The Centre has revoked its decision to ban retail sale of Oxytocin, a life saving drug for pregnant women in India after petitioners moved court. But tight restrictions remain in place.
Oxytocin is a hormone drug used in the treatment of postpartum haemorrhage (PPH), the predominant cause of maternal mortality in India. Its misuse in other sectors prompted the Union Ministry of Health and Family Welfare to announce a ban on the production and sale of the drug by the private sector, effective from September 1st.
The MoHFW’s decision sparked the misgivings of doctors, many of whom feared it would result in shortages of the life-saving drug. Private retailers will now be able to sell the drug, albeit with restrictions.
Under the new rules, private chemists must keep a record of the person who prescribed the drug and the patient, as well as the quantity prescribed. These records must be kept for three years and be available for inspection.
“The Centre has revoked its decision to ban retail sale of oxytocin, a life saving drug for pregnant women in India after petitioners moved court. But tight restrictions remain in place.”
The news will no doubt come as a relief to those who protested the government’s decision. Malini Aisola, co-convener of the All India Drug Action Network (AIDAN), said the centre’s u-turn on the issue “demonstrates that the decision to ban/restrict Oxytocin was unplanned and arbitrary. It was without consultation with maternal health experts and those who would be affected.”
While the Centre is now permitting supply of the drug by private firms, it has not yet overturned its decision to limit production of the drug to the public sector. Karnataka Antibiotics and Pharmaceuticals (KAPL) will enjoy sole licensure to make the drug as of September 1st.
This means fears of shortages could still be prescient. Many have expressed fears that KAPL – having never produced Oxytocin before – is underprepared. And while KAPL themselves have said they are prepared and will have five million ampules of Oxytocin ready by August 31st, there are further concerns that their monopoly in the field could limit access to the drug for new mothers. The absence of KAPL distribution centres in nineteen states and union territories (UTs) and potential price hikes could pose obstacles to access to the life-saving medicine.
The reversal of the Centre’s decision to disallow private retailers from stocking Oxytocin may go some way to assuaging some of the fears surrounding the ban. However, with concerns over production and supply still very much abundant, the issue is far from settled.