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MHRA clears all drugs except Isotab-20

February 09, 2012

LAHORE, Feb 9: The British Medicines and Healthcare Regulatory Agency (MHRA) in its detailed report issued on Thursday cleared all the suspected drugs, except Isotab-20, dispensed to the patients by the Punjab Institute of Cardiology. The MHRA final report, however, reconfirmed its previous analysis regarding Isotab-20 manufactured by Efroze Pharma, Karachi. The lab experts traced 50mg Pyrimethamine contamination in each Isotab 20mg tablet.

A source familiar to development told Dawn the final and thorough report was issued by the experts of MHRA and the School of Pharmacy, London.

Quoting the report, the source said the MHRA completed screening on 16 samples out of total 20 of five suspected drugs and found no contamination except in the previously declared substandard drug -- Isotab-20.

“The MHRA has cleared all the four drugs -- Cardiovestin 20mg of Mega Pharma, Corcont 5mg of Swiss Pharma, Zafnol 50mg of Zafa Pharma and Solprin 300mg of Pharma Wise,” the source said.

He said the MHRA tested samples of Isotab-20 drug sent for analysis under batch numbers J093, J094, J095, j097 and J098.

All the samples of the drug were found up to the laid down standard except for J093, he said. The controversial batch, J093, was declared adulterated with Pyrimethamine, he said.

The source further said during manufacturing of Isotab-20 in Efroze Pharma, the officials mixed 25kg pyrimethamine in the container instead of 25kg starch, a non-active material.

It was the major processing fault which caused deaths, he said adding that each batch of the Isotab-20 was carrying 400,000 tablets.

The source said the analysis study of the MHRA also showed a positive side as only one batch of five suspected drugs was found adulterated that meant the pharmaceutical companies in Pakistan were manufacturing medicines as per standard despite having minimum resources.

World Health Organization representatives in Pakistan and the chief of the International Health Partners helped the Punjab government conduct the study on suspected drugs in a short time.