It's Drug Admin which is at fault
Two officials of the Drug Administration involved in the case against Rid Pharmaceuticals Ltd knowingly violated due procedure of law, and exhibited sheer negligence, inefficiency and incompetence in dealing the case, the Drug Court in Dhaka said.
The then director of the Directorate General of Drug Administration (DGDA) Brig Gen Md Ismail Hossain “mechanically” gave permission for the case to go ahead without considering all aspects, the court said in its verdict delivered on November 28.
Of the three charges framed, one was related to the production of unregistered drug by Rid Pharmaceuticals. But the prosecution did not even produce any witness to prove it, the verdict delivered by judge M Atoar Rahman read.
And all these lacunas led to the acquittal of all five officials of Rid Pharmaceuticals, which allegedly manufactured the toxic paracetamol syrup that killed at least 28 children in 2009.
The Daily Star obtained a copy of the full judgment of the case.
The two officials are Shafiqul Islam and Altaf Hossain. Both of them were drug superintendents in 2009. Shafiqul is now an assistant director of DGDA while Altaf is a deputy director, said a DGDA director.
Then DGDA director Ismail Hossain has passed away, the official said.
The deaths of over two dozen children at Dhaka Shishu Hospital, between June and August 2009, due to renal failure allegedly after they had been administered Rid Pharmaceuticals' drug created huge uproar in the country.
The authorities suspended manufacturing and marketing of Rid Pharmaceuticals' drugs, sealed off its factory in Brahmanbaria, and asked for the withdrawal of Rid Pharmaceuticals products from the market. They filed several cases against the company officials.
On November 28, the Drug Court in Dhaka acquitted all the accused in the first of the cases filed, sparking huge criticism of the role of the Drug Administration.
The following day, Health Minister Mohammed Nasim said if the accused were acquitted due to negligence of drug administration officials, appropriate actions would be taken against them after receiving the full verdict.
THE CASE
According to the case documents, drug superintendents Shafiqul and Altaf visited Dhaka Shishu Hospital on July 21, 2009, following reports that relatively more children with renal failure had been admitted to the hospital and many of them had died after taking paracetamol syrups.
The same day, they seized two drugs of Rid Pharmaceuticals -- Temset suspension (paracetamol), and Ridaplex Syrup (Vitamin B Complex) -- in presence of Prof AR Khan and HSK Alam, the director and deputy director of the hospital.
Prof Mohammad Hanif, head of Nephrology Department of the hospital, first noticed the abnormality in the number of renal failure patients and he gave the drugs in question to the director. The drug administration officials seized those drugs, the documents said.
Shafiqul sent the drugs to Government Drug Testing Laboratory at Public Health Institute in Mohakhali and Abu Bakar Siddique, the then assistant analyst of the laboratory, released the results of tests on July 29 that year.
According to the test results, the sample of Temset was “substandard” as it had less paracetamol (96.42mg/5ml) than the amount (120mg/5ml) claimed by the company. It was also “adulterated and spurious” because it was a syrup, not a suspension (syrup containing solid particles) as claimed.
Ridaplex Syrup was also “substandard” as there was difference between the claimed and actual amount of ingredients in the drug, showed the test results which was mentioned in the verdict.
On August 10 that year, Shafiqul filed the case against Rid's Managing Director Mizanur Rahman, directors Sheuli Rahman and Abdul Gani, and pharmacists Mahbubul Islam and Enamul Haque under section 16 (C) and 17 of the Drug (Control) Ordinance 1982.
On March 9, 2011, the Drug Court framed charges against the five accused under section 16 (A) and (C). Section 16 (A) deals with unregistered drugs while section 16 (C) is about adulterated drugs. Section 17 deals with substandard drugs.
CASE FLAWED
The prosecution produced Prof AR Khan, HSK Alam, Shafiqul, Altaf and Abu Bakar as their witnesses.
But the complainant did not cite Prof Hanif as prosecution witness and prosecution did not take any step to produce him before the court, the judgment said.
“For this reason, it can't be known from where or whom Prof Hanif had collected the drugs,” it added.
Prof Khan and Alam testified that the drug samples seized by Shafiqul and Altaf were produced by Rid Pharmaceuticals.
But Shafiqul, also the investigator of the case, testified that he did not probe whether the said drugs were produced by Rid Pharmaceuticals.
Shafiqul said he did not visit the factory before filing the case and he was unable to say whether the accused produced the said drugs. Name of the company was written on the bottle, he had said.
Altaf, in his testimony, also did not say the samples collected from the Shishu Hospital were produced by Rid Pharmaceuticals.
The court concluded that the prosecution utterly failed to prove “beyond reasonable doubt” that the drugs were produced by the accused company.
It also said section 23 of the Drug Act, 1940, clearly says how to seize, divide and seal a drug sample and it appeared, from their testimonies, that Shafiqul and Altaf were aware of due procedure.
“But, it appears that the procedures were violated directly and knowingly. As a result, the matter whether the drugs produced by Rid Pharmaceuticals were substandard or adulterated remained in the dark,” the court said.
About Shafiqul's claim that he could not divide the samples into four parts as he was supplied only two bottles of the drugs, the court said the complainant, taking information from the hospital, should have collected the required amount of the drugs either from the factory or the quality control room or agent or designated drug stores of the company.
The court said the relevant law, which talks about the necessary procedure that complainant should follow after receiving test results, was also violated.
Although a charge for allegedly producing unregistered drug was framed against the accused, no witness was produced to prove the charge, said the court.
“The then drug superintendents Shafiqul Islam and Altaf Hossain showed sheer negligence, inefficiency and incompetence in taking necessary steps following section 23 and 25 of the Drugs Act, 1940,” the court said.
MORE LEFT OUT
Following the death of the children, the government formed a seven-member probe committee to investigate the matter and the committee submitted its report to the then Health Minister AFM Ruhal Haque on July 28, 2009.
Ruhal at a press conference that day said Rid Pharmaceuticals obtained licence to produce paracetamol suspension but it manufactured paracetamol syrup violating the law.
"Furthermore, instead of Propylene Glycol, they used poisonous Diethylene Glycol, which is used in tanneries and in the battery industries," he had said.
Thirteen days after the report, Shafiqul filed the case but did not mention the presence of poisonous Diethylene Glycol, said Prof Mohammad Hanif of the Dhaka Shishu Hospital.
“This should have been mentioned in the case … That was a weakness of the case,” Prof Hanif told The Daily Star yesterday.
Besides, no autopsy was done on any of the 28 children. According to The Daily Star reports, at least three children died after the probe committee found the presence of Diethylene Glycol in Rid Pharmaceuticals drugs.
Jyotirmoy Barua, a Supreme Court lawyer, said there was “negligence” from the side of the then police administration too. The police should have filed a murder case against the factory owners and officials but they did not do anything, he said yesterday.
The Daily Star could not reach Shafiqul and Altaf for their comments.
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