As the deadline for implementation of the ban on retail sale of oxytocin from September 1 draws near, gynaecologists across the country are uncertain about how medical facilities will access supplies of the life-saving drug.

In April 2018, the Ministry of Health and Family Welfare passed an order prohibiting the import of oxytocin, and restricting the manufacture of oxytocin for domestic use to the public sector. The order also stated that oxytocin would not, in any form, be sold through retail stores. This means that the drug will have to be supplied directly from a licenced manufacturer to hospitals, nursing homes and clinics.

The restrictions on oxytocin come after the Himachal Pradesh High Court in 2016 observed that it was being misused in the dairy industry.

The government has given only one public sector company, Karnataka Antibiotics and Pharmaceuticals Limited or KAPL, the licence to manufacture the drug.

“As of now there is no shortage of oxytocin and the usual channels are open,” said Dr Parikshit Tank, a gynaecologist who works at a private hospital in Mumbai.

Many gynaecologists currently get oxytocin from distributors of pharmaceutical companies like Mylan and Pfizer. But it is also available at pharmacies across India.

“We have to see what happens three to four weeks after September,” Tank added.

Oxytocin is a hormone that is naturally produced in the human body. A synthetic version of this hormone is manufactured as a drug that is usually administered to a woman in childbirth in the third stage of labour, that is, after the baby has been delivered, to prevent and treats excessive bleeding. In some cases, it might also be given to induce labour.

Government preparedness

On Monday, the health ministry issued a press release saying that it had held a video conference with health officials from states and union territories to assess the preparedness of state governments to implement the new rules and to assess the current stocks of oxytocin. The ministry asked state officials to ensure the availability of oxytocin at all government hospitals and clinics by placing purchase orders with KAPL and to watch for any artificial shortages.

The health ministry has also directed state officials to meet representatives of the Federation of Obstetric and Gynaecological Societies of India, the Indian Medical Association and the Pradhan Mantri Bharatiya Janaushadi Pariyojana to make sure that oxytocin is available at all private clinics.

On Wednesday, a group of doctors met health ministry officials in Delhi and relayed their concerns about the distribution of oxytocin after September 1. “We spoke to the officials about our concerns,” said Dr Jaideep Malhotra, the president of the Federation of Obstetric and Gynaecological Societies of India. “We are also contacting members of Parliament, who have promised to bring up the issue in the House.”

Malhotra said that the crux of the problem is how the restrictions on sale of oxytocin will affect smaller hospitals and private practitioners. She said she was worried that a shortage of oxytocin would not only endanger the lives of many women across the country but also affect gynaecologists who may be blamed for deaths that occur due to unavailability of the drug.

Doctors not convinced

Most doctors are still asking how KAPL, as the sole manufacturer, could meet demand for oxytocin from across the country.

“I heard that the manufacturing company was ordered to start around August but we don’t know whether this company has the single manufacturing capacity to fulfill the needs of the country,” said Dr Nikhil Datar, an obstetrician at a private hospital in in Mumbai.

KAPL has sent a letter to the Federation of Obstetric and Gynaecological Societies of India reiterating the health ministry order and containing details of the company’s regional branches for doctors to make requests for the medicine.

“KAPL has admitted that they don’t have a distribution network set up everywhere,” said Malhotra. “The distribution centres are not present in 19 states. They will not take small orders and will only deliver orders above 1,000 ampoules of oxytocin. This is just bizarre.”

Dr MC Patel, a gynaecologist who runs a private practice in Ahmedabad, said that it is unfair of the government to allow only one company to manufacture oxytocin. “Any high standard pharmaceutical company which has a good reputation and maintains quality should be given the chance,” he said.

A gynaecologist with a private hospital who did not want to be identified said that even if the authorities made sure that there was no shortage of oxytocin “there could be more paperwork from the administrative side that the hospital has to deal with.”

Malhotra pointed out that the alternative that she and most other gynaecologists would use, should they run short of oxytocin, is a drug called misoprostrol, which is expensive.

She also said that having a single supplier could allow spurious drugs to enter the market. “If there is no availability of the drug, it could give rise to a black market,” she said. “Now oxytocin [sold by a number of private manufacturers] costs Rs 12 to Rs 13, but KAPL is selling it for Rs 17.5. We are not able to understand why they are selling it at a higher rate.”

Moreover, India’s progress with bringing down maternal mortality has largely been by preventing deaths of women in childbirth in rural areas. These areas will be the most affected with restricted oxytocin supply, raising the threat of increased maternal deaths

“We can’t know the repercussions now but maybe in five years or so we will,” said Malhotra.