CDSCO Launches Nationwide 'Special Operations' To Prevent Illegal Manufacturing And Import Of Oxytocin

CDSCO Launches Nationwide 'Special Operations' To Prevent Illegal Manufacturing And Import Of Oxytocin

New Delhi, 25 May 2018: The Central Drugs Standard Control Organisation (CDSCO) has launched ‘special operations’ to crack down on illegal manufacturing and import of oxytocin, a neurotransmitter and peptide hormone widely misused in the dairy and horticulture industry. A letter issued by Drugs Controller General of India (DCGI) Dr S Eswara Reddy in this regard has been sent to all zonal, subzonal and port offices of the CDSCO, it is learnt. 


The CDSCO officials are directed to conduct lightning raids with the help of local police wherever required. The decision to conduct inspections is taken at the highest level of government and should be given top priority as reports of oxytocin misuse appear in various fora from time to time, the DCGI has stated it his letter. The zonal offices are asked to conduct inspections and keep the DCGI posted about the actions taken against rule flouters. 


The Central government regulation restricting manufacture of oxytocin for domestic use to public sector undertakings (PSUs) will come into force on July 1. However, a ban on the import of the hormone was in place from April and customs officials have been asked to step up vigilance against those trying to smuggle it into the country. The latest step by the DCGI proves that the government is unrelenting in its efforts to crack whip on illegal manufacturing of the drug despite discontent among private manufacturers. 


Often called the ‘love hormone’ as it is released when people snuggle up or bond socially, oxytocin causes uterine contractions thereby inducing labour and controls post-delivery bleeding. It is misused in the dairy industry where livestock are injected with it to make them release milk at a convenient time. Many farmers use it to plump up vegetables. Its sustained use can cause hormonal imbalance in humans and cut the life span of animals substantially.


Under the new rule, the active pharmaceutical ingredient (API) of oxytocin can be supplied only to the PSUs if it is intended for domestic use. The label of the product should bear barcodes and its sale won’t be allowed through a retail chemist in any form or name. 

There are more than 60 companies, spread across Maharashtra, Andhra Pradesh, Gujarat and Punjab manufacturing oxytocin injections in India. The decision to block its production in the private sector has put a huge question mark over the future of these firms. Many of them will be forced to down shutters after July, say industry sources. 


Manufacturers also warn of an acute shortage of the drug in the market when the new restrictions take effect. “The government’s move will definitely create huge shortage and logistic problems as the PSUs don’t have the capacity or wherewithal to make this wonder drug available across the country,” Federation of Pharma Entrepreneurs (Fope) President BR Sikri pointed out. The federation, which supports checks and balances to tighten the supply chain and weed out unscrupulous manufactures, has unsuccessfully lobbied against the proposal to stop private companies from producing the hormone. 


As per the new norms, even the PSU producers of oxytocin formulations could supply the product only to registered hospitals and clinics directly or to the Pradhan Mantri Bhartiya Janaushadhi Pariyojana and Affordable Medicines and Reliable Implants for Treatment (Amrit) outlets.Pharmabiz