India: Oxytocin Will Not Be Sold At Retail Medical Shop Any More

Oxytocin is a neuro-hormone and neurotransmitter normally produced by the paraventricular nucleus of the hypothalamus and is released in large amounts by the posterior pituitary gland in mammals. Oxytocin is known to induce contractions of the uterus during labour, and stimulate the ejection of milk during breastfeeding. It is also known as love-hormone as it plays a role in the female reproductive functions including sexual activity, child birth, maternal nurturing behavior along with general psychological stability. However, over time people started misusing Oxytocin by resorting to its unprescribed and frequent use for benefit/profit, for example –milch cattle are regularly injected with Oxytocin twice a day just five minutes prior to milking, for faster milk flow from the udder.

With a Central Government order banning the import of oxytocin and restricting its manufacturing, sales and distribution in the country from 1st September 2018, the Central Drug Standard Control Organization (CDSCO), as a preparatory action, has directed all its State/UT regulators to sensitize their inspectorate staff to keep a strict vigil and ensure that oxytocin is not manufactured/sold illegally to prevent its misuse in dairy and agriculture products1.

Further, the zonal/sub zonal offices and all port offices are also directed to keep strict vigilance and ensure that oxytocin in any form/name is not imported in the country2. In continuance, CDSCO has asked all its State/UT regulators, zonal/sub zonal offices, and all port offices to submit action taken report in this regard to Head Quarter (CDSCO) on a quarterly basis for further necessary action.

Oxytocin, a lifesaving drug, will be regulated in the following manner after 1st September 2018:

  1. Oxytocin shall not be imported in any form/any name in the country.
  2. Manufacturing of Oxytocin formulations for domestic use shall be restricted to public sector companies like Karnataka Antibiotics & Pharmaceuticals Limited (KAPL) only.
  3. Manufacturing of Oxytocin formulations for export purposes shall be open to both public and private sector companies.
  4. Manufacturers of Active Pharmaceutical Ingredient (API) of Oxytocin shall supply the API only to the public sector manufacturers if formulations are meant for domestic use, and manufacturers may supply API to both public and private sector in case oxytocin formulations is meant for export purposes.
  5. Distribution/supply of oxytocin formulations meant for domestic consumption, to be to the registered hospitals and clinics in public and private sector directly by the manufacturer. The manufacturers can also supply the formulations to the retail outlets specified by the Central Government like - Pradhan Mantri Bhartiya Janaushadhi Pariyojana(PMBJP) and Affordable Medicines and Reliable Implants for Treatment (AMRIT) etc.
  6. Oxytocin in any form or name shall not be allowed to be sold through retail chemists.

The Health Ministry on August 06, 2018, held a video conference with the States/UTs on various issues relating to regulation of Oxytocin including the status of preparedness of the State Governments for implementing the amended rules in regard to manufacture, distribution and sale of Oxytocin. The video conference also assessed the stock of Oxytocin in the States to ensure that there is no shortage after restricted manufacturing and sale, through Karnataka Antibiotics & Pharmaceuticals Limited (KAPL), comes into effect from   September 01, 2018.

The States have been advised to assess their requirement of the drug and to place the orders with KAPL in time or in advance for bulk procurement. The Government also asked the States to mount an awareness campaign about the government notification on restricting the manufacture and sale of Oxytocin to KAPL and asked KAPL Ltd to ensure a robust supply chain to prevent any stock outs.

KAPL on this, requested the states to place their orders in advance for bulk procurement. KAPL assured that they have the required manufacturing capacity. KAPL also assured maintenance of adequate quality of the drugs. It also assured that it shall be revising its bulk purchase pricing3.

Apart from this, the Central Government also proposes to re-classify Oxytocin and assign it to schedule H1 of Drugs and Cosmetics Rules, 1945, as against its current placement in schedule H. Schedule H1 allows chemists to check the indiscriminate use of oxytocin in the country, and also enables them to maintain the data of the customer/prescriber for at least 3 years4.

Note - The Delhi High Court, on August 31, 2018, suspended this ban till October 2018 while the court hears petitions opposing the ban on manufacturing, sale and distribution of oxytocin by private pharma companies.

Conclusion – The Health Ministry's order to restrict the sale of oxytocin formulation via retail chemist is seems vague, as in other way ministry proposing oxytocin under schedule H1empower chemist to control its indiscriminate use and to maintain prescriber consumer data for certain period.






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