The people of Bangladesh have no way to know about the quality of medicine as the controlling authority has the capacity to test less than 10 per cent of the drugs sold in the country.
The government-run drug testing laboratories in the country do not have the ability to test the quality, efficacy, potency and toxicity of drugs available in the market here, according to officials and drug experts.
Two labs in the country test drugs but they cannot test the raw materials imported from over 2,800 sources to manufacture medicines at local factories.
The Drug Administration, country’s regulatory authority, tests merely some 10 per cent of the drugs produced in the country each year and relied mostly on the announcement of the drug makers that their drugs were standard, said officials and experts.
Though the country’s pharmaceutical industry is booming and some top drug makers are exporting their drugs to the United States and Europe, the World Health Organisation is yet to certify that Bangladesh’s drug laborites meet its standard, they said.
According to the Drug Administration, some 272 pharmaceutical companies of Bangladesh produce 3,645 generic allopathic drugs under 29,854 brand names.
But the National Control Laboratory in Dhaka, the prime drug-testing lab run by the Drug Administration, tested only 2,331 brand-name drugs last year, from July 2018 to June 2019.
The other lab located in Chattogram, the Central Drug Testing Laboratory, tested only 158 brand-name drugs during the same period.
The need for testing of homeopathy, biochemic, Ayurvedic, unani and herbal medicines is largely ignored.
At least 557 manufacturers produce these alternative medicines under more than 1,300 brand names.
Dhaka University pharmacy professor Sitesh Chandra Bachar said that testing of drugs was essential to know the quality, efficacy, potency and toxicity of any drugs, vaccines and biological products.
There are different types of tests including physico-chemical, microbiological, virological, and pharmacological to know the standard medicines, he said.
‘But, the Drug Administration testing labs do not have the technical capabilities to carry out all such tests,’ he told New Age.
Sitesh pointed out that the drugs are released in the market mostly following self-designed tests of the pharmaceutical companies in Bangladesh.
‘Only some top 10 companies of the more than 270 drug makers in Bangladesh have high-end labs and that there does not exist any scope for the people to get a drug which is thoroughly tested by the regulators,’ he added.
Sitesh also said that though there were high-tech tools in the National Control Laboratory but there were few technically sound personnel to use them.
‘Experts like pharmacists, chemists, biochemists and microbiologists are required to test drugs but our labs are run by even MBBS doctors,’ he said.
He mentioned that testing of drugs produced in the country or imported from abroad are needed to ensure a safe and effective use of drugs by the patients.
Recently, Bangladesh recalled ranitidine after the popular acidity drug was withdrawn globally as a cancer-causing substance named NDMA was found in it.
NDMA in ranitidine was detected by the US Federal Drug Administration.
The Drug Administration and the pharmaceutical companies of Bangladesh lacked the technical capability to test and detect NDMA in medicines.
The Drug Administration later sent ranitidine samples to Singapore for testing, officials said.
Bangabandhu Sheikh Mujib Medical University pharmacology professor Sayedur Rahman told this newspaper that when any drug was manufactured, any harmful substance might get into it in the process.
When a chemical is found in any medicine, the batch in question of the medicine is usually withdrawn, he said.
He, too, said that Bangladesh did not have any testing capacity to detect NDMA or other harmful substances in medicines.
‘Our regulator [the Drug Administration] has to have the capability to detect such substances in the medicines, or else, recall of a particular drug would not yield much benefit,’ Sayedur said.
Sitesh said that drug tests like metabolite analysis of a drug is required to know the quality of harmful chemicals like NDMA.
There is no lab in Bangladesh that can perform metabolite analysis of a drug, he said.
Bangladeshi drug makers import raw materials from 2,805 sources all over the world, including 2,409 raw materials from Indian sources and 517 from Chinese sources.
But the quality of the raw materials is not tested by the drug laboratories of the Drug Administration.
Sayedur said that cheap raw materials were used to produce drugs in Bangladesh and possibility of contamination was not unlikely.
But, he went on, neither the country’s regulator nor drug manufactures tend to strengthen their capacity to detect harmful substances in the medicines in order to ensure good quality products.
Bangladesh’s top 10 pharmaceutical companies make quality drugs and some of them export their products to the US, Europe and other countries, Sitesh said, adding that if the quality of overall drugs was not ensured the local patients would suffer and the export market would also shrink.
Although medicines are meant to treat or prevent illnesses and diseases, sometimes even well-tested drugs can cause even extreme outcomes like death and disabilities, said National Pharmacovigilance Centre focal person Akter Hossain.
He also said that proper testing of drugs is essential to ensure quality and safe drugs.
But reporting of adverse drug reactions is also largely ignored in Bangladesh, Akter said.
Pharmacovigilance started operating in 2013 in Bangladesh and a guideline was prepared in 2018 by the Drug Administration in this regard.
But since 2013 it has got only 2,543 adverse drug reaction reports, including 740 in 2017, 665 in 2018 and 340 until June 30 in 2019.
Drug Administration director general Major General Mahbubur Rahman admitted that while the country’s pharmaceutical industry was expanding its capacity of testing drugs has not improved.
‘We lack the capacity to test all the drugs,’ he told New Age.
He disclosed that a plan was taken up to expand the capacity of testing drugs and drug laboratories in other regions of the country would be set up under the plan.
Mahbubur said that the WHO officials recently visited the National Control Laboratory in the capital’s Mohakhali for an evaluation of its capacity.
‘The WHO did not give any critical observation,’ he said.
‘We are expecting that the NCL will get WHO accreditation by six months,’ he said.
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