drug regulation

India’s plan to ban life-saving drug could endanger women during childbirth, say experts

Oxytocin is used to stop postpartum bleeding but is also widely misused in health settings and the dairy industry.

Health activists have written to the government opposing a proposal to restrict production of oxytocin and to ban its retail sales. Such restrictions could be detrimental the health of women during labour and childbirth as the drug is used to control postpartum haemorrhage, a leading cause of maternal mortality in India.

Oxytocin in a hormone that occurs naturally in the human body. Synthetic versions of this hormone are used in medical settings to ensure safe childbirth. The life-saving drug has been listed as an essential medicine by the World Health Organisation and is also on India’s National List of Essential Medicines.

Several government agencies have raised concerns about rampant misuse of oxytocin, especially in the dairy industry, where milch cattle are sometimes given the hormone to boost milk production, which is detrimental to the health of the animal. There are also concerns that oxytocin can enter the food chain through milk that can be harmful for human consumption, but any adverse outcomes have not been well established.

The government has taken several steps to regulate the production and sale of oxytocin. In April this year, the Ministry of Health and Family Welfare passed an order prohibiting the import of oxytocin citing public interest. The ministry also moved to restrict the manufacture of oxytocin for domestic use only to public sector undertakings, while oxytocin for export can continue to be made by both private and public sector companies. Furthermore, the government proposed that no retail chemist be allowed to sell oxytocin in any form or under any name. Oxytocin manufacturers can only directly supply registered hospitals or clinics in the public or private sector and specific government health programmes.

In May, the Central Drugs Standard Control Organisation issued a notice saying that the order regarding the oxytocin manufacture for domestic use would come into effect on July 1. The restrictions have reportedly been deferred to September.

In their statement, a group of public health activists with the Coalition for Maternal-Neonatal Health and Safe Abortion or CommonHealth have said that the government has taken several steps backwards on maternal health by proposing such restrictions.

“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 statement says.

Availability of oxytocin

Oxytocin is an inexpensive drug, out of patent and so easily available in the private sector. But bottlenecks in the supply of medicines across India has hurt the availability of oxytocin in the public sector, said S Srinivasan of LOCOST, a charitable trust that makes essential medicines. “It is a very important drug and it is very difficult to get in the public sector,” he said. “States like Tamil Nadu and Rajasthan have had no problem in procuring oxytocin. Many other states have not got their act together on drug procurement and distribution in general. Oxytocin is one of them and should be high priority because of its role in preventing maternal mortality.”

Instead of ensuring better access to the life-saving drug, the ban on retail sales of oxytocin will immediately affect the availability of the drug in private health facilities as well as and public health centres.

“There are constant stock outs and bottlenecks in places like Bihar, Uttar Pradesh and Jharkhand,” said Dr Subhasri B of CommonHealth. “In many of these states, oxytocin is not available at public health facilities and people have to go and purchase it from retail chemists.”

There are a few alternatives to oxytocin like misoprostol, but these are even more difficult to get.

“Across the country, those who are dealing with maternal health say that the availability of misoprostol is a problem,” said Dr Mira Shiva, coordinator for the Initiative for Health and Equity in Society and one of the founders of the All India Drug Action Network. “The health ministry itself has trained doctors and auxiliary nurse midwives on how to administer oxytocin.”

Public health experts argue that alternatives to oxytocin like misprostol are scientifically inferior preventing and treating of postpartum haemorrhage.

The health ministry also issued a notification restricting the production of oxytocin to a single public sector manufacturer, the Karnataka Antibiotics and Pharmaceutical Limited, raising questions about the company’s ability to meet demand for oxytocin from across the country.

Use and misuse

Oxytocin is usually administered to a woman in childbirth in the third stage of labour, that is, after the baby has been delivered, to both prevent and treat excessive bleeding. In some cases, it might also be given to induce labour.

“For women who are pregnant and their due date has passed and labour pains have not started, it has been used for the induction of labour,” said Shiva.

Oxytocin can also be rationally used during the first and second stage of labour, if labour is not progressing adequately. Gynaecologists say that such use of oxytocin must be done with medical supervision.

However, studies from different parts of the country have shown that oxytocin is not always administered with the required care.

“The problem is that some people are using it without those kind of monitoring mechanisms or without medical supervision,” said Subhasri “It is supposed to be given in very small doses through intravenous infusion whereas people are giving it either direct IV or intramuscular injections – so wrong dosages, wrong routes, without medical supervision that that is again very dangerous for the woman and the baby.”

The solution to prevent such misuse, public health activists argue is to implement existing regulations. For instance, oxytocin is a Schedule H drug, which means that it can only be bought with a prescription. “Schedule H and H1 drugs can be bought only on producing a prescription but that law is more often breached than obeyed,” said Srinivasan. “The law should be implemented.”

CommonHealth and other activists groups have demanded that the government immediately revoke the restrictions on manufacture and sale of oxytocin, that the availability of oxytocin is ensured at all levels of public health, and that regulatory mechanisms are put in place to prevent misuse of oxytocin in such a way that they enable the drug’s availability.

“The government has to ensure access to essential life saving drugs keeping safety, efficacy and affordability in mind,” said Shiva. “If you don’t have medicines for postpartum haemorrhage, women will die. If there was one Millenium Development Goal that we could not meet, it was maternal mortality.”

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