India Warns Defitelio Fakes | Today’s news
India has issued an urgent regulatory alert and mobilized drug inspectors nationwide after the World Health Organization (WHO) warned that a counterfeit batch of Defitelio (defibrotide), an intravenous drug used to treat severe veno-occlusive disease (VOD) of the liver after hematopoietic stem cell transplantation, was illegally circulating in domestic supply chains.
“WHO, through its Department of Market Surveillance and Control, Regulation and Safety, has informed that a suspected counterfeit medicinal product with the following details may be available for sale and purchase in India,” said a document dated October 23, issued by the enforcement and intelligence cell of the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services and reviewed by Mint.
The alert marks boxes labeled DEFITELIO (defibrotide) 80 mg/ml concentrate for solution for infusion, with lot number 24GC01A and an expiration date of April 2027.
The packaging falsely identifies Patheon’s facility in Ferentino, Italy as the manufacturer and Gentium Srl, a subsidiary of Jazz Pharmaceuticals, as the marketing authorization holder.
“However, the manufacturer or its authorized representative has confirmed that the above batch of product was never supplied to India,” CDSCO pointed out in the document.
International tracking records from the German government of Upper Bavaria show that the investigation began on September 21 when Gentium Srl received a request from India to verify the authenticity of the package with serial number 35118817455532.
The document quoted a German quick warning: “It should be noted that Defitelio does not have a marketing authorization in India.”
After examining the photographic evidence, European regulators and the drug manufacturer discovered that the packaging was counterfeit.
Safety notice
“The use of counterfeit DEFITELIO will result in ineffective treatment of patients and may pose other serious health risks due to its intravenous administration and could be life-threatening under certain circumstances,” Rajeev Singh Raghuvanshi, Drugs General of India (DCGI), said in the document, highlighting the risks of administering counterfeit drugs to vulnerable transplant patients.
The DCGI also directed police officers, zonal directorates and port health officers to strictly monitor the movement, sale, distribution and stock of the said drug products in the market, collect samples of the said product lying in the market and initiate necessary action under the provisions of the Drugs and Cosmetics Act, 1940.
Doctors and hospitals have been urged to report any adverse events, while consumers have been advised to check proof of purchase. The All India Organization of Chemists and Druggists (AIOCD) has also been asked to alert the pharmacy chains and immediately stop the sale of the fake medicine.
According to experts, this will help patients have safer access to medicines. “By spreading the alert across the country, CDSCO has helped ensure that doctors, pharmacists and patients can identify suspect products and report them immediately. Such coordinated action is essential to prevent harm and protect patient safety,” said Saurabh Arora, CEO of Auriga Research.