Polio Scare: Tainted Firm Asks Drug Sleuths To Re-Test Samples Detected With Dead Strain

New Delhi, 16 Nov 2018: The Ghaziabad-based vaccine manufacturer accused of releasing contaminated polio vaccines wants a re-test of the batches that triggered a major health scare in September.

Bio-Med Pvt Ltd has challenged the investigation report of the Central Drugs Standard Control Organisation (CDSCO), the country’s apex drug regulation body under the ministry of health and family welfare, which contained the damning findings.

The report, at the heart of the entire controversy, alleged that some batches of the oral vaccines for polio manufactured by the firm contained traces of the Type-2 virus, which was declared eliminated years ago.

It said as many as 30 lakh children may have been infected in two states, triggering an alarm even as the government said there was no cause for worry.

The octogenarian managing director and founder of Bio-Med was then arrested.

Bio-Med has questioned the findings in a letter to the CDSCO, seen by ThePrint, and asked the drug regulator to re-test the samples. “Bio-Med has challenged the findings of our investigations and we will be sending their samples for re-testing,” said a senior official at the CDSCO.

According to the Drugs and Cosmetics Act, if a drug fails a quality test or is deemed to be “not of standard quality”, the manufacturer can challenge the investigation, but within 28 days of receiving the report. Though the exact date of the letter could not be affirmed, Bio-Med kept to the deadline.

The government will now send the samples for a re-test to the Central Drugs Laboratory (CDL), Kasauli, the same facility that made the initial findings. The conclusion drawn in the second inquiry will be considered final.The Print