This is the third time that Health Minister Dinesh Gundu Rao is flagging the issue of sale of substandard drugs in Karnataka by manufacturers from other States.
| Photo Credit: H S MANJUNATH
Drawing the attention of the Union Health Minister to the sale of contaminated injectable drugs within Karnataka by manufacturers from outside the State, Health Minister Dinesh Gundu Rao demanded that the Centre immediately withdraw such drugs from markets across India.
In a letter dated February 20, addressed to Union Health Minister Jagat Prakash Nadda, Mr Rao pointed out that, between January 1, 2025, and February 16, 2025, nine injectable drugs manufactured in other States failed ‘sterility testing’ in laboratories of the Karnataka government. These drugs include the commonly used Diclofenac Sodium, Dextrose and Calcium Gluconate injections. He provided details of the drugs, along with batch numbers, in the letter.
“This list does not include numerous injectables manufactured by Paschim Banga Pharmaceuticals, based in West Bengal, whose contaminated injectables caused the death of five young mothers in Ballari district of Karnataka,” the letter stated.
Flagged for third time
This is the third time that Mr Rao is flagging the issue of sale of substandard drugs in Karnataka by manufacturers from other States. On January 9, he had written to Mr Nadda urging the Union Health Minister to take the initiative to introduce legislative reforms to help improve the quality of drugs, not just in Karnataka, but across the country.
In December 2024, Karnataka’s Health Department had written to the Drugs Controller General of India (DCGI) pointing out a mismatch in the test results conducted by the State and the Central Drugs Laboratory (CDL), Kolkata. The department had sought an investigation into the Standard Quality certification issued by the CDL, Kolkata, to Paschim Banga Pharmaceuticals, the manufacturer of Compound Sodium Lactate Injection I.P (Ringer’s Lactate) that caused maternal deaths.
What the letter says
In the latest letter dated February 20, Mr Rao has said although he has instructed his department to take adequate steps to ensure the contaminated injectable 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 markets across India. These companies should not be allowed to sell any more drugs until they are inspected by the Central Drugs Standard Control Organization (CDSCO) for compliance with Good Manufacturing Practices (GMP),” the letter states.
Sharing alerts
Besides, he requested the Union Health Minister 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 that could potentially cause serious adverse events for patients.
“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,” the letter states.
Published – February 21, 2025 01:29 pm IST