• Friday, October 31, 2014

Drug custodian was careless

Full verdict on toxic Paracetamol syrup also observes law to be incomplete, soft

Chaitanya Chandra Halder and Emran Hossain

Many lives could have been saved had the Directorate General of Drug Administration acted efficiently in 1991, said the verdict in a drug adulteration trial.

The Daily Star has got a copy of the full judgment in which an owner and two employees of Adflame Pharmaceuticals were jailed last month for producing tainted Paracetamol syrup.

This is the first-ever conviction for drug adulteration in the country.

A study by Bangabandhu Sheikh Mujib Medical University (BSMMU) suggests as many as 2,700 children died from adulterated Paracetamol syrup between 1982 and 1992.  

But it is difficult to determine how many lives were lost between 1991 and 1992, thanks to an unavailability of documents. The newspaper has traced about a dozen families which lost children in 1992.

In July 1991, the then DGDA drug superintendent, Abul Khair Chowdhury, had collected samples of several syrup brands from Shishu Hospital, and had them tested at the Mohakhali government laboratory the same month. One of the tested samples was Adflame-produced Flammadol of batch No 06090. The test found nothing suspicious.

But in another test a year later, Flammadol of the same batch was proven tainted with toxic diethylene glycol.

Regarding the 1991 test, the then Shishu Hospital Director Brig Moksul Hossain Chowdhury was quoted in the judgment as saying, “Toxicity of the medicine was not examined.”

The drug was not tested for determining whether it contained the substance causing deaths, he added. 

The 1991 test had come after child kidney specialist Dr Mohammad Hanif rang the alarm over adulterated drugs.

“The kidney failure was suffered by those who had consumed Paracetamol syrup,” Hanif mentioned in his testimony in court, citing reports published in national and international media at that time.

“Definitely we did not send the Paracetamol syrup samples just for routine tests to identify the ingredients,” Hanif told The Daily Star on Sunday, in a reaction to the 1991 drug test mentioned in the judgment. “Rather, it should have been a toxicity test.” 

Still the 1991 test did not speak of detecting diethylene glycon, a poisonous chemical that saw propylene glycol replaced by dishonest drug makers around the globe for doubling profit.

Newspaper reports showed children continued to die throughout the country from the complexity even after 1991, prompting Shishu Hospital to test Paracetamol samples for the second time in November 1992. Brig Moksul sent the samples for test this time, read the verdict.

The 1992 test report found the chemical unusable in food or manufacturing drug. The judgment quoted a part of the report, “It is a poisonous chemical that may cause people to die.”

The judgment revealed that the chemical was used in violation of the approved formula for producing Paracetamol syrup.

Hanif thinks things would have been different had the first test been properly done. “It could have saved many lives,” he said. “But doctors continued to prescribe Paracetamol syrup on the drug administration's reassurance.”

The court observed the “main reason” behind the deaths of a number of children at Shishu Hospital was the toxic diethylene glycol used in syrup.

The accused deserve the highest punishment provided in the law, it added. “Although punishment for murders should be death sentence, the existing law provides for no such provision.” The judge also pointed out another shortcoming of the law regarding compensating the families of victims.

“The accused have committed crime against children, society and humanity as well,” the judge summed up the offence in these words as he convicted the three Adflame officials.

Published: 12:02 am Wednesday, August 13, 2014

Last modified: 9:35 pm Wednesday, August 13, 2014

TAGS: paracetamol syrup Drug custodian Directorate General of Drug Administration Bangabandhu Sheikh Mujib Medical University (BSMMU)

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