While the medical fraternity in the country is voicing concerns over the impact of oxytocin shortage on women’s reproductive healthcare as ban on its manufacture and sale in private sector takes effect, an alternative drug, heat-stable carbetocin, is creating a buzz in the industry. The World Health Organisation (WHO) is expected to soon amend its guidelines to recommend carbetocin as remedy for postpartum haemorrhage (PPH) and the drug manufacturer, Ferring Pharmaceuticals, is getting ready to approach the Central Drugs Standard Control Organisation (CDSCO) for necessary regulatory clearances to market the product, it is learnt.

A recent global clinical trial has unequivocally proven the new medication’s potential to replace oxytocin, a peptide hormone widely misused in the dairy and horticulture industry. At present, WHO norms recommend oxytocin as the first-choice drug for preventing post-partum excessive bleeding. The novel medicine is expected to prove a boon to countries like India where, as per a WHO report, five women die every hour from complications developed during childbirth with heavy blood loss caused by haemorrhage being a major factor.

The randomised clinical trial involving nearly 30,000 women was conducted by the UN health agency along with MSD for Mothers and Ferring Pharmaceuticals, the manufacturer of the drug, at hospitals in India, Argentina, Egypt, Kenya, Nigeria, Singapore, South Africa, Thailand, Uganda and the UK. There were six centres in India and the results have been highly promising.

“Our study has shed light on carbetocin’s various practical advantages over oxytocin in the Indian context,” Dr Shivaprasad S Goudar, principal investigator of the clinical trial at J N Medical College in Belgaum, one of the Indian centres, told Pharmabiz. The details of carbetocin clinical trials conducted at Indian centres are available with Clinical Trials Registry of India. The data, reviewed by Pharmabiz, showed that the new drug was clinically non-inferior to oxytocin for the primary outcome of greater than or equal to 500 ml blood loss or additional uterotonic use. The frequency of blood loss was 14.5 per cent in the carbetocin group and 14.4 per cent in the oxytocin group. It also maintained effectiveness for at least three years at 30 degrees Celsius and six months at 40 degrees Celsius.

“The heat-stable carbetocin is a patented drug researched and developed by Ferring. But the company has committed to the WHO to make the product available in the market at the same price as oxytocin. The drug is expected to hit the shelves in India in a year’s time after obtaining the approval of the regulators,” an industry source said.

More than the government ban on oxytocin which might lead to a shortage of the life-saving drug, medical professionals like Gaudar are concerned about the compromised potency of oxytocin formulations available in the domestic market. The new heat-stable drug is an ideal product for developing nations with inadequate logistical infrastructure, they say.

“On most occasions, oxytocin we get from pharmacies here lacks potency thanks to lack of storage facilities and poor supply chain management. Many village pharmacies don’t even know that the medication should be kept in a refrigerator. This seriously reduces its efficacy as it must be stored and transported at 2-8 degrees Celsius. The new drug remains stable at room temperature, which means it has the potential to save lives of thousands of women in low- and lower-middle income countries, where 99 per cent of PPH-related deaths occur and where the refrigeration of medicines can be difficult to achieve and maintain,” Dr Goudar pointed out.