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Cases of illegal sale, misuse of Oxytocin detected in West Bengal, Bihar following DCGI directive
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Shardul Nautiyal, Mumbai
November 02 , 2017
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Central Drugs Standard Control Organization (CDSCO) has detected illegal
sale, misuse of Oxytocin in animals in West Bengal and Bihar following
recent DCGI order with regard to controlling manufacture, sale and
distribution of Oxytocin for reasons including non compliance to GMP,
GLP and GDP.
The DCGI directive comes following a meeting in
this regard convened by the secretary, union health ministry on March
14, 2017 to take stock of the situation relating to regulating
manufacturing of Oxytocin and to permit its manufacturing in public
sector units (PSU) in compliance to the judgement of the High Court of
Himachal Pradesh.
It was decided in the meeting that cases where
stoppage of production of Oxytocin has been ordered for reasons
including non compliance to GMP, GLP and GDP etc should be monitored by
the DCGI.
The DCGI, in his directive, has asked the state drug
controllers to submit the details of such cases where manufacturers have
been directed by them to stop manufacturing of Oxytocin bulk/injection
in their state due to above mentioned reasons and the action taken
thereon.
Cases detected by the drug control departments warrants
the need for oversight from the respective animal husbandry departments
as well as the drug is often being misused for milching animals and more
so as it has neither been banned for use in humans nor in animals.
Offenders
have also faced prosecutions in the past for violations under the
provisions of the law and some of them are also behind bars, according
to a senior official.
Part of the problem lies in not plugging
the loopholes in the retail supply chain and the illegal imports from
across borders which act as conduits for circulating the drug in the
country. This is also with reference to the cases detected in
Maharashtra recently and in the past, according to a senior CDSCO
official.
Maharashtra Food and Drug Administration (FDA) has
issued stop sale notice to manufacturers, distributors, wholesalers and
retailers in Uttar Pradesh and Maharashtra for illegal distribution and
sale of Oxytocin injection recommended against a prescription for
complications related to pregnancy.
The state regulator in a
series of raids detected mislabeled Oxytocin injections being sold by
stockists, manufacturers and retailers to hospitals and patients thus
endangering patient safety. The mislabeled brand had a conspicuous
warning on the blister pack stating -Not for Human Use, For Animal
Treatment only with the dosage prescription-As directed by physician.
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