innovative obstetric drug for preventing post-partum hemorrhage. It is a Room Temperature Stable (RTS) formulation of Carbetocin and addresses limitations in refrigeration and cold-chain transportation
CARITEC® is indicated for the prevention of excessive bleeding in women after vaginal or caesarean child birth. The condition is commonly known as post-partum hemorrhage (PPH). Postpartum hemorrhage is defined as a blood loss of 500 ml or more within 24 hours after birth.
As per agreement terms, Sun Pharma is granted rights for co-marketing of the drug in India in the private market under the brand name CARITEC®.
Ferring has developed the drug and received approval from the Drugs Controller General of India (DCGI) for introducing the drug in India.
Kirti Ganorkar, CEO-India business, Sun Pharma, said, “PPH is one of the leading causes of maternal mortality worldwide. As per WHO, 25% of maternal deaths occur due to this condition. Through our collaboration with Ferring, we are introducing an innovative medicine that will help in reducing thousands of deaths from PPH every year. We believe this unique RTS formulation of Carbetocin will play an important role in PPH prevention in India.”
PPH is leading cause of maternal mortality worldwide and especially in countries like India. India’s current Maternal Mortality Ratio (MMR) stands at 113 deaths per 100,000 live births.
PPH is a frequent complication of child birth and its reported incidence in India is 2% – 4% after vaginal delivery and 6% after caesarean section. As per a survey conducted in India, PPH contributes to 38% of maternal deaths.
WHO stated that, every year about 14 million women around the world suffer from PPH. The risk of maternal mortality from hemorrhage is 1 in 1 000 deliveries in developing countries (100 per 100 000 live births).
Postpartum bleeding is a largely preventable and manageable condition. In the absence of prevention and timely and appropriate action, however, even a healthy woman could die within a few hours.