196 Circular regarding strict regulatory control over the manufacture,sale and distribution of Oxytocin 2014-Oct-22 897kb

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File No. BD/VET.CELL/10.2014 Directorate General of Health Services Central Drugs Standard Control Organization (O/o Drugs Controller General India)

FDA Bhawan, Kotla Road New Dethi-110002 Dated:- 22—-lo— {4

To

All State Drug Controllers

Subject: Strict regulatory control over the manufacture, sale and distribution of Oxytocin and measures required to be taken to curb the misuse of cxytocin by dairy owners for milking milch animals - regarding.

Sir, The Government of India, Ministry of Health and Family Welfare, in exercise of powers conferred under Section 26A of the Drugs and Cosmetics Act, 1940 had issued . _@ Gazette Notification GSR 29(E) dated 17.01.2014 under which it has been directed that the drug oxytocin shall be manufactured for sale or for distribution or sold in the manner specified below, in addition to the provisions contained in the said Act and Rules made thereunder, namely:-

1. 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.

2. The formulations meant for veterinary use shall be sold to the veterinary hospitals only.

and A copy of the said Notification was earlier forwarded to you for your information necessary action in the matter.

Under the above notification that manufacturers licenced to manufacture bulk oxytocin drug are required to 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 and the formulations meant for veterinary use shall be sold to the veterinary hospitals only. has Smt. Maneka Sanjay Gandhi, Hon'ble Minister of Women & Child Development the taken up the matter with the Secretary, Ministry of Health and Family Welfare that onlymisuse of Oxytocin, is leading to a substantial loss of livestock in the country. Not thus does this drug made cows barren sooner, but also lowers the life span of the animal, dairycausi1g economic loss to the owner in the long run. It is being widely used in the industry despite there being a ban on its sale, except by a prescription from a registered medical practitioner.

its In order to examine the issue of misuse of oxytocin injection and effectively check misuse an Inter-Ministerial Committee has been constituted by the Ministry of Health and Family Welfare. The committee noted that there is a need to take stringent measures onUT all cases of misuse of oxytocin by the State Drug Control Authorities in their State/ 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.

details In this connection, the State Drugs Controllers are requested to provide the the of the manufacturers of bulk and formulations of oxytocin in their State along with 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.

This may kindly be taken on priority.

Yours faithfully,

(Dr. G. N. Singh) Drugs Controller Geferal (india)

offices Copy forwarded for information and necessary action to all Zonal /sub zonal their jurisdiction.of CDSCO for necessary follow up with the State Licensing Authorities under