The Government Medical Officers Association (GMOA) is calling for an independent authority to be established to deal with import, manufacture and distribution of drugs in the country as a growing number of cases where outdated or sub-standard medicines being issued to patients are coming to light.
“Currently authority rests solely with one person - the Director General of Health Services (DGHS) - and there is no transparency in the procedures. There have been instances where medical drug suppliers have been registered without the recommendation of the Drug Evaluation Sub Committee (DESK),” GMOA assistant secretary Dr. Chandana Atapattu said.
Dr. Atapattu said there have been instances where the DGHS has issued ‘no objection’ letters for drugs to be released from the Customs bypassing the legal and quality assurance process that an imported drug has to go through under normal circumstances.
According to him Sri Lanka does not have the facilities to test the quality of all drugs that are being imported to the country as the National Drug Quality Assurance Lab does not have the needed capacity to test all the drugs imported into the country.
“According to the drugs index which was last published in 2004 by the Health Ministry we import 9000 varieties of drugs and we clearly do not have the capacity to quality test all the drugs that are being brought to the country. Further post-marketing surveillance does not happen as it should due to restrictions in capacity,” Dr. Atapattu told the Sunday Times.
The GMOA is calling for a revision of the drug index and the import of only what is needed in the country.
“Address the need only. Have only a few brands to import not a large number. According to the last printed drug index there are over 50 brands of Paracetamol, for instance, and it’s the same for other basic drugs such as Amoxicillin and Atenolol. This causes problems such as what we are experiencing now, so the best policy is to have a needs-based system,” Dr. Atapattu said.
According to Dr.H.Beneragama, Chairman of the National Drug Authority the facilities at the National Drug Quality Assurance Laboratory are not adequate for quality testing of all the drugs imported into the country.
According to him all provincial and district authorities try to carry out post-marketing surveillance but for this also the capacity of the lab has become a bottle-neck, he admitted.
“There are restrictions in the capacity of the lab which is under expansion now but it will take time to complete, so there may be shortcomings,” he said.
Health Ministry Secretary Dr. Athula Kahadaliyanage said that the legal process in place is enough to ensure low quality drugs are not brought into the country.
However he said that the State Pharmaceuticals Corporation which imports the drugs lacks the capacity to test the quality of each and every batch that is imported.
“We lack the capacity in this case so we expect the supplier to supply good quality drugs. In a case where we find out, through random tests or post market surveillance, that good quality drugs have not been supplied, then we recall the drugs and in extreme cases cancel the registration of the importer. Now the medical staff is more vigilant as to the quality of the drugs used, which is a good thing so we could detect more cases,” he said.