NEW DELHI: The Drug Controller General of India (DCGI) has advised doctors and healthcare professionals to educate their patients to discontinue the use of Digene gel – a commonly prescribed anti-acidity formulation – in case there is an adverse drug reaction (ADR).
The healthcare professionals have also been advised to report any suspicious cases of adverse events linked to the product to the authorities.
Digene is considered a safe drug. It tastes sweet and is sold in multiple flavours, for example mint, orange and mix-fruits.
The DCGI, in its advisory, says they received a complaint about the Digene gel mint flavour manufactured at the Goa facility of Abbott India, the manufacturing company, being white in colour instead of light pink. The impugned product was also bitter in taste and its smell was pungent, according to the complaint received on August 9.
Abbott India recalled all products of the said batch and also stopped products of all variants of Digene gel at its Goa facility.
A spokesperson of Abbott told TOI that the company voluntarily recalled Digene gel antacid medicine manufactured at their Goa site due to isolated customer complaints on taste and odour. “There have been no reports of patient health concerns,” the spokesperson said.
The spokesperson clarified further that other forms of Digene, such as tablets and stick packs are not impacted and Digene gel manufactured at the company’s other production site isn’t affected either and that the product continues to be available in sufficient quantities to meet current demand.
The DCGI, in its advisory, has said patients should discontinue the use of Digene gel which are manufactured in the Goa facility.
The drug regulator has also asked all state drug controllers and the zonal and sub-zonal officers of the Central Drug Standards Control Organisation (CDSCO) to instruct their officers to keep a strict vigil on the movement, sale, distribution, stock of the said drug products in the market, draw samples if said product lying in market and initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules made thereunder.
The healthcare professionals have also been advised to report any suspicious cases of adverse events linked to the product to the authorities.
Digene is considered a safe drug. It tastes sweet and is sold in multiple flavours, for example mint, orange and mix-fruits.
The DCGI, in its advisory, says they received a complaint about the Digene gel mint flavour manufactured at the Goa facility of Abbott India, the manufacturing company, being white in colour instead of light pink. The impugned product was also bitter in taste and its smell was pungent, according to the complaint received on August 9.
Abbott India recalled all products of the said batch and also stopped products of all variants of Digene gel at its Goa facility.
A spokesperson of Abbott told TOI that the company voluntarily recalled Digene gel antacid medicine manufactured at their Goa site due to isolated customer complaints on taste and odour. “There have been no reports of patient health concerns,” the spokesperson said.
The spokesperson clarified further that other forms of Digene, such as tablets and stick packs are not impacted and Digene gel manufactured at the company’s other production site isn’t affected either and that the product continues to be available in sufficient quantities to meet current demand.
The DCGI, in its advisory, has said patients should discontinue the use of Digene gel which are manufactured in the Goa facility.
The drug regulator has also asked all state drug controllers and the zonal and sub-zonal officers of the Central Drug Standards Control Organisation (CDSCO) to instruct their officers to keep a strict vigil on the movement, sale, distribution, stock of the said drug products in the market, draw samples if said product lying in market and initiate necessary action as per the provisions of the Drugs and Cosmetics Act and Rules made thereunder.