The Government may place further curbs on the sale of oxytocin injections against the misuse of the same by the dairy owners, adding additional clause to the already issued notification that restrained its sale. The chemists would be asked to maintain the records of its sale.
After the approval of the Drugs Technical Advisory Board (DTAB), the Health Ministry had already issued a notification to restrict the manufacture and sale,
The manufacturers of bulk oxytocin drug shall supply the active pharmaceutical drug only to the manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug. The formulations meant for veterinary use shall be sold to the veterinary hospitals only, as per the notification issued in January this year.
Maneka Sanjay Gandhi, M.P. Has, however, again written to the Ministry of Health and Family Welfare claiming that the misuse of oxytocin was leading to a substantial loss of livestock in the country. Not only does this drug made cows barren sooner, but also lowers the life span of the animal, thus causing economic loss to the owner in the long run. It is being widely used in the dairy industry despite there being a ban on its sale, except by a prescription from a registered medical practitioner, she said, pressing for a complete ban.
However, the DTAB meeting recently, opined against the complete ban of the same as it had a definite role in the medical field both for humans and animals.
“After deliberations, members were of the view that the drug is already a prescription drug and can be sold only under the prescription of an RMP. The drug as such has a definite role in the medical field both for humans and animals and as such the legitimate manufacture and sale of the drugs cannot be stopped. For the purpose of medical emergency in rural or remote areas, the drug could be obtained from the sale outlets only. The misuse of the drug for milking purposes is however, a matter of serious concern and is required to be stopped for the health of the livestock,” according to the DTAB minutes.
So far as the manufacture and sale of the drug through illegal channels is concerned, it cannot be simply stopped by banning the drug as the bulk drug is liable to be smuggled from the neighboring countries for illegal use. Misuse can only be contained by enhanced surveillance by the regulatory authorities followed by strict action against the violators. The public at large is also required to be sensitised. Campaigns could be launched by the public spirited organisations in the areas prone to such misuse through print and audio visual media to educate the public about the harmful effects of misuse of oxytocin. The help of the local police could also be enlisted to book cases under Prevention of Cruelty to Animals Act, 1960, the Drugs and Cosmetics Act, 1940 which does not permit the sale of the drug except under proper prescription, the DTAB members felt.
The board, after deliberations, recommended that in order to curb the illegitimate sale by the chemists, a new clause may be added to the already issued notification stating that the supply of the oxytocin shall be recorded by the retail chemist at the time of supply giving the name and address of the prescriber, the name of the patient and the quantity supplied. Such records shall be maintained for three years and be open for inspection. This would help in not only maintaining the legitimate supply of the drug but also to curb misuse of the drug through the legitimate sale channels, the DTAB said.