Oxytocin curb relook call
New Delhi: India's largest body of doctors has asked the health ministry to review proposed restrictions on the sales of the life-saving medicine oxytocin, citing the risk of maternal deaths from bleeding during childbirth.
The Indian Medical Association (IMA) has joined obstetricians and gynaecologists in opposing the ban on the sale of oxytocin through retail chemists from September 1 and the requirement for all hospitals and nursing homes to procure the drug from a single company.
The restrictions, announced earlier this year, were motivated by concerns that oxytocin was being abused in the animal husbandry industry to enhance milk production, senior officials have said.
Under the new rules, the public-sector Karnataka Antibiotics and Pharmaceuticals Limited (KAPL) alone will supply oxytocin across the country.
Oxytocin is a key drug that doctors routinely use to prevent excessive bleeding during childbirth.
"Any disruptions in oxytocin supplies could lead to a rise in maternal mortality," Hrishikesh Pai, a Mumbai-based gynaecologist and chairperson of an IMA panel on oxytocin, told The Telegraph.
Health ministry officials have directed the KAPL to ensure a robust supply chain and make the drug available wherever required. But doctors are concerned whether a single company can cater to a demand currently met by over 50 companies.
"We think the decision on oxytocin was taken in haste; we've asked for a review," said Ramender Tandon, secretary-general of the IMA. "This is a life-saving medication during childbirth and should be available in each and every corner of the country."
Office-bearers of the IMA and the Federation of the Obstetrics and Gynaecological Societies of India met health officials earlier this week and voiced their concerns.
"We're extremely worried. Restrictions on the legitimate use of life-saving oxytocin is not the way to address criminal abuse of the drug," federation president Jaideep Malhotra told this newspaper.
"The World Health Organisation has emphasised that this drug should be easily available
Doctors say that oxytocin, used to prevent post-partum haemorrhage (heavy bleeding during childbirth), is likely to have played a key role in helping reduce India's maternal mortality from 167 per 100,000 during 2011-13 to 130 during 2014-16.
K.V. Babu, an ophthalmologist in Kerala and a member of the IMA panel on oxytocin, wrote to the Prime Minister's Office on Thursday, questioning the rationality of the restrictions on oxytocin sales.
He cited a study by the National Institute of Nutrition that found that oxytocin injections do not influence the content of milk and that any oxytocin present in milk degrades rapidly during intestinal digestion.
"The study had ruled out intestinal absorption and associated adverse health effects," Babu said.
Niti Upasani, a Mumbai-based gynaecologist and member of the IMA's oxytocin panel, said the government would need to take responsibility if deaths occur because of a lack of oxytocin.
"It is the government's job to stop all illegal criminal activity, including the abuse of oxytocin on farms, but not by restricting a life-saving medication," she said.
"It will be the government's responsibility if a single woman dies because she is unable to receive timely oxytocin."
Members of the Federation of the Obstetrics and Gynaecological Societies say KAPL has informed them that it would supply oxytocin in bulk consignments of 1,000 ampoules at a time to each hospital or nursing home. Some doctors said this was absurd.
"What would small clinics and nursing homes that handle maybe four or five deliveries a month do with 1,000 ampoules?" Malhotra said.
"This suggests the company doesn't have in place an adequate and efficient distribution network."