9 Injectable Drugs Fail Sterility Test: Karnataka Health Min Writes To Nadda For Market Withdrawal Across India

Gundurao asked Nadda to create a system for all states and central laboratories to share alerts with each other regarding drugs failing quality checks.

Bengaluru: Karnataka Health Minister Dinesh Gundurao on Friday urged the Union Government to withdraw the products of as many as nine pharmaceutical companies after they failed in the drug sterility tests carried out by the state laboratories.

Gundurao urged the Centre to press the Central Drugs Standard Control Organisation (CDSCO) to inspect those pharmaceuticals’ products that failed the test. Also, to check if these companies are complying with the Good Manufacturing Practices(GMP).

He wrote to his counterpart in the Union Government J P Nadda after as many as nine injectable drugs supplied by pharmaceutical companies failed to pass the sterility tests conducted at the state's laboratories between January 1 and February 16.

First and second page of the annexe showing drugs which failed the sterility test. (ETV Bharat)

He also shared the details of the drugs along with the batch numbers to Nadda. This list excludes numerous injectable drugs manufactured by Paschim Banga Pharmaceuticals in West Bengal, whose contaminated injectables caused the death of five young mothers in Ballari district.

After the laboratory reports, Rao ordered for withdrawal of these drugs from markets in Karnataka.

"It is highly likely that other contaminated drugs manufactured by these companies are being sold in other states. Injectables as you are aware are used in acute care and therefore are high risk to patients. Therefore, I request you to use your good offices to ensure that all products sold by these companies are withdrawn from the market across India and that these companies are not allowed to sell any more drugs until they are inspected by the central Drugs Standard Control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," the minister from Karnataka said.

He also proposed the Union 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 which could potentially cause serious adverse events for patients. "Besides, 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," Rao suggested.

Third page of the annexure showing the drugs that failed sterility test. (ETV Bharat)

He suggested that a system is required to alert doctors, pharmacists and patients about the drugs that fail on quality and offered his department's assistance.

List of drugs that failed sterility testing

1) Metronidazole Injection IP 100ml (drug) -- Pharma Impex Labouratories, West Bengal (Manufacturer) -2408A0235 (Batch No)

2) Diclofenac Sodium Injection IP -- Alpa Laboratories, Indore, Madhya Pradesh - AV3396

3) Dextrose Injection IP 25% W/V D25 -- Rusoma Laboratories, Indore, Madhya Pradesh -- P240625

4) Metronidazole Injection IP 100 ml - IHL Lifesciences, Khargone, Madhya Pradesh - 4NS401 49

5) Frusemide Injection IP 2ml (Frulix 10mg) -- Paksons Pharmaceutical, Bahadurgarh , Haryana -- P23L230