Toxic drugs slip thru' monitoring
The Drug Administration (DA), the country's sole drug regulatory body, fails to monitor the domestic drug manufacturing companies due to lack of sufficient laboratory equipment and facilities and manpower shortage, posing serious threat to public health.
Sources said though the drug superintendents are supposed to visit the allopathic, ayurvedic and homeopathic medicine producing factories and sales stores and examine the brands, local or imported, as part of their monitoring job, they hardly visit the places on the excuse of manpower shortage and lack of other logistic supports.
As the DA officials are not visiting the factories, the company owners are producing drugs with low quality raw materials and sometimes they are even mixing harmful chemicals like diethylene glycol that causes acute renal failure and death when ingested, said Prof Mohammad Hanif, of nephrology department of Dhaka Shishu Hospital.
He suggested that the government should restrict import and open market sale of such chemicals that are harmful for public health.
Owners and executives of the factories and pharmacies frequently bribe drug administration officials for early clearance of files on permission for new products and import of raw materials, said drug sellers and company insiders.
“For inspection of our company, the DA officials ask us to send car for them and after the visit, we have to give them a handsome amount in bribe for a good certificate,” said an executive officer of a company.
A high official of the DA recently told The Daily Star, “As we have no vehicle to visit the companies, we use the company vehicle to visit their factory.”
The official said that the drug superintendents get only Tk 700 each month as travel and daily allowances, which should be increased.
Drug manufacturing company Rid Pharmaceutical produced spurious drugs due to lack of monitoring by the DA officials. The spurious drugs claimed lives of at least 28 children in two months in the areas of Comilla, Narsingdi, Habiganj, Barisal and Chittagong.
“The DA or the government does not mete out exemplary punishment to the offenders that produce spurious drugs. And dishonest businessmen are taking the opportunity of producing sub-standard drugs,” said Health Rights Movement President Rashid-e-Mahbub, also the former vice-chancellor of Bangabandhu Sheikh Mujib Medical University.
On the move to punish Rid Pharma, one of the assistant directors of the DA tried to shift the blame on the media. “Only 28 or 29 children died of drug intake. What about the road accidents that claim hundreds of lives every day? The media should report these things, not the 28 death cases only,” the official said.
Sources in the Drug Administration said an official of the DA made the proposal in favour of Rid Pharma and the company did not comply with other requirements for establishing a drug manufacturing company.
“The company got approval to start production in 2006. Now some other officials are trying to prove that traders at Mitford had supplied diethylene glycol to the company instead of propylene glycol," DA sources said.
The DA and only two drug testing laboratories monitor 600 allopathic, ayurvedic and homeopathic medicine factories, 24,000 brands and about 82,000 drug stores.
The drug regulatory body has one drug testing laboratory in Chittagong while it uses another drug-testing laboratory at Mohakhali under the Directorate General of Health Services. Both the government's drug testing laboratories remain in shabby state.
A small army of 17 officers, aided by insufficient office staff and two outdated drug testing laboratories, are entrusted with the whole job of ensuring production and sales of safe drugs for 144 million people, industry sources said.
Getting the seal of approval for drug samples is not that difficult. “Buy medicines of a reputed company, remove the trademark and submit those in powder or suspension form using your company tag. You will get the certificate and then you are free to produce and market it as you like,” a pharmaceutical company executive said.
Asked about the allegations against the DA, its Director Brigadier General M Ismail Hossain said it is impossible for a few officers to monitor production and sale of drugs across the country with backdated law and ill-equipped testing laboratory. Now the total manpower of the Drug Administration is 122.
The drug authorities can at best cancel the licence of a pharmaceutical company for serious violation of the Drugs (Control) Act 1982. The court, however, can sentence people to 10 years' imprisonment and fine them Tk 2 lakh or both if they are found guilty of producing counterfeit and adulterated drugs.
Asked whether any step has been taken to contain corruption in the department, the director said he would take punitive action against the staff members if any specific complaints were lodged.
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