2011-12 REPORT OF THE DEFECTIVE DRUGS INQUIRY TRIBUNAL -I N D E X- - 3 - I N D E X PAGE NO. ABBREVIATIONS ◊----------------------------------------------------------------------------◊ 06 CHAPTER-1 ◊----------------------------------------------------------------------------◊ Introduction ◊----------------------------------------------------------------------------◊ 07 Setting up the Inquiry ◊------------------------------------------------------------------◊ 09 Public Inquiries ◊------------------------------------------------------------------◊ 09 Inquiry Process: ◊------------------------------------------------------------------◊ 10 o Appointment of Registrar; ◊-----------------------------------------------◊ 10 o Communications and Media Relations; ◊---------------------------◊ 11 o Infrastructure: ◊---------------------------------------------------------◊ 12 o Hearing Room; ◊---------------------------------------------------------◊ 12 o Terms of Reference and Rules of Procedure; ◊---------------------◊ 13 o Public Participation; ◊-----------------------------------------------◊ 13 o Investigation; ◊---------------------------------------------------------◊ 14 o Expert Witnesses; ◊---------------------------------------------------------◊ 15 o Appointment of Local Commission to visit Karachi; ◊-------◊ 16 Expenditure ◊----------------------------------------------------------------------------◊ 19 CHAPTER-2 ◊----------------------------------------------------------------------------◊ First signs of Drug Contamination ◊-----------------------------------------------◊ 22 Clinical Response ◊------------------------------------------------------------------◊ 25 Committee set up by the Secretary Health ◊-------------------------------------◊ 28 Manufacturing/Production Record ◊-----------------------------------------------◊ 35 Sale/Administration ◊------------------------------------------------------------------◊ 36 CHAPTER-3 ◊----------------------------------------------------------------------------◊ Punjab Institute of Cardiology (PIC) ◊-----------------------------------------------◊ 46 Procurement of Isotab 20mg Tablets ◊-----------------------------------------------◊ 47 2011-12 REPORT OF THE DEFECTIVE DRUGS INQUIRY TRIBUNAL -I N D E X- - 4 - CHAPTER-4 ◊----------------------------------------------------------------------------◊ Weakness of Administrative Structure and Failure of Systems at PIC ◊--------------------------------------------------------◊ 60 Discovery of ISPTAB 20MG Batch J093 through Recovery of Tablets from patients ◊----------------------------------------------◊ 62 PIC Visit ◊----------------------------------------------------------------------------◊ 63 CHAPTER-5 ◊----------------------------------------------------------------------------◊ Retrieval of Suspected Medicines ◊-----------------------------------------------◊ 71 CHAPTER-6 ◊----------------------------------------------------------------------------◊ Finding the Culprit Ingredient ◊--------------------------------------------------------◊ 74 o Role of Local Drug Testing Laboratories; ◊---------------------------◊ 74 o Role of other Local Institutions, Laboratories & Universities; ◊-◊ 75 o The Central Drug Testing Laboratory (CDL); ◊-----------------◊ 76 o Role of International Laboratories; ◊-----------------------------------◊ 79 CHAPTER-7 ◊----------------------------------------------------------------------------◊ Causes of Deaths ◊------------------------------------------------------------------◊ 80 CHAPTER-8 ◊----------------------------------------------------------------------------◊ Role of Pharmacists ◊------------------------------------------------------------------◊ 83 CHAPTER-9 ◊----------------------------------------------------------------------------◊ Response of the Government of Punjab ◊-------------------------------------◊ 85 CHAPTER-10 ◊----------------------------------------------------------------------------◊ The Distributor ◊------------------------------------------------------------------◊ 88 CHAPTER-11 ◊----------------------------------------------------------------------------◊ Involvement of the Police and conduct of investigation ◊-----------------◊ 97 CHAPTER-12 ◊----------------------------------------------------------------------------◊ Manufacturer of Adulterated Drug M/s Efroze Chemical Industries (Pvt.) Ltd, Karachi ◊------------------------------------------------------------------◊ 104 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 Non-Compliance of cGMPs by Efroze Chemical Industries ◊-----------------◊ 115 Circumstances and Causes of Contamination ◊---------------------------◊ 119 Responsibility for Contamination & its Consequences ◊-----------------◊ 141 CHAPTER-13 ◊----------------------------------------------------------------------------◊ Consolidated Recommendations ◊-----------------------------------------------◊ 144 o Recommendations Relating to Manufacturers/ Producers of Drugs; ◊-----------------------------------------------◊ 144 o Recommendations Regarding Distributors; ◊-----------------◊ 147 o Recommendations for Investigating Agencies; ◊--------------◊ 149 o Recommendations Regarding Pharmaco Vigilance & Poison Control Centers; ◊---------------------------◊ 150 o Recommendations Regarding PIC ◊---------------------------◊ 150 o Recommendations Regarding Acquisition of Medicines◊--------------------------------------------◊ 152 o Recommendations Regarding Administration of Hospitals; ◊------------------------------------◊ 154 o Recommendations Regarding Monitoring & Upgrading Testing Laboratories; ◊--------------------------◊ 155 o Recommendations Regarding Licensing; ◊-----------------◊ 157 CHAPTER-14 ◊----------------------------------------------------------------------------◊ Conclusion ◊----------------------------------------------------------------------------◊ 159 SCHEDULES ◊----------------------------------------------------------------------------◊ 164 APPENDICES ◊----------------------------------------------------------------------------◊ 234 EXHIBITS/MARKS ◊----------------------------------------------------------------------------◊ 235 SNAPS GALLERY ◊----------------------------------------------------------------------------◊ 244 **** 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 ***** REPORT OF THE DEFECTIVE DRUGS INQUIRY TRIBUNAL 2011 - 2012 C HAPTER -1- 2011-12 REPORT OF THE DEFECTIVE DRUGS INQUIRY TRIBUNAL - CHAPTER-1 - - 7 - INTRODUCTION he Government of Punjab issued Notification No.SO(JUDL-III)9- 84/2012, under the West Pakistan T 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