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Continued from Previous……
Ten years ago, the tragic episode of several deaths due to contaminated drug – ISOTAB – Batch J093 – manufactured by Efroze Chemical Industries, Karachi took place. A Judicial Inquiry Tribunal under a High Court Judge was commissioned to find out the causes of this great human loss. The JIT report is available on the WHO international website. The full report is spread on 297 pages and those interested may follow the link at the end to access the report.
PIC tragedy led to admission of hundreds of patients in various hospitals. PIC ran a campaign to ask patients to stop using drugs including five alleged drugs. It was before Pyrimethamine was discovered. Their staff urged the patients to return unused drugs and get free replacement. The whole episode unfolded in about three months, from first patients reporting to knowing all about it.
213 deaths were reported in various hospitals with similar symptoms – bone marrow suppression, darkening of skin, bleeding. It was a huge tragedy, the parallel of which cannot be drawn from history of pharmaceuticals in Pakistan.
The summary of important JIT findings is as follows.
Efroze Chemical Industries Karachi – The ISOTAB Manufacturer
Inspection team found that the GMP – Good Manufacturing Practices – were grossly neglected. Storage of raw materials was improper, without segregation and markings. A drum of 25kg Pyrimethamine was found missing and reported to the owners, who did not bother to investigate. They just arranged some more quantity when the manufacturing of its relevant product was planned. Quality Control Lab could not identify any problem with the Isotab batches because they only tested for the active drug – Isosorbide mononitrate – and it was there.
Efroze won the tender at PIC and supplied multiple batches. In one consignment, they supplied 7 batches – from J092 to J098 – amounting to 2 million tablets. The contaminated batch J093 was the only batch contaminated that created the disaster.
Umar Trading Company – The Distributor
UTC represented Efroze as institutional distributor at PIC. They received the stock of 7 batches and supplied direct from truck stand to PIC. However, on the delivery challan, they mentioned only two batches – J092 and J095. PIC stores also recorded the same two batches.
Samples from each batch that is supplied to government are submitted by the manufacturer along with the testing fee to DTL – Drug Testing Laboratory, Government of Punjab. Probably the reason for showing 2 instead of 7 batches might have been saving on drug quantity and testing fee. There would have been no way to detect J093 from stock but fortunately it came out of the supplies returned by the patients. Otherwise, only 2 batches would go to UK for testing and would be cleared, and the mystery would not be solved.
JIT found contradictions and discrepancies in the statements of owners and employees of Umar Trading.
PIC – The User
JIT found major non-conformities and deficiencies at the stores at PIC. The storekeeper did not bother to see the entire stock and just entered 2 batches in the system. PIC’s internal inspection committee which is supposed to check entire consignments of incoming drugs also did not do its job. If the storekeeper did it on purpose in connivance with the distributor is open to conjecture but cannot be confirmed.
PIC is an elite institution for cardiac treatments in Punjab. However, proper SOPs were not found for organized running of the institution.
The Investigators – Police, CIA, FIA
JIT found that the entire investigation personnel and system was not organized, and that none of the investigating officer had any clue about how to investigate a case of this nature. They resorted to usual criminal investigating techniques and wasted time.
There was a talk on paying compensation to those who died – 213 patients, and those who were hospitalized. JIT did not make any recommendation on this issue. Efroze did not pay anything, though the CM banned their sales of all their products in Punjab. Efroze did suffer financially on this account, but the patients’ families were not compensated. Punjab government also did not pursue the compensation matter any further.
Money is certainly not the compensation for the suffering of families who lost their dear ones. However, it could have eased some of their financial burden.
PIC tragedy was a great tragedy. Apparently, the culprits went scot-free after some legal hassles. However, there is a divine power which takes its own decisions. Efroze never recovered its market position. We do not know if their owners suffered personally. UTC never recovered from this episode. Their business suffered greatly and the owner, whom I knew personally also, passed away some time ago. The divine justice takes its course and cannot be challenged or stopped.
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