DCGI alerts medical community and patients about counterfeit liver and cancer drugs in the market
New Delhi, September 11: The Central Drugs Standard Control Organisation (CDSCO), India's top drug regulator, has issued warnings to state regulators, healthcare professionals, and patients regarding two medications—Defitalio, used for liver conditions, and Adcetris, used for a type of blood cancer. The alerts were prompted by the World Health Organization (WHO) raising concerns about counterfeit versions of these drugs being circulated in multiple countries, including India.
Defitalio is prescribed for a severe condition where liver vessels are blocked, while Adcetris is used in the treatment of a specific type of blood cancer.
The CDSCO has called for strict vigilance in monitoring the movement, sale, and distribution of these products in the market and recommends thorough testing of medication samples. Healthcare providers are advised to exercise caution when prescribing these medications and educate patients on reporting any adverse events. It is also emphasized that patients should only purchase these medicines from authorized sources.
Counterfeit versions of Defitalio for liver conditions were identified in India and Turkey. These falsified products were distributed outside of regulated and authorized channels. The genuine drugs are packaged in Germany and Austria, while the counterfeit versions falsely claim to be packaged in the UK and Ireland. The stated expiry dates on the counterfeit products are false and do not align with registered shelf life. Additionally, these falsified versions lack marketing authorization in India and Turkey.
Regarding Adcetris, the drug controller has detected counterfeit injections in four countries, including India. These counterfeit products are frequently available at the patient level and are distributed through unregulated supply chains, particularly online. The WHO has identified eight different batches of counterfeit Adcetris products in circulation.
The use of counterfeit Defitalio can lead to ineffective treatment and pose serious health risks due to its intravenous administration, potentially becoming life-threatening in some cases, according to WHO and Indian drug regulators.
These alerts come shortly after the CDSCO issued a similar warning about Digene Gel, a medication for acid reflux and gastritis. Some customers reported that the syrup was white in color, bitter in taste, and had a pungent odor, leading the company Abbott to voluntarily recall the product manufactured at its Goa facility. Abbott reassured that adequate supplies of Digene Gel from its larger Baddi facility were available in the market and that the tablet and stick pack forms of the medication remained safe.
- With inputs from agencies
