By By Imtiaz Ali
A controversy has erupted between the Sindh Health Department and a multinational pharmaceutical company over the efficacy of three antibiotic drugs, The News learnt on Tuesday.
The Drug Testing Laboratory Sindh claimed that three capsules were of substandard quality while the pharma firm said that the active ingredients and efficacy of the drugs were found intact when they conducted their test at their lab. The Provincial Inspector of Drugs Karachi-II submitted his report to the Health Department on December 15, 2008, stating that Ampiclox 250mg, Ampiclox 500mg and Amoxil 500mg were of substandard quality.
Official sources told The News that the samples of the drugs were received on October 20, 2008, and the condition of the seals on the packet was intact. The provincial government analyst or director of the lab tested and analysed the samples, which were found of substandard quality as defined in the Drugs Act-1976.
Sources said that the capsules were tested as per “protocols” provided by the manufacturer. The test revealed that the amount of ampicillin in Ampiclox 250mg capsule was 98.63mg while it’s stated amount was 125mg, hence its percentage was 78.9 against the limit of 90 to 110 percent.
Similarly, the amount of cloxaoillin was found to be only 104.3mg while its stated amount was 125mg. Therefore, its percentage stood at 83.44 percent against the range of 90 to 110 percent, hence the sample was substandard with regard to the tests performed by the lab.
Sources said that the determined amount of ampicillin in Ampiclox 500mg capsule was 174.2mg while its stated amount was 250mg. Its percentage stood at 69.68 against the limit of 90 to 110 percent. Similarly, the analysis revealed that cloxaoillin amount in the capsule was 201.77mg while its stated amount was 250mg. Its percentage was 80.7 against the limit of 90 to 110 percent, thus the sample was found to be substandard.
The determined amount of Amoxil 500mg capsule was 445.04mg while its stated amount was 500mg. Its percentage stood at 77.39 against the limit of 90 to 110 percent, hence it was also found to be of substandard quality.
Meanwhile, Deputy Secretary Monitoring and Inspection, Health Department, Dr Insaf Ahmed Magsi said that a summary has been prepared and necessary action would be taken against the drug company, adding that they would withdraw supply. He said that according to the relevant law, the pharma company was responsible for providing another drug of quality. According to the law, they would not make payment to the company till it withdraws the said drugs from the market, he said, adding that all government hospitals in the province would be asked to cancel their orders in this regard.
The said drugs are manufactured by GlaxoSmith Klin (GSK).
GSK Legal and Cooperative Affairs Director Shahid Mustafa Qureshi told The News that they had received “complaint samples” from Drug Inspector Saleem Leghari and their lab test showed that active ingredients and efficacy of the drugs were intact. He said that when amendments were made in the law concerned for the last three years, pharma companies were also entitled to conduct tests of challenged drugs to assess their efficacy.
He alleged that the drug inspectors had not sought protocols (procedure of analysis) from them, addingthat the drug inspectors were also supposed to provide samples to the manufacturer but they only issued a letter to the manufacturer, which was not a proper procedure.
He said after receiving the letter, they sought the samples for assessing their efficacy. He said the quality of their drug testing lab was much better than the Sindh government’s lab, which had old equipment.
Mustafa said they had written a letter to the Health Department on Monday (January 19), showing that the drugs’ efficacy was intact. He said they would approach the Central Drug Testing Laboratory in PECHS against the Sindh government’s lab report. He said they have kept the samples of the said drugs and would also file an “appeal” before the National Institute of Health’s laboratory in Islamabad if the provincial drug lab did not accept their contention about the efficacy of the drugs.