MedBodh Drug Safety Alert | Published: 28 October 2026 | Regulatory listing dated: 26 October 2026
India’s Central Drugs Standard Control Organization (CDSCO) has listed a public notice titled WHO Alert on falsified DEFITELIO (defibrotide) 80 mg/mL concentrate for solution for infusion. The listing identifies batch 24GC01A, expiry 04/2027 and describes the product as identified in India. This is a specific product-authenticity warning—not evidence that every defibrotide product or batch is falsified.
At a glance
- Regulator: CDSCO, Government of India.
- Notice listing date: 26 October 2026.
- Product named: DEFITELIO (defibrotide), 80 mg/mL concentrate for infusion.
- Affected identifier in notice title: 24GC01A; stated expiry April 2027.
- Clinical relevance: Specialist transplant and haematology services must check supply-chain authenticity before administration.
Why this alert matters
Defibrotide is used in selected patients with severe hepatic veno-occlusive disease/sinusoidal obstruction syndrome associated with haematopoietic stem-cell transplantation. A falsified intravenous medicine may contain incorrect, inadequate or unknown ingredients or may have compromised sterility. A hospital should never infer safety from packaging appearance alone.
Practical hospital-pharmacy response
- Check whether the hospital, distributor or transplant unit possesses stock bearing the exact product and batch identifiers named in the notice.
- If there is a possible match, segregate and quarantine the affected stock pending confirmation. Do not use it while authenticity is unresolved.
- Record batch, expiry, supply invoice, supplier, packaging photographs and chain-of-custody details; do not circulate patient identifiers publicly.
- Notify the hospital pharmacist, treating specialist and appropriate drug-control authority. Obtain confirmation from official regulator/manufacturer channels.
- If a patient may have received suspected falsified material, arrange clinical evaluation and appropriate pharmacovigilance reporting; avoid unsupported assumptions about exposure or harm.
Important distinction: earlier WHO alerts
WHO also published an earlier falsified-DEFITELIO alert on 4 September 2023 describing a different lot, 20G20A. The 2023 lot details should not be copied onto the 2026 CDSCO listing. Read the actual 2026 notice for the identifiers relevant to the current investigation.
What the notice does not establish
A public-alert listing does not by itself establish that all current DEFITELIO inventory is affected, that a particular hospital has received the product, or that an adverse outcome has occurred. Verify the product-specific notice and contact regulatory channels for case-specific advice.
Official references
- CDSCO Latest Public Notices — 26 October 2026 DEFITELIO alert
- WHO Medical Product Alert N°7/2023 (historical; different lot)
Editorial review: 28 October 2026. Educational safety information for healthcare professionals; hospital pharmacy protocols and current regulator instructions prevail.