CONTEXT:

  • Recently, Drug manufacturer Abbott India has withdrawn all batches of the popular antacid syrup, Digene gel, which were manufactured at its Goa facility.

MORE ABOUT THE NEWS:

  • Apex drug controller, Central Drugs Standard Control Organisation (CDSCO), said on its website: "The impugned product may be unsafe, and its use may result in adverse reaction."
  • Abbott India has withdrawn all batches of the popular antacid syrup, Digene gel, which were manufactured at its Goa facility, after customers reported that the liquid in the bottle had turned white, tasted bitter and had a pungent smell when they bought it early August.

WHAT IS DIGENE ?

  • The pink liquid — or its pill form — 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.

ISSUES WITH DIGENE GEL :

  • Digene gel has a sweet taste, is pink, and is released in multiple flavours such as orange, mint and mix-fruits.
  • The DGCI said in its advisory that they received a complaint on August 9 about the Digene gel mint flavour manufactured at the Goa facility.
  • The complaint was about the gel being white instead of light pink.
  • The impugned product was also bitter, and its smell was pungent.
  • In response, Abbott India voluntarily recalled the impugned product and all batches of Digene gel of all flavours (Mint, Orange, Mix Fruits flavour) within shelf life and manufactured at the Goa facility.
INDIA’S DRUG RECALL LAW : Drug recalls are typically issued when a product is found to be defective, contaminated, mislabeled, or poses a risk to the health and safety of patients.
  • There is no law in India to withdraw the entire batch of substandard drugs from the market, but the demand for a national Drug Recall Law is a long-standing one.
  • At most, state drug regulators in India can order withdrawal of a particular batch from their state, but given that India is a common market, the same batch may be dispersed across multiple states.
Syllabus: Prelims