Findings of Inquiry Committee on Isotab 20 reaction

Punjab Institute of Cardiology

The findings of the inquiry committee headed by DIG Zulfiqar Cheema have recommended registration of a murder case against 10 officials, including the owner of the Karachi-based Efroze Chemical Industry, for criminal negligence resulting in contamination of one of its medicines, which claimed the lives of nearly 150 cardiac patients registered with Punjab Institute of Cardiology (PIC), Lahore. 

The inquiry report of a three-member committee, headed by DIG Zulfiqar Cheema and comprising SSP Zulfiqar Hameed and SSP Farooq Mazhar, available with The News, also recommended action under various sections of Pakistan Penal Code and Drug Act 1976 against two officials of distributing company, Umer Trading Company, and five officials/doctors of PIC for tempering record of delivery and receipt of the tainted medicine to the PIC. 

The action has been recommended against 10 officials including 

1. Muhammad Abdullah Feroze (owner)
2. Nadir Feroze (deputy managing director)
3. Khurram Munaf (director technical)
4. Shakeel Ahmad Khan (general manager plant)
5. Muhammad Imtiaz (quality control manager)
6. Tabish Naumani (production executive)
7. Syed Waqas Hussain (supply chain executive)
8. Syed Iftikhar Ahmad (store officer)
9. Syed Razi Haider Kazmi (helper)
10. Muhammad Shoaib Ansari (helper) of Efroze Chemical Industry 

under Sections 322, 302 of PPC and 23/27 of Drug Act 1976. 

The inquiry committee has also recommended action against the two distributors (owners of Umer Trading Company) including Muhammad Musharraf and Tariq Rehman under Section 322 of PPC and 23/27 of Drug Act. 

Moreover, around five doctors/officials of PIC have also been held responsible for tempering record of batch of contaminated medicine including Muhammad Yousaf (pharmacist/store in charge), Zulfiqar Ali (storekeeper) and members of Inspection of Medicines Committee including Dr Abdul Hameed (AMS Store), Dr Ali Hasan (DMS Store) and Dr Ameer Ali (DMS admn), who signed the document, under Sections 420, 467, 468, 471 of PPC. 

The committee has submitted the inquiry report to the IG Punjab, Javed Iqbal with recommendation of strict compliance with the findings to punish the culprits as well as to set a deterrence for all multinational and local pharmaceutical companies to avoid such unfortunate incidents in future by providing quality medicines to the patients without any discrimination. 

Earlier, the committee has found that the pharmaceutical company had been manufacturing two different drugs - Isotab (blood-thinning medicine) and Maladar (anti-malaria medicine containing Pyrimethamine) - simultaneously, which caused contamination up to 14 times in Isotab-20, which were supplied to the PIC and ultimately caused deaths of at least 120 heart patients registered with the hospital. 

It found that the officials of pharmaceutical company didn’t follow the pre and post manufacturing standard operating procedures including the rules set under Pakistan’s law and Good Manufacturing Practices (GMP), Current Good Manufacturing Practices (CGMP) and World Health Organisation. 

The company’s production unit had identified the contamination of Pyrimethamine in Isotab on September 21, 2011, and this information was passed on to the owners on September 29, 2011. On October 4, 2011, GM Plant Shakeel Ahmad Khan had also e-mailed to the owners that a container of Pyrimethamine weighing 25 kg was missing but no action had been taken in this regard. It is also worth mentioning that the raw material of Pyrimethamine was taken from the store without proper requisition. 

Senior Quality Control Officer Fayyaz told inquiry committee that an unusual spike was detected during the post-manufacturing test, but still the batch of medicine was cleared by the management and distributed but was never recalled from the hospital or market shelves. The matter, however, was hushed up through an internal inquiry of the company. 

The committee observed that the pharmaceutical company had ignored the standard operating procedures in manufacturing of the medicine owing to provision of this medicine to PIC at very cheap rate as compared to market price of Rs 20 per tablet. 

The distributing company supplied a consignment of 2 million tablets of Isotab to PIC on October 8, 2011 vide challan No. 462 on which batch No. J092 and J095 were printed, whereas the afore-mentioned pharmaceutical company had provided the medicines to the distributors under batch Nos. J091, J092, J093, J094, J095 and J096 vide invoice No. 49969 on September 30, 2011 and another invoice No. 50039 dated October 4, 2011. These medicines were received at PIC by storekeeper Zulfiqar on October 8, 2011 and also entered into stock registered on October 10, 2011 but omitted batch No. J093. 

The committee also noted that there were several other batches of different medicines, which were neither registered nor their examination was conducted by the Drug Testing Laboratory before distributing to the patients. 

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