MoH to regulate manufacture and sale of Oxytocin

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The Health Ministry has issued an order to regulate and restrict the manufacturing and sale of controversial oxytocin injection, which has been allegedly misused by diary owners in different places to extract milk from milch animals.

“The manufacturers of bulk oxytocin drug shall supply the active pharmaceutical drug only to the manufacturers licensed under the Drugs and Cosmetics (D&C) Rules, 1945 for manufacture of formulations of the said drug. The formulations meant for veterinary use shall be sold to the veterinary hospitals only,” according to a notification by the health ministry.

The notification said that the Central Government was satisfied that the drug oxytocin had a definite therapeutic use in certain medical conditions. “It is necessary and expedient to regulate and restrict the manufacture, sale and distribution of the said drug in the country to prevent its misuse in public interest,” said the notification issued under the provisions of the Section 26A of the D&C Act.

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 D&C 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.

However, it has been noticed that the drug was being sold to dairy owners who reportedly misused it for milking the milch animals, in violations of the laws, in many parts of the country. 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.

Source: Pharmabiz


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