India sounds alert over counterfeit Defitelio

The CDSCO alerts drug inspectors after the WHO warns that a counterfeit batch of Defitelio (defibrotide) is circulating in domestic supply chains.

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 hepatic veno-occlusive disease (VOD) following haematopoietic stem-cell transplantation, is circulating illegally in domestic supply chains.

“The WHO, through its market surveillance and control regulation and safety department, has informed that a suspected falsified medicinal product bearing the following particulars may be available for sale and purchase in India,” said a document dated 23 October, issued by the Central Drugs Standard Control Organization’s (CDSCO) enforcement and intelligence cell under the Directorate General of Health Services and reviewed by Mint.

The alert flags cartons labelled DEFITELIO (defibrotide) 80 mg/mL concentrate for solution for infusion, bearing batch number 24GC01A and an expiry date of April 2027.

The packaging falsely identifies Patheon’s facility in Ferentino, Italy, as the manufacturer and Gentium S.r.l., a subsidiary of Jazz Pharmaceuticals, as the marketing authorization holder.

“However, the manufacturer or its authorized agent has confirmed that the above-mentioned product batch was never supplied to India,” the CDSCO stressed in the document.

International surveillance filings from Germany’s Government of Upper Bavaria show that the inquiry began on 21 September, when Gentium S.r.l. received a request from India to verify the authenticity of a pack bearing serial number 35118817455532.

The document quoted a German rapid alert as saying: “It should be noted that Defitelio does not have marketing authorization in India.”

After examining photographic evidence, European regulators and the drugmaker determined that the packaging was counterfeit.

Safety alert

“The use of falsified DEFITELIO will result in the ineffective treatment of patients and may pose other serious risks to health because of its intravenous administration and could be life-threatening in some circumstances,” said Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI) in the document, while highlighting the risks of administering falsified drugs to vulnerable post-transplant patients.

The DCGI also directed the field enforcement officers, zonal directorates, and port health officers to keep strict vigil on the movement, sale, distribution, and stock of the said drug products in the market, draw samples of said product lying in the market and initiate necessary action as per the provisions of the Drugs and Cosmetics Act, 1940.

Doctors and hospitals have been directed to report any adverse events, while consumers have been advised to verify purchase documents. The All India Organization of Chemists and Druggists (AIOCD) has also been asked to alert pharmacy networks and halt sales of the counterfeit drug immediately.

Experts said this will help patients access drugs more safely. "By circulating the alert nationwide, the CDSCO has helped ensure that doctors, pharmacists and patients can identify suspicious products and report them promptly. Such coordinated action is crucial to prevent harm and protect patient safety,” said Saurabh Arora, managing director of Auriga Research.

About the Author

Priyanka Sharma is a journalist at Mint, where she covers the Union Ministry of Health and the pharmaceutical industry. Her work focuses on explaining government policies and how they impact healthcare and the medicine market in India. With 12 years of experience in journalism, she has built a reputation for providing clear and honest news on important health topics that affect the entire country.<br><br>Her educational background includes a journalism degree from the prestigious Indian Institute of Mass Communication (IIMC) and specialized training in public health from the Public Health Foundation of India. Before her current role at Mint, Priyanka worked with India Today, The Pioneer, and ANI. She also served as a lead consultant for the National Health Authority, which gave her firsthand knowledge of how the government manages large-scale health programmes.<br><br>Priyanka is based in New Delhi and is an avid traveller who loves visiting the mountains. She has a great interest in regional flavours, particularly South Indian food.