Question : Oxytocin Drug



Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

(a) whether the Government is planning to ban the import of the controversial growth drug Oxytocin in a bid to curb its misuse by dairy owners and farmers who use it to boost milk production and increase the size of vegetables;
(b) whether studies in Karnataka have shown that Oxytocin is being misused to speed up deliveries for pregnant women in overcrowded Government hospitals;
(c) whether there is any proposal to amend rule 96 of the Drugs and Cosmetics Rules, 1945 to ensure that barcoding system is adopted for manufacture of Oxytocin formulations so as to ensure tracking and traceability of the product to avoid its misuse; and
(d) whether the Drug Technical Advisory Board (DTAB) plans to prohibit the import of oxytocin and its formulations for human use as well as animal use under section 10 of the Drugs and Cosmetics Act, 1940?

Answer given by the minister



MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY OF SHIPPING AND MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

(a) Proposal to prohibit the import of Oxytocin and its formulations for human as well as animal use and also to regulate and restrict oxytocin for human use so that the drug is supplied only to registered hospitals and clinics in public and private sector, is under consideration. In this regard, a public notice seeking comments/ suggestions of stakeholders was posted in Central Drugs Standard Control Organisation (CDSCO) website on dated 28/02/2018.
(b) As per the information received from Drugs Control, Karnataka, on investigation/inquiry in Haveri circle, no such cases of misuse of Oxytocin to speedup deliveries for pregnant, women in overcrowded Government Hospitals was observed.
(c) Proposal to adopt bar-coding system for manufacture of Oxytocin formulations so as to ensure track and traceability of the product to avoid its misuse is under consideration. In this regard also, comments/ suggestions of stakeholders was sought through the public notice posted in CDSCO website on dated 28/02/2018.
(d) The Drug Technical Advisory Board (DTAB) in its 78th meeting held on 12.02.2018 has agreed to prohibit the import of Oxytocin and its formulations for Human use as well as animal use under Section 10 of the Drugs and Cosmetics Act, 1940.

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