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.