Why govt's ban on a lifesaving drug was flawed

By Nabeela Inayati

Published on 30, January, 2019

The Union Health Ministry on June 27, 2018 announced that only one public sector undertaking, Karnataka Antibiotics & Pharmaceutical Ltd. (KAPL) would be authorised to manufacture and supply oxytocin, a life-saving drug for new mothers. Under the National list of Essential Medicines (NELM), section 22 list oxytocin as an essential drug. 

Essential Medicines are those that satisfy the priority health care needs of the population and such medicines are intended to be available in adequate amounts, in appropriate dosage forms and strengths with assured quality and affordable rates. The UN Population Fund and its partners have identified Oxytocin as one of the four priority medications to save mother's life during pregnancy and child birth.

Moreover, the WHO recommends oxytocin as the first-choice drug for preventing excessive bleeding after childbirth. As the majority of women who experience PPH complications have no identifiable clinical risk factors, it is recommended that oxytocic drugs should be offered routinely in the management of the third stage of labour in all women. "It's not a good idea to ban it. Oxytocin is used in the management of third stage labour, it prevent women from bleeding and and it saves lives. Therefore it is an important life-saving drug", Dr. Priya Sindhwani from Sitaram Bhartiya Hospital said. India accounts for around 17 per cent of the burden of global maternal deaths and the biggest cause of maternal deaths is post-partum Hemorrhage (PPH) which is 37 per cent.

The restrictions came after the Himachal Pradesh High Court in 2016 observed that oxytocin was being misused in the dairy industry.The proceedings were taken suo motu notice after taking into account the report in the Hindi vernacular Amar Ujala . The fact that it is used as an essential drug and that it has therapeutic value was never taken into consideration.

In 2018, following the Himachal Pradesh high court's order, the Centre said that only one public sector undertaking - Karnataka Antibiotics and Pharmaceuticals Limited - would be permitted to manufacture oxytocin for the domestic market.

Fiona Theunissen of Geneva based Concept Foundation points out that " the regulation is driven by political pressures and women's health is being forgotten. The gains that India has made on maternal mortality could be lost very quickly if a solution isn’t found that ensures that women have access to quality uterotonics for every birth ".

In reply to a query in the Parliament on 01.08.2014, the Union Minister of Health and Family Welfare admitted that there was reports in media about the misuse of Oxytocin injection and further "scientific data on the extent of such practice is not available". Yet the government went ahead to restrict manufacturing and the sale of this life-saving drug.

The copy of court proceedings highlighted that a report from The National Dairy Research Institute (NDRI) said "there is no scientific evidence that artificial use of Oxytocin has adversely affected progeny of cattle and buffaloes rresulting in dwindling of livestock." The document further highlights that the ministerial committees, the multi-disciplinary committee set up by the Government in July 2014 had highlighted that ―there was no data to support the allegation of misuse of Oxytocin; it was notified that the drug was used to induce labour and to control post-partum hemorrhage.  

Last month in December, a 100-page judgement of the Delhi High Court quashed the Centre government’s attempts to restrict the sale of oxytocin. The court order called the government's moves 'arbitrary and unreasonable ' as there is no scientific research or record to prove the ill effects of oxytocin on animals and after effects on human health.