JUDGMENT :

S. RAVINDRA BHAT, J.

"Youth fades; love droops; the leaves of friendship fall. A mother's secret hope outlives them all." --Oliver Wendell Holmes.

1. This common judgment disposes of a batch of writ petitions challenging the validity of a notification; the writ petitioners complain that the impugned notification endangers the lives of pregnant women and young mothers. The said notification [GSR 411(E) : dated 27.04.2018 (hereafter "impugned notification"]was issued by the Union of India and the Ministry of Health & Family Welfare (the first two Respondents, referred to variously as "MHA" and "UOI" respectively), acting through the third respondent in exercise of the powers under Section 26A of the Drugs and Cosmetics Act, 1940 (hereafter the "Act").The notification prohibited the manufacture and distribution for domestic use, of the essential drug OXYTOCIN injection for human use, by private sector companies, including the Petitioners. The Petitioners also challenge the validity of an Office Memorandum dated 21.05.2018 in File No. X-11026/103/2018-BD (Annexure P-31-hereafter "impugned OM") issued by the fourth Respondent (hereafter "DCI").

2. The facts of the case are that the BGP Products Operations Gmbh (hereafter "BGP") is the petitioner in W.P.(C) 6084/2018; the petitioner in W.P.(C) 8555/2018 is an association, All India Drug Action Network ("AIDAN"); that in W.P.(C) 8666/2018 is the Neon Laboratories Ltd. ("Neon"); and in W.P.(C) 9601/2018 is the Ciron Drugs and Pharmaceuticals (P) Ltd. (hereafter "Ciron"). BGP is the subsidiary of Mylan Inc, a leading generic pharmaceutical manufacturer; Neon and Ciron, likewise are drug manufacturers; all of them hold licenses to manufacture Oxytocin, which is termed 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. According to the petitioners, 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 drug of choice used for pregnant woman for induction or reinforcement of labor. It is also used in state of incomplete or threatened abortion. Postpartum Haemorrhage (PPH) occurs when a woman bleeds excessively after she gives birth. As she bleeds, she become anemic and goes into shock and may eventually die of the condition if the bleeding does not stop or she does not receive blood transfusion. Worldwide, every year 8 million of 136 million women who give birth develop PPH. PPH is a leading cause of maternal mortality and causes a quarter of all 2,79,000 maternal deaths that occur yearly worldwide or approximately 69,000 deaths. Stemming postpartum bleeding among animals, prominently cattle, during childbirth, is also a known veterinary and approved use of the drug. The World Health Organization (WH) describes the post-partum period as the most critical "yet the most neglected phase in the lives of mothers and babies" and that most maternal and/or new born deaths occur during this period (Ref. "WHO Recommendations on postnatal care of mothers and newborns" WHO Publication, 2014 http://www.who.int/maternal_child_adolescent/documents/postnatal-care-recommendations/en/accessed at 09:31 hours, 28.11.2018).

3. It is stated 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. It is alleged that such the respondents' failure to check the misuse of the life-saving drug results in its abuse in cattle. The petitioners allege that State and Central Authorities are tasked with p