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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, it is learnt.
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.
According to industry sources, 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.
The new drug is seen as a boon for developing nations such as India with inadequate logistical infrastructure and storage facilities. “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 Shivaprasad S Goudar from JN Medical College, Belgaum, a lead investigator of the WHO trial, pointed out.
While the government is unlikely to backpedal on oxytocin manufacturing restrictions, industry sources have hinted at the possibility of allowing private sector companies to market the crucial drug. No public sector undertaking has the capacity or wherewithal to make this wonder drug available across the country, they say.
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