The health ministry is planning to ban the manufacture and sale of oxytocin injection for veterinary use following the misuse of the same by dairy owners in different places to extract milk from milch animals.

Section 26A of the Drugs and Cosmetics Act 1940 will be amended to effect this ban, along with the condition that the manufacturers of bulk drug oxytocin should supply the active pharmaceutical drug only to the manufacturers licensed for manufacture of oxytocin formulation for human use.

The Drugs Consultative Committee, which deliberated the matter sometime in 2012, again took up the matter and made a recommendations to make the amendment in this regard recently also.

“The members felt that the illicit manufacture of oxytocin injection for the use of extracting milk from milch animals by the dairy owners is a clandestine activity. The manufacture of the drug for dairy owners etc takes places in the regions where drug control administration is lax and then the drug is transported to other States clandestinely. It is available in unlabelled or wrongly labelled packs. Even though many of the State have taken action on the basis of intelligence gathered through surveillance. However, strong measures are required to restrict the supply of oxytocin injection for veterinary use and also ensured that diversion of the bulk drug to illegal channels is curtailed,” the DCC said.

The matter was raised first by Maneka Gandhi, MP, in a letter to the health ministry, pointing out the harmful effects on the health of cows and as well as the consumers. Even though the drug is considered as an essential drug in medical practice for certain conditions in human as well as veterinary field, the alleged abundant availability and use of the drug in a clandestine way is a matter of great concern for public health, she pointed out.

The drug oxytocin has medical use for induction and augmentation of labour, to control post partum bleeding and uterine hypo tonicity. The sale of the oxytocin injection is regulated under Schedule H of the Drugs and Cosmetics Rules, 1945 which require the drug to be dispensed on the prescription of a Registered Medical Practitioner only. Further, to avoid its bulk sale oxytocin injection is required to be packed in single unit blister pack only.

The use of oxytocin injection for extracting milk from milch animals is also prohibited under the Cruelty to Animals Act, 1960. It is provided under section 11 (1)(c) that if any person wilfully and unreasonably administers any injurious drug or injurious substance to any animal or wilfully and unreasonably causes or attempts to cause any such drug or substance to be taken by any animal, he is punishable under the Act.

In spite of the above provisions the reports of manufacture and sale of the drug in clandestine way in large quantities and its misuse by the farmers or dairy owners is a matter of great concern. The office DCG(I) had earlier also written to the State Drugs Controllers to check and unearth the clandestine manufacture and sale of drug to the farmers or dairy owners in violation of the provision of the Drug and Cosmetic Rules through surveillance and raids conducted on the possible hide outs where such activities are being undertaken.