A drug safety alert by the World Health Organization has triggered increased vigil on the movement and sale of a fake cancer injection Adcetris. The global health body told India that there are at least eight different batch numbers of falsified versions in circulation in the country.
Central Drugs Standard Control Organisation (CDSCO) issued an alert on September 5 instructing drug regulators across the country to draw random samples after WHO said it found fake versions in four countries, including India. The national regulatory agency also asked doctors and healthcare professionals to “carefully prescribe” the medicine and “educate their patients for reporting any adverse drug reactions”.
Manufactured by Japanese drug maker Takeda Pharmaceuticals, Adcetris injection is a critical medicine used to treat adults with previously untreated stage 3 or 4 classical Hodgkin lymphoma in combination with chemotherapy. It is also given to children aged above two with previously untreated high-risk classical Hodgkin lymphoma.
“We strongly recommend that Adcetris should be procured from Takeda-authorised distribution sources only,” Takeda’s spokesperson told News18 in a reply to an email.
The spokesperson added: “Falsified medical products present a significant threat to public health. Takeda India is committed to safeguarding the integrity of its products and supporting the fight against falsified medicines in order to protect patient safety, which is our highest priority.”
News18 also sent an email to WHO but the UN agency could not respond in detail and replied: “Due to public holidays in Geneva on September 7 and 8, we have limited capacity.”
What does the CDSCO alert say?
According to the alert signed by the Drug Controller General of India (DCGI), who is the chief of CDSCO, the WHO has told the regulator about finding multiple fake versions of Adcetris Injection 50 mg in India as well.
“The WHO has informed about a safety alert identified with multiple falsified versions of Adcetris Injection 50 mg (brentuximab vedotin) manufactured by Takeda Pharmaceuticals company identified in four different countries, including India,” stated the communication, accessed by News18.
The alert asks consumers and patients to be careful and only procure medical products from authorised sources with proper purchase invoices. It asks doctors to educate patients on reporting the side effects (if any), and to find out if they are using the fake product.
The agency – in the communication marked to all zonal, sub-zonal offices of CDSCO and drug regulators in states and union territories – has instructed officers to keep a “strict vigil on the movement, sale, distribution, stock of the said drug products in the market, draw samples and initiate necessary action…”
Possible distribution via unregulated supply chains
Indicating the possibility of circulation of the fake version of the medicine available in unregulated markets, the DCGI said these products are “most often available at the patient level and distributed in unregulated supply chains (mainly online)”. It said the products have been “identified in both regulated and illicit supply chain, sometimes at patient levels as well”.
“WHO has reported that there are at least eight different batch numbers of falsified versions in circulation…” the communication stated while listing the batch numbers.
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