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DCGI asks state DCs to provide data on Oxytocin to curb its illegal movement in India
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Ramesh Shankar, Mumbai
October 31 , 2014
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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.
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