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.