The Centre has been encouraged to scrap its controversial ban on private sector sales of Oxytocin by the Drug and Technical Advisory Board (DTAB). In a stunning u-turn from the body’s previous stance, it is now exhorting the health ministry to ensure that the hormone drug is “[available] for human use.”
Oxytocin is used to prevent postpartum hemorrhage (PPH) – one of the main causes of maternal mortality in India. Though it is a life-saving drug, it is controversial because of its misuse in other sectors such as dairy farming and the sex industry.
The Ministry of Health and Family Welfare (MoHFW) issued a notification earlier this year, barring private companies from manufacturing and selling oxytocin. The MoHFW’s decision was prompted by the recommendation of the DTAB that oxytocin be solely manufactured by one firm – Karnataka Antibiotics and Pharmaceuticals Limited (KAPL) – and solely distributed by another – HLL Lifecare, Ltd..
The MoHFW proceeded to announce a ban on oxytocin’s production and retailing by private companies on June 27th. The ban was to be effective from July 1st.
The MoHFW further announced that, in accordance with the DTAB’s recommendations, KAPL would be solely licensed to make the drug in India. In addition, KAPL would be afforded sole responsibility for oxytocin’s distribution, being allowed to supply it to registered hospitals and clinics in both the public and private sectors.
“Fears were expressed that KAPL – a firm which has never produced oxytocin before – would not be able to cope with the demand for the drug and that this would lead to shortages”
The ban was controversial, with The Wire likening it to the Centre’s demonetisation policy because of the short notice given before the ban was due to come into effect. Fears were expressed that KAPL – a firm which has never produced oxytocin before – would not be able to cope with the demand for the drug and that this would lead to shortages. Such fears prompted the MoHFW to postpone the ban until September 1st.
The DTAB has now reversed course as far as selling oxytocin is concerned. It has warned that the ban could be an “impediment in its free and easy availability for human use…likely to result in a significant rise in the loss of women’s lives due to PPH.” Its recommendation to the MoHFW makes it likely that the ban on private sector companies retailing the drug will be lifted.
The volte face by the DTAB has led to sighs of relief from healthcare providers across the country. Many feared acute shortages of the drug in the ban’s aftermath, as KAPL lacks distribution centres in nineteen states and union territories. This could have resulted in unnecessary, preventable deaths of women from excessive bleeding after labour.
Some are still concerned, however, about the role of KAPL in oxytocin supply in India.
“The fact that…KAPL, which has never manufactured oxytocin, continues to hold the monopoly in the manufacture, distribution and sale of an essential drug like this, raises important questions,” one gynaecologist told The Hindu. “Also, nothing has been said about the pricing of oxytocin by KAPL — at ₹17.78 (including GST) per five IU vial — when several private pharma firms were earlier supplying it for as low as ₹4.82. Several concerns remain still.”