While heat-stable carbetocin, a potential alternative to oxytocin, is set to be registered with the Central Drugs Standard Control Organisation (CDSCO) for relevant permissions to sell in the domestic market, the health ministry has no plans to promote the new medication or pilot its usage in the public health system.
A clinical trial spearheaded by the World Health Organisation (WHO) covering 30,000 women across 10 countries has recently proved heat-stable carbetocin’s potential to replace oxytocin as remedy for postpartum haemorrhage (PPH). The UN health agency is expected to soon amend its guidelines to recommend carbetocin as the first-choice drug to prevent PPH. The new formulation does not require refrigeration and retains its efficacy for at least three years when stored at 30 degrees celsius and 75 per cent relative humidity.
According to sources, the top brass of the ministry are of the view that the availability of carbetocin will not eliminate the need for oxytocin in institutional deliveries in the country as the latter is imperative for labour induction and augmentation apart from treatment of PPH.
The ministry had decided to restrict the manufacture and sale of oxytocin, a peptide hormone widely misused in the dairy and horticulture industry, to Karnataka Antibiotics and Pharmaceuticals Limited from July 1. However, amid fears raised by medical professionals over major disruption and shortage of supplies, the move was put on hold for two months. “The ministry is looking for ways to make sure that oxytocin is available in every nook and corner of the country for therapeutic purposes. Inspections and raids to check illegal manufacturing will continue and supply chain will be tightened to curb its misuse,” sources added.
The heat-stable carbetocin is a patented drug developed by Ferring Pharmaceuticals, which has a manufacturing and research centre at Genome Valley in Hyderabad.
