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.

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.