India’s Drug Regulator Urges Strict Vigilance Amidst Rising Falsified Drug Threats

India's Drug Regulator Urges Strict Vigilance Amidst Rising Falsified Drug Threats
India's Drug Regulator Urges Strict Vigilance Amidst Rising Falsified Drug Threats
India's Drug Regulator Urges Strict Vigilance Amidst Rising Falsified Drug Threats
India's Drug Regulator Urges Strict Vigilance Amidst Rising Falsified Drug Threats

India’s Drug Regulator Urges Strict Vigilance Amidst Rising Falsified Drug Threats

India’s Drug Regulator Urges Strict Vigilance Amidst Rising Falsified Drug Threats.

WHO Alerts on Falsified Adcetris and Defitelio Raise Concerns.

The Drugs Controller General of India (DCGI) has issued a directive to state and union territory drug controllers to intensify their efforts in monitoring the sale and distribution of counterfeit versions of two critical drugs: Defitelio, a liver medication, and Takeda’s cancer drug Adcetris (injection). The urgency arises following safety alerts issued by the World Health Organisation (WHO).

Multiple Falsified Versions of Adcetris Detected.

In a recent advisory, the DCGI highlighted the WHO’s safety alert identifying multiple counterfeit versions of Adcetris injection 50 mg, produced by Takeda Pharmaceutical Company Limited. These fake products have been discovered in several countries, including India, and are commonly found at the patient level, often distributed through unregulated supply chains, primarily online. Even regulated and illicit supply chains have not been spared from these counterfeit products.

Concerns Surrounding Defitelio’s Falsified Version.

On September 6, the DCGI issued another advisory, referring to a WHO safety alert from September 4 regarding a falsified product, Defitelio (Defibrotide) 80 mg/ml concentrate for infusion, manufactured by Gentium Srl. This fraudulent product has surfaced in India and Turkey, outside the regulated and authorized distribution channels. The genuine manufacturer of Defitelio has confirmed the existence of these falsified products.

Safety Measures and Warnings.

The use of counterfeit Defitelio can result in ineffective patient treatment and may even pose life-threatening risks due to its intravenous administration. As a response to these safety alerts, the DCGI has advised healthcare professionals to prescribe drugs carefully and encourage patients to report any adverse drug reactions (ADRs). Additionally, state and regional regulatory offices are urged to closely monitor the movement, sale, distribution, and stock of these drug products, taking necessary actions under the Drugs and Cosmetics Act.

Consumers and patients are cautioned to procure medical products only from authorized sources, accompanied by proper purchase invoices. For wholesalers and distributors, the DCGI has instructed the removal of impacted products from distribution and emphasized that Adcetris (injection) should be obtained solely from authorized distribution sources.

In a statement, Takeda Pharmaceutical Company Limited stressed the importance of procuring Adcetris from their authorized distribution sources. They highlighted their commitment to patient safety and the fight against falsified medicines, considering it their highest priority. Falsified medical products pose a substantial threat to public health, and the company aims to safeguard the integrity of its products to protect patients.

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