New Delhi: The ban on the sale and manufacturing of the oxytocin formulations likely to lift up as the Drug Technical Advisory Board (DTAB) has approved a proposal to amend the health ministry notification banning the retail sale of oxytocin in order to ensure availability for human use.
Oxytocin is a naturally-occurring hormone that causes uterine contractions during labour and helps new mothers lactate. It is used to prevent and treat post-partum haemorrhage or excessive bleeding after childbirth, one of the top causes of maternal deaths.
The DTAB in a meeting held on July 25, 2018, deliberated on the proposal to amend the Health ministry notification issued on 27th April 2018 to continue the sale of oxytocin formulation by the licencee licensed under the Drugs and Cosmetics Act, 1940 and Rules, 1945 for sale or distribution of drugs and to it in order to ensure the availability.
The minutes of the meeting stated that,
“DTAB Deliberated and agreed to the proposal to amend the notification issued vide G.S.R. 411(E) dated 27.04.2018 to continue the sale of Oxytocin formulation by the licencee licensed under the Drugs and Cosmetics Act, 1940 and Rules, 1945 for sale or distribution of drugs, so as to ensure availability for human use by deleting Clause No. (v) & Clause No. (vi) of G.S.R. 411(E).”
Medical dialogues had earlier reported that the Ministry of Health and Family Welfare has restricted the manufacture of Oxytocin formulations for domestic use to the public sector only from 1st July 2018. It has also banned the import of Oxytocin and its formulations.
From the day the ban comes into effect, only Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), a public sector company, would be manufacturing the drug for domestic use.
Later in June the, the ban was deferred by two months by the ministry.
The government is considering relaxation of norms for distribution and supply of the drug in the wake of strong resistance by drug firms and doctors all over the country to its move to restrict the distribution of oxytocin, according to two people aware of the matter reports Mint.
There has been widespread panic among obstetricians and gynecologists, who have been appealing to the government to reconsider the ban. Oxytocin is considered a life-saving drug in cases of post partem haemmoerrage and doctors have been extremely vocal about its production limitation to just one public sector unit. Many have also pointed it out to be a motivated move
“In effect, the lower priced brands of private pharma companies, which are time-tested, will be replaced with the costly brand of the KAPL, which is a newcomer, in the name of misuse of oxytocin,” Dr KV Babu, a public health activist who has been opposing the ban, had pointed out to TOI..