To save environment from the abuse of drugs, the government has decided to ban production of such formulations which was being used to enhance dairy and vegetable productions. Almost a month after banning import of Oxytocin formulations, the Government has prohibited the private sector from producing the drug, a move aimed to curb its misuse by dairy owners and farmers who use it to boost milk production and increase size of vegetables like watermelons and pumpkins. The order issued by the Drug Controller General of India (DCGI) under the Union Health Ministry will be effective from July 1. The move follows concern over the frequent abuse of the drug, as had been regularly pointed out by Union Minister of Women and Child Maneka Gandhi who in various letter to the Health Ministry seeking its ban, pointing out that the drug has harmful effects on the health of cows and as well as the consumers. However, the Government’s decision has not gone down well with the industry representatives who have warned shortage of the drastic drug that is being also prescribed for the initiation of uterine contractions and induction of labour in women as well as stimulation of contractions during labour. It is also used to help abort the fetus in cases of incomplete abortion or miscarriage, and control bleeding after childbirth.
As per the order, now only Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), a public sector company, would be manufacturing this drug for domestic use from that date. Moreover, the label of the product shall bear barcodes and its sale won’t be allowed through a retail chemist in any form or name. In May, the Government had banned the import of Oxytocin and its formulations, besides bringing in some more regulations on the manufacture and sale of the controversial hormone.
“Oxytocin formulations meant for domestic consumption will be supplied by KAPL, to registered hospitals and clinics in public and private sector directly. Oxytocin in any form or name will not be allowed to be sold through retail chemist,” a health ministry statement said. All the registered hospitals and clinics in public and private sector in the country have been directed to contact KAPL and place their orders with the company as the drug will not be available with retail chemists or any other manufacturer. The Himachal Pradesh High Court had in its judgment in 2016 observed that large-scale clandestine manufacture and sale of oxytocin was leading to its grave misuse, which was harmful to animals and humans.
Expressing reservation on the ban in private sector, BR Sikri, President of Federation of Pharma Entrepreneurs (Fope) said that “The government›s move will definitely create huge shortage and logistic problems as the PSUs don›t have the capacity or wherewithal to make this wonder drug available across the country.” The Agriculture Ministry too has been opposing the complete ban on production and use of Oxytocin for veterinary use asserting that the drug has therapeutic application in case of expulsion of fetus, retention of placenta.