The Union Government on August 21, 2018 permitted private retail chemists to sell Oxytocin with effect from September 1, 2018.
Earlier, through a notification dated April 27, 2018, the government stated that the sale of Oxytocin through private retail chemists would be banned from July 1, 2018. However, fearing shortage of Oxytocin in the market, the government deleted the provisions of its April 27 notification stating that the Oxytocin would be sold through government chemists only.
Oxytocin to be moved under Schedule H1
As per the recent notification, with effect from September 1, 2018, oxytocin will be moved from Schedule H to Schedule H1.
Schedule H & Schedule H1
Drugs under Schedule H can only be sold against a prescription by a registered medical practitioner.
Under Schedule H1, the retailer has to maintain a separate register giving the name and address of the prescriber, the patient, the drug and the quantity supplied. These records have to be maintained for three years and be available for inspection.
Schedule H1 was introduced in 2013 to prevent misuse of third and fourth generation antibiotics.
April 27 notification of the Union Government regarding restriction on sale of Oxytocin
• The Ministry of Health and Family Welfare restricted the manufacture of Oxytocin formulations to public sector for domestic use only from July 2018.
• It also banned the import of Oxytocin and its formulations.
• No private manufacturer will be allowed to manufacture or sell the drug for domestic use.
• Only Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL), a public sector company, would be manufacturing this drug for domestic use.
• The Oxytocin formulations meant for domestic consumption will be supplied by KAPL to the registered hospitals and clinics in public and private sector directly.
• All the registered hospitals and clinics in public and private sector in the country shall contact KAPL and place their orders with the company as the drug will not be available with retail chemists or any other manufacturer.
Oxytocin ban was unplanned
The move demonstrates that the decision to ban Oxytocin was unplanned. As per Malini Aisola, co-convenor of the All India Drug Action Network (AIDAN), government’s decision was without consultation with maternal health experts and those who would be affected.
Oxytocin, a hormone naturally produced in the human body, is manufactured as a drug that is usually administered to a woman during pregnancy in the third stage of labour to prevent excessive bleeding.
Oxytocin is administered to “prevent and treat” postpartum haemorrhage (PPH), which is the leading cause of maternal mortality across the world according to World Health Organization (WHO). PPH accounts for about 35 percent of all maternal deaths.
The hormone stimulates the uterine muscles to contract, so that the labour begins. Synthetic oxytocin (pitocin) is sometimes used to induce a woman to start labour, if she cannot start naturally. Once the baby is born, oxytocin promotes lactation, causing the milk to release so the baby can feed.
Currently, Pfizer and Mylan are two leading producers of Oxytocin in India.
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