Regulator Warns Of Counterfeit Liver, Cancer Drugs Being Sold On The Indian Market

The Drugs Controller General of India (DCGI) has instructed the drugs controllers of all states and Union territories to closely monitor the sale and distribution of counterfeit versions of two drugs, namely liver medication Defitelio and Takeda's cancer drug Adcetris (injection).

This action comes after alerts were issued by the World Health Organization (WHO).

On 5 September, the DCGI released an advisory stating that the WHO has issued a safety alert regarding multiple counterfeit versions of Adcetris injection 50 mg, which is manufactured by Takeda Pharmaceutical Company Limited.

These falsified versions have been identified in four different countries, including India.

According to the DCGI, these counterfeit products are primarily available at the patient level and are distributed through unregulated supply chains, particularly online. They have also been found in both regulated and illegal supply chains, sometimes even reaching patients directly.

The WHO has reported that there are currently at least eight different batch numbers of these falsified versions in circulation. The DCGI has communicated this information to the state drugs controllers.

Takeda Pharmaceutical Company Limited has "strongly recommend that Adcetris should be procured from Takeda authorised distribution sources only."

Adcetris (Brentuximab Vedotin) is used to treat patients with Hodgkin's lymphoma who have not responded to an autologous stem cell transplant and systemic anaplastic large cell lymphoma.

On 6 September, the DCGI issued an advisory regarding the falsified product Defitelio (Defibrotide) 80 mg/ml concentrate for solution for infusion, which is manufactured by Gentium Srl.

This advisory was in response to a 4 September safety alert issued by the WHO.

The WHO had reported that the falsified Defitelio product has been found in India and Turkey. The genuine manufacturer of Defitelio confirmed that the product mentioned in the alert is indeed falsified.

The use of this falsified product can lead to ineffective treatment and pose serious health risks, especially when administered intravenously. In some cases, it could be life-threatening.

In light of these safety alerts, the DCGI has advised healthcare professionals to prescribe drugs with caution and educate their patients about reporting any adverse drug reactions (ADRs).

The DCGI has instructed state and regional regulatory offices to closely monitor the movement, sale, distribution, and stock of these specific drug products in the market.

They have been asked to draw samples and take appropriate action in accordance with the Drugs and Cosmetics Act and its rules.

To ensure their safety, consumers and patients are advised by the top drug regulator to exercise caution and only obtain medical products from authorised sources with a valid purchase invoice.

On 31 August, the DCGI had issued an advisory alert regarding Abbott's antacid, Digene gel.

This action was taken due to safety concerns after the United States-based drug maker voluntarily recalled several batches of Digene gel in India.

The DCGI urged consumers and patients to discontinue the use of Digene gel, which is manufactured at a facility in Goa.

Wholesalers and distributors have been instructed by the DCGI to remove all batches of the affected product, manufactured at the Goa facility and within its active shelf life, from distribution.