Oxytocin: Drug regulator calls for ‘strict vigil’https://indianexpress.com/article/business/oxytocin-drug-regulator-calls-for-strict-vigil-5294828/

Oxytocin: Drug regulator calls for ‘strict vigil’

CDSCO has also requested state drug regulators to sensitise its inspectorate staff “to keep strict vigil on manufacture, sale and distribution of Oxytocin in the country”.

Oxytocin: Drug regulator calls  for ‘strict vigil’
Oxytocin production by private pharmaceutical firms and Oxytocin sale by private retail chemists will be banned from September 1. (Representational Image)

The Central Drugs Standard Control Organization (CDSCO) has directed all its port offices and zonal offices to keep a “strict vigil” to ensure that Oxytocin is not imported and that imported stocks of the drug are not used “in any form or name”.

CDSCO has also requested state drug regulators to sensitise its inspectorate staff “to keep strict vigil on manufacture, sale and distribution of Oxytocin in the country”. The central drug regulator has told its state peers, its port offices as well as its zonal offices that the Oxytocin issue “is being discussed and monitored at highest level of the government from time to time for proper implementation of the … measures taken to prevent misuse of the drug in the country.”

The CDSCO, in its letter to port and zonal offices, also asked them to submit a quarterly action-taken report so that “further necessary action” can be taken.

Oxytocin production by private pharmaceutical firms and Oxytocin sale by private retail chemists will be banned from September 1. However, government-run chemist shops would not be affected by this ban. Oxytocin’s import was banned by Centre on April 24 this year. From September 1, only Karnataka Antibiotics & Pharmaceuticals Limited (KAPL), a public entity, would be permitted to manufacture and distribute Oxytocin in India.

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Union health ministry held a video conference call with all states on Monday to discuss their current position of Oxytocin stock and the steps they are taking to make sure there is no shortage of this drug from September 1. KAPL also participated in this call. According to a guidance note issued by the health ministry, KAPL is going to have 17 distribution centres across the country. Distribution centres are not present in 19 states and Union territories including all north-eastern states, Jammu and Kashmir, Himachal Pradesh, Haryana, Punjab and Goa, among others.

“In the states where distribution centres are not present, a nodal centre in the vicinity will be responsible for the distribution of oxytocin formulations. For example, Chandigarh can be a distribution centre for Jammu and Kashmir, Himachal Pradesh, Haryana and Punjab. Similarly, for the north-eastern states, Kolkata can act as a distribution centre,” the note stated.

Oxytocin is administered to pregnant women to “prevent and treat” postpartum haemorrhage which accounts for about 35 per cent of all maternal deaths, according to World Health Organization. In the dairy industry, Oxytocin is injected into livestock to increase milk production artificially. Vegetables are also injected with this drug as it helps in increasing their weight.

According to the source privy to the discussions, the Centre is considering using district level government medicine stores as nodal centres. “However, these district level drug stores are either defunct or operating at minimum capacity in many states. So, the central government is not sure if these stores have requisite distribution prowess to help in Oxytocin availability,” the source added.

Currently, Pfizer and Mylan are two leading producers of Oxytocin in India. Both — being private firms — would not be permitted to manufacture and distribute Oxytocin in India from September 1.

Mylan’s spokesperson told The Indian Express on Saturday: “We have challenged the notification, issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, placing restrictions on the manufacture and supply of Oxytocin, before the Honourable Delhi High Court and the matter is sub judice”. Pfizer did not respond to the queries sent by The Indian Express.