Bengaluru, Feb 21 The Karnataka government has sought assistance from the Union Health Minister in countering the menace of sale of drugs which have failed tests and further appealed to ensure steps to withdraw contaminated drugs from market all across India.
Minister for Health Dinesh Gundu Rao wrote a letter on Friday to the Union Health Minister J.P. Nadda in this regard.
“I am writing to bring to your attention the repeated instances of sale within Karnataka of contaminated injectable drugs manufactured in other states.
“Between January 1 and February 16, nine injectable drugs manufactured in other states failed sterility testing in our state government laboratories. The details of drugs, along with batch numbers, are provided in the annexure to this letter,” Minister Rao stated.
This list does not include numerous injectables manufactured by Paschim Banga Pharmaceuticals based in West Bengal, whose contaminated injectables caused the deaths of five young mothers in Ballari district of Karnataka, Rao said.
“While I am instructing my department to take adequate steps to ensure these drugs are no longer sold within Karnataka, it is highly likely that other contaminated drugs manufactured by these companies are being sold in other states in India. Injectables, as you are aware, are used in acute care and therefore are high risk to patients.
“Given the ‘life or death’ consequences for patients being administered these contaminated drugs, I request you to use your good offices to ensure that all products sold by these companies are withdrawn from the market across India and that these companies are not allowed to sell any more drugs until they are inspected by the Central Drugs Standard Control Organisation (CDSCO) for compliance with Good Manufacturing Practices (GMP),” Rao urged.
Minister Rao further requested, “In addition, I also request you to create a system for all states and central laboratories to share alerts with each other regarding drugs which have failed quality testing, especially those failures which could potentially cause serious adverse events for patients.”
He further suggested, “In addition to sharing alerts with each other there should also be a legal requirement to share sales records from the manufacturer to enable seizure of the contaminated drugs from the supply chain before they are dispensed to patients.
“Lastly, we need a system to alert doctors, pharmacists and patients about the drugs that are failing testing in our respective testing laboratories. My department would be glad to assist in this regard.”
Rao has ended the letter stating that he is anticipating a positive response in this regard.
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