CDSCO directs officials to keep strict vigil on falsified products of Defitelio 80 mg/ml

September 11, 2023

The central drug regulator has directed drug controllers of all states and Union Territories (UTs) and all zonal and sub-zonal offices of the Central Drugs Standard Control Organisation (CDSCO) to keep strict vigil on the sale and distribution of falsified product Defitelio (defibrotide) 80 mg/ml concentrated for solution for infusion manufactured by Italian drug maker Gentium Srl, following an alert by the World Health Organisation (WHO).

This is the second alert by the CDSCO in two days regarding a falsified version of a drug reportedly having presence in the country, following WHO communication. On September 5, it issued an alert on falsified versions of Japanese drug major Takeda's cancer drug Adcetris injection 50 mg (brentuximab vedotin) in the country.

The drug is indicated for the treatment of severe hepatic VOD also known as sinusoidal obstructive syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. It is indicated for adults, adolescents, children and infants over 1 month of age. VOD is a condition in which the veins in the liver become blocked and stop the liver working correctly.

The Drugs Controller General (India) (DCGI) Dr Rajeev Singh Raghuvanshi, in a drug alert issued on September 6, directed all regulatory authorities including State and Union Territory drug controllers and all zonal and sub-zonal offices of CDSCO and all port offices of the Organisation to instruct their officers to keep strict vigil on the movement, sale, distribution, stock of the said drug products in the market.

He also directed the officials to draw samples if the particular product lying in the market and initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules, made thereunder.

"This falsified product has been detected in India (April 2023) and Turkiye (July 2023) and was supplied outside of regulated and authorised channels," said the drug regulator. Because of the significant threat to public health posed by these falsified products, and the risk posed to more than one country and region - the WHO Global Surveillance and Monitoring System (GSMS) has issued a medical product alert to highlight the detection of this product in the WHO regions of Europe and SouthEast Asia, he added.

The genuine manufacturer of the product confirmed that the genuine product was packaged in German/Austrian packaging while the falsified products are in UK/Ireland packaging. The stated expiry date is falsified and does not comply with the registered shelf life and the stated serial number is not associated with batch 20G20A. Defitelio does not have marketing authorisation in India and Turkey, it added.

"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 Raghuvanshi in the alert.

The drug regulator advised doctors and healthcare professionals to carefully prescribe and educate their patients for reporting of any adverse drug reactions (ADRs) and advised the consumers and patients to be careful and only procure the medical products from authorised sources with proper purchase invoice.

On September 5, DCGI said that the WHO has informed about a safety alert identified with multiple falsified versions of Adcetris injection 50 mg manufactured by Takeda Pharmaceutical Company Ltd, identified in four different countries including India.

These products are most often available at patient level and distributed in the unregulated supply chains (mainly online). The products have been identified in both regulated and illicit supply chains, sometimes at patient levels as well, it said. WHO has reported that there are at least eight different batch numbers of falsified versions in circulation.

Adcetris is a CD30-directed antibody-drug conjugate indicated for treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and systemic anaplastic large cell lymphoma.

Takeda in a statement issued later said that it makes it available to the company's patients in India through well-established supply chain networks and the company strongly recommended that Adcetris should be procured from Takeda authorized distribution sources only.

It may be noted that in the end of August, the drug regulator has alerted the State, UT drug controllers and Zonal and sub-zonal offices of CDSCO to keep vigil on the distribution and sale of falsified Digene gel manufactured by Abbott India following the company's recall of the drug manufactured in its Goa plant. The company also informed the drug regulator that it has stopped manufacturing of the product in its Goa plant after there were complaints about discolouration and pungent odour in some of the products.

The CDSCO has declared three drug samples it tested in the month of July as spurious, following the actual manufacturer (as per the label claim) informed that the batch of product has not been manufactured by them and that it is spurious drug.

In another drug alert, the drug regulator said that two drug samples declared by its labs as Not of Standard Quality (NSQ) in June are also purported to be spurious and the same is subject to outcome of investigation.

PHARMABIZ.com