“It will be wrong to place the responsibility of producing Oxytocin for national requirement on only one company, be it public or private. This is not a drug that doctors can compromise on.”
New Delhi: The dispute over the crucial medicine, Oxytocin turns grave as the Indian Medical Association (IMA) has moved the Supreme Court challenging the Government’s decision to ban oxytocin production by private drugmakers.
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 death.
The issue of ban on Oxytocin has been going on for a long time. The matter originated after the health ministry had said in April 2018 that oxytocin will not be available at retail private chemist stores and that private pharmaceutical companies will have to stop manufacturing the drug from September. The decision was taken after the Drug Technical Advisory Board (DTAB), in a meeting on 12 February 2018 recommended various measures to check widespread misuse of the drug.
DTAB proposed restrictions on imports and decided to confine manufacturing to Karnataka Antibiotics and Pharmaceuticals Ltd, a government company.
The proposal, however, displeased many. The private firms resisted the decision while the Health activist group All India Drug Action Network had also filed public interest litigation to revoke the ban.
Various cases by drug makers like Mylan and Neon Laboratories and patient activist group All India Drug Action Network (AIDAN) were filed and the Delhi High Court in December 2018 quashed the ban on various grounds, including that it lacked scientific basis.
However, the centre challenged the Delhi HC order setting aside the Centre’s ban of manufacture and sale of oxytocin. It also reportedly moved the Supreme Court asking for the ban to be reinstated.
Following this, the Indian Medical Association had come out in protest of the Oxytocin Ban. Undaunted, IMA stated that they would hold the Government responsible for unfortunate consequences as a result of shortages in Oxytocin.
IMA has now moved an application in the apex court to intervene in the ongoing appeal at the apex court. The application states that there is “no ambiguity” in the Delhi High Court’s judgement.
“The risk of such a consequence can be drastic: the scarcity of the drug or even a restricted availability can cause increase in maternal fatalities, during childbirth, impairing the lives of thousands of innocent young mothers,” quotes the application.
According to a recent media report, the application adds that reserving the manufacture of this drug for domestic use to the public sector “clearly is a statutory override” and cannot be supported under Section 26 A of India’s Drugs and Cosmetics Act, 1940. Section 26 A empowers the government to regulate, restrict or prohibit the manufacture and sale of a drug “in public interest”.
“It will be wrong to place the responsibility of producing this drug for national requirement on only one company, be it public or private. This is not a drug that doctors can compromise on. We simply cannot allow our mothers to die,” RV Asokan, Honorary Secretary General, IMA, told The Indian Express.
“We feel that this is a failure of governance. What is the point in bringing a ban when there are adequate laws to prevent a misuse of this drug?” he added. On February 14, the apex court accepted an application by the Federation of Obstetric and Gynaecological Societies of India (FOGSI) to intervene in the appeal.
“We don’t have an objection to whoever manufactures the drug, but we want it to be available easily, especially in rural regions. The current (public sector) manufacturer has outlets in only 17 states. How will they manufacture and see to it that everyone who needs this life-saving drug gets it?” said Nandita Palshetkar, president, FOGSI.
There are around 26 million births in India every year, she added.