New Delhi:

The Drugs Controller General of India (DCGI) has directed the drugs controllers of all states and Union territories to keep a strict vigil on the sale and distribution of falsified versions of two drugs, liver medication Defitelio and Takeda’s cancer drug Adcetris (injection), following alerts issued by the World Health Organisation (WHO).

In an advisory on September 5, the DCGI said the WHO has issued a safety alert identified with multiple falsified versions of Adcetris injection 50 mg manufactured by Takeda Pharmaceutical Company Limited, identified in four different countries including India.

“These products are most often available at the 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. WHO has reported that there are at least eight different batch numbers of falsified versions in circulation,” the DCGI said in a communication to the state drugs controllers.

Adcetris (Brentuximab Vedotin) is a CD30-directed antibody-drug conjugate indicated for the treatment of patients with Hodgkin’s lymphoma after the failure of an autologous stem cell transplant and systemic anaplastic large cell lymphoma.

On September 6, the DCGI issued another advisory, referring to a safety alert issued by the WHO on September 4 for falsified product Defitelio (Defibrotide) 80 mg/ml concentrate for solution for infusion, manufactured by Gentium Srl.

“This falsified product has been detected in India (April 2023) and Turkiye (July 2023), and was supplied outside of regulated and authorised channels,” the WHO said.

It said the genuine manufacturer of Defitelio has confirmed that the product referenced in the alert is falsified.

“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,” the health body of the United Nations (UN) said.

Following the safety alerts for both the products, the DCGI has advised doctors and healthcare professionals to carefully prescribe drugs and educate their patients for reporting any adverse drug reactions (ADRs).

The DCGI has also asked the state and regional regulatory offices to instruct their officers to keep a strict vigil on the movement, sale, distribution and stock of the mentioned drug products in the market.

They should also draw samples and initiate necessary action in accordance with the provisions of the Drugs and Cosmetics Act and the rules made thereunder, the DCGI said.

For consumers and patients, the apex drug regulator has asked them to be careful and only procure the medical products from authorised sources with a proper purchase invoice.

On August 31, the DCGI had issued an advisory alert against Abbott’s antacid Digene gel, citing safety concerns as the United States-based drugmaker voluntarily recalled several batches of its Digene gel in India after the drug regulator raised an alert.

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

As for wholesaler and distributors, the DCGI had said the impacted product, with all batch numbers, manufactured at the Goa facility within the active shelf life to be removed from distribution.

Reacting to the development, Takeda Pharmaceutical Company Limited said Adcetris (injection) should be procured only from the authorised distribution sources.

“We would like to clarify that the Central Drugs Standard Control Organisation has issued a general advisory cautioning against falsified versions of Adcetris Injection (Brentuximab vedotin) identified in India.

“Takeda has been authorised by the Drug Controller General of India to import, sell and distribute Adcetris in India, and we make it available to our patients here through well-established supply chain networks. We strongly recommend that Adcetris should be procured from Takeda authorised distribution sources only,” the firm said in a statement.

It said falsified medical products pose a significant threat to public health and asserted that the firm 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”. 

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Abbott India informed drug controller Central Drugs Standard Control Organisation of the voluntary recall of Digene Gell and stopped production of all variants of the product manufactured at their Goa facility. Photo: digeneindia.com

The Central Drugs Standard Control Organisation (CDSCO) has alerted healthcare professionals, consumers, patients, wholesalers, distributors, and regulatory authorities about the voluntary recall of Abbott India’s popular antacid syrup Digene Gel, manufactured at its Goa facility.

The public notice issued by the apex drug controller on its website said: “The impugned product may be unsafe and its use may result in adverse reaction.”

The Drugs Controller General of India (DCGI), who heads the CDSCO, also advised the doctors and healthcare professionals to carefully prescribe and educate their patients to discontinue the use and to report any adverse drug reactions arising due to consumption of Digene Gel.

“Healthcare professionals should promptly report any suspicious cases of adverse events linked to this product,” the DCGI stated in the letter.

The drug controller’s notice said the company initially withdrew one batch of its product available in mint flavour and four batches in orange flavour after receiving a complaint about a product that was white, had bitter taste and pungent smell early August. Within a week the company recalled all batches of its Digene syrup sold in mint, orange, and mixed-fruit flavours manufactured at its Goa facility.

CDSCO said it was reported on August 9 that one bottle of Digene Gel Mint Flavour used by customers was of regular taste (sweet) and light pink colour whereas another bottle of the same batch was of white colour with bitter taste and pungent odour as per the complaint.

Abbott India Limited informed the drug controller of the voluntary product recall and voluntarily stopped production of all variants of Digene Gel manufactured at their Goa facility.

CDSCO also urged distributors and users to discontinue the use of Digene Gel manufactured at the Goa facility while stating that there is no need to panic.

The drug is known to relieve acidity and its symptoms such as heartburn, stomach discomfort, abdominal pain and gas. It can be prescribed for gastritis (inflammation of the stomach lining) and acid reflux (a condition where stomach acid flows back to the food pipe). It uses basic compounds like magnesium hydroxide to neutralise the stomach acid.

Abbott spokesperson on Wednesday noted that the company had voluntarily recalled the antacid medicine manufactured at Goa site due to isolated customer complaints on taste and odour. 

“There have been no reports of patient health concerns. Other forms of Digene, such as tablets and stick packs are not impacted and Digene Gel manufactured at our other production site is not affected and continues to be available in sufficient quantities to meet current demand. The other production site is in Baddi,” the spokesperson added.