New Delhi: Last month, the government issued a notification banning the manufacture of oxytocin for domestic use by any player (especially targeted at private players) other than the government-run Karnataka Antibiotics and Pharmaceuticals Limited (KAPL).
It said the ban would come into effect from July 1, 2018.
The Wire has now confirmed through multiple sources that KAPL had not even started the production of oxytocin in time for this ban. In fact, KAPL began production only on July 2, a day after the ban was introduced.
This poor planning could cause a nationwide shortage of oxytocin, a life-saving hormone for pregnant women.
“What the government has done is like demonetisation – they suddenly decided to remove oxytocin from the market without making any arrangements,” said Dr K.V. Babu from Kerala, who first found out that the production hadn’t yet begun.
Oxytocin is life-saving for pregnant women – it prevents bleeding after pregnancy, reduces maternal mortality and induces labour. However, the government’s decision to introduce this ban has largely stemmed from the fact that the hormone is also misused in cattle to stimulate milk production.
The concern for cattle over the concern for pregnant women and their maternal mortality comes even from the Prime Minister’s Office. The Wire had reported earlier in the month that the PMO itself had held meetings to discuss the regulation of the hormone.
The government’s notification laid out two things: domestic demand for oxytocin would have to be met only by KAPL; and a ban on the import of oxytocin and its formulations.
A few days after the notification last month, the press reported that the government had changed the deadline for the ban from July 1 to September 1. There were no reasons or clarifications issued in this regard.
‘Demonetisation’ on oxytocin
“What was the hurry to bring about a ban like this? This shows that the government is giving more importance to cattle and taking maternal issues lightly,” says Babu.
“This is to inform you that we have started the manufacturing of inj. Oxytocin from July 2nd 2018 and it will be made available to you in the month of August 2018,” said KAPL in their email to Babu. The reply also stated that the government had decided to extend the July 1 ban to August 31 and said that until then, “Please contact your local distributor/stockist for your current requirements of oxytocin.”
The Wire confirmed with four doctors that oxytocin is usually used only in its injectable form – it is given as an intra-muscular injection or via a drip. But when it is supplied to the hospital, it is in the form of an injectable.
@kapl_bangalore is all geared up to be the sole manufacturer of #Oxytocin and meet the domestic demand of the drug.@AnanthKumar_BJP @mansukhmandviya @MoHFW_INDIA @CDSCO_INDIA_INF @NHPINDIA https://t.co/thRraj8YyS pic.twitter.com/ZP7a2yeKFX
— Dept. of Pharma (@Pharmadept) July 17, 2018
Apart from the hurry with which this measure seems to have been brought in, healthcare watchers have pointed out that shortages can also arise from the fact that the entire country’s domestic demand for oxytocin will have to now be supplied by one single public sector undertaking, based in Karnataka.
A recent letter sent to the health ministry, signed by a number of health practitioners, raised this issue as well: “Given that women deliver in multiple settings and health facilities in different parts of the country, restricting the production and sale of oxytocin, we fear, will immediately impact the availability of oxytocin. The order restricts production of oxytocin to a single public sector manufacturer and its ability to meet the demand from across the country is in serious doubt.”
While confirming to The Wire that the government had not allowed KAPL to begin production of oxytocin before July, Dr Mukesh Kumar at KAPL said, “We have the capacity to manufacture 35 lakh ampoules of oxytocin a month, on a single shift. Domestic demand as per our estimate is for 25 lakh ampoules a month. We can also do a double shift if needed.”
He also said that “alternatives” could be used for women. The letter sent to the health ministry responds to this as well: “Alternatives to oxytocin, example, misprostol, are proven scientifically to be inferior in effectiveness in prevention and treatment of post-partum haemorrhaging.”
“We have been silently working on this for the last two years – since 2016. Even PMO and NITI Aayog are taking care,” says Kumar, even while health practitioners have been concerned that this move has been pushed through by the “cow-lobby”.
“It was needed. I think all Indians should support this cause,” says Kumar.