The crucial drug has been under the scanner for a few years now, after allegations of its misuse in animals. There have been alleged diversions of the drug for use on cows to increase their milk-producing capacity.
Retail or wholesale chemists will not be allowed to stock this drug in their shops in any form or name. The Ministry of Health and Family Welfare has zeroed in on Karnataka Antibiotics & Pharmaceuticals Ltd (KAQPL) to manufacture the drug and supply it directly to registered private and public hospitals. The manufacture and sale of this drug has been banned for domestic use in the private sector by the Government. Import of the drug has also been banned. Oxytocin, a vital drug, and its formulations, used to stop bleeding during childbirth, will not be freely available for use by doctors.
The drug will be available on a demand basis from KAPL after placing an order with the company, a release from the Ministry stated.
“Oxytocin is a life-saving drug in those women who bleed during child birth or undergo an abortion. There are alternatives like Misoprostol, but the government has restricted its use in private clinics, as they are worried about misuse of Misoprostol in sex-selective abortions,” said Duru Shah, a Mumbai-based doctor.
The domestic annual market of Oxytocin is pegged at ₹45-50 crore. Up to three crore ampoules of the drug are used for life-saving treatment of pregnant women.
There are 133 licensed manufacturers of the drug. However, only 80 are actively involved in production. While they will not be able to produce the drug for domestic supply, the drug can be manufactured by Indian pharma companies for export.
The official added that KAPL has the capacity to produce 1.5 lakh ampoules per shift in a day and that it will continue mass production to meet demand in three shifts.
The Ministry had only last year directed KAPL to obtain the licence for production of Oxytocin. The PSU obtained the licence in March. Last month, KAPL wrote to all public and private hospitals to procure the drug only from itself.
KAPL maintains that a possible shortage of Oxytocin can be met by alternative drugs. But gynaecologists have raised concerns about whether KAPL will be able to cater effectively to seamless supply and distribution of the drug, especially in remote villages.
“Maternal mortality in India is still a concern. Oxytocin is a life-saving drug in those women who bleed during child birth or undergo an abortion. There are alternatives like Misoprostol, but the government has restricted its use in private clinics, as they are worried about misuse of Misoprostol in sex-selective abortions,” said Dr Duru Shah, a noted Mumbai-based doctor and member of Federation of Obstetric and Gynaecological Society of India (FOGSI).
As a build up to the ban, the drug technical advisory board (DTAB) in its 78th meeting held on February 12, earlier this year, had deliberated on restricting the supply of Oxytocin to registered private and public hospitals. It had also proposed to ban it's import, both for human and animal use.
The DTAB has, however, warned that there should be no shortage of the drug in the country. Also, a bar coding system should be adopted for manufacture of Oxytocin formulations so as to track the product to avoid its misuse, even in case of exports.
The MoHFW has also taken a cue from a case pursuant since 2014, judgment of which was arrived at in 2016, in which the High Court of Himachal Pradesh had observed that there is a large-scale clandestine manufacture and sale of the drug Oxytocin leading to its grave misuse, which is harmful to animals and humans.