Dr. MC Gupta, a former Dean and Professor of Medicine and now a practising lawyer, writes about a landmark judgement passed in 2018 concerning an essential medicine- oxytocin.

Quashing the ban on Oxytocin 

1—The Government of India issued a notification no. GSR 411(E) dated 27.04.2018 which prohibited the manufacture and distribution for domestic use, of the essential drug OXYTOCIN injection for human use, by private sector companies.

2—The fact is that oxytocin is listed as an essential medicine in terms of the 20th World Health Organization (WHO) Model List of Essential Medicines, March, 2017. Oxytocin injection is also included as an essential medicine under National List of Essential Medicines, 2015 (NLEM) published under the First Schedule to the Drugs (Prices) Control Order, 2013. Oxytocin is recommended by WHO as the first line drug for prevention and treatment of postpartum haemorrhage (excess bleeding immediately after childbirth). Oxytocin is also the drug of choice used for pregnant woman for induction or reinforcement of labour. It is also used in a state of incomplete or threatened abortion.

3—The ostensible reason for issuing the said notification was that Oxytocin is capable of misuse by its administration in cattle to induce easier lactation; it can also be injected in fruits and vegetables to artificially induce their ripening.

4—The predominant or sole rationale for the impugned notification was the direction contained in a judgment dated 15.03.2016 passed by the Himachal Pradesh High Court (in CWPIL No. 16/2014) which, inter alia, directed the State of Himachal Pradesh and Central Government bring about an efficient Drug Regulatory System both at the Centre and the State for better coordination and handling of entire problem as to regulate the manufacture, import and distribution, especially, drugs like Oxytocin.

5—It is clear that the Himachal Pradesh High Court did not ask the Government to issue a ban on oxytocin and that the impugned notification was an unreasoned and excessive over-reaction to the judgment.

6—Several writ petitions were filed challenging the said notification. These were decided by the Delhi High Court on 14.12.2018. It was held in the judgment as follows:

i)-- that the impugned notification is both unreasonable and arbitrary;

the UOI did not adequately weigh in the danger to the users of Oxytocin, nor consider the deleterious effect to the public generally and women particularly, of possible restricted supply if manufacture is confined to one unit, to the pregnant women and young mothers, of a potentially life-saving drug.

ii)--The consequences of the impugned notification can be drastic. The scarcity of the drug, or even a restricted availability can cause an increase in maternal fatalities, during childbirth, impairing lives of thousands of innocent young mothers.

iii)--The trigger for issuing the impugned notification was the HP High Court judgment, which did not notice that Oxytocin was an essential drug.

iv)—“In view of the above conclusions, the writ petitions have to succeed; the impugned notification and all the consequential orders are hereby declared as arbitrary and unreasonable; it is, therefore, quashed and set aside. All writ petitions are accordingly allowed.”

This judgment can be viewed at https://indiankanoon.org/doc/99589920/

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The writer, Dr. MC Gupta is a practising lawyer specialising in medical negligence cases. He also has an MD Medicine from AIIMS, Delhi where he also worked as a faculty member for 18 years, later working another 10 years as a Professor and Dean at National Institute of Health and Family Welfare, New Delhi, before pursuing law.