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Civil society organisation, the Drug Action Forum-Karnataka has written an open letter to Maneka Gandhi, Union Minister for Women and Child Development, addressing her concerns on Oxytocin, a critical drug used to prevent excessive bleeding during pregnancy.
The Health Ministry had restricted the private manufacture and distribution of Oxytocin to prevent misuse. According to social workers, it is used to induce puberty in young girls. Also, it is abused in the cattle and poultry industries to enhance production. Further, the Health Ministry directive allows only one public sector company, Karnataka Antibiotic & Pharmaceuticals Ltd (KAPL), to make the drug.
In its letter, the Forum echoes the concerns raised by gynaecologists on limiting the production and supply of the drug across the country to just one company.
“Such restricted manufacturing will create a shortage of the availability of a life-saving drug because Oxytocin is administered to prevent bleeding which may occur after the baby is delivered,” the letter said.
The deadline banning private producers of the drug was extended to September 1. But the issue is presently in the Delhi High Court, with companies like Mylan and civil society group AIDAN (All India Drug Action Network) taking legal recourse and the next hearing comes up on Wednesday.
Post Partum Haemorrhage (PPH) or bleeding following delivery is a major cause of maternal deaths in India, The Forum said, “Nigeria and India, account for more than one-third of all global maternal deaths in 2015, though these deaths have declined as per the Ministry of Health Ministry, but it is well known that the single major medical cause of maternal death is PPH..”
Referring to the concerns raised by Ms Gandhi on the drug's veterinary misuse, the letter said that the drug is legally used by medical and veterinarians to stop and or prevent PPH.
“Any drug, if it is substandard or spurious or illegally manufactured requires surveillance and legal action needs to be taken against such manufacturing companies,” the Forum’s Gopal Dabade told BusinessLine . In the past, the Forum has raised critical issues on irrational drugs, drug pricing and clinical trial practices.
Further clarifying Gandhi’s concerns, the Forum said, “Oxytocin acts on the uterus only when there is a pregnancy and not otherwise.
“So the labour pain is induced when the uterus has a foetus not otherwise and so the animal does not writhe in pain for two hours every time Oxytocin is injected, as stated by you. Rather Oxytocin acts on the muscle (called myoepithelial cells) of the breast tissue and squeezes the milk out. It does not increase milk secretion.”
It urged Gandhi to write to the Health Ministry to ensure the drug was available in the interest of maternal health.
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