CDL tests also find Isotab adulterated
KARACHI: The Central Drugs Laboratory verified here on Thursday the presence of a material used in certain combinations to treat malaria in a sample of the Isotab tablet (20mg) reportedly given to a good number of patients registered with the Punjab Institute of Cardiology.
Functioning under the cabinet division since the devolution of the health sector, the laboratory also found the tablets which a team from the Drug Control Administration had collected on Wednesday from the factory manufacturing the medicine in Karachi, diluted, adulterated and substandard, containing the anti-malarial agent, Pyrimethamine.
Analyst Obaid Ali told Dawn that an unknown peak had been found with isosorbide-5 mononitrate manufactured by Efroze Chemical Industries, during high performance liquid chromatography analysis under conditions of the USP on Wednesday night.
For reliable, selective and specific determinations, support from experts outside the laboratory was sought on Thursday.
“Now I am in a position to say that the samples of solution and tablet of one particular batch tested by the national laboratory has been found with Pyrimethamine,” he said, adding that the concentration of the anti-malaria active was about 56mg in one tablet.
Three samples of the tablet were delivered to the CDL on Jan 30 by an additional secretary of the Punjab health department and the laboratory issued details of its latest findings on a priority basis.
According to sources, a letter from the Punjab government authorising the federal government’s analyst to carry out the tests is awaited by the laboratory to fulfil the requirements of the Drugs Act of 1976.
Earlier, the laboratory tested one sample of medicines from a factory in Lahore that was reportedly associated with about 130 deaths among cardiac patients receiving treatment from the PIC.
“It declared a batch of Alfagril as substandard,” an official said.
According to experts, prolonged use of the anti-malaria substance may cause a decrease in red blood cells. The problem can be addressed by using folinic acid.
After sealing the active sections of the Efroze factory in Korangi on Wednesday on suspicion that it had produced and supplied tainted medicines to the PIC, a team of the federal government’s drug and investigation officers told the firm to suspend manufacturing drugs for two weeks and not to dispose of any relevant material outside the premises.
The Drug Control Administration’s Deputy Director General Dr Shahid H. Pechuho said that since the government laboratory had confirmed that the sample was substandard as defined in the Drugs Act, the factory deserved legal action under its Sections 23 (import, manufacture and sale of drugs) and 27 (offence, penalties and procedure). “We are seeking guidance from the cabinet division.”
Replying to a question, he said the Central Licensing Board did not exist currently and he had proposed to seek special permission from the prime minister for lodging an FIR and initiating prosecution under the act.
“Another option is that under Section 19 (procedure for inspectors of drugs), a federal inspector shall report the matter and hand over the stock to the provincial drug inspector for further action,” he added.
On Wednesday, Punjab Chief Minister Mian Shahbaz Sharif had told the media that a British laboratory had found 50mg of an anti-malarial agent in Isotab produced by Efroze Chemicals.