LAHORE, Jan 29: A judicial probe into the Punjab Institute of Cardiology, Lahore scam has revealed that 213 patients had died and 1,000 others suffered adverse symptoms when they took a medicine distributed by the institute through its Free Pharmacy last year.

It mainly holds a Karachi-based pharmaceutical company responsible for the deaths and also points out loopholes in the distribution and storage management at the PIC. It criticises the law-enforcement agencies for lacking a sense of direction while probing the case.

The judicial commission has also raised questions about the entire system of manufacturing, supplying and procurement of life-saving drugs for the poor patients who largely depend on state-run health institutions.

“In view of our finding that the first and foremost responsibility for this tragedy lies on Efroze Chemical Industries, Karachi, we strongly recommend strict legal action against the company, its management and others involved under the Drugs Laws as well as the relevant provisions of the PPC,” states the report.

It further says the top management of the company had a legal obligation to ensure that the drug supplied by them was fit for human consumption, did not contain any ingredient which was not prescribed in the pharmacopoeia and the drug was manufactured and tested in strict compliance with the Current Good Manufacturing Practice (cGMP).

Former CJ Sheikh Azmat Saeed had constituted a commission in February to probe the scam and submit a report within 30 days. The report was finalised by Justice Ijazul Ahsan and handed over to the Punjab home secretary by the registrar of the tribunal at Judges’ Library on Dec 17 last.

The report has blamed Isotab 20mg for the deaths of poor cardiac patients, which was manufactured by Efroze Chemical Laboratories.

The report says: “Isotab Batch J063 was administered by PIC to its patients in the month of Nov/Dec 2011. Immediately thereafter, the patients complaining of adverse drug reaction symptoms started reporting to different hospitals of Lahore and other areas. Such adverse symptoms stopped when the medicine was discontinued, its half-life expired or when the antidote (folonic acid) suggested by London-based laboratory Medicines and Healthcare Products Regulatory Agency (MHRA) for overdose of pyrimethamine, was administered.

“It is therefore concluded that the causes of the ailments had a direct link to Isotab Batch J093 administered and procured from PIC.”

About the distributor, the judicial report says the distributor of the drug -- Umar Trading Co -- and its partners are also responsible insofar as they committed acts and omissions which resulted in incorrect documentation being provided by the PIC by omitting mention of Batch J093 in the delivery challan.

Consequently, the records of the PIC did not reflect that Batch J093 had been received by it and samples from the said batch were not sent for testing to the Drug Testing Laboratory. All three witnesses, two of them are partners of Umar Trading Company, admitted this fact.

“Had medicines dispensed by PIC from Batch J093 not been recovered directly from some of the patients, it would have been impossible to discover the cause of drug reactions that would surely have led to loss of many more lives,” says the report.

“During the course of proceedings before the Tribunal it has transpired that a large number of manufacturers engaged in the manufacture of pharmaceuticals in Punjab and other provinces may not be in compliance of provisions of Drug Act 1976. We have reasons to believe that an equal number of manufacturers all over the country are not cGMP compliant,” it says.

The commission says it’s an alarming situation because the only safety net against errors, omissions, defects, contamination etc., of the drugs and preventing such drugs from reaching the hospitals, markets and patients is at the stage of manufacturing. It recommends constitution of a task force comprising adequate number of qualified experts in the field of pharmaceutical manufacturing to undertake thorough and detailed cGMP compliance audits of all manufacturers in Punjab.

“The Tribunal examined various investigating officers, who investigated the matter after FIR was lodged on Jan 24, 2012 with police station and most glaring deficiency found in the investigating process was that it lacked direction and expertise,” according to the report which also recommends a separate unit on the lines of special investigation units established for white collar crimes, cyber crimes etc., to deal with the drug-related offences.

The report observes that one of the reasons the police investigation lacked direction and coherence was that the investigating officers were frequently changed.

The inquiry exposes major structural weakness and loopholes in the administrative process and proceedings of the PIC. “The mode of manner in which medicines were procured, received and stored, documented and dispensed is not in consonance with the requirements of running an organised and efficient hospital,” it says.

Further, it says, the Free Pharmacy of the PIC, its storage area, its staff working in the store room, inventory control, who checked and approved the consignment, but missed the presence Batch J093 are liable to answer for their actions.

The inquiry has also brought into focus complete absence of systems at the level of health department to handle situations like these.

The commission takes exception to the government and described its remedial measures as “a shot in the dark”. The Punjab administration’s response was neither structured nor was it based upon standard operating procedures.

“It was sheer good luck that the contaminated drug was swiftly identified in a matter of weeks and an antidote found by laboratories of the MHRA, UK.”

The last chapter covers detailed recommendations on how to improve the mechanisms.

“It is our earnest hope that the conclusions drawn, responsibilities fixed and recommendations made in this report will result in appropriate action by the competent authorities in accordance with law,” the commission chairman says.

He further states that the Punjab government may share this report with the federal government/Drug Regulatory Authority whose involvement for implementation of recommendations made herein is necessary.

“This report should act as an eye-opener for all concerned who must take immediate steps to implement existing laws in letter and spirit, introduce fresh legislation where required, frame new rules and regulations, put in place efficient, effective and modern systems and administrative structures as suggested herein so that the lives lost in this tragic incident would not have been lost in vain,” he concludes.