Bonesupport, a Sweden-based emerging leader in injectable bone substitutes related to orthopaedic surgery, has received Indian drug regulatory approval to market Cerament Bone Void Filler and Cerament G in India.

The company announced that the Central Drugs Standards Control Organization (CDSCO) and their MDAC (Medical Device Approval Committee) has granted this approval recently.

Cerament G is the first injectable antibiotic eluting bone substitute indicated to promote and protect bone healing being jeopardised by infection, and the first of its kind approved for the management of osteomyelitis in India. Bonesupport will work closely with regional distributors to launch Cerament to leading hospital groups in India.

Osteomyelitis, or bone infection is a $1.7 billion market where prolonged, long-term antibiotic therapy, multiple surgical interventions and the threat of amputation are the current standard of care. Rising prosthetic infections, diabetic ulcers, war injuries, sports injuries, and an increasing resistance to antibiotics contribute to this growing condition.

“With the population of India exceeding a billion people, this approval represents one of the more significant international markets for Cerament and is an important step in our geographic expansion plan,” says Vikram Johri, executive vice president International at Bonesupport.  “In a country where synthetic bone void fillers are widely accepted, quality is gaining importance as regulations increase. In addition, the combination of an antibiotic loaded product that promotes bone healing and remodelling presents an important clinical option in a country with a high rate of bone infection and limb salvage procedures.”

According to the 2014 IDF Diabetes Atlas, middle and low-income countries often have higher rates of adult diabetes compared to the world average.  In India, more than 66 million adults have been diagnosed with the disease in addition to an estimated 35 million undiagnosed cases.  It’s expected that more than 10 per cent of diabetic sufferers will be afflicted with osteomyelitis due to diabetic foot ulcers.

“The Cerament platform has a long standing safety profile and we are pleased to see this once again confirmed by India’s approval,” says Lloyd Diamond, chief executive officer, of Bonesupport. “Cerament G is an important advancement in the management of bone infections and we are proud to be at the forefront in addressing an unmet need to patients in India.”