Gynaecologists and obstetricians across the country can now exhale in relief: the Drug Technical Advisory Board (DTAB) has recommended to the Union Ministry of Health and Family Welfare that the ban on the retail sale of the life-saving drug, oxytocin, may be lifted.
The DTAB, in its meeting on July 25, recommended that the Health and Family Welfare Ministry’s notification on April 27, banning retail sale of the drug formulation, oxytocin, may be amended and that its sale and distribution for human use, under the Drugs and Cosmetics Act 1940 and Rules 1945, be continued.
The ban had been imposed citing the serious misuse of oxytocin in the dairy sector.
While it recommended lifting of the ban, the DTAB has not said anything about the Ministry’s decision (vide notification dated June 27) that only a single PSU — Karnataka Antibiotics and Pharmaceuticals Ltd. — could manufacture and supply the drug across the country.
‘Welcome move’
The DTAB recommendation has brought immense relief to gynaecologists and obstetricians, who had said that the ban on retail sale of the drug could affect its availability in hospitals and clinics in rural areas, where more women were likely to bleed to death post-partum in labour rooms.
“It is certainly a welcome decision. But the fact that a single PSU, 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. 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,” a senior gynaecologist here said.
“In effect, the lower priced and time-tested oxytocin brands of private pharma companies will be replaced with the costly brand of KAPL, in the name of misuse of oxytocin,” points out K. V. Babu, a physician and public health activist in Kerala.
