Oxytocin: Delhi High Court Asks for Data, Regulator Raids at Least 3 Factories

With the Delhi High Court criticizing the center for not having the data regarding Oxytocin’s diversion to illegal market by private licensed manufacturers, the Central Drugs Standard Control Organization (CDSCO) has raided the factories of at least three such companies to collect purchase data, production data as well as dispatch data of the drug for the past three financial years. According to a CDSCO official, who spoke on the condition of anonymity, the central drug regulator “has raided the factories of Ciron Drugs and Pharmaceuticals, Sovereign Pharma and Neon Laboratories on and around September 6 to collect purchase data of raw material as well as production and dispatch data regarding Oxytocin for last three financial years i.e. 2015-16, 2016-17 and 2017-18”. Sovereign has a contract with US-based Mylan Laboratories to manufacture Oxytocin for it. However, the Central government’s counsel told the Delhi High Court on August 29 that Sovereign has stopped manufacturing Oxytocin altogether. When it comes to counting Oxytocin sales by volume in India, Mylan had a 50 per cent market share till April this year.

The CDSCO official added that the data is being collected to check if the Oxytocin is being diverted by any such private licensed manufacturer “at any stage of production”. These raids have come after the Delhi high court asked the Centre on August 30 to show the data on how much Oxytocin is being diverted into misuse by private licensed manufacturers. Ciron, Sovereign, Mylan and Neon did not respond to the queries sent by The Indian Express. The Drugs Controller General of India (DCGI) S Eswara Reddy, who heads the CDSCO, also did not respond to the queries sent by this newspaper. During the hearing on August 30 at Delhi High Court, Additional Solicitor General Maninder Acharya — who was appearing on behalf of the Central government —said: “Most of the (private) licensed manufacturers — we may not have the data to back it — but they are selling two types of drugs: one for the abuse and one for the normal market.”

Listening to this, Justice S Ravindra Bhat said: “There is the possibility that there are some stray cases but it is not rampant.” When the government counsel replied that it is rampant, Justice Bhat stated: “That is the whole point of the matter. In India, there is nothing in statistics. Nothing empirical.” A two-judge Bench of Justices Bhat and A K Chawla have been hearing three petitions at Delhi High Court against the proposed ban on Oxytocin production by private companies for domestic use. As per Centre’s notification, this ban was supposed to come in effect from September 1. However, on August 31, the court passed the interim order postponing the date of ban to October 1 as it is currently hearing the arguments of all the parties regarding this matter. The next date of hearing is September 20. If the ban is upheld by the court, only Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL), a public sector entity, would be permitted to manufacture and distribute Oxytocin in India from October 1. According to a source privy to the development, KAPL started production of Oxytocin for the first time on July 2. – Indian Express

Share this:

Related Post

Stay Updated on Medical Equipment and Devices industry.
Receive our Daily Newsletter.