India sounds alert over counterfeit Defitelio

The warning concerns a falsified version of DEFITELIO, also called defibrotide. It is labelled as an 80 mg/mL concentrate for solution for infusion. The medicine is given intravenously, so a counterfeit product can reach patients directly and quickly.

The key identifiers are batch number 24GC01A and an expiry date of April 2027. The packaging names Patheon’s facility in Ferentino, Italy, as manufacturer and Gentium S.r.l. as marketing authorization holder. Regulators found that these details were used falsely.

The Central Drugs Standard Control Organization issued the alert nationwide after WHO surveillance information. Officials ordered inspectors to watch for the product, collect samples, and take action. Doctors, hospitals, pharmacies, and patients should treat packs with these details as suspicious and report them through the instructed channels.

Defitelio is the brand name for defibrotide, an intravenous medicine. The article identifies its use in treating severe hepatic veno-occlusive disease, or VOD, after haematopoietic stem-cell transplantation. Because it is delivered by infusion, the product must be genuine and correctly manufactured.

Hepatic veno-occlusive disease is a serious liver complication associated with the period after transplantation. Haematopoietic stem-cell transplantation replaces or rebuilds blood-forming cells. In the reported case, the suspected counterfeit was labelled as an 80 mg/mL concentrate for solution for infusion.

The product has no marketing authorization in India, according to the German rapid alert quoted by regulators. Even so, officials said the falsified medicine may be circulating illegally in domestic supply chains. They warned that it could provide ineffective treatment and create serious health risks.

The response covers India’s medicine supply system from entry points to patients. CDSCO’s enforcement and intelligence cell issued the alert, while the Drugs Controller General directed field enforcement officers, zonal directorates, and port health officers to remain vigilant.

Officials were told to monitor movement, sale, distribution, and stocks. They must draw samples found in the market and begin action under the Drugs and Cosmetics Act, 1940. The All India Organization of Chemists and Druggists was asked to alert pharmacy networks and halt sales immediately.

Doctors and hospitals must report adverse events. Consumers were advised to verify purchase documents. This broad coordination matters because the counterfeit product may move through several supply-chain stages before reaching a patient. Nationwide alerts can help different participants recognise and report suspicious packs quickly.

The main danger is ineffective treatment. A patient receiving falsified Defitelio may not receive the intended medicine for severe hepatic veno-occlusive disease after transplantation. Delayed or absent treatment can leave a serious condition inadequately managed.

The product is intravenous, meaning it is delivered directly through an infusion rather than taken as a tablet. The DCGI warned that this route can pose other serious health risks when the product is falsified. The suspect pack may contain the wrong ingredients, an incorrect strength, or unsafe contamination, although the article does not identify its contents.

Regulators described the possible outcome as life-threatening in some circumstances. The risk is especially concerning for post-transplant patients, whom the alert calls vulnerable. Doctors and hospitals were instructed to report adverse events, while inspectors were told to sample products and take legal action where necessary.

Regulators concluded that the batch was counterfeit because the companies connected to the genuine product did not recognise its Indian distribution. The manufacturer or its authorized agent confirmed that batch 24GC01A had never been supplied to India.

The inquiry began after Gentium S.r.l. received an Indian request on 21 September to verify a pack with serial number 35118817455532. European regulators and the drugmaker examined photographs of the packaging and determined that it was counterfeit. The pack falsely named Patheon’s Ferentino facility and Gentium S.r.l. as responsible companies.

A German rapid alert also stated that Defitelio does not have marketing authorization in India. Taken together, the absent legitimate supply, false packaging details, and photographic examination distinguished the product from an authentic medicine legally supplied in the country. CDSCO therefore ordered surveillance and enforcement action.

Hospitals and pharmacists should inspect the product’s label, batch number, expiry date, manufacturer details, and purchase documents. For this alert, the warning signs include batch 24GC01A, April 2027 expiry, and the named companies on the package. A suspicious pack should be held for investigation rather than sold or administered.

The article describes an authenticity check involving Gentium S.r.l. An Indian request asked the company to verify a pack using its serial number, 35118817455532. Regulators then examined photographic evidence. This shows that supply-chain checks can involve the named manufacturer or authorized agent, together with drug authorities.

Doctors and hospitals should report adverse events. Consumers should verify purchase documents. Pharmacy networks should alert their members and stop sales. CDSCO enforcement officers can draw samples and act under the Drugs and Cosmetics Act, 1940. These steps connect patients, sellers, manufacturers, and regulators.

Hepatic veno-occlusive disease, or VOD, is a condition in which small veins in the liver become blocked or narrowed, impairing liver blood flow. Haematopoietic stem-cell transplantation is a treatment that replaces blood-forming stem cells, often after intensive medical therapy. These are established medical definitions; the article itself identifies VOD as occurring after transplantation.

Defitelio is used for severe VOD following haematopoietic stem-cell transplantation. It is supplied as an intravenous infusion, so the medicine reaches the patient directly. A counterfeit version may fail to provide the intended treatment and may introduce other serious risks, as India’s DCGI warned.

The article specifically highlights vulnerable post-transplant patients. Their treatment is specialised, and the suspected product was intended for a serious complication. That is why regulators ordered nationwide surveillance, sample collection, reporting of adverse events, and immediate action against sales of the falsified medicine.