Punjab Institute of Cardiology (PIC)

297 Pages·2012·7.15 MB·English

2011-12 REPORT OF THE DEFECTIVE DRUGS INQUIRY TRIBUNAL -I N D E X- - 3 -

I N D E X

PAGE NO.

ABBREVIATIONS ---------------------------------------------------------------------------- 06
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CHAPTER-1 ----------------------------------------------------------------------------
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Introduction ---------------------------------------------------------------------------- 07
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Setting up the Inquiry ------------------------------------------------------------------ 09
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Public Inquiries ------------------------------------------------------------------ 09
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Inquiry Process: ------------------------------------------------------------------ 10
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o Appointment of Registrar; ----------------------------------------------- 10
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o Communications and Media Relations; --------------------------- 11
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o Infrastructure: --------------------------------------------------------- 12
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o Hearing Room; --------------------------------------------------------- 12
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o Terms of Reference and Rules of Procedure; --------------------- 13
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o Public Participation; ----------------------------------------------- 13
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o Investigation; --------------------------------------------------------- 14
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o Expert Witnesses; --------------------------------------------------------- 15
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o Appointment of Local Commission to visit Karachi; ------- 16
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Expenditure ---------------------------------------------------------------------------- 19
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CHAPTER-2 ----------------------------------------------------------------------------
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First signs of Drug Contamination ----------------------------------------------- 22
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Clinical Response ------------------------------------------------------------------ 25
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Committee set up by the Secretary Health ------------------------------------- 28
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Manufacturing/Production Record ----------------------------------------------- 35
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Sale/Administration ------------------------------------------------------------------ 36
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CHAPTER-3 ----------------------------------------------------------------------------
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Punjab Institute of Cardiology (PIC) ----------------------------------------------- 46
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Procurement of Isotab 20mg Tablets ----------------------------------------------- 47
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2011-12 REPORT OF THE DEFECTIVE DRUGS INQUIRY TRIBUNAL -I N D E X- - 4 -
CHAPTER-4 ----------------------------------------------------------------------------
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Weakness of Administrative Structure and
Failure of Systems at PIC -------------------------------------------------------- 60
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Discovery of ISPTAB 20MG Batch J093 through
Recovery of Tablets from patients ---------------------------------------------- 62
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PIC Visit ---------------------------------------------------------------------------- 63
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CHAPTER-5 ----------------------------------------------------------------------------
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Retrieval of Suspected Medicines ----------------------------------------------- 71
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CHAPTER-6 ----------------------------------------------------------------------------
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Finding the Culprit Ingredient -------------------------------------------------------- 74
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o Role of Local Drug Testing Laboratories; --------------------------- 74
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o Role of other Local Institutions, Laboratories & Universities; - 75
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o The Central Drug Testing Laboratory (CDL); ----------------- 76
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o Role of International Laboratories; ----------------------------------- 79
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CHAPTER-7 ----------------------------------------------------------------------------
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Causes of Deaths ------------------------------------------------------------------ 80
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CHAPTER-8 ----------------------------------------------------------------------------
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Role of Pharmacists ------------------------------------------------------------------ 83
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CHAPTER-9 ----------------------------------------------------------------------------
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Response of the Government of Punjab ------------------------------------- 85
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CHAPTER-10 ----------------------------------------------------------------------------
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The Distributor ------------------------------------------------------------------ 88
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CHAPTER-11 ----------------------------------------------------------------------------
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Involvement of the Police and conduct of investigation ----------------- 97
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CHAPTER-12 ----------------------------------------------------------------------------
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Manufacturer of Adulterated Drug M/s Efroze Chemical Industries
(Pvt.) Ltd, Karachi ------------------------------------------------------------------ 104
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Weakness of Enforcement, Lax Inspection Criteria
2011-12 REPORT OF THE DEFECTIVE DRUGS INQUIRY TRIBUNAL -I N D E X- - 5 -
and Regulatory Failures at Karachi ----------------------------------------------- 114
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Non-Compliance of cGMPs by Efroze Chemical Industries ----------------- 115
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Circumstances and Causes of Contamination --------------------------- 119
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Responsibility for Contamination & its Consequences ----------------- 141
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CHAPTER-13 ----------------------------------------------------------------------------
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Consolidated Recommendations ----------------------------------------------- 144
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o Recommendations Relating to Manufacturers/
Producers of Drugs; ----------------------------------------------- 144
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o Recommendations Regarding Distributors; ----------------- 147
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o Recommendations for Investigating Agencies; -------------- 149
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o Recommendations Regarding Pharmaco
Vigilance & Poison Control Centers; --------------------------- 150
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o Recommendations Regarding PIC --------------------------- 150
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o Recommendations Regarding
Acquisition of Medicines -------------------------------------------- 152
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o Recommendations Regarding
Administration of Hospitals; ------------------------------------ 154
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o Recommendations Regarding Monitoring
& Upgrading Testing Laboratories; -------------------------- 155
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o Recommendations Regarding Licensing; ----------------- 157
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CHAPTER-14 ----------------------------------------------------------------------------
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Conclusion ---------------------------------------------------------------------------- 159
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SCHEDULES ---------------------------------------------------------------------------- 164
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APPENDICES ---------------------------------------------------------------------------- 234
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EXHIBITS/MARKS ---------------------------------------------------------------------------- 235
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SNAPS GALLERY ---------------------------------------------------------------------------- 244
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****
2011-12 REPORT OF THE DEFECTIVE DRUGS INQUIRY TRIBUNAL -ABBREVIATIONS- - 6 -

ABBREVIATIONS

API Active Pharmaceutical Ingredient

BHT Butylated Hydroxytoluene

CDTL Central Drug Testing Laboratory

cGMP Current Good Manufacturing Practices

DTL Drug Testing Laboratory

Excipients Inactive Ingredients

FTIR Fourier Transform Infrared Spectrometer

GC/MS Gas Chromatography/Mass Spectrometer

GMP Good Manufacturing Practices

HPLC High Performance Liquid Chromatogrphy

IHP International Health Partners

LC/MS Liquid Chromatography/Mass Spectrometer

LSP London School of Pharmacy

MHRA Medicines and Healthcare products Regulatory Agency

OPD Out Patient Department

PIC Punjab Institute of Cardiology

SOP Standard Operating Procedures

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REPORT OF THE DEFECTIVE DRUGS INQUIRY TRIBUNAL

2011 - 2012

C R
HAPTE

-1-
2011-12 REPORT OF THE DEFECTIVE DRUGS INQUIRY TRIBUNAL - CHAPTER-1 - - 7 -

INTRODUCTION

T
he Government of Punjab issued Notification No.SO(JUDL-III)9-
84/2012, under the West Pakistan
Tribunals of Inquiry Ordinance,
1969 (the Ordinance). The Notification was
issued pursuant to a request made by the
Government of Punjab to the Chief Justice,
Lahore, High Court Lahore, to appoint a
Judge of the Court to conduct an inquiry
pursuant to section 3 of the Ordinance. Mr. Efroze Chemical Industry
Justice Sheikh Azmat Saeed, the Honourable Chief Justice, Lahore High
Court (as he then was), named me to assume the role of the Tribunal of
Inquiry.
1.2. The Tribunal of Inquiry was necessitated on account of
numerous deaths being reported prima
facie due to bone marrow suppression
and other related complications amongst
patients registered with the Punjab
Institute of Cardiology (“PIC”), Lahore.
The terms of reference of the Tribunal
Punjab Institute of Cardiology (PIC)
were as follows:-
i) To ascertain the cause(s) of death(s)
and ailment(s);
ii) To determine if any such cause is
related to the drug(s) administered and
procured from the PIC, Lahore;
iii) If the drug reaction is established as the
cause of death and/or ailment, to
2011-12 REPORT OF THE DEFECTIVE DRUGS INQUIRY TRIBUNAL - CHAPTER-1 - - 8 -

determine the source, manufacturing,
processing, storage, dispensing and
dosage of such drug(s);
iv) To fix responsibility of lapses at each
stage;
v) To make recommendation for averting
such like incidents in future.
1.3. The Notification empowered the Tribunal to co-opt any
expert and/or person for the purpose of this inquiry. Syed Shahid Nasir, Ex-
Member, Central Licensing Board, Cabinet Division, 207-Sector “S”, Phase-
II, DHA, Lahore, was co-opted as an expert. It was directed that he shall
attend all hearings of the Tribunal.
1.4. In the course of its working, the Tribunal summoned and examined
seventy two witnesses who placed thousands of documents on record. An
effort was made to examine a wide range of witnesses who could possibly
have any information regarding the facts,
circumstances, causes and effects of the
aforenoted catastrophe. The witnesses who
appeared before the Tribunal included doctors,
representatives of the Punjab bureaucracy,
pharmacists, representatives of WHO, employees
of the Punjab Institute of Cardiology,
representatives of the distributor of
pharmaceutical products, Government Analysts, Federal and Provincial
Drug Inspectors, employees of Efroze Chemicals Industries (Private)
Limited, Pharmacologists, Pathologists, epidemiologists, Histopathologists,
Advocates, representatives of the Investigating Agencies, Professors of
reputable medical institutions, Director of the Punjab Forensic Science
2011-12 REPORT OF THE DEFECTIVE DRUGS INQUIRY TRIBUNAL - CHAPTER-1 - - 9 -

Agency, Chief Chemical Examiner Government of Punjab, Chemical
Examiners Office, independent experts including professionals from Agha
Khan University Hospital, Karachi, Shaukat Khanum Memorial Cancer
Hospital, Lahore, representatives of Pakistan Medical Association and
members of the public who wanted to appear before the Tribunal.
SETTING UP THE INQUIRY

1.5 Design and operation of the inquiry process poses several unique
challenges. The terms of reference which defined issues to be investigated
and reported on, cannot be expected to advise as how to begin. I was
fortunate in that I could consult my colleagues at the Lahore High Court
who had spear headed other public inquiries for guidance. I thank them for
their help and support.
PUBLIC INQUIRIES

1.6 A public inquiry in Pakistan is an official review by an inquiry tribunal
of specific events or actions. Its purpose is to establish the facts and the
causes of the subject matter of the inquiry, to fix responsibility and to make
recommendations that may prevent the recurrence of undesirable events.
An inquiry tribunal is not a civil or a criminal court of law, and the role of the
tribunal is not to reach conclusions regarding the civil or criminal liability of
any person involved in the subject matter of the tribunal.
1.7 By its very nature, the inquiry is investigative in its approach. It
encourages an open, fair, efficient and transparent process. Every inquiry is
unique, shaped by its mandate. While prior inquiries do provide guidance,
each tribunal must design its own rules and procedures. That is a daunting