Maha FDA issues stop sale notices to curb illegal distribution of Oxytocin, seizes over 50,000 samples
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Shardul Nautiyal, Mumbai
November 01 , 2017
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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 to be administered
during 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.
Ghaziabad based
Romax Pharma which produced 52,500 samples sold the mislabeled drugs to
stockist United Pharma, Raigad which then sold to stockist Jain Pharma
based in Thane. This drug to the tune of 1,000 sample was further
distributed to Life Care Medico in Thane amongst other such retailers in
Maharashtra. These retailers further supplied it to hospitals. In one
such case, the hospital pharmacy of Aadhar Hospital, Thane sold it to
the patient in violation of Section 17 (C) of Drugs and Cosmetics Act,
1940.
Maharashtra have started investigations against Ghaziabad
based Romax Pharma, Thane based Jain Pharma and Lifecare Medico, Raigad
based United Pharma, Haryana based Macin Remedies Pvt Ltd in
contravention to section 17 (c) of Drugs and Cosmetics Act, 1940.
The
Drugs Controller General of India (DCGI) has directed the state drug
controllers to maintain strict regulatory control over manufacture, sale
and distribution of Oxytocin and to curb its misuse by the
manufacturers, especially where stoppage of production of Oxytocin has
been ordered for various 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 restrict and regulate
manufacturing of Oxytocin and to permit its manufacturing in PSU in
compliance to the judgement of the High Court of Himachal Pradesh.
In
regard to control over manufacture, sale and distributions of Oxytocin,
it was decided in the meeting that cases where stoppage of production
of Oxytocin has been ordered for various 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.
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