The Drugs Controller General of India (DCGI) Dr. GN Singh has directed all the state drug controllers in the country to provide details of the manufacturers of bulk and formulations of oxytocin in their states along with the statistical information to curb the illegal movement of this restricted and regulated drug in the country.
“The State Drugs Controllers are requested to provide details of the manufacturers of bulk and formulations of oxytocin in their State along with the statistical information on the seizures conducted, quantity seized along with its value, persons arrested, prosecutions filed, samples taken, reports of sub-standard quality received during the last three years to the office of DCG(I) within 30 days of receipt of this letter”, the DCGI directive said.
Oxytocin has medical use for induction and augmentation of labour, to control post partum bleeding and uterine hypo toxicity. 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.
Earlier in January this year, the Union health ministry had issued a notification regulating and restricting the manufacture and sale of Oxytocin injection, which has been allegedly misused by diary owners in different places to extract milk from milch animals. As per the notification, 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.
But, despite a ban on its sale, except by a prescription from a registered medical practitioner, there were reports that the drug was being widely used in the dairy industry. Concerned over the misuse of oxytocin, Union health minister Maneka Gandhi took up the matter with the health secretary.
In order to examine the issue of misuse of oxytocin injection and effectively check its misuse, an inter-ministerial committee was constituted by the health ministry. The committee noted that there is a need to take stringent measures on all cases of misuse of oxytocin by the state drug control authorities in their state/UT and a constant vigil needs to be kept on the illegal movement of the oxytocin. The state/UT drugs inspectors after picking of the samples from different places should investigate the source of the illegal supply of the oxytocin concoction sold to dairy owners. The help from the NGOs in the state/UT could be taken to locate the areas where such illegal sale is being done.