Proposed restrictions on oxytocin put on hold till September
THIRUVANANTHAPURAM: In a huge relief to the maternal health sector of the state, the Ministry of Health and Family Welfare has decided to put on hold by two months its decision to restrict the manufacture and supply of oxytocin to the Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL).
Originally, the decision was to come into effect on Sunday. But the ministry decided to reconsider the same following a slew of complaints it received from various states including Kerala. According to sources, the two-month relaxation will be used by the ministry for deliberations with states for the smooth implementation of its decision.
Confirming the same, the Health Minister’s Office said it was after the state voiced its apprehensions to the ministry the latter intimated Kerala about the two-month relaxation.
“What we had highlighted with the ministry is that for the maternal health sector of the state, oxytocin is an indispensable drug and has helped it to put the maternal mortality rates under control. Thus we had asked it to reconsider the said decision,” said a source in the health ministry.
Asked about this Health Secretary Rajeev Sadanandan told Express the move by the ministry to restrict the manufacture of oxytocin formulations for domestic use to the public sector has a ‘far-reaching impact’ on the state’s health sector. He also said the two-month relaxation might help the states to voice their concerns over the proposed move.
It was last Wednesday the ministry came out with a statement on the restriction to be imposed from Sunday. The ministry had earlier banned the import of oxytocin and its formulations.
According to the communique, KAPL alone will be allowed to supply oxytocin to the registered hospitals and clinics in the public and private sector directly and retail chemists will not be allowed to sell oxytocin in any form or name.
“Oxytocin is an indispensable part in the labour room. Even the WHO has recognised its importance. Severe bleeding after birth can kill a healthy woman within hours if she is not attended to. Injecting oxytocin immediately after childbirth effectively reduces the risk of bleeding,” said Presannakumari B, Kerala Federation of Obstetrics and Gynaecology president.
According to Presannakumari, a unilateral decision to restrict oxytocin in the name of its misuse might thrown the state’s maternal health sector into a tizzy and highlighting the same, the federation had written to the Union Health Minister and Union Health Secretary to reconsider the move.
How the regulation came about:
Oxytocin is the recommended first-choice uterotonic drug for the prevention of postpartum haemorrhage (PPH), a leading cause of maternal mortality in caesarean sections
Restriction on oxytocin follows a judgment by the Himachal Pradesh High Court in March 2016
The court had observed there is large-scale clandestine manufacture and sale of the drug leading to its grave misuse
It also recommends the feasibility of restricting the manufacture of oxytocin only in public sector companies
Following this, the Centre decided to regulate and restrict the supply of oxytocin only to registered hospitals and clinics
At the same time, there were reports the WHO is weighing the aspects of introducing an alternative for oxytocin
The alternative, carbetocin, might replace oxytocin for the prevention of PPH if the Guideline Development Group of WHO gives its nod